Assessing the Reliability of Commercially Available Point of Care in Various Clinical Fields

Federica Pezzuto1, Antonio Scarano2, Carlotta Marini3, Giacomo Rossi3, Roberta Stocchi3, Alfredo Di Cerbo4, Alessandro Di Cerbo3, *
1 University of Modena and Reggio Emilia, Modena, Italy
2 Department of Medical, Oral and Biotechnological Sciences, Dental School, University G. d`Annunzio of Chieti-Pescara, Chieti, Italy
3 School of Biosciences and Veterinary Medicine, University of Camerino, Matelica, Italy
4 Leonardo da Vinci Private Clinic, Foggia, Italy

Article Metrics

CrossRef Citations:
Total Statistics:

Full-Text HTML Views: 10636
Abstract HTML Views: 1438
PDF Downloads: 1480
ePub Downloads: 390
Total Views/Downloads: 13944
Unique Statistics:

Full-Text HTML Views: 5903
Abstract HTML Views: 727
PDF Downloads: 822
ePub Downloads: 254
Total Views/Downloads: 7706

Creative Commons License
© 2019 Pezzuto et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: ( This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the School of Biosciences and Veterinary Medicine, University of Camerino, Via Circonvallazione, 93/95, 62024 Matelica (MC) – Italy; Tel: +39 0737403457; Fax: +39 0737403402;


Updated and precise molecular diagnostics are essential in disease identification, treatment and management. Conventional technologies are limited to laboratories, which are expensive, require moderate to great volumes of biological fluids and generally create great discomfort among patients. This review discusses some key features of commercially available point of care (POC) devices, such as time to provide results, accuracy and imprecision, in several medical and veterinary fields. We searched Pubmed/Medline using the keywords “point” “of” “care” “device”, selected papers from 1984 to 2019 on the basis of their content and summarized the features in tables.

Fast turnaround time and overall good reliability, in terms of accuracy and imprecision, were observed for most of POCs included in the research.

POC devices are particularly useful for clinicians since they hold the potential to deliver rapid and accurate results in an inexpensive and less invasive way with an overall improvement of patients' quality of life in terms of time spent at the point-of-care and sample volume withdrawn. These features gain great relevance also in the veterinary practice, where patients’ compliance is generally poor, available sample volumes are quite far from the human ones and analysis costs are higher.

Keywords: Disease, POC, Accuracy, Imprecision, Human, Veterinary.


The point-of-care (POC) is generally used outside the central laboratory to facilitate the patient’s faster diagnosis and treatment. It is one of the innovations that impact potentially on the quality and rapidity of care, as well as on system redesign of a more patient-centred care approach [1, 2]. POCs are commercially available either as small bench-top analyzers or as hand-held devices. The latter are used by patients for homecare and by healthcare professionals. If, on one hand, laboratory results can take from several hours to few days, on the other hand, POCs reduce analysis time from hours to few seconds, therefore, gaining relevant importance especially in emergency conditions (Table 1).

To evaluate a safe and reliable POC, it is important to consider its sensitivity (the percentage of true positive results), specificity (percentage of true negative results) and positive and negative predictive values (PPV, NPV, respectively) according to the disease prevalence in the considered population [3]. The analytical performance of a device is assessed through imprecision, quantified by calculating the within-run coefficient of variation (CV) from the test result data of a given device, and accuracy, estimated by means of a coefficient of correlation (r) from the set of data obtained from the two devices-analyzer (POC) and a reference or standard instrument [4].

This review firstly considers the commercially available POCs, sorting them by medical application and analyzing some key features such as time to provide results, accuracy and imprecision. In fact, most of the current reviews on POC dealt with singular medical applications providing information about their performance with respect to centralized laboratory instruments. In this sense, the aim of this review was to provide human and animal healthcare a useful tool for a correct choice of a POC for a specific disease, particularly, in this modern era where the concepts efficiency and costs have become a public health concern.


The aim of this review was to provide the actual status of point of care (POC) devices highlighting some key features, such as time to result, accuracy and imprecision, in several medical fields including ematobiochemistry, cardiology, infectious disease, andrology and gynecology, toxicology, oncology, genetics, dentistry ophthalmology ultrasology and even veterinary medicine.

We searched Pubmed/Medline and other external sources using the keywords “point of care device”. Selected papers from 1984 to 2019 were chosen on the basis of their content and included. Moreover, some technical data were also downloaded from website of the POC’s manufacturer.

2.2. Point of Care in Human Practice

2.2.1. Ematobiochemistry

Rapid evaluation of blood parameters, in particular, glucose, electrolyte and metabolic parameters, gained even more attention in the last years due to the wide diffusion of POC devices also among non-laboratory trained individuals including patients themselves [5, 6]. Most of these devices are based on a photometric method, share an overall high degree of accuracy and are characterized by a rapid turnaround time of test results providing them an edge over conventional central laboratory analyzers (Table 1).

2.2.2. Diabetes

Glucose meters are used worldwide providing fast analysis of blood glucose, glycated hemoglobin, β-hydroxybutyrate, TSH and free T4 levels, allowing the management of hypoglycemic and hyperglycemic disorders [115]. They mainly rely on an electrochemically-based measurement test, which reduced the time-to-result from minutes to few seconds requiring blood volumes as little as few microliters [116]. Besides the need to monitor glycemia to reduce morbidity and mortality, the primary requirement of clinicians is the reliability of glucose meters (inaccuracy and imprecision remain fundamental) even in the presence of interfering substances including but not limited to ascorbate, hematocrit and maltose [117]. Despite the presence of many other factors able to undermine the accuracy of such devices, the degree of precision reached by current POCs is very high, although their handling should be generally left to a well-trained staff (Table 2) [118].

2.2.3. Cardiology

The need for enabling a rapid assessment of patients with chest discomfort, both in an ambulance and emergency rooms, as well as the management of bleeding and clotting risks and myocardial infarction prevention led to a rapid increase in technological advancements of POC devices [155]. Among cardiac biomarkers, cardiac troponins gained great relevance with respect to creatine kinase [156, 157]. B-Type Natriuretic Peptide has been successfully used to discriminate between heart failure symptoms and shortness of breath due to pulmonary causes [158], nevertheless also high sensitivity c-reactive protein, D-dimer, myoglobin and N-terminal pro-B-type natriuretic peptide are also assessed [159].

Moreover, a rapid turnaround time, ranging from less than 20 minutes to few seconds, has now been generally achieved by all POC devices, thus allowing an immediate and effective patient triage (Table 3) [160, 161].

Table 1. Differences between laboratory analysis and POCTs times.
1-Test requested 1-Test ordered
2-Specimen obtained 2-Specimen obtained
3-Specimen processed 3-Specimen analyzed
4-Specimen analyzed 4-Therapy prescribed by clinician
5-Results reviewed by qualified staff
6- Therapy prescribed by clinician
Table 2. Commercially available POC devices in Ematobiochemistry.
(Callegari S.r.l., Parma, Italy) [7]
TC, HDL cholesterol, LDL cholesterol, TG, Hb, HCT, RBC, UA, lac 10 - 180 seconds CV = 1.37 - 5.38% r = 0.75 - 0.99
FORT, FORD, Redox Index, ALT, AST and AST/ALT 5 - 10 minutes
LeadCare II blood lead analyser® (Magellan Diagnostics, USA) [8] lead 3 minutes CV = 1.7 - 1.8% r = 0.94
Spotchem EZ® (Menarini, Italy) [9] TP, ALB, CR, TB 5 minutes CV = 1.9 - 4.7% r = 0.97- 0.99
iSTAT creatinine test® (Abbott, USA) [10-14] hct, TCO2, pO2, pCO2, Na+, K+, Cl, lac, cardiac markers, coagulation factors 3 minutes CV = 0.4 -3.4% r = 0.99
StatStrip Lactate® (Nova Biomedical, Waltham, MA, USA) [15-17] fetal scalp lac 13 seconds CV = 5.72% r = 0.99
iSTAT-1® (Nova Biomedical, Waltham, MA, USA) [18-21] lac 2 minutes CV = 3.1 - 7.27% r = 0.94 - 0.97
StatStrip-Lactate® (Abbott, Princeton, USA) [18, 22, 23] lac 13 seconds CV = 2.6 - 5.1% r = 0.90
qLabs Electrometer Plus® (Micropoint Biotechnologies) [24] PT, INR, aPTT 7 minutes CV = 5% r = 0.71 - 0.90
IRMA (DIAMETRICS, ChemoMedica-Austria, Vienna, Austria) [25, 26] pH, pCO2, pO2, Na+, K+, iCa+, HCO3−, CO2,
TCO2, BEb, BEecf, O2SAT
< 2 minutes CV = 0.2 - 1.9% r = 0.97- 0.99
GEM Premier 3000/4000 (Instrumentation Laboratory, Lexington, MA, USA) [4, 20, 25, 27, 28] tHb, COHb, MetHb, O2Hb, HHb, Na+, K+, Cl, Ca2+, glucose, lac, hct 95 seconds CV = 0.2 - 4.0% r > 0.92
Stat Profile Critical Care Xpress analyzer (Nova Biomedical, Waltham, MA, USA) [25, 29] pH, pCO2, pO2, glucose, urea, CR, Na+, K+, Cl-, iCa, iMg, tHb, O2Hb, COHb, HHB, MetHB, SO2 52 seconds CV = from < 5.7 to 13.8% r = 0.91 - 0.97
Rapidpoint 405 (Siemens Healthcare, Sudbury, UK) [25, 30] pH, pCO2, pO2, Na+, K+, Cl-, glucose, hct, tHb, HHb, O2Hb, SO2, COHb, MetHB, TB 1 minute CV = from 0 to > 2.4% r = 0.94 - 1.04
ABL 700/725/825/90-FLEX (Radiometer Medical A/S, Bronshoj, Denmark) [25, 31, 32] pH, pCO2, pO2, cK+, cNa+, cCl-, cCa2+, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHH,
FHbF, ctBil, glucose, lac
35 seconds CV = < 3% r = 0.87
Cobas b 123 (Roche Diagnostics, Graz, Austria) [25, 33] pCO2, pO2, iCa2+, K+, glucose, lac, tHb 2 minutes CV = 0 - 6% r = 0.89 - 0.99
Nova Lactate plus (Nova Biomedical, Waltham, MA, USA) [25, 34] lac 13 seconds CV = 0% r = 0.99
Rapid lab 865 (Siemens, Germany) [25, 35] pH, pO2, pCO2, Ca2+, Na+, K+, glucose, lac, Hb 1 minute CV = from < 2 to < 3% r = 0.96 - 0.99
iSTAT-1 (Hewlett Packard, Les Ulis, France) [36] Na+, K+, Cl, glucose, urea, nitrogen, hact,
PO2, PCO2, pH
< 2 minutes CV < 10% r = 0.83 - 0.98
Stat Sensor® (Nova biomedical, Waltham, USA) [37-40] CR 30 seconds CV = 6.4 - 8.9% r = 0.99
STAT-Site® M Hgb (POCD, Australia) [41] Hb 50 - 120 seconds CV = 2.9 - 4.2% r = 0.96
Nova 16 Electrolyte/Chemistry Analyzers® (NovaBiomedical, USA) [42] Na+, K+, Cl-, TCO2, Ca2+, Mg2+ Li2+, TCa, glucose, BUN, CR, hct, pH 36 seconds CV = 0.4 - 26% r = 0.90 - 0.99
Microsemi CRP® (HORIBA, Japan) [43] blood cell count 4 minutes CV = 5 - 10% r ≥ 0.99
BR-501® (Apel, Japan) [44] TBL Few seconds CV = 5% r = 0.93
Accusport® (Boehringer Ingelheim,USA) [45-48] lac 1 minute CV = 4.6 - 7% r = 0.99
Accutrend® Lactate (Accusport International) [49, 50] lac 1 minute CV = 1.8 -3.3% r = 1.03
Accutrend® Plus (Roche Diagnostics, Belgium) [51, 52] TC, TG, glucose, lac 3 minutes CV = 3.4 - 3.7% r ≥ 0.80
BeneCheck® Plus (General Life Biotechnology Ltd, Taiwan) TC, glucose, uric acid 30 seconds CV = 3.1 - 6.9% r = 0.89
Piccolo xpress® Chemistry Analyzer (Abaxis Inc, USA) [53, 54] Na+, K+, Cl-, Ca2+, TCO2, AST, ALT, TBL, ALP, BUN, CR, ALB, TP, glucose 12 minutes CV = 0 - 5.6% r = 0.98
CardioChek® PA (Polymer Technology Systems Inc, USA) [55-58] TC, HDL cholesterol, TG, direct LDL, glucose, ketones, CR < 2 minutes CV = 4.4 - 7.4% r > 0.84
Cholestech® LDX (Alere, USA) [55, 57, 59] TC, HDL cholesterol, LDL cholesterol, TG, glucose 5 minutes CV = 2.6 - 6.2% r > 0.90
Reflotron Plus® (Roche Diagnostics, Belgium) [60] K+, CR, CK, α-Amylase, Hb, pancreatic amylase, glucose, Urea, AST/GOT, TC, ALT/GPT, TG, γ-GT, HDL cholesterol, uric acid, TBL, LDL, cholesterol, ALP/GOT 2-3 minutes CV = 5% r = 0.98
HPS MultiCare (Biochemical System International, Arezzo, Italy) [61] TC, TG 2-3 minutes CV = 4.51% r = 0.94 - 0.99
CoaguChek® XS Plus (Roche Diagnostics, Belgium) [61-76] INR < 1 minute CV = 2% r = 0.96
PlaCor PRT® (PlaCor, Inc.) [77, 78] shear-induced platelet aggregation 10 minutes CV = 12.9% r = -0.05 - 0.19
VerifyNow® P2Y12 (Accumetrics, Inc., San Diego, CA, USA) [79, 80] Platelet response to P2Y12 inhibitor 10 minutes CV = 8% r = 0.66
ROTEM® (Tem International GmbH, Germany) [81] platelet function 5-10 minutes CV = 1.2 - 4.4% r = 0.99
FRAS 4 EVOLVO (H&D, Parma, Italy) [82] plasma antioxidant power 2-5 minutes CV = 4.17% r = 0.99
CompoLab™ (Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany) Hb < 2 seconds
Spinit (Biosurfit SA, Lisboa, Portugal) [83] CRP, hct, WBC, neutrophils, lymphocytes, monocytes < 12 minutes CV = 1.8 -10.1% r = 0.83 - 0.99
HemoScreen (PixCell Medical Technologies, Yokneam Ilit, Israel) [84] WBC, RBC, HGB, hct, PLT, neutrophils, lymphocytes and eosinophils 5 minutes CV = 0.58 - 39.4% r = 0.82 - 0.96
Radical-7 Pulse
Co-Oximeter (Masimo Corporation, Irvine, USA) [85]
SpHb Few seconds CV = 2.8% r = 0.97
StatStrip Xpress Lactate Meter (Nova Biomedical, Waltham, MA, USA) [86] lac 13 seconds CV = 5 - 9% r = 0.97 - 0.98
Pronto-7 (Masimo Corporation, Irvine, USA) [20, 86, 87] Hb Few seconds CV = 1.5% r = 0.83
Liaison® Calprotectin (Diasorin, Saluggia, Italy) [88, 89] calprotectin 35 minutes CV = 2.8 - 4.7% r = 0.95
Quantum Blue® (Bühlmann-Alere®) [89, 90] calprotectin 12-15 minutes CV = 22% r = 0.94
Mission® (Acon biotech, San Diego, USA) [91] hct < 15 seconds CV = -5.5 - 5.1% r = 0.93
B-722 LAQUAtwin (Lt, Horiba, Japan) [92] Na+ Few seconds CV = -0.4 - 0.2% r = 0.99
HemoCue® WBC DIFF (HemoCue®, Sweden) [26] eosinophils 5 minutes CV = 1 - 13.7% r = 0.85
Rainbow R20L® (Masimo Corporation, Irvine, USA) [71] Hb Few seconds CV = 2.8% r = 0.97
B.R.A.H.M.S PCT direct™ (Thermo Fisher Scientific Inc., Waltham, USA) [93] PCT 25 minutes CV < 20% r = 0.96
ABSOGEN™ (Bumyoungbio,
Inc., Suwon, Korea) [94]
PCT 10 minutes CV < 15% r = 0.85
LABGEO PT10 (Samsung healthcare, Korea) [95] ALB, ALP, ALT, AST, TBL, glucose,
GGT, TP, TC, HDL, TG, CR, amylase, BUN, LDL
10 minutes CV = -22.8 - 54.0% r > 0.95
HEMOCHRON® Jr. Signature+ (International Technidyne Corporation, Edison, USA) [96] INR Few minutes CV ≤ 10% r = 0.92
Proxima™ (Sphere Medical Ltd, Harston, UK) [97] pH, pCO2, pO2, HCO3-, BE, K+, Hct < 4 minutes CV = 2.4 - 251% r = 0.90 - 2.04
VerOFy®& LIAM™ (Oasis Diagnostics® Corporation, Vancouver, USA) [98] Salivary cortisol 20 minutes CV = 7% r = 0.95
INRatioTM (Alere, Hemosense, Milton Keynes, UK) [99] INR 1 minute CV = 5% r = 0.73
TrueHb (Wrig Nanosystems PVT. Ltd, New Delhi, India) [100] Hb < 1 minute CV = 2.2% r = 0.99
NBM-200 (OrSense ltd, NesZiona, Israel) [101] Hb < 1 minute CV = 4.28% r = 0.89
FIA8000 (GeTein BioMedical Inc., Portland, USA) [102] CysC, mAlb, NGAL, ß2-MG, hs-CRP, PCT 10-20 minutes CV = 1% r = 0.99
ProTime InRhythmTM System (Accriva Diagnostics, Inc, San Diego, USA) [103, 104] INR < 1 minute CV = 5.1% r = 0.97
Spotchem® EL (Elitech-Arkray, Kyoto, Japan) [105] Sweat Cl- 1 minute CV < 5% r = 0.96
Aution® Micro (Menarini Diagnostics, Florence, Italy) [106] UBG, TB, protein, nitrite, ketones, glucose, pH, specific gravity and leucocytes 1 minute N/A r = 0.80
Combur-Test® strips (Roche Diagnostics Ltd., Rotkreuz, Switzerland) [107, 108] ALB, specific gravity, protein, glucose, leukocytes, nitrites, pH, Hb, ketones, TB, UBG 1 minute CV = 1.7 - 4.9% r = 0.92
ICR–001® (Techno Medica Co, Japan) [109] urinary 8-oxodG 5 minutes CV < 13% r = 0.98
Radiometer AQT90 FLEX. PCT assay (Neuilly-Plaisance, France) [110] PCT 19 minutes CV < 10% r = 0.99
EasyTouch® GU (Bioptik Technology, Inc., Jhunan, Taiwan) [111] serum uric acid 20 seconds CV = 8.6 - 26.3% r = 0.27
BeneCheckTM Plus (General Life Biotechnology Co., Ltd., New Taipei City, Taiwan) [111] serum uric acid 15 seconds CV= 3.1 - 6.9% r = 0.71
HumaSensplus (HUMAN, Wiesbaden, Germany) [111] serum uric acid 15 seconds CV = 4.5 - 8.0% r = 0.75
UASure (Apex Biotechnology, Hsinchu, Taiwan) [111] serum uric acid 30 seconds CV ) 9.5 - 31.2% r = 0.16
i-Stat (Abbott Laboratories, Abbot Park, IL) [112] Hb 15 minutes N/A r = 0.67
Cobas® b221 (Roche Diagnostics, Belgium) [113] TCO2, pO2, pCO2, Na+, K+, Cl, CO-oximetry and metabolites < 2 minutes CV = 0.1 - 8% r = 0.99
FastPack® IP System (Sekisui Diagnostics, LLC, Lexington, USA) [114] αGST 12 minutes CV = 7.9 - 14.1% r = 0.99
(CR = creatinine; hct = hematocrit; TG = triglycerides; hemoglobin = Hb; TC = total cholesterol; HDL = high density lipoprotein; LDL = low density lipoprotein; Lac = lactate; HbA1c = glycated hemoglobin; ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; FORT = Free Oxygen Radicals test; FORD = Free Oxygen Radicals Defence; MCHC = Mean Corpuscular Hemoglobin Concentration; WBC = white blood cells; PLT = platelets; TP = total protein; ALB = albumin; TCO2 = Total Carbon dioxide; pO2 = partial pressure of oxygen; pCO2 = partial pressure of carbon dioxide; PT = prothrombin time; INR = international normalised ratio; aPTT = activated partial thromboplastin time; Na+ = sodium; K+ = potassium; iCa+ = ionized calcium; HCO3 = bicarbonate; CO2 = carbon dioxide; BEb = base excess of blood; BEecf = extracellular fluid; O2SAT = oxygen saturation; tHb = total hemoglobin; COHb = carboxyhemoglobin; MetHb = methemoglobin; O2Hb = oxyhemoglobin; HHb = deoxy-hemoglobin; iMg = ionized magnesium; sO2 = oxygen saturation; cK+ = potassium ion concentration; cNa+ = sodium ion concentration, cCl- = chloride ion concentration, cCa2+ = calcium ion concentration; ctHb = total hemoglobin, FO2Hb = fractional oxyhemoglobin, FCOHb = fractional carboxyhemoglobin, FMetHb = fractional methemoglobin, FHH = faecal human haemoglobin, FHbF = fetal hemoglobin fraction, ctBil = concentration of total bilirubin in plasma; Li2+ = lithium; TCa = total calcium; BUN = blood urea nitrogen; TBL = total bilirubin level; CK = creatine kinase; γ-GT = gamma glutamyl transferase; CRP = c-reactive protein; WBC = white blood cell, RBC = red blood cell; SpHb = total hemoglobin; PCT = procalcitonin; BE = base excess; CysC = Cystatin C; mAlb = microalbumin; NGAL = eutrophil gelatinase associated lipocalin; β2-MG = beta-2 microglobulin, hs-CRP = high-sensitivity CRP; UBG = urobilinogen; αGST = Alpha Glutathion S-Transferase)

Table 3. Commercially available POC devices for diabetes management.
StatStrip® (Nova Biomedical, Waltham,
MA, USA) (119-123)
glucose 6 seconds CV = 5 - 7% r = 0.99
NovaStatstrip® (Nova Biomedical, Waltham, MA, USA) (124-126) glucose < 10 minutes CV = 3.0 - 4.7% r = 0.97 - 0.98
Precision Xtra™ (MediSense/Abbott Diabetes Care, Abbott Park, IL) (127, 128) BHB 10 seconds CV = 2.4 - 5.9% r = 0.92
Accu-Chek Inform® II (Roche Diagnostics, Belgium) (129) glucose 5 seconds CV = 1.7 - 3.7% r = 0.99
Precision Xceed Pro blood glucose® (Abbott, USA) (128, 130] BHB 20 seconds CV = 2.4 - 5.9% r = 0.99
Assure Platinum blood glucose monitoring system® (Arkray, USA) glucose 7 seconds CV = 1.9 - 4.9% r = 0.99
HemoCue® Glucose 201+ System (HemoCue®, Sweden) [131-133] glucose 1 minute CV = 2.52 - 3.66% r = 0.96
YSI 2300 STAT® Plus (YSI Life Sciences, USA) [134-139] glucose and lactate 45-65 seconds CV = 3.03% r = 0.96
Scan SureStep Flexx (LifeScan, Johnson & Johnson Company, USA) [140] glucose 15 seconds CV = 1.4 - 4.1% r = 0.98
NycoCard II (Axis-Shield, Norway) (141-143) HbA1c 3 minutes CV = 3.1% r = 0.93
Accu-chek Advantage II (Roche, Basel, Switzerland) [144, 145] glucose 5 seconds CV = 0.07 - 2.5% r = 0.99
Precision PCx (Abbott, Illinois, USA) [144, 146] glucose 20 seconds CV = 3.8 -5.4% r = 0.96
SureStep Flexx (LifeScan, Malpitas, CA) [147] glucose 15 seconds CV = 4.2 - 5.9% r = 0.68
DCA VantageTM (Siemens Healthcare Diagnostics Inc, Australia) [148-150] Albumin/creatinine, HbA1c, glucose 6 minutes CV = 1.7 - 3.6% r = 0.74 - 0.98
FreeStyle Precision Neo (Abbott, Diabetes Care Ltd, UK) [151] glucose, BHB 5 seconds CV < 3.5% r = 0.89
StatStrip® (Nova Biomedical, Waltham,
MA, USA) [119-123]
glucose 6 seconds CV = 5 - 7% r = 0.99
NovaStatstrip® (Nova Biomedical, Waltham, MA, USA) [124-126] glucose < 10 minutes CV = 3.0 - 4.7% r = 0.97 - 0.98
LABGEO PT10 (Samsung Electronics, Suwon, South Korea) [152] HbA1c 7 minutes CV = 2.6% r = 0.99
A1C EZ 2.0 (Biohermes,
Wuxi, China) [153]
HbA1c 3 minutes CV = 1.9 - 2.3% r = 1.00
DPN-Check (Neurometrix Inc., Waltham, MA) [154] nerve amplitude potential and sural nerve conduction velocity 2 minutes CV = 3.6 - 8.8% r = 0.67
FIA8000 (GeTein BioMedical Inc., Portland, USA) [102] HbA1c 10-20 minutes CV = 1% r = 0.99
FastPack® IP System (Sekisui Diagnostics, LLC, Lexington, USA) [114] TSH 12 minutes CV = 4 - 7% r = 0.97
vitamin d CV = 4.7 - 15.1% r = 0.92
free T4 7 minutes CV = 7.2 - 11.5% r = 0.95
(Callegari S.r.l., Parma, Italy) [7]
Glu 10 - 180 seconds CV = 1.37 - 5.38% r = 0.75 - 0.99
HbA1c 5 - 10 minutes
(BHB = β-hydroxybutyrate; TSH = thyroid stimulating hormone; T4 = Thyroxine, HbA1c = glycated hemoglobin)
Table 4. Commercially available POC devices in cardiology.
i-Stat® Troponin I (Abbott Point-of-Care, Princeton, NJ) [156, 162] cTnI 7 minutes CV = 10% r = 1.06
Triage Cardio3 Tropinin I (Alere™, U.K) [156, 163, 164] cTnI 20 minutes CV = 11 - 16.7% r = 0.94
Pathfast® (Mitsubishi Chemical Medience Corporation, Tokyo) [156, 163] cTnI 20 minutes CV = 3.9 - 6.1% r = 0.89
AQT90® Flex troponin I (Radiometer Medical ApS, 2700 Bronshoj, Denmark [156, 165, 166] cTnI 10-20 minutes CV = 10% r = 0.90
RAMP® troponin
I (Biomedical Corp) [156, 167]
cTnI 20 minutes CV = 10% r = 0.98
Cardiac Reader® troponin T (Roche Diagnostics, Vilvoorde, Belgium) [156, 168] myoglobin and troponin T 14 minutes CV < 9% r = 0.89 - 0.91
Stratus® CS troponin
I (Siemens Medical Solutions Diagnostics) [156, 162]
cTnI 14 minutes CV = 10% r = 0.89
Stratus® CS D-dimer (Siements Diagnostic, Marburg, Germany) [159] D-dimer 14 minutes CV = 2.9% r = 0.90
Rapidpia® (Sekisui Medical Co., Ltd. Tokyo) [169] BNP 15 minutes CV = 0.9 - 2.1% r = 0.93
Shionospot® Reader (Shionigi&Co, Osaka, Japan) [169] BNP 15 minutes CV = 0.9 - 2.1% r = 0.93
Biosite® Triage System (Biosite Diagnostics Inc., USA) [170] cTnl, CK-MB, myoglobin, and NT-proBNP 15 minutes CV = 6.1 -15.4 r = 0.86
Cobas h232 (Roche Diagnostics Ltd., Rotkreuz, Switzerland) [171] NTproBNP 8 - 12 minutes CV = 5.9 - 13.8% r = 0.97
FIA8000 (GeTein BioMedical Inc., Portland, USA) [102] cTnI, NT-proBNP, D-Dimer, CK-MB, NT-proBNP/cTnI, CK-MB/cTnI, CK-MB/cTnI/Myo, hFABP, CK-MB/cTnI/hFAB 10-20 minutes CV = 1% r = 0.99
Meritas Troponin I (Trinity Biotech Plc, Co Wicklow, Ireland) [156] cTnI 15 minutes CV = 10% r = 0.98
ARTSENSTouch (National Instruments S.r.l., Assago, Italy) [172] Arterial stiffness Few seconds CV = 6.2 - 12.5% r = 0.89
Multiplate® (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) [173] platelet function 10 minutes CV > 2% r = 0.75-0.89
(cTnI = Cardiac troponin I; hsCRP = high sensitivity c-reactive protein; BNP = B-Type Natriuretic Peptide; NTproBNP = N-terminal pro-B-type natriuretic peptide; CK-MB = creatine kinase-muscle/brain; hFABP = heart-type fatty acid binding protein)

2.2.4. Viral Infections

Infectious diseases require an accurate and rapid diagnosis in order to limit the spread of infection. Their management mainly relies on the identification of the cause of the infection and on the initiation of a therapy to control host reaction against infection. In clinical practice, the time required to reach the final diagnosis generally exceeds 24 hours leading to unnecessary sufferings and even deaths. In the last few years, nucleic acid-based testing for infectious diseases have become particularly useful in those situations where fast turnaround times are required and centralized laboratories are overloaded. Moreover, conventional instruments are PCR-based, are limited to well-trained hospital staff and are expensive [174]. In the case of HIV infection, enumeration of CD4 lymphocytes accomplished by POCs is a pivotal diagnostic tool for initiating therapy and monitoring its efficacy, thus decentralizing the laboratories and providing results during the course of the patient visit [175]. Implementation of rapid HIV POCs may improve the prevention of such diseases by increasing testing uptake rates, timely diagnosis and access to treatment, and consequently reducing the further virus transmission (Table 5).

2.2.5. Bacterial Infections

Among bacterial infections, syphilis is one of the most commonly worldwide occurring infection since it can be sexually and congenitally transmitted, with more than 6 million of new cases yearly [243, 244].

Syphilis diagnosis can be accomplished either on clinical manifestations or on serological assays, also accomplished by POCs, which detect IgM, IgG and IgA antibodies from whole blood, serum or plasma, exploiting immunochromatographic strips. Results are available within 30 minutes and the overall procedure requires minimal equipment and training (Table 6).

Table 5. Commercially available POC devices for viral infections detection.
INSTITM (bioLytical Laboratories, Richmond BC) [176, 177] HIV-1/2 antibodies 10 minutes N/A r = 0.99
MBioTM (MBio Diagnostics, USA) [178] CD4 count 10 minutes CV = 8.1% r = 0.97
VISITECT® (Omega Diagnostics Ltd, Scotland, UK) [179] CD4 count 40 minutes CV = 15% r = 0.98
Alere q 1/2 Detect (Alere Healthcare, Waltham, Massachusetts, USA) [180-182] HIV nucleic acids 56 minutes CV = 5.58% r = 0.99
Cobas® Liat® system
(Roche Molecular Systems, Pleasanton, USA) [183-186]
Influenza A/B nucleic acid 20 minutes CV = 0.9 - 2.9% r = 0.98
SAMBA I and II (Diagnostics for the Real World Ltd., Cambridge, UK) [187, 188] HIV-1 nucleic acid 90 minutes N/A r = 0.99
OraQuick ADVANCE® (OraSure Technologies, Inc., Bethlehem, USA) [189-191] HIV-1/2 antibodies 20 minutes N/A N/A
Dual Path Platform (Chembio Diagnostic Systems, Inc, Medford, NY, USA) [192-194] HIV/HCV Antibody 15 - 25 minutes CV = 0.47% N/A
SD Bioline (Standard Diagnostics Yongin, Korea) [195] anti-HCV antibody 5 minutes CV = 0% r = 0.83
Bioeasy® (Bioeasy Diagno´stica, Belo Horizonte, Minas Gerais, Brazil) [196, 197] anti-HCV antibody 10-15 minutes N/A N/A
Hexagon® (Human Diagnostics
Worldwide, Wiesbaden, Germany) [198, 199]
anti-HCV antibody 5-20 minutes N/A N/A
Genedia® Rapid LF (Green Cross Medical Science, Yongin, Korea) [200] anti-HCV antibody 20-30 minutes N/A r = 0.83
Diagnos® Bi-Dot (Mitra, New Delhi, India) [198] anti-HCV antibody 3 minutes CV < 20% N/A
HCV Spot® (MP Biomedicals, Santa Ana, California, USA) [201] anti-HCV antibody 2 minutes N/A r = 0.93
SM-HCV (SERO-Med, Germany) [202] anti-HCV antibody 10 minutes N/A N/A
Ab rapid test (Tema Ricerca, Italy) [203] anti-HCV antibody < 3 minutes N/A N/A
Orthopox® Bio Threat Alert assay (Tetracore, USA) [204] anti-OPV antibody 15 minutes N/A N/A
Clearview® Exact Influenza A+B (Alere, USA) [205, 206] influenza A and B nucleoprotein antigens 15 minutes N/A N/A
Directigen® EZ Flu A+B (Becton, Dickinson, & Co. Diagnostics, USA) [207-209] influenza A and B nucleoprotein antigens 15 minutes CV = 4 - 4.5% r = 0.78
QuickVue® Influenza A+B (Quidel Corp, USA) [210, 211] influenza A and B nucleoprotein antigens 10 minutes N/A r = 0.81
3M Rapid Detection® Flu A+B (3M, USA) [212] influenza A and B nucleoprotein antigens 15 minutes N/A N/A
OSOM® Influenza A&B (Sekisui Chemical Co. Ltd, Japan) [213] influenza A and B nucleoprotein antigens 10 minutes N/A r = 0.95
Influenzatop® (All.Diag, France) [214] influenza A and B nucleoprotein antigens 10 minutes N/A r = 0.78
Actim® Influenza A&B (Medix Biochemica, Finland) [215, 216] influenza A and B nucleoprotein antigens 10 minutes N/A r = 0.81
Influ-A&B Respi-Strip® (Coris BioConcept, Belgium) [216, 217] influenza A and B nucleoprotein antigens 15 minutes N/A r = 0.81
Quick® Ex-Flu/ Quick® S- Influ A/B (Denka Seiken Co Ltd, Japan) [216] Detection of influenza A and B nucleoprotein antigens 15 minutes N/A r = 0.86
Espline® Influenza A&B-N (Fujirebio, Japan) [205] influenza A and B nucleoprotein antigens 15 minutes N/A N/A
Rockeby® Influenza A Antigen (Rockeby, Singapore) [218] influenza A and B nucleoprotein antigens 15 minutes N/A N/A
Merlin® dengue (Merlin, Diagnostika GmbH, Bornheim, Germany) [219] Dengue virus IgM antibody 10 minutes N/A r = 0.79
Dengue Duo® (Standard Diagnostics, South Korea) [220, 221] Dengue virus IgM antibody 15-20 minutes CV = 3% r = 0.86
Biosynex® Immunoquick dengue (Biosynex, France) [219] Dengue virus IgM antibody 15 minutes N/A N/A
Bio-Rad® NS1 antigen strip (Bio-Rad, France) [222] Dengue virus IgA antibody < 15 minutes N/A r = 0.77
Panbio® Dengue (Inverness, Australia) [222] Dengue virus IgA antibody 10-20 minutes N/A r = 0.66
Pima™ CD4 (Alere Inc, Waltham, MA, USA) [223, 224] CD4 testing 20 minutes CV = 4.0 -17% r = 0.89
Liat™ HIV Quant (Roche Molecular Systems, Inc., Branchburg, USA) [225] HIV-1 nucleic acid 30 minutes CV = 1.8 - 2.7% r = 0.96
GeneXpert® HIV-1 Quant (Cepheid Innovations Pvt. Ltd., USA) [226, 227] HIV-1 nucleic acid 90 minutes CV = 3.52 - 4.15% r = 0.88
Xpert® HIV-1 (Cepheid, Sunnyvale, USA) [228] HIV-1 nucleic acid 90 minutes CV < 3% r = 0.96
Dengue DAY 1 Test (J. Mitra & Co., India) [229] NS1 antigen, IgM and IgG 20 minutes N/A N/A
Simplexa HSV1 & 2 Direct kit (DIASORIN MOLECULAR LLC, Cypress, USA) [230, 231] HSV1 and HSV2 nucleic acids 75 minutes CV = 1.8 - 3.9% r = 0.84 - 0.89
ReEBOV Antigen Rapid Test (Autoimmune Technologies, New Orleans, USA) [232, 233] Ebola virus rVP40 antigen 15–25 minutes N/A r = 0.96
Aeonose® (The eNose Company, Zutphen, The
Netherlands) [234]
viral infections in acute exacerbations of chronic obstructive pulmonary disease 15 minutes N/A r = 0.74
i RSV test (Alere Inc. Waltham, USA) [235] RSV nucleic acid 13 minutes N/A N/A
EBOLA Ag K-SeT (Coris BioConcept, Gembloux, BELGIUM) [236] Ebola virus VP40 viral matrix protein 15 minutes N/A N/A
HIV Combo (Alere Inc. Waltham, USA) [237, 238] HIV core protein p24 20 minutes CV = 3.6 - 24.11% r = 0.98
VIKIA® Rota-Adeno (bioMérieux, Marcy l’Etoile, France) [239] rotavirus structural protein VP6 10 minutes CV = 3.6 - 12.5% r = 0.99
GeneXpert® (Cepheid, Sunnyvale, USA) [240] MPXV nucleic acid < 90 minutes N/A N/A
FACSPresto (Becton Dickinson Biosciences, NJ, USA) [241, 242] CD4 120 minutes CV = 9.79% r = 0.91
(HIV = Human Immunodeficiency Virus; HCV = Hepatitis C Virus; OPV = orthopoxvirus; NS1 = Nonstructural Protein 1; HSV = Herpes Simplex Virus; RSV = respiratory syncytial virus; MPXV = Monkeypox virus).
Table 6. Commercially available POC devices for bacterial infections detection.
Determine® Syphilis TP (Abbott, Princeton, USA) [245] Treponema pallidum antibody 15 minutes CV = 2.7 - 6.1% r = 0.98
SD BioLine® Syphilis Duo (Standard Diagnostics, Inc., Gyeonggi-do, South Korea) [246-248] IgG, IgM, and IgA Treponema pallidum 15-20 minutes N/A r = 0.85
Syphicheck® (Qualpro Diagnostics, Goa, India) [249] IgM and IgG class of Treponema pallidum specific antibodies 15 minutes N/A N/A
Signify Strep A (Abbott, Princeton, USA) [250] group A Streptococcus carbohydrate antigen 5 minutes N/A r = 0.93
ACCEAVA® Strep A (Inverness Medical Professional Diagnostics, Princeton, USA) [251] streptococcal A antigen 5 minutes N/A r = 0.98
CT/NG Xpert Rapid (Cepheid, Sunnyvale, USA) [252, 253] Chlamydia trachomatis and Neisseria gonorrhoeae DNA 90 minutes CV = 2% N/A
BioStar® (GC OIA, ThermoFisher/BioStar, Boulder, Colorado, USA) [254, 255] L7/L12 ribosomal protein of Neisseria gonorrhoeae 25 - 40 minutes N/A N/A
Immunoquick® Malaria (Meridian Healthcare srl, Catania, Italy) [256, 257] Pf HRP-2 and pan malaria-specific pLDH 15 - 30 minutes CV = 0.2% r = 0.93
RAPIRUN®S. pneumonia (Otsuka Pharmaceutical Co.,Ltd., Tokyo, Japan) [258, [259] pneumococcal C-ps < 25 minutes N/A r = 0.77
HELIPROBE® (Kibion AB, Uppsala, Sweden) [260, 261] 14C-Urea 15 minutes N/A r = 0.95
Determine™ TB LAM (Alere Inc., Waltham, USA) [262-264] LAM of Mycobacterium tuberculosis 25 minutes N/A r = 0.68
BinaxNOW® (Alere, USA) [265, 266] pneumococcal and L. pneumophila serogroup 1 antigens 15 minutes CV < 25% r = 0.97
Multiplo™ Rapid (Medmira Inc, Halifax, Nova Scotia, Canada) [234, 267] IgM and IgG antibodies to recombinant Treponema pallidum antigens (Tp0171 (TpN15), Tp0435 (TpN17) and Tp0574 (TpN47) 3 minutes CV = 4.8% N/A
aQcare Chlamydia TRF kit (Medisensor, Inc., Daegu, Korea) [268] Chlamydia trachomatis antigen 15 minutes N/A N/A
Chlamydia Rapid Test (Diagnostics for the Real World, Cambridge, UK) [269] Chlamydia trachomatis antigen 30 minutes N/A N/A
ACON Chlamydia Rapid Test (ACON Laboratories, San Diego, CA, USA) [270-272] Chlamydia trachomatis antigen 30 minutes N/A r = 0.64
QuickVue Chlamydia Rapid Test (QuickVue) (Quidel Corporation, San Diego, CA, USA) Chlamydia trachomatis antigen 12 minutes N/A N/A
RealStar Filovirus Screen RT-PCR kit 1.0 (altona Diagnostics, Hamburg, Germany) [233] Filovirus RNA 15 minutes CV = 1.10 - 1.16% N/A
TrueNat® Malaria (bigtec Labs, Bangalore, India) [273] Plasmodium falciparum and Plasmodium vivax malaria nuceic acids 45 minutes N/A N/A
TrueNat MTBTM (Molbio Diagnostics Pvt. Ltd, India) [274] Mycobacterium tuberculosis nuceic acid 35 minutes N/A r = 0.96
FilmArray® (BioFire Diagnostics, LLC, Salt Lake City, Utah) [275, 276] Chlamydia trachomatis,
Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis, Mycoplasma genitalium, Ureaplasma urealyticum,
Haemophilus ducreyi nuceic acids
          60 minutes CV = 4 - 40% r = 0.89
Aeonose® (The eNose Company, Zutphen, The
Netherlands) [234]
bacterial infections in acute exacerbations of chronic obstructive pulmonary disease 15 minutes N/A r = 0.72
VIKIA Malaria Ag Pf/Pan™ (IMACCESS©, Lyon, France) [277] Plasmodium falciparum (HRP-2) and non-P. falciparum (aldolase) 20–30 minutes N/A N/A
Dual Path Platform (DPP®) (Chembio Diagnostic Systems, Inc., Medford, USA) [278] Candida albicans antigen 20 minutes N/A N/A
QuikRead go® Strep A (Orion Diagnostica Oy, Finland) [279] Streptococcus pyogenes < 7 minutes N/A N/A
Circulating Cathodic Antigen Urine Cassette Test (Rapid Medical Diagnostics; Pretoria, South Africa) [280-282] Schistosoma mansoni 20 minutes N/A r = 0.99
Filariasis Test Strip (Alere, Scarborough,
ME) [283]
bancrofti circulating filarial antigen
10 minutes N/A r = 0.94
(Pf HRP-2 = Plasmodium falciparum-specific histidine-rich protein-2; pLDH = pan lactate dehydrogenase; C-ps = capsular polysaccharide; LAM = Lipoarabinomannan; HRP-2 = histidine-rich protein 2).

2.2.6. Fertility and Pregnancy

Infertility phenomenon affects 10–15% of couples and usually male factors account approximately half of the cases. Due to the difficulty in diagnose of male subfertility on the basis of only sperm count, simple diagnostic sperm tests have been marketed to allow men to monitor their sperm concentration, motility but also the testosterone concentration [114, 284]. As to the female counterpart, self-tests of pregnancy are increasing due to women’s preferences for confidentiality, accessibility of the test tool and rapid results [285, 286] (Table 7)

2.2.7. Drug of Abuse

Drug abuse either recreational or in competitive sports is considered a significant social problem worldwide. In the last few years, many tests using alternative specimens for drug analysis have been developed in several formats, ranging dipsticks to cup devices, cards or plastic cassettes. Current POCs are immunoassay-based and can discriminate from one class to multiple classes of drugs, i.e., cannabinoids and cocaine and amphetamines. These provide a line or color when the drug of interest is at or above the defined threshold and can utilize paper, thin-layer, or gas chromatography methods. It is crucial for users to understand the strengths, weaknesses, and limitations of these devices to facilitate accurate interpretation of results in order to avoid false-positive results due to cross-reactivity with foods, over-the-counter preparations or commonly prescribed drugs. This latter condition is exacerbated in the case of POC manufacturers who use misleading nomenclature. Among possible available samples saliva is a good candidate being a noninvasive way to evaluate the presence of a drug (Table 8).

2.2.8. Cancer

Cancer is considered as the second cause of death in the world, with prostate and breast cancer as the most common type of cancers in men and women, respectively (326). Most of the diagnostics tests are based on ELISA technique but unfortunately provide protein markers levels that correspond to advanced stages of the disease. Thus, cancer biomarkers-based POCs are of fundamental importance to diagnose, monitor but also to provide a prognostic approach and treatment of the disease (Table 9).

Table 7. Commercially available POC devices for pregnancy and infertitlity.
(PrincetonBioMeditech) [287-289]
sperm count 10 minutes CV < 7% r = 0.99
Clinitest® hCG pregnancy test (Siemens Healthcare GmbH, Erlangen,
Germany) [290, 291]
hCG 5 minutes CV = from < 10% to < 4% r = 0.99
Triage® PLGF test (Alere, San Diego, USA) [292, 293] PlGF 15–20 minutes CV = 12.8 - 13.2% r = 0.86
Actim Prom® (Alere SAS, Jouy-en Josas, France) [294-299] IGFBP-1 5 minutes N/A r = 0.78
ICON 25 Rapid hCG (Beckman Coulter Inc., Brea, USA) [300] hCG 3 - 5 minutes N/A r = 0.99
YO®Home Sperm Test (Medical Electronics Systems) [284] sperm concentration and motility 30 minutes CV = 9.4 - 11.2% r = 0.97
ROM Plus® (Clinical Innovations, Salt Lake City, UT, USA) [295, 301] AFP, IGFBP-1 20 minutes N/A r = 0.97
Amnisure® (QIAGEN Sciences LLC, Germantown, USA) [295, 302] PAMG-1 10 minutes N/A r = 0.80
CLINITEK Status+ Analyzer (Siemens Healthcare GmbH, Erlangen, Germany) [303, 304] hCG 1 minute CV = 0.44% r = 0.99
hCG Combo Cassette (Alere San Diego, Inc., San Diego, USA) [305] hCG 3-5 minutes N/A r = 0.94
ICON 20 hCG (Beckman
Coulter, Inc., Brea, USA) [305]
hCG 3-5 minutes N/A r = 0.97
OSOM hCG Combo Test (Sekisui Diagnostics,
LLC, SanDiego, USA) [305]
hCG 3-5 minutes N/A r = 0.86
Sure-Vue Serum/Urine hCG-STAT (Fisher Scientific Company, Waltham, USA) [305] hCG 3-5 minutes N/A r = 0.96
Elecsys® (Roche Diagnostics, Basel, Switzerland) [306] AMH 18 minutes CV = 5.61% r = 0.97
VIDAS® (bioMèrieux,
Marcy L’Etoile, France) [306]
AMH 35 minutes CV = 5.18% r = 0.97
FastPack® IP System (Sekisui Diagnostics, LLC, Lexington, USA) [114] hCG 12 minutes CV = 7.8 - 14.5% r = 0.99
testosterone N/A N/A
SHBG 8 minutes CV = 3.21 - 11.53% r = 0.98
(hCG = human Chorionic Gonadotropin; IGFBP-1 = insulin-like growth factor binding protein-1; AFP = Alpha-fetoprotein; AMH = Anti-Müllerian Hormone; PAMG-1 = placental alpha-microglobulin-1; PlGF = placental growth factor; SHBG = Sex Hormone Binding Globulin).
Table 8. Commercially available POC devices for drugs of abuse detection.
Syva RapidTest d.a.u. 8 (Siemens Medical Solutions Diagnostics) [307] cocaine, THC, amphetamines, opioids, PCP 5 - 10 minutes N/A r = 0.74
Cozart®RapiScan (Cozart Bioscience, London, UK) [308, 309] cocaine, benzoylecgonine, ecgonine methyl ester 3 minutes N/A r = 0.99
Drugwipe® (Securetec, Ottobrunn, Germany) [310, 311] benzodiazepine, codeine 5 minutes CV = 10.8% r > 0.95
Monitect® Oxycodone (Branan Medical Co. (Irvine, USA) [312] oxycodone and metabolites 4-8 minutes N/A N/A
E-Z Split Key® Cup II (Innovacon Company, San Diego, USA) [313, 314] amphetamine, BZD, buprenorphine, cocaine, marijuana, methadone, METH, MDMA, oxycodone, and propoxyphene, THC, secobarbital, oxazepam, benzoylecgonine, morphine and nortriptyline 5 minutes N/A r > 0.96
Triage® TOX Drug Screen (Alere Healthcare, Waltham, USA) [315-317] paracetamol, amphetamines, METH, barbiturates, benzodiazepines, cocaine, methadone, opioids, PCP, THC, TCAs 15 minutes N/A r > 0.93
DDS®2 Mobile Test System (Alere, Waltham, USA) [318-321] amphetamine, benzodiazapines, cocaine, METH, opioids, THC 5 minutes N/A r = 0.97
Instant-View® Drug Screen Tests (Alfa Scientific Design; Poway, USA) [322] METH, amphetamines 7 minutes N/A N/A
Roche TesTcup (Roche Diagnostic, Basel, Switzerland) [307] cocaine, THC, amphetamines, opioids, PCP 4 minutes N/A r = 0.73
Casco-Nerl microLINE (CASCO NERL DIAGNOSTICS, Baltimore, USA) [307] cocaine, THC, amphetamines, opioids, PCP 3-8 minutes N/A r = 0.70
Biosite Triage (Alere Healthcare, Waltham, USA) [307] cocaine, THC, amphetamines, opioids, PCP 13 minutes N/A r = 0.67
Syva RapidCup d.a.u. 5 (Siemens Medical Solutions Diagnostics) [307] cocaine, THC, amphetamines, opioids, PCP 4 minutes N/A r = 0.66
Drugwipe 5+® (Securetec, Ottobrunn, Germany) [323, 324] cocaine and metabolites, THC, amphetamines and amphetamine-type designer drugs, ketamine. 5 minutes N/A r > 0.92
DrugWipe 5A (Securetec, Ottobrunn, Germany) [325] cannabis, amphetamines, cocaine,
10 minutes CV = 1.7 - 13.1% r = 0.99
(THC = tetrahydrocannabinol; PCP = phencyclidine; MDMA = methylenedioxymethamphetamine; METH = methamphetamine; TCAs = tricyclic antidepressants; BZD = benzodiazepines).
Table 9. Commercially available POC devices for cancer detection.
HemoCue® WBC DIFF (HemoCue®, Sweden) [327] WBC 5 minutes CV = 1 - 13.7% r > 0.95
PSAwatch (Mediwatch Plc, Rugby, UK) [328] PSA 10 minutes N/A r = 0.88
EZ DETECT™ (Biomerica, Inc., Irvine, USA) [329] FOB 2 minutes N/A r = 0.70
NMP22 BladderChek Test (Matritech, MA, USA) [330, 331] urine NMP22 30 minutes N/A r = 0.82
UBC® rapid test (Concile GmbH, Freiburg/Breisgau, Germany) [332, 333] CYFRA 8 and 18 10 minutes N/A r = 0.77
BTA® stat (Polymedco, Inc., Cortlandt Manor, NY) [334, 335] CFHRP 5 minutes N/A r = 0.85
CancerCheck® PSA (concile GmbH, Freiburg, Germany) [336] PSA 20 minutes N/A r = 0.74
Prevent ID CC (Immundiagnostik AG, Bensheim, Germany) [337, 338] FOB 10 minutes N/A N/A
Quantum Blue® (BÜHLMANN Laboratories AG, Schönenbuch,
Switzerland) [339, 340]
calprotectin 12 minutes CV = 4.6 - 5.9% r = 0.73
M2-PKstool test (ScheBo Biotech AG, Giessen, Germany) [341-343] Pyruvate kinase isoenzyme 120 minutes CV = 4.5 - 6.1% r = 0.96
FastPack® IP System (Sekisui Diagnostics, LLC, Lexington, USA) [114] PSA 12 minutes CV = 9.4 - 13.1% r = 0.97
free PSA CV = 11.6 - 13.9 r = 0.97
(WBC = White Blood Cells, PSA = Prostate-Specific Antigen; FOB = Fecal occult blood; NMP22 = nuclear matrix protein 22; CYFRA = cytokeratin fragment; CFHRP = complement factor H–related protein).
Table 10. Commercially available POC devices for genetic disorders detection.
Carestart™ (Access Bio, Somerset, USA) [344-346] G-6-PDH activity 10 minutes N/A r = 0.73
G6PD Assay (Trinity Biotech, St. Louis, USA) [344, 347] G-6-PDH activity < 70 minutes CV = 4.5% r = 0.98
Sickle SCAN™ test (BioMedomics, Inc., Durham, USA) [348-351] HbA, HbS, HbC 2 minutes N/A r = 0.99
Q3 portable real-time PCR instrument (Thermo Fisher Scientific, Waltham, USA) [352] ABCB1 3435, CYP2C19*2
and CYPC2C19*17 polymorphisms
30 minutes N/A r = 1.00
GeneXpert® (Cepheid, Sunnyvale, USA) [353] BCR-ABL gene fusion in leukemia cells 150 minutes CV = 41.35% r = 0.99
Verigene CYP2C19 Nucleic Acid Test (Nanosphere Inc, Northbrook, USA) [354, 355] CYP2C19 polymorphisms 210 minutes N/A r = 1.00
RX CYP2C19 System (Spartan Bioscience Inc., Ottawa, Canada) [355, 356] CYP2C19 polymorphisms < 60 minutes N/A r = 1.00
(G-6-PDH = Glucose 6-Phosphate Dehydrogenase; HbA = adult normal hemoglobin; HbS = human sickle cell hemoglobin; HbC = human hemoglobin C; CYP2C19 = Cytochrome P450 2C19).
Table 11. Commercially available POC devices in dentistry.
DK13-PG-001 device kit [359, 360] Porphyromonas gingivalis 15 minutes N/A r = 0.86
Sonosite Edge (FUJIFILM SonoSite, Inc., Amsterdam, Netherlands) [361] Mandible evaluation Few seconds N/A N/A
Oral Chroma (Abimedical, Abilit Corp., Osaka, Japan) [362] hydrogen sulphide, methyl mercaptan, dimethylsulphide 8 minutes N/A N/A

2.2.9. Genetics

Traditional DNA tests are used to detect genotypes related to a heritable disease or phenotype of interest for clinical purposes. These methods generally require days to weeks before results are available, thus limiting the clinical practice in different circumstances, whereas POC, employ sophisticated techniques able to identify variations in the genetic sequence requiring a time ranging from few minutes to few hours (Table 10).

2.2.10. Dentistry

One of the challenges in dentistry is the rapid management of diseases such as chronic periodontitis, generally caused by Porphyromonas gingivalis, the rapid detection of which is important for an effective treatment [357, 358]. In this sense, a novel immunochromatographic device for the rapid detection and quantification of Porphyromonas gingivalis in subgingival plaque has been recently developed [359, 360]. Also, ultrasonology has now acquired great relevance in dentistry, particularly in those situations where computed tomography may prove hazardous, such as pediatric patients, where a rapid identification of mandibular fractures may rule out the necessity for operative management [361]. An updated overview of commercially available POC in dentistry is given below (Table 11).

2.2.11. Ophthalmology

Eye injuries and ocular complications frequently occur in emergency department visits, convenient care appointments or primary care evaluations requiring specific training and expert knowledge of ophthalmic diagnostic equipment, which generally are of high costs and are not portable. This latter feature results in problems in case of serious ocular injuries present outside the ophthalmology office. Seidel Test is conventionally used to evaluate the integrity of the anterior globe in trauma patients and the wound severity in post-operative patients. This test is based on a subjective and not standardized outcome due to the different amount of pressure and technique used by clinicians. Other devices used to aid in the diagnosis of eye injuries include X-ray, computed tomography, ultrasound and magnetic resonance imaging that are expensive and restricted to hospital settings due to their size and cost. The OcuCheck Biosensor is considered a valid alternative to the subjective Seidel Test providing an objective, rapid (5 minutes) and reliable result of ascorbic acid concentration within the ocular tear film, as a surrogate biomarker of anterior scleral or corneal wound integrity with a good accuracy degree (r = 0.89) [363].

2.2.12. Ultrasonology

In the last 50 years, ultrasonography has become an integral part in many medicinal fields and ongoing technological advancements led to a rapid diffusion of POC ultrasound devices among medical wards, emergency rooms, intensive care units and outpatient clinics; due to high performance, reduced size and low costs (Table 12).

2.3. POCs in Veterinary Practice

Feline immunodeficiency virus (FIV) and feline leukaemia virus (FeLV) are the two most common viruses in cats associated with significant morbidity [377]. One of the key challenges of POCT manufacturers is to identify infected cats, and beyond ELISA and other immunochromatographic tests, new in-house tests for FIV and FeLV diagnosis have been introduced to the market. Besides these two viruses, group A rotaviruses, parvovirus and influenza virus tests have also been successfully used in other species including dogs and horses. Moreover, biochemical parameters of POC devices, such as bilirubin, ketones, creatinine, hemoglobin, glucose, leucocytes, nitrites, specific weight, pH, proteins, urobilinogen, lactate, Cai and Mgi, have been investigated for other species including cow and cattle. The turnaround time of result of veterinary POC devices is generally below 20 minutes with an overall high degree of accuracy, providing the veterinarian with a good chance to clearly diagnose the disease, to the clients the possibility to save money and to the animals to minimize the discomfort and the sample volume required (Table 13).

Table 12. Commercially available POC devices in ultrasonology.
Vscan Dual Probe (GE Medical Systems, Milwaukee, Wisconsin) [364-366] deep vein thrombosis 7 minutes N/A r = 0.94
FibroScan (Echosens, Paris, France) [367] liver disease 10 minutes CV = 2.4 - 15.8% r = 0.94
ApneaLink® (ResMed, Sydney, Australia) pulse oximetry and oronasal flow 12 minutes N/A r = 0.67
Mindray M7 (Mindray Bio-Medical Co., Shenzhen, China) [368, 369] chronic heart failure, pneumonia, asthma,
chronic obstructive pulmonary disease, pulmonary thromboembolism, acute renal failure
< 6 minutes N/A r = 0.90 - 1.00
Vscan™ (GE Healthcare) [370] kidney length, hydronephrosis, renal pelvis width, diameter of the largest cyst, presence of ureteral jet signs, prostate volume, post-void bladder volume 7 minutes N/A r = 0.07 - 0.81
Vscan™ (GE Healthcare) [371] heart and inferior vena cava < 3 minutes N/A r = 0.78
Vscan (GE Vingmed
Ultrasound, Horten, Norway) [372, 373]
left ventricular global systolic function, regional left ventricular dysfunction, right ventricular global systolic function, left atrial size, aortic calcification and stenosis, aortic regurgitation, mitral regurgitation, tricuspid regurgitation, pericardial effusion, pleural effusion, abdominal aorta, inferior vena cava, kidneys, liver and gallbladder < 11 minutes N/A r = 0.44 - 0.86
Vscan™ (GE Healthcare) [374] acute dyspnoea < 10 minutes N/A N/A
TEG® 5000 (Haemonetics Inc., Braintree, USA) [375, 376] thrombelastography Few minutes CV ≤ 2.1% r = 0.93
Table 13. Commercially available POC devices in veterinary.
SNAP FIV/FeLV Combo (IDEXX Laboratories, Inc., Westbrook, USA) [378-380] antibodies to p15 and p24 protein of FIV and soluble antigen p27 coreprotein of FeLV 10 minutes CV = 0.6 - 1.1% r = 0.81 - 0.98
Witness FeLV/FIV (Zoetis US, Parsippany, USA) [378-381] antibodies to gp40 protein of FIV and soluble antigen p27 coreprotein of FeLV 10 minutes CV = 0.4 - 1.3% r = 0.81 - 0.98
Anigen Rapid FIV/FeLV (BioNote, Inc., Hwaseong-si, Korea) [378, 380] antibodies to p24 and gp40 protein of FIV and soluble antigen p27 coreprotein of FeLV 10 minutes N/A r = 0.97
VetScan Feline FeLV/FIV Rapid Test (Abaxis, Inc., Union City, USA) [380, 381] antibodies to gp40 protein of FIV and soluble antigen p27 coreprotein of FeLV 10 minutes N/A r = 0.70
Duo Speed (Bio Veto Test, France) [379] antibodies to gp40 protein of FIV and soluble antigen p27 coreprotein of FeLV 15 minutes CV = 1.1 - 1.9% r = 0.94 - 0.98
Virachek®FIV/FeLV (Zoetis US, Parsippany, USA) [379] antibodies to gp40 protein of FIV and soluble antigen p27 coreprotein of FeLV 15 minutes CV = 0.2 - 0.6% r = 0.86 - 0.98
FASTest® ROTA Strip (MEGACOR, Diagnostk GmbH, Hörbranz, Austria) [382] equine G3P [12]-I6 and G14P [12]-I2 Group A rotaviruses genotypes 5 minutes N/A r = 0.88
Witness Parvo (Synbiot-ics, France [383] canine parvovirus antigen 5 minutes CV = 0% N/A
Snap Parvo (Idexx, Germany) [383] canine parvovirus antigen 8 minutes CV = 0% N/A
SpeedParvo (Bio Veto Test, France) [383] canine parvovirus antigen and feline panleukopenia virus 5 minutes CV = 0% N/A
FastestParvo Strip (MegaCor, Austria) [383] canine parvovirus antigen and feline panleukopenia virus 5 minutes CV = 0% N/A
SAS Parvo (SA Scientific, USA) [383] canine parvovirus antigen and feline panleukopenia virus 10 minutes CV = 0.5% N/A
InPouch™ TF-Feline medium (Bio-Med Diagnostics, White City, USA) [384] feline Tritrichomonas foetus 15 minutes N/A N/A
Lactate Plus (Nova Biomedical, Waltham, MA, USA) [385] canine cerebrospinal fluid lactate 13 seconds CV < 15% r = 0.97
Hemoccult Single Slides (Beckman Coulter, Brea, USA) [386] feline FOB 6 minutes N/A N/A
Keto-Test (Elanco Animal Health, Greenfield, USA) [387] BHBA in cow milk < 2 minutes N/A N/A
Accutrend Plus (Roche Diagnostics, Mannheim, Germany) [388] cattle blood L-lactate concentration 1 minute N/A r = 0.95
Lactate Pro (Abbott Point of Care, Abbott Laboratories, Chicago
, USA) [388]
cattle blood L-lactate concentration 15 seconds N/A r = 0.99
i-STAT (Arkray Inc, Kyoto, Japan) [388] cattle blood L-lactate concentration 2 minutes N/A r = 0.99
Lactate Scout (SensLab GmbH, Leipzig, Germany) [388] cattle blood L-lactate concentration 10 seconds N/A r = 0.99
Nova CRT8 analyser (Nova Biomedical, Rödemark, Germany) [389, 390] feline Cai, Mgi 55 seconds CV = 0.45 - 2.29% r = 1.00
Accutrend (Roche Diagnostics, Mannheim, Germany) [391] canine blood L-lactate concentration < 3 minutes CV < 5.3% r = 0.86
Quick chaser Flu A, B (Mizuho Medy Co., Ltd., Tosu, Japan) [392] equine influenza virus strain A/equine/Kildare/2/2010 nucleic acid 5-10 minutes N/A r = 0.67
ESPLINE INFLUENZA A&B-N (Fujirebio Inc., Malvern, USA) [392] equine influenza virus strain A/equine/Kildare/2/2010 nucleic acid 15 minutes N/A r = 0.27
Prorast Flu (Mitsubishi Chemical Medience Co., Tokyo, Japan) [392] equine influenza virus strain A/equine/Kildare/2/2010 nucleic acid 10 minutes N/A N/A
BD Flu Examan™ (Beckton, Dickinson and Co., Franklin Lakes, USA) [392] equine influenza virus strain A/equine/Kildare/2/2010 nucleic acid 15 minutes N/A r = 0.73
ImmunoAce®Flu (Tauns Laboratories, Inc., Izunokuni, Japan) [392] equine influenza virus strain A/equine/Kildare/2/2010 nucleic acid 3-8 minutes N/A r = 0.67
Clinitek 50 Chemistry Analyzer using Multistix10SGTM/MicroalbustixTM dipsticks (Siemens Healthcare Diagnostics, Inc., Tarrytown, USA) [393] canine glucose, protein, bilirubin, ketones, pH 5 minutes N/A r = 0.62 - 0.96
Oral Chroma (Abimedical, Abilit Corp., Osaka, Japan) [394] hydrogen sulphide, methyl mercaptan, dimethylsulphide in dogs 8 minutes N/A N/A
(FIV = feline immunodeficiency virus; FeLV = feline leukaemia virus; FOB = fecal occult blood; BHBA = β-hydroxybutyrate; Cai = ionized; Mgi = ionized magnesium)


POC devices are revolutionizing clinical and veterinary practice providing rapid test results in different clinical settings, located outside the human and veterinary hospital environment such as physician or vet office and pharmacy. POC technology is particularly helpful in the pre-analytical phase, reducing misidentification of patients and specimen, sample handling, transport and storage, but also in the post-analytical phase, limiting excessive turnaround time. The advancements in POCs have generally improved the quality of care, the health outcomes, and the affordability of the tests.

The use of POC by clinical personnel might have a positive impact on health-care by identifying patients at risk who need to be referred to the next level of care for an accurate diagnosis and treatment, involving patients in their own care, addressing therapeutic issues with the patients once the results are obtained and designing the disease management programs based on a POC device. Another key element of POC is connectivity, related to the possibility to link laboratory and hospital information systems with electronic the patient records. With the advent of the POCT1-A2 standard, it has now become possible to improve devices, data concentrators, and clinical information systems’ interoperability and communication [395]. Although there are many challenges related to the implementation of POCT1-A2 protocol in a POC, a framework-based approach has been shown to standardize implementation across devices with consequent ease of maintenance and a return on investment for POC vendors.

However, besides the growing need for connectivity of POC, the regulatory pressure for digitalization of all medical records and patient outcomes, led to another critical issue: the cybersecurity of such records. This latter becomes particularly critical among interconnected devices or through external interfaces (i.e. USB or Ethernet cables), with possible life-threatening consequences for patients. In fact, FDA imposed a serious vigilance to POC manufacturers in order to minimize the risk of cybersecurity threats by constantly monitoring, evaluating and updating their devices [396].

Since POC outcomes depend on the operator’s expertise, training and routine updating are crucial to reduce errors [397]. Moreover, when used appropriately, POC devices are invaluable tools for patients but also for animal care, offering a rapid delivery of results and also allowing a reduction in costs due to: 1) Decreased facility costs [398], 2) Decreased maintenance costs [398], 3) Decreased waiting time [399], 4) Decreased hospitalization [399], 5) Decreased screening time [399] and 6) Improved home care delivery [398].

Nanotechnology-based devices have revolutionized the concept of accuracy in diagnosis and therapy by integrating nanomaterials and biosensors, thus consequently minimizing costs and time to provide results.


Not applicable.




The authors declare no conflict of interest, financial or otherwise.


Declared none.


[1] St John A, Price CP. Existing and emerging technologies for point-of-care testing. Clin Biochem Rev 2014; 35(3): 155-67.
[2] Lippi G, Plebani M, Favaloro EJ, Trenti T. Laboratory testing in pharmacies. Clin Chem Lab Med 2010; 48(7): 943-53.
[3] McNerney R, Daley P. Towards a point-of-care test for active tuberculosis: obstacles and opportunities. Nat Rev Microbiol 2011; 9(3): 204-13.
[4] Bénéteau-Burnat B, Pernet P, Pilon A, et al. Evaluation of the GEM Premier 4000: A compact blood gas CO-Oximeter and electrolyte analyzer for point-of-care and laboratory testing. Clin Chem Lab Med 2008; 46(2): 271-9.
[5] Shaw JLV. Practical challenges related to point of care testing. Pract Lab Med 2015; 4: 22-9.
[6] Asimos AW, Gibbs MA, Marx JA, et al. Value of point-of-care blood testing in emergent trauma management. J Trauma 2000; 48(6): 1101-8.
[7] Callegari S. Available from:
[8] Pineau A, Fauconneau B, Rafael M, Viallefont A, Guillard O. Determination of lead in whole blood: comparison of the LeadCare blood lead testing system with Zeeman longitudinal electrothermal atomic absorption spectrometry. J Trace Elem Med Biol 2002; 16(2): 113-7.
[9] Hetzel N, Papasouliotis K, Dodkin S, Murphy K. Biochemical assessment of canine body cavity effusions using three bench-top analysers. J Small Anim Pract 2012; 53(8): 459-64.
[10] Shephard MD. Point-of-care testing and creatinine measurement. Clin Biochem Rev 2011; 32(2): 109-14.
[11] Moreno M, Schwartz A, Dvorkin R. The accuracy of point-of-care creatinine testing in the emergency department. Advances in Emergency Medicine 2015; 2015: 5.
[12] Dimeski G, Tilley V, Jones BW, Brown NN. Which point-of-care creatinine analyser for radiology: direct comparison of the i-Stat and StatStrip creatinine methods with different sample types. Ann Clin Biochem 2013; 50(Pt 1): 47-52.
[13] Lee-Lewandrowski E, Chang C, Gregory K, Lewandrowski K. Evaluation of rapid point-of-care creatinine testing in the radiology service of a large academic medical center: impact on clinical operations and patient disposition. Clin Chim Acta 2012; 413(1-2): 88-92.
[14] Gault MH, Seymour ME, Howell WE. Evaluation of i-STAT creatinine assay. Nephron 2001; 88(2): 178-82.
[15] Heinis AM, Dinnissen J, Spaanderman ME, Lotgering FK, Gunnewiek JM. Comparison of two point-of-care testing (POCT) devices for fetal lactate during labor. Clin Chem Lab Med 2011; 50(1): 89-93.
[16] Orsonneau JL, Fraissinet F, Sébille-Rivain V, Dudouet D, Bigot-Corbel E. Suitability of POC lactate methods for fetal and perinatal lactate testing: considerations for accuracy, specificity and decision making criteria. Clin Chem Lab Med 2013; 51(2): 397-404.
[17] Reif P, Lakovschek I, Tappauf C, Haas J, Lang U, Schöll W. Validation of a point-of-care (POC) lactate testing device for fetal scalp blood sampling during labor: clinical considerations, practicalities and realities. Clin Chem Lab Med 2014; 52(6): 825-33.
[18] van Horssen R, Schuurman TN, de Groot MJM, Jakobs BS. Lactate point-of-care testing for acidosis: Cross-comparison of two devices with routine laboratory results. Pract Lab Med 2015; 4: 41-9.
[19] Dascombe BJ, Reaburn PR, Sirotic AC, Coutts AJ. The reliability of the i-STAT clinical portable analyser. J Sci Med Sport 2007; 10(3): 135-40.
[20] Maslow A, Bert A, Singh A, Sweeney J. Point-of-care hemoglobin/hematocrit testing: Comparison of methodology and technology. J Cardiothorac Vasc Anesth 2016; 30(2): 352-62.
[21] Ismail F, Mackay WG, Kerry A, Staines H, Rooney KD. The accuracy and timeliness of a Point Of Care lactate measurement in patients with Sepsis. Scand J Trauma Resusc Emerg Med 2015; 23: 68.
[22] Acton QA. Advances in blood transfusion research and application 2012 Ed.. 2012.
[23] Léguillier T, Jouffroy R, Boisson M, et al. Lactate POCT in mobile intensive care units for septic patients? A comparison of capillary blood method versus venous blood and plasma-based reference methods. Clin Biochem 2018; 55: 9-14.
[24] Jerez Calero AE, Fernández Jiménez D, Molina Oya M, Narbona López E, Uberos Fernández J. Validation of a portable coagulometer for routine in-hospital use for newborns. Pediatr Crit Care Med 2017; 18(11): e569-74.
[25] Kapoor D, Srivastava M, Singh P. Point of care blood gases with electrolytes and lactates in adult emergencies. Int J Crit Illn Inj Sci 2014; 4(3): 216-22.
[26] Hedlund KD, Oen S, LaFauce L, Sanford DM. Clinical experience with the Diametrics IRMA (Immediate Response Mobile Analysis) blood analysis system. Perfusion 1997; 12(1): 27-30.
[27] Kim WH, Lee HC, Ryu HG, et al. Reliability of Point-of-Care Hematocrit Measurement During Liver Transplantation. Anesth Analg 2017; 125(6): 2038-44.
[28] Zatloukal J, Pouska J, Kletecka J, Pradl R, Benes J. Comparison of the accuracy of hemoglobin point of care testing using HemoCue and GEM Premier 3000 with automated hematology analyzer in emergency room. J Clin Monit Comput 2016; 30(6): 949-56.
[29] Flegar-Mestrić Z, Perkov S. Comparability of point-of-care whole-blood electrolyte and substrate testing using a Stat Profile Critical Care Xpress analyzer and standard laboratory methods. Clin Chem Lab Med 2006; 44(7): 898-903.
[30] Couck P, Ghys T, Van Gastel E, Van Coillie M, Gorus F, Gerlo E. Preliminary performance evaluation of blood gas analyzers. Clin Chem Lab Med 2006; 44(8): 1030-4.
[31] Suen WW, Ridley B, Blakney G, Higgins TN. Comparison of lactate, bilirubin and hemoglobin F concentrations obtained by the ABL 700 series blood gas analyzers with laboratory methods. Clin Biochem 2003; 36(2): 103-7.
[32] Karon BS, Scott R, Burritt MF, Santrach PJ. Comparison of lactate values between point-of-care and central laboratory analyzers. Am J Clin Pathol 2007; 128(1): 168-71.
[33] De Koninck AS, De Decker K, Van Bocxlaer J, Meeus P, Van Hoovels L. Analytical performance evaluation of four cartridge-type blood gas analyzers. Clin Chem Lab Med 2012; 50(6): 1083-91.
[34] Hart S, Drevets K, Alford M, Salacinski A, Hunt BE. A method-comparison study regarding the validity and reliability of the Lactate Plus analyzer. BMJ Open 2013; 3(2)e001899
[35] Leino A, Kurvinen K. Interchangeability of blood gas, electrolyte and metabolite results measured with point-of-care, blood gas and core laboratory analyzers. Clin Chem Lab Med 2011; 49(7): 1187-91.
[36] Sediame S, Zerah-Lancner F, d’Ortho MP, Adnot S, Harf A. Accuracy of the i-STAT bedside blood gas analyser. Eur Respir J 1999; 14(1): 214-7.
[37] Srihong C, Pangsapa K, Chuaboonmee K, Kotipan Y, Charuruks N. Evaluation of the analytical performance of the nova StatSensor creatinine meter for blood testing. J Med Assoc Thai 2012; 95(9): 1225-31.
[38] van Lint CL, van der Boog PJ, Romijn FP, et al. Application of a point of care creatinine device for trend monitoring in kidney transplant patients: fit for purpose? Clin Chem Lab Med 2015; 53(10): 1547-56.
[39] Houben IPL, van Berlo CJLY, Bekers O, Nijssen EC, Lobbes MBI, Wildberger JE. Assessing the risk of contrast-induced nephropathy using a finger stick analysis in recalls from breast screening: The CINFIBS explorative study. Contrast Media Mol Imaging 2017; 20175670384
[40] Kosack CS, de Kieviet W, Bayrak K, Milovic A, Page AL. Evaluation of the Nova StatSensor® Xpress(TM) Creatinine point-of-care handheld analyzer. PLoS One 2015; 10(4)e0122433
[41] Jaggernath M, Naicker R, Madurai S, Brockman MA, Ndung’u T, Gelderblom HC. Diagnostic accuracy of the hemoCue Hb 301, STAT-site MHgb and URIT-12 Point-of-care hemoglobin meters in a central laboratory and a community based clinic in durban, South Africa. PLoS One 2016; 11(4)e0152184
[42] Kampa IS, Keffer P. The use of a whole-blood benchtop analyzer (Nova 16) in a cardiac STAT intensive care unit. Clin Chem 1998; 44(4): 884-5.
[43] Nomura N, Saito K, Ikeda M, et al. Evaluation of the Microsemi CRP, an automated hematology analyzer for rapid 3-part WBC differential and CRP using whole blood. Int J Lab Hematol 2015; 37(4): 466-73.
[44] Thielemans L, Hashmi A, Priscilla DD, et al. Laboratory validation and field usability assessment of a point-of-care test for serum bilirubin levels in neonates in a tropical setting. Wellcome Open Res 2018; 3: 110.
[45] Fell JW, Rayfield JM, Gulbin JP, Gaffney PT. Evaluation of the accusport lactate analyser. Int J Sports Med 1998; 19(3): 199-204.
[46] Permpikul C, Ratanarat R, Neungton N. Blood lactate determined by a portable device in critically ill patients. J Med Assoc Thai 2000; 83(11): 1348-53.
[47] Pinnington H, Dawson B. Examination of the validity and reliability of the Accusport blood lactate analyser. J Sci Med Sport 2001; 4(1): 129-38.
[48] Bishop D. Evaluation of the Accusport lactate analyser. Int J Sports Med 2001; 22(7): 525-30.
[49] Baldari C, Bonavolontà V, Emerenziani GP, Gallotta MC, Silva AJ, Guidetti L. Accuracy, reliability, linearity of Accutrend and Lactate Pro versus EBIO plus analyzer. Eur J Appl Physiol 2009; 107(1): 105-11.
[50] Waiswa M, Byarugaba BB, Ocama P, et al. Hyperlactatemia and concurrent use of antiretroviral therapy among HIV infected patients in Uganda. Afr Health Sci 2012; 12(3): 268-75.
[51] Scafoglieri A, Tresignie J, Provyn S, Clarys JP, Bautmans I. Reproducibility, accuracy and concordance of Accutrend Plus for measuring circulating lipid concentration in adults. Biochem Med (Zagreb) 2012; 22(1): 100-8.
[52] Stoll D, Englund E, Hillborg H, Vedin S, Larsson A. Capillary and venous lactate measurements with a handheld device compared to venous blood-gas analysis for emergency patients. Scand J Trauma Resusc Emerg Med 2018; 26(1): 47.
[53] Park H, Ko DH, Kim JQ, Song SH. [Performance evaluation of the piccolo xpress Point-of-care chemistry analyzer]. Korean J Lab Med 2009; 29(5): 430-8. [Performance evaluation of the Piccolo xpress Point-of-care Chemistry Analyzer].
[54] Murata K, Glaser L, Nardiello M, Ramanathan LV, Carlow DC. Data from the analytical performance of the Abaxis Piccolo Xpress point of care analyzer in whole blood, serum, and plasma. Data Brief 2017; 16: 81-9.
[55] Shephard MD, Mazzachi BC, Shephard AK. Comparative performance of two point-of-care analysers for lipid testing. Clin Lab 2007; 53(9-12): 561-6.
[56] Lartey A, Marquis GS, Aryeetey R, Nti H. Lipid profile and dyslipidemia among school-age children in urban Ghana. BMC Public Health 2018; 18(1): 320.
[57] Bastianelli K, Ledin S, Chen J. Comparing the accuracy of 2 point-of-care lipid testing devices. J Pharm Pract 2017; 30(5): 490-7.
[58] Park PH, Chege P, Hagedorn IC, Kwena A, Bloomfield GS, Pastakia SD. Assessing the accuracy of a point-of-care analyzer for hyperlipidaemia in western Kenya. Trop Med Int Health 2016; 21(3): 437-44.
[59] Donato LJ, Deobald GR, Wockenfus AM, Hornseth JM, Saenger AK, Karon BS. Comparison of two point of care devices for capillary lipid screening in fasting and postprandial adults. Clin Biochem 2015; 48(3): 174-6.
[60] Mistral T, Boué Y, Bosson JL, et al. Performance of point-of-care international normalized ratio measurement to diagnose trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med 2017; 25(1): 59.
[61] Rapi S, Bazzini C, Tozzetti C, Sbolci V, Modesti PA. Point-of-care testing of cholesterol and triglycerides for epidemiologic studies: evaluation of the multicare-in system. Transl Res 2009; 153(2): 71-6.
[62] Urwyler N, Staub E, Staub LP, et al. Point-of-care prothrombin time testing in paediatric intensive care: An observational study of the ease of use of two devices. Eur J Anaesthesiol 2012; 29(2): 75-81.
[63] Lawrie AS, Hills J, Longair I, et al. The clinical significance of differences between point-of-care and laboratory INR methods in over-anticoagulated patients. Thromb Res 2012; 130(1): 110-4.
[64] Hur M, Kim H, Park CM, et al. Comparison of international normalized ratio measurement between CoaguChek XS Plus and STA-R coagulation analyzers. BioMed Res Int 2013; 2013213109
[65] Meneghelo ZM, Barroso CM, Liporace IL, Cora AP. Comparison of the international normalized ratio levels obtained by portable coagulometer and laboratory in a clinic specializing in oral anticoagulation. Int J Lab Hematol 2015; 37(4): 536-43.
[66] Riva N, Vella K, Meli S, et al. A comparative study using thrombin generation and three different INR methods in patients on Vitamin K antagonist treatment. Int J Lab Hematol 2017; 39(5): 482-8.
[67] Baker WS, Albright KJ, Berman M, et al. POCT PT INR - Is it adequate for patient care? A comparison of the Roche Coaguchek XS vs. Stago Star vs. Siemens BCS in patients routinely seen in an anticoagulation clinic. Clin Chim Acta 2017; 472: 139-45.
[68] Beynon C, Erk AG, Potzy A, Mohr S, Popp E. Point of care coagulometry in prehospital emergency care: An observational study. Scand J Trauma Resusc Emerg Med 2015; 23: 58.
[69] Biedermann JS, Leebeek FW, Buhre PN, et al. Agreement between Coaguchek XS and STA-R Evolution (Hepato Quick) INR results depends on the level of INR. Thromb Res 2015; 136(3): 652-7.
[70] Hegener MA, Li H, Han D, Steckl AJ, Pauletti GM. Point-of-care coagulation monitoring: First clinical experience using a paper-based lateral flow diagnostic device. Biomed Microdevices 2017; 19(3): 64.
[71] Hsu DP, French AJ, Madson SL, Palmer JM, Gidvani-Diaz V. Evaluation of a noninvasive hemoglobin measurement device to screen for anemia in infancy. Matern Child Health J 2016; 20(4): 827-32.
[72] Nusa D, Harvey I, Almansouri AY, et al. Assessment of point-of-care measurement of international normalised ratio using the CoaguChek XS Plus system in the setting of acute ischaemic stroke. Intern Med J 2013; 43(11): 1205-9.
[73] Fu CH, Chen WT, Chang PY, Lee MT, Wen MS. Revalidation of CoaguChek XS plus system for INR monitoring in Taiwanese patients: effects of clinical and genetic factors. Biomed J 2014; 37(6): 380-5.
[74] Richter C, Taylor J, Wright J, Fletcher B. Clinical validation of R-T estimation for coaguChek XS INR results. Ann Pharmacother 2016; 50(8): 645-8.
[75] Wee HE, Sin KY, Chiang P, Guo KW. Validation of the use of a point-of-care device in monitoring the international normalised ratio in postoperative cardiac patients. Ann Acad Med Singapore 2016; 45(9): 424-6.
[76] Markham R, Challa A, Kyranis S, et al. Point-of-care INR compared to laboratory INR in patients supported with a continuous flow left ventricular assist device. Int J Cardiol 2016; 221: 652-3.
[77] Würtz M, Hvas AM, Wulff LN, Kristensen SD, Grove EL. Shear-induced platelet aggregation in aspirin-treated patients: initial experience with the novel PlaCor PRT device. Thromb Res 2012; 130(5): 753-8.
[78] Johnson GJ, Sharda AV, Rao GH, Ereth MH, Laxson DD, Owen WG. Measurement of shear-activated platelet aggregate formation in non-anticoagulated blood: utility in detection of clopidogrel-aspirin-induced platelet dysfunction. Clin Appl Thromb Hemost 2012; 18(2): 140-9.
[79] Lordkipanidzé M, Pharand C, Nguyen TA, Schampaert E, Diodati JG. Assessment of VerifyNow P2Y12 assay accuracy in evaluating clopidogrel-induced platelet inhibition. Ther Drug Monit 2008; 30(3): 372-8.
[80] Lv HH, Wu S, Liu X, et al. Comparison of VerifyNow P2Y12 and thrombelastography for assessing clopidogrel response in stroke patients in China. Neurol Sci 2016; 37(2): 277-82.
[81] Scalambrino E, Padovan L, Clerici M, et al. Thromboelastometry. Reproducibility of duplicate measurement performed by the RoTem® device. Thromb Res 2018; 172: 139-41.
[82] Serena B, Mariangela P, Annarosa F, Davide G, Simona C, Serafina B, et al. Determination of Plasma Antioxidant Power in Capillary Blood through the Innovative system PAT (Plasma Antioxidant Test). Free Radic Antioxid 2018; 8(2): 149-52.
[83] de Graaf AJ, Hiemstra SW, Kemna EWM, Krabbe JG. Evaluation of a POCT device for C-reactive protein, hematocrit and leukocyte differential. Clin Chem Lab Med 2017; 55(11): e251-3.
[84] Ben-Yosef Y, Marom B, Hirshberg G, D’Souza C, Larsson A, Bransky A. The HemoScreen, a novel haematology analyser for the point of care. J Clin Pathol 2016; 69(8): 720-5.
[85] Bridges E, Hatzfeld JJ. Noninvasive Continuous Hemoglobin Monitoring in Combat Casualties: A Pilot Study. Shock 2016; 46(3)(Suppl. 1): 55-60.
[86] Colon-Franco JM, Lo SF, Tarima SS, Gourlay D, Drendel AL, Brook Lerner E. Validation of a hand-held point of care device for lactate in adult and pediatric patients using traditional and locally-smoothed median and maximum absolute difference curves. Clin Chim Acta 2017; 468: 145-9.
[87] Shamah Levy T, Méndez-Gómez-Humarán I, Morales Ruán MD, Martinez Tapia B, Villalpando Hernández S, Hernández Ávila M. Validation of Masimo Pronto 7 and HemoCue 201 for hemoglobin determination in children from 1 to 5 years of age. PLoS One 2017; 12(2)e0170990
[88] Oyaert M, Boel A, Jacobs J, et al. Analytical performance and diagnostic accuracy of six different faecal calprotectin assays in inflammatory bowel disease. Clin Chem Lab Med 2017; 55(10): 1564-73.
[89] Delefortrie Q, Schatt P, Grimmelprez A, et al. Comparison of the Liaison® Calprotectin kit with a well established point of care test (Quantum Blue - Bühlmann-Alere®) in terms of analytical performances and ability to detect relapses amongst a Crohn population in follow-up. Clin Biochem 2016; 49(3): 268-73.
[90] Labaere D, Smismans A, Van Olmen A, et al. Comparison of six different calprotectin assays for the assessment of inflammatory bowel disease. United European Gastroenterol J 2014; 2(1): 30-7.
[91] Olatunya O, Ogundare O, Olaleye A, et al. Point-of-Care Testing for Anaemia in Children Using Portable Haematocrit Meter: A Pilot Study from Southwest Nigeria and Implications for Developing Countries. Ethiop J Health Sci 2016; 26(3): 251-8.
[92] Goulet ED, Asselin A. Reliability and validity of a low cost, pocket-sized and battery operated sodium analyzer in measuring urinary sodium concentration. Technol Health Care 2015; 23(6): 881-91.
[93] Kutz A, Hausfater P, Oppert M, et al. Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods - a prospective multinational trial. Clin Chem Lab Med 2016; 54(4): 577-84.
[94] Kwon HJ, Lee J, Park HI, Han K. Evaluation of a novel point-of-care test kit, ABSOGEN™ PCT, in semi-quantitative measurement of procalcitonin in whole blood. J Clin Lab Anal 2017; 31(6)
[95] Lim J, Kim H, Koo SH, Kwon GC. Evaluation of the LABGEO PT10 Point-Of-Care Testing Device: Comparison of Analyte Measurements in Capillary Whole Blood and Lithium Heparin Whole Blood Samples With Those in Central Laboratory. J Clin Lab Anal 2017; 31(3)
[96] Mace HS, Lightfoot NJ, Cordero-Rochet MJ, Srinivas C, Karkouti K, McCluskey SA. Reliability of a point-of-care device for international normalized ratio testing during the three surgical phases of orthotopic liver transplantation: A retrospective observational study. Can J Anaesth 2015; 62(3): 258-64.
[97] Miles LF, Giraud K, Ferris R, et al. Evaluation of a novel in-line point-of-care blood gas analyser. Anaesthesia 2016; 71(9): 1044-52.
[98] Shirtcliff EA, Buck RL, Laughlin MJ, Hart T, Cole CR, Slowey PD. Salivary cortisol results obtainable within minutes of sample collection correspond with traditional immunoassays. Clin Ther 2015; 37(3): 505-14.
[99] Sen I, Stephen E, Agarwal S, Rebekah G, Nair SC. Analytical performance of a point-of-care device in monitoring patients on oral anticoagulation with vitamin K antagonists. Phlebology 2016; 31(9): 660-7.
[100] Srivastava A, Koul V, Dwivedi SN, Upadhyaya AD, Ahuja A, Saxena R. Performance analysis of newly developed point-of-care hemoglobinometer (TrueHb) against an automated hematology analyzer (Sysmex XT 1800i) in terms of precision in hemoglobin measurement. Int J Lab Hematol 2015; 37(4): 483-5.
[101] Singh A, Dubey A, Sonker A, Chaudhary R. Evaluation of various methods of point-of-care testing of haemoglobin concentration in blood donors. Blood Transfus 2015; 13(2): 233-9.
[102] Hu J, Cui X, Gong Y, et al. Portable microfluidic and smartphone-based devices for monitoring of cardiovascular diseases at the point of care. Biotechnol Adv 2016; 34(3): 305-20.
[103] van den Besselaar AM, van der Meer FJ, Abdoel CF, Witteveen E. Analytical accuracy and precision of two novel Point-of-Care systems for INR determination. Thromb Res 2015; 135(3): 526-31.
[104] Braham S, Novembrino C, Moia M, Torresani E, Tripodi A. Evaluation of a new PT-INR monitoring system in patients with the antiphospholipid syndrome. Int J Lab Hematol 2016; 38(5): 497-504.
[105] Nguyen-Khoa T, Borgard JP, Miled R, Rota M. Sweat chloride measurement using direct potentiometry: Spotchem(®) (Elitech-Arkray) evaluation and comparison with coulometry and conductivity. Ann Biol Clin (Paris) 2013; 71(4): 443-8.
[106] Schot MJ, van Delft S, Kooijman-Buiting AM, de Wit NJ, Hopstaken RM. Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice. BMJ Open 2015; 5(5)e006857
[107] Decavele AS, Fiers T, Penders J, Delanghe JR. A sensitive quantitative test strip based point-of-care albuminuria screening assay. Clin Chem Lab Med 2012; 50(4): 673-8.
[108] Kumar A, Debata PK, Ranjan A, Gaind R. The role and reliability of rapid bedside diagnostic test in early diagnosis and treatment of bacterial meningitis. Indian J Pediatr 2015; 82(4): 311-4.
[109] Kaneko K, Kimata T, Tsuji S, et al. Measurement of urinary 8-oxo-7,8-dihydro-2-deoxyguanosine in a novel point-of-care testing device to assess oxidative stress in children. Clin Chim Acta 2012; 413(23-24): 1822-6.
[110] Dupuy AM, Chevrier Q, Olejnik Y, Bargnoux AS, Badiou S, Cristol JP. Analytical evaluation of point-of-care procalcitonin (PCT) and clinical performances in an unselected population as compared with central lab PCT assay. Clin Chem Lab Med 2017; 55(8): e167-71.
[111] Paraskos J, Berke Z, Cook J, et al. An analytical comparison between point-of-care uric acid testing meters. Expert Rev Mol Diagn 2016; 16(3): 373-82.
[112] Ryan ML, Maxwell AC, Manning L, et al. Noninvasive hemoglobin measurement in pediatric trauma patients. J Trauma Acute Care Surg 2016; 81(6): 1162-6.
[113] Marrocco A, Cristol JP, Boularan AM. Setting up of 15 POC blood gas analyzers at Montpellier Hosptital (France). Ann Biol Clin (Paris) 2016; 74(1): 79-92.
[114] Diagnostics S. Available from:
[115] Tonyushkina K, Nichols JH. Glucose meters: A review of technical challenges to obtaining accurate results. J Diabetes Sci Technol 2009; 3(4): 971-80.
[116] Gubala V, Harris LF, Ricco AJ, Tan MX, Williams DE. Point of care diagnostics: Status and future. Anal Chem 2012; 84(2): 487-515.
[117] O’Kane MJ. The accuracy of point-of-care glucose measurement. Ann Clin Biochem 2012; 49(Pt 2): 108-9.
[118] Hopf S, Graf B, Gruber M. Comparison of point-of-care testing glucose results from intensive care patients measured with network-ready devices. Diabetes Technol Ther 2011; 13(10): 1047-56.
[119] Vanavanan S, Santanirand P, Chaichanajarernkul U, et al. Performance of a new interference-resistant glucose meter. Clin Biochem 2010; 43(1-2): 186-92.
[120] Vučić Lovrenčić M, Radišić Biljak V, Božičević S, Pape-Medvidović E, Ljubić S. Validation of Point-of-Care Glucose Testing for Diagnosis of Type 2 Diabetes. Int J Endocrinol 2013; 2013206309
[121] Lv H, Zhang GJ, Kang XX, et al. Factors interfering with the accuracy of five blood glucose meters used in Chinese hospitals. J Clin Lab Anal 2013; 27(5): 354-66.
[122] Lindquist KA, Chow K, West A, et al. The StatStrip glucose monitor is suitable for use during hyperinsulinemic euglycemic clamps in a pediatric population. Diabetes Technol Ther 2014; 16(5): 298-302.
[123] Karon BS, Blanshan CT, Deobald GR, Wockenfus AM. Retrospective evaluation of the accuracy of Roche AccuChek Inform and Nova StatStrip glucose meters when used on critically ill patients. Diabetes Technol Ther 2014; 16(12): 828-32.
[124] Nuntnarumit P, Chittamma A, Pongmee P, Tangnoo A, Goonthon S. Clinical performance of the new glucometer in the nursery and neonatal intensive care unit. Pediatr Int 2011; 53(2): 218-23.
[125] Lockyer MG, Fu K, Edwards RM, et al. Evaluation of the Nova StatStrip glucometer in a pediatric hospital setting. Clin Biochem 2014; 47(9): 840-3.
[126] Rabiee A, Magruder JT, Grant C, et al. Accuracy and reliability of the Nova StatStrip® glucose meter for real-time blood glucose determinations during glucose clamp studies. J Diabetes Sci Technol 2010; 4(5): 1195-201.
[127] Rewers A, McFann K, Chase HP. Bedside monitoring of blood beta-hydroxybutyrate levels in the management of diabetic ketoacidosis in children. Diabetes Technol Ther 2006; 8(6): 671-6.
[128] Yu HY, Agus M, Kellogg MD. Clinical utility of Abbott Precision Xceed Pro® ketone meter in diabetic patients. Pediatr Diabetes 2011; 12(7): 649-55.
[129] Mitsios JV, Ashby LA, Haverstick DM, Bruns DE, Scott MG. Analytic evaluation of a new glucose meter system in 15 different critical care settings. J Diabetes Sci Technol 2013; 7(5): 1282-7.
[130] Akinbami F, Segal S, Schnipper JL, Stopfkuchen-Evans M, Mills J, Rogers SO Jr. Tale of two sites: Capillary versus arterial blood glucose testing in the operating room. Am J Surg 2012; 203(4): 423-7.
[131] Segerhag E, Gyberg V, Ioannides K, et al. Accuracy of a Simplified Glucose Measurement Device--The HemoCue Glucose 201RT. Diabetes Technol Ther 2015; 17(10): 755-8.
[132] Zueger T, Schuler V, Stettler C, Diem P, Christ ER. Assessment of three frequently used blood glucose monitoring devices in clinical routine. Swiss Med Wkly 2012; 142w13631
[133] Shahim B, Kjellström B, Gyberg V, Jennings C, Smetana S, Rydén L. The Accuracy of Point-of-Care Equipment for Glucose Measurement in Screening for Dysglycemia in Patients with Coronary Artery Disease. Diabetes Technol Ther 2018; 20(9): 596-602.
[134] Freckmann G, Link M, Schmid C, Pleus S, Baumstark A, Haug C. System accuracy evaluation of different blood glucose monitoring systems following ISO 15197:2013 by using two different comparison methods. Diabetes Technol Ther 2015; 17(9): 635-48.
[135] Luijf YM, Avogaro A, Benesch C, et al. Continuous glucose monitoring accuracy results vary between assessment at home and assessment at the clinical research center. J Diabetes Sci Technol 2012; 6(5): 1103-6.
[136] Krinsley J, Bochicchio K, Calentine C, Bochicchio G. Glucose measurement of intensive care unit patient plasma samples using a fixed-wavelength mid-infrared spectroscopy system. J Diabetes Sci Technol 2012; 6(2): 294-301.
[137] Brazg RL, Bailey TS, Garg S, et al. The ASPIRE study: design and methods of an in-clinic crossover trial on the efficacy of automatic insulin pump suspension in exercise-induced hypoglycemia. J Diabetes Sci Technol 2011; 5(6): 1466-71.
[138] Percival MW, Bevier WC, Wang Y, et al. Modeling the effects of subcutaneous insulin administration and carbohydrate consumption on blood glucose. J Diabetes Sci Technol 2010; 4(5): 1214-28.
[139] Peet AC, Kennedy DM, Hocking MD, Ewer AK. Near-patient testing of blood glucose using the Bayer Rapidlab 860 analyser in a regional neonatal unit. Ann Clin Biochem 2002; 39(Pt 5): 502-8.
[140] Larsen CL, Jackson C, Lyon ME. Interference of Accel wipes with LifeScan SureStep Flexx glucose meters. Clin Biochem 2006; 39(4): 414-6.
[141] Razi F, Nasli Esfahani E, Rahnamaye Farzami M, et al. Effect of the different assays of HbA1c on diabetic patients monitoring. J Diabetes Metab Disord 2015; 14: 65.
[142] Alawad AO, Merghani TH, Ballal MA. Resting metabolic rate in obese diabetic and obese non-diabetic subjects and its relation to glycaemic control. BMC Res Notes 2013; 6: 382.
[143] Mohammadzadeh G, Zarghami N. Hypoadiponectinemia in obese subjects with type II diabetes: A close association with central obesity indices. J Res Med Sci 2011; 16(6): 713-23.
[144] Pereira AJ, Corrêa TD, de Almeida FP, et al. Inaccuracy of Venous Point-of-Care Glucose Measurements in Critically Ill Patients: A Cross-Sectional Study. PLoS One 2015; 10(6)e0129568
[145] Newman JD, Ramsden CA, Balazs ND. Monitoring neonatal hypoglycemia with the Accu-chek advantage II glucose meter: The cautionary tale of galactosemia. Clin Chem 2002; 48(11): 2071.
[146] Miendje Deyi VY, Philippe M, Alexandre KC, De Nayer P, Hermans MP. Performance evaluation of the Precision PCx point-of-care blood glucose analyzer using discriminant ratio methodology. Clin Chem Lab Med 2002; 40(10): 1052-5.
[147] Raizman JE, Shea J, Daly CH, et al. Clinical impact of improved point-of-care glucose monitoring in neonatal intensive care using Nova StatStrip: Evidence for improved accuracy, better sensitivity, and reduced test utilization. Clin Biochem 2016; 49(12): 879-84.
[148] Health Quality O. Health Quality Ontario. Point-of-Care Hemoglobin A1c Testing: An Evidence-Based Analysis. Ont Health Technol Assess Ser 2014; 14(8): 1-30.
[149] Valdez-González LA, Méndez-Padrón A, Gómez-Díaz RA, et al. Agreement between the ‘point of care’ tests for microalbuminuria and HbA1c performed in mexican family medicine units and the results of standard laboratory tests. Scand J Clin Lab Invest 2018; 78(1-2): 87-93.
[150] Tanyanyiwa D, Dandara C, Bhana SA, et al. Implementation of POCT in the diabetic clinic in a large hospital. Afr Health Sci 2015; 15(3): 902-7.
[151] Walta AM, Keltanen T, Lindroos K, Sajantila A. The usefulness of point-of-care (POC) tests in screening elevated glucose and ketone body levels postmortem. Forensic Sci Int 2016; 266: 299-303.
[152] Jeong TD, Cho EJ, Shim Y, et al. Accuracy assessment of three different lots of the LABGEO PT hemoglobin A1c test using reference materials. Ann Clin Lab Sci 2016; 46(1): 72-7.
[153] Wang Y, Peng W, Tang J, et al. Verification of a novel point-of-care HbA1c device in real world clinical practice by comparison to three high performance liquid chromatography instruments. Biochem Med (Zagreb) 2018; 28(2)020705
[154] Scarr D, Lovblom LE, Cardinez N, et al. Validity of a point-of-care nerve conduction device for polyneuropathy identification in older adults with diabetes: Results from the Canadian Study of Longevity in Type 1 Diabetes. PLoS One 2018; 13(4)e0196647
[155] King K, Grazette LP, Paltoo DN, et al. Point-of-Care Technologies for Precision Cardiovascular Care and Clinical Research: National Heart, Lung, and Blood Institute Working Group. JACC Basic Transl Sci 2016; 1(1-2): 73-86.
[156] Amundson BE, Apple FS. Cardiac troponin assays: A review of quantitative point-of-care devices and their efficacy in the diagnosis of myocardial infarction. Clin Chem Lab Med 2015; 53(5): 665-76.
[157] Apple FS, Murakami MM. The diagnostic utility of cardiac biomarkers in detecting myocardial infarction. Clin Cornerstone 2005; 7(Suppl. 1): S25-30.
[158] Morrison LK, Harrison A, Krishnaswamy P, Kazanegra R, Clopton P, Maisel A. Utility of a rapid B-natriuretic peptide assay in differentiating congestive heart failure from lung disease in patients presenting with dyspnea. J Am Coll Cardiol 2002; 39(2): 202-9.
[159] Freyburger G, Reboul MP, Labrouche S, Saillour F, Grenier N. Diagnosis accuracy of a new challenger for thrombosis exclusion, the Stratus CS DDMR. Clin Chim Acta 2005; 354(1-2): 181-9.
[160] Guo X, Feng J, Guo H. The predictive value of the bedside troponin T test for patients with acute chest pain. Exp Clin Cardiol 2006; 11(4): 298-301.
[161] Christenson RH, Azzazy HM. Cardiac point of care testing: A focused review of current National Academy of Clinical Biochemistry guidelines and measurement platforms. Clin Biochem 2009; 42(3): 150-7.
[162] Apple FS, Murakami MM, Christenson RH, et al. Analytical performance of the i-STAT cardiac troponin I assay. Clin Chim Acta 2004; 345(1-2): 123-7.
[163] Peacock WF, Diercks D, Birkhahn R, et al. Can a point-of-care troponin I assay be as good as a central laboratory assay? A MIDAS investigation. Ann Lab Med 2016; 36(5): 405-12.
[164] Ezekowitz JA, Welsh RC, Weiss D, et al. Providing rapid out of hospital acute cardiovascular treatment 4 (PROACT-4). J Am Heart Assoc 2015; 4(12)e002859
[165] Mion MM, Bragato G, Casarotti A, et al. Clinical performance of cardiac Troponin I: A comparison between the POCT AQT90 FLEX and the Dimension Vista analyzer in an emergency setting. Clin Biochem 2017; 50(13-14): 763-7.
[166] Greiser A, Winter T, Mahfoud H, et al. The 99th percentile and imprecision of point-of-care cardiac troponin I in comparison to central laboratory tests in a large reference population. Clin Biochem 2017; 50(18): 1198-202.
[167] Wu AH, Smith A, Christenson RH, Murakami MM, Apple FS. Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction. Clin Chim Acta 2004; 346(2): 211-9.
[168] Goldmann BU, Langenbrink L, Matschuck G, et al. Quantitative bedside testing of troponin T: Is it equal to laboratory testing? The Cardiac Reader Troponin T (CARE T) study. Clin Lab 2004; 50(1-2): 1-10.
[169] Ishida J, Suzuki T, Aizawa K, Sawaki D, Nagai R. Comparison of analytical performance of two single-step measurement devices of B-type natriuretic Peptide. Int Heart J 2012; 53(5): 320-3.
[170] Peetz D, Schweigert R, Jachmann N, Post F, Schinzel H, Lackner KJ. Method comparison of cardiac marker assays on PATHFAST, StratusCS, AxSYM, Immulite 2000, triage, elecsys and cardiac reader. Clin Lab 2006; 52(11-12): 605-14.
[171] Hex C, Smeets M, Penders J, et al. Accuracy, user-friendliness and usefulness of the Cobas h232 point-of-care test for NT-proBNP in primary care. J Clin Pathol 2018; 71(6): 539-45.
[172] Joseph J, Thrivikraman AS, Radhakrishnan R, Sivaprakasam M. ARTSENSTouch--A portable device for evaluation of carotid artery stiffness. Conf Proc IEEE Eng Med Biol Soc 2015; 2015: 3755-8.
[173] Würtz M, Hvas AM, Christensen KH, Rubak P, Kristensen SD, Grove EL. Rapid evaluation of platelet function using the Multiplate® Analyzer. Platelets 2014; 25(8): 628-33.
[174] Niemz A, Ferguson TM, Boyle DS. Point-of-care nucleic acid testing for infectious diseases. Trends Biotechnol 2011; 29(5): 240-50.
[175] Laursen L. Point-of-care tests poised to alter course of HIV treatment. Nat Med 18 United States 2012; 1156.
[176] Adams S, Luo W, Wesolowski L, et al. Performance evaluation of the point-of-care INSTI™ HIV-1/2 antibody test in early and established HIV infections. J Clin Virol 2017; 91: 90-4.
[177] Ndjoyi-Mbiguino A, Nzengui Nzengui GF, Robin L, M’Boyis Kamdem H, Bélec L. Performance of rapid HIV-1/HIV-2 INSTI on plasma and capillary blood for serological diagnosis of non B subtypes and circulating recombinant forms of HIV-1 in Gabon. Med Mal Infect 2015; 45(8): 339-40.
[178] Givens M, Weaver A, Bickman S, et al. Near patient CD4 count in a hospitalized HIV patient population. Cytometry B Clin Cytom 2017; 92(6): 451-5.
[179] Luchters S, Technau K, Mohamed Y, et al. Field performance and diagnostic accuracy of a low-cost instrument-free point-of-care CD4 test (Visitect CD4) performed by different health worker cadres among pregnant women. J Clin Microbiol 2019; 57(2)e01277-18
[180] Hsiao NY, Dunning L, Kroon M, Myer L. Laboratory evaluation of the alere q point-of-care system for early infant HIV diagnosis. PLoS One 2016; 11(3)e0152672
[181] Dunning L, Kroon M, Hsiao NY, Myer L. Field evaluation of HIV point-of-care testing for early infant diagnosis in Cape Town, South Africa. PLoS One 2017; 12(12)e0189226
[182] Chang M, Steinmetzer K, Raugi DN, et al. Detection and differentiation of HIV-2 using the point-of-care Alere q HIV-1/2 Detect nucleic acid test. J Clin Virol 2017; 97: 22-5.
[183] Young S, Illescas P, Nicasio J, Sickler JJ. Diagnostic accuracy of the real-time PCR cobas® Liat® Influenza A/B assay and the Alere i Influenza A&B NEAR isothermal nucleic acid amplification assay for the detection of influenza using adult nasopharyngeal specimens. J Clin Virol 2017; 94: 86-90.
[184] Melchers WJG, Kuijpers J, Sickler JJ, Rahamat-Langendoen J. Lab-in-a-tube: Real-time molecular point-of-care diagnostics for influenza A and B using the cobas® Liat® system. J Med Virol 2017; 89(8): 1382-6.
[185] Gibson J, Schechter-Perkins EM, Mitchell P, et al. Multi-center evaluation of the cobas® Liat® Influenza A/B & RSV assay for rapid point of care diagnosis. J Clin Virol 2017; 95: 5-9.
[186] Chen L, Tian Y, Chen S, Liesenfeld O. Performance of the Cobas(®) Influenza A/B assay for rapid Pcr-Based detection of influenza compared to prodesse proFlu+ and viral culture. Eur J Microbiol Immunol (Bp) 2015; 5(4): 236-45.
[187] Ritchie AV, Ushiro-Lumb I, Edemaga D, et al. SAMBA HIV semiquantitative test, a new point-of-care viral-load-monitoring assay for resource-limited settings. J Clin Microbiol 2014; 52(9): 3377-83.
[188] Goel N, Ritchie AV, Mtapuri-Zinyowera S, et al. Performance of the SAMBA I and II HIV-1 Semi-Q Tests for viral load monitoring at the point-of-care. J Virol Methods 2017; 244: 39-45.
[189] Guillon G, Yearwood G, Snipes C, Boschi D, Reed MR. Human anti-HIV IgM detection by the OraQuick ADVANCE(R) Rapid HIV 1/2 Antibody Test. PeerJ 2018; 6e4430
[190] Stekler JD, Ure G, O’Neal JD, et al. Performance of determine combo and other point-of-care HIV tests among Seattle MSM. J Clin Virol 2016; 76: 8-13.
[191] Parisi MR, Tecco S, Gastaldi G, et al. Point-of-care testing for hepatitis C virus infection at alternative and high-risk sites: an Italian pilot study in a dental clinic. New Microbiol 2017; 40(4): 242-5.
[192] Shivkumar S, Peeling R, Jafari Y, Joseph L, Pant Pai N. Accuracy of rapid and point-of-care screening tests for hepatitis C: A systematic review and meta-analysis. Ann Intern Med 2012; 157(8): 558-66.
[193] Gaitán-Duarte HG, Newman L, Laverty M, et al. Comparative effectiveness of single and dual rapid diagnostic tests for syphilis and HIV in antenatal care services in Colombia. Rev Panam Salud Publica 2016; 40(6): 455-61.
[194] Masciotra S, Price KA, Sprinkle P, Wesolowski L, Owen SM. Performance evaluation of the CHEMBIO DPP® (dual path platform) HIV-1/2 assay in early and established infections. J Clin Virol 2015; 70: 97-100.
[195] Mane A, Sacks J, Sharma S, et al. Evaluation of five rapid diagnostic tests for detection of antibodies to hepatitis C virus (HCV): A step towards scale-up of HCV screening efforts in India. PLoS One 2019; 14(1)e0210556
[196] Scalioni LdeP, Cruz HM, de Paula VS, et al. Performance of rapid hepatitis C virus antibody assays among high- and low-risk populations. J Clin Virol 2014; 60(3): 200-5.
[197] da Rosa L, Dantas-Corrêa EB, Narciso-Schiavon JL, Schiavon LdeL. Diagnostic Performance of Two Point-of-Care Tests for Anti-HCV Detection. Hepat Mon 2013; 13(9)e12274
[198] Khuroo MS, Khuroo NS, Khuroo MS. Diagnostic accuracy of point-of-care tests for hepatitis C virus infection: A systematic review and meta-analysis. PLoS One 2015; 10(3)e0121450
[199] Tang W, Chen W, Amini A, et al. Diagnostic accuracy of tests to detect Hepatitis C antibody: A meta-analysis and review of the literature. BMC Infect Dis 2017; 17(Suppl. 1): 695.
[200] Kim MH, Kang SY, Lee WI. Evaluation of a new rapid test kit to detect hepatitis C virus infection. J Virol Methods 2013; 193(2): 379-82.
[201] Poovorawan Y, Theamboonlers A, Chumdermpadetsuk S, Thong CP. Comparative results in detection of HCV antibodies by using a rapid HCV test, ELISA and immunoblot. Southeast Asian J Trop Med Public Health 1994; 25(4): 647-9.
[202] Yuen MF, Hui CK, Yuen JC, Young JL, Lai CL. The accuracy of SM-HCV rapid test for the detection of antibody to hepatitis C virus. Am J Gastroenterol 2001; 96(3): 838-41.
[203] Montebugnoli L, Borea G, Miniero R, Sprovieri G. A rapid test for the visual detection of anti-hepatitis C virus antibodies in whole blood. Clin Chim Acta 1999; 288(1-2): 91-6.
[204] Townsend MB, MacNeil A, Reynolds MG, et al. Evaluation of the Tetracore Orthopox BioThreat® antigen detection assay using laboratory grown orthopoxviruses and rash illness clinical specimens. J Virol Methods 2013; 187(1): 37-42.
[205] De Witte E, Goossens H, Ieven M. Evaluation of the ESPLINE® Influenza A & B-N assay for the detection of influenza A and B in nasopharyngeal aspirates. Eur J Clin Microbiol Infect Dis 2012; 31(5): 761-6.
[206] de la Tabla VO, Antequera P, Masiá M, et al. Clinical evaluation of rapid point-of-care testing for detection of novel influenza A (H1N1) virus in a population-based study in Spain. Clin Microbiol Infect 2010; 16(9): 1358-61.
[207] Boyanton BL Jr, Almradi A, Mehta T, Robinson-Dunn B. Performance of the Directigen EZ Flu A+B rapid influenza diagnostic test to detect pandemic influenza A/H1N1 2009. Diagn Microbiol Infect Dis 2014; 78(4): 360-2.
[208] Karre T, Maguire HF, Butcher D, Graepler A, Weed D, Wilson ML. Comparison of Becton Dickinson Directigen EZ Flu A+B test against the CDC real-time PCR assay for detection of 2009 pandemic influenza A/H1N1 virus. J Clin Microbiol 2010; 48(1): 343-4.
[209] Yuan Q, Cheng XD, Yang BC, et al. Differential diagnosis of pandemic (H1N1) 2009 infection by detection of haemagglutinin with an enzyme-linked immunoassay. Clin Microbiol Infect 2011; 17(10): 1574-80.
[210] Velasco JM, Montesa-Develos ML, Jarman RG, et al. Evaluation of QuickVue influenza A+B rapid test for detection of pandemic influenza A/H1N1 2009. J Clin Virol 2010; 48(2): 120-2.
[211] Bose ME, Sasman A, Mei H, et al. Analytical reactivity of 13 commercially available rapid influenza diagnostic tests with H3N2v and recently circulating influenza viruses. Influenza Other Respir Viruses 2014; 8(4): 474-81.
[212] Paulson J. 3M Rapid Detection Flu A + B Test: A new diagnostic test for rapid detection of influenza A and influenza B. Mol Diagn Ther 2009; 13(1): 15-8.
[213] Antoniol S, Fidouh N, Ghazali A, et al. Emergency Department study group on respiratory viruses. Diagnostic performances of the Xpert® Flu PCR test and the OSOM® immunochromatographic rapid test for influenza A and B virus among adult patients in the Emergency Department. J Clin Virol 2018; 99-100: 5-9.
[214] Keitel K, Wagner N, Lacroix L, Manzano S, Gervaix A. Performance characteristics of a rapid immunochromatographic assay for detection of pandemic influenza A (H1N1) virus in children. Eur J Pediatr 2011; 170(4): 511-7.
[215] Ghebremedhin B, Engelmann I, König W, König B. Comparison of the performance of the rapid antigen detection actim Influenza A&B test and RT-PCR in different respiratory specimens. J Med Microbiol 2009; 58(Pt 3): 365-70.
[216] Steininger C, Redlberger M, Graninger W, Kundi M, Popow-Kraupp T. Near-patient assays for diagnosis of influenza virus infection in adult patients. Clin Microbiol Infect 2009; 15(3): 267-73.
[217] Reynders M, De Foor M, Maaroufi Y, et al. Prospective evaluation of Coris Influ-A&B Respi-Strip and of BinaxNOW Influenza A&B assay against viral culture and real-time PCR assay for detection of 2009 pandemic influenza A/H1N1v in Belgian patients. Acta Clin Belg 2012; 67(2): 94-8.
[218] Hurt AC, Alexander R, Hibbert J, Deed N, Barr IG. Performance of six influenza rapid tests in detecting human influenza in clinical specimens. J Clin Virol 2007; 39(2): 132-5.
[219] Blacksell SD, Jarman RG, Bailey MS, et al. Evaluation of six commercial point-of-care tests for diagnosis of acute dengue infections: the need for combining NS1 antigen and IgM/IgG antibody detection to achieve acceptable levels of accuracy. Clin Vaccine Immunol 2011; 18(12): 2095-101.
[220] Simonnet C, Okandze A, Matheus S, Djossou F, Nacher M, Mahamat A. Prospective evaluation of the SD BIOLINE Dengue Duo rapid test during a dengue virus epidemic. Eur J Clin Microbiol Infect Dis 2017; 36(12): 2441-7.
[221] Stephen S, Charles MV, Anitharaj V, Deepa C, Umadevi S. Early dengue diagnosis by nonstructural protein 1 antigen detection: rapid immunochromotography versus two the enzyme-linked immunosorbent assay kits. Indian J Pathol Microbiol 2014; 57(1): 81-4.
[222] Pok KY, Lai YL, Sng J, Ng LC. Evaluation of nonstructural 1 antigen assays for the diagnosis and surveillance of dengue in Singapore. Vector Borne Zoonotic Dis 2010; 10(10): 1009-16.
[223] Pham MD, Agius PA, Romero L, et al. Performance of point-of-care CD4 testing technologies in resource-constrained settings: A systematic review and meta-analysis. BMC Infect Dis 2016; 16(1): 592.
[224] Faye B, Mbow M, Cheikh Seck M, et al. evaluation of PIMATM CD4 System for decentralization of immunological monitoring of HIV-Infected patients in senegal. PLoS One 2016; 11(5)e0154000
[225] Scott L, Gous N, Carmona S, Stevens W. Laboratory evaluation of the Liat HIV Quant (IQuum) whole-blood and plasma HIV-1 viral load assays for point-of-care testing in South Africa. J Clin Microbiol 2015; 53(5): 1616-21.
[226] Kulkarni S, Jadhav S, Khopkar P, et al. GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India. BMC Infect Dis 2017; 17(1): 506.
[227] Ndlovu Z, Fajardo E, Mbofana E, et al. Multidisease testing for HIV and TB using the GeneXpert platform: A feasibility study in rural Zimbabwe. PLoS One 2018; 13(3)e0193577
[228] Technau KG, Kuhn L, Coovadia A, Murnane PM, Sherman G. Xpert HIV-1 point-of-care test for neonatal diagnosis of HIV in the birth testing programme of a maternity hospital: A field evaluation study. Lancet HIV 2017; 4(10): e442-8.
[229] Shukla MK, Singh N, Sharma RK, Barde PV. Utility of dengue NS1 antigen rapid diagnostic test for use in difficult to reach areas and its comparison with dengue NS1 ELISA and qRT-PCR. J Med Virol 2017; 89(7): 1146-50.
[230] Kuypers J, Boughton G, Chung J, et al. Comparison of the Simplexa HSV1 & 2 Direct kit and laboratory-developed real-time PCR assays for herpes simplex virus detection. J Clin Virol 2015; 62: 103-5.
[231] Gitman MR, Ferguson D, Landry ML. Comparison of Simplexa HSV 1 & 2 PCR with culture, immunofluorescence, and laboratory-developed TaqMan PCR for detection of herpes simplex virus in swab specimens. J Clin Microbiol 2013; 51(11): 3765-9.
[232] Cross RW, Boisen ML, Millett MM, et al. Analytical Validation of the ReEBOV Antigen Rapid Test for Point-of-Care Diagnosis of Ebola Virus Infection. J Infect Dis 2016; 214(Suppl. 3): S210-7.
[233] Broadhurst MJ, Kelly JD, Miller A, et al. ReEBOV Antigen Rapid Test kit for point-of-care and laboratory-based testing for Ebola virus disease: a field validation study. Lancet 2015; 386(9996): 867-74.
[234] Van Den Heuvel A, Smet H, Prat I, et al. Laboratory evaluation of four HIV/syphilis rapid diagnostic tests. BMC Infect Dis 2019; 19(1): 1.
[235] Schnee SV, Pfeil J, Ihling CM, Tabatabai J, Schnitzler P. Performance of the Alere i RSV assay for point-of-care detection of respiratory syncytial virus in children. BMC Infect Dis 2017; 17(1): 767.
[236] Colavita F, Biava M, Mertens P, et al. EBOLA Ag K-SeT rapid test: field evaluation in Sierra Leone. Clin Microbiol Infect 2018; 24(6): 653-7.
[237] Fitzgerald N, Cross M, O’Shea S, Fox J. Diagnosing acute HIV infection at point of care: A retrospective analysis of the sensitivity and specificity of a fourth-generation point-of-care test for detection of HIV core protein p24. Sex Transm Infect 2017; 93(2): 100-1.
[238] Ramos EM, Harb S, Dragavon J, Swenson P, Stekler JD, Coombs RW. Performance of an alternative HIV diagnostic algorithm using the ARCHITECT HIV Ag/Ab Combo assay and potential utility of sample-to-cutoff ratio to discriminate primary from established infection. J Clin Virol 2013; 58(Suppl. 1): e38-43.
[239] Lagare A, Moumouni A, Kaplon J, et al. Diagnostic accuracy of VIKIA® Rota-Adeno and Premier™ Rotaclone® tests for the detection of rotavirus in Niger. BMC Res Notes 2017; 10(1): 505.
[240] Li D, Wilkins K, McCollum AM, et al. Evaluation of the GeneXpert for Human Monkeypox Diagnosis. Am J Trop Med Hyg 2017; 96(2): 405-10.
[241] Makadzange AT, Bogezi C, Boyd K, et al. Evaluation of the FACSPresto, a new point of care device for the enumeration of CD4% and Absolute CD4+ T Cell Counts in HIV Infection. PLoS One 2016; 11(7)e0157546
[242] Gebremicael G, Belay Y, Girma F, et al. The performance of BD FACSPresto™ for CD4 T-cell count, CD4% and hemoglobin concentration test in Ethiopia. PLoS One 2017; 12(4)e0176323
[243] French P. Syphilis. BMJ 2007; 334(7585): 143-7.
[244] Korenromp EL, Rowley J, Alonso M, et al. Global burden of maternal and congenital syphilis and associated adverse birth outcomes-Estimates for 2016 and progress since 2012. PLoS One 2019; 14(2)e0211720
[245] Diaz T, Almeida MG, Georg I, Maia SC, De Souza RV, Markowitz LE. Evaluation of the Determine Rapid Syphilis TP assay using sera. Clin Diagn Lab Immunol 2004; 11(1): 98-101.
[246] Holden J, Goheen J, Jett-Goheen M, Barnes M, Hsieh YH, Gaydos CA. An evaluation of the SD Bioline HIV/syphilis duo test. Int J STD AIDS 2018; 29(1): 57-62.
[247] Shakya G, Singh DR, Ojha HC, et al. Evaluation of SD Bioline HIV/syphilis Duo rapid test kits in Nepal. BMC Infect Dis 2016; 16(1): 450.
[248] Shimelis T, Tadesse E. The diagnostic performance evaluation of the SD BIOLINE HIV/syphilis Duo rapid test in southern Ethiopia: A cross-sectional study. BMJ Open 2015; 5(4)e007371
[249] Jafari Y, Peeling RW, Shivkumar S, Claessens C, Joseph L, Pai NP. Are Treponema pallidum specific rapid and point-of-care tests for syphilis accurate enough for screening in resource limited settings? Evidence from a meta-analysis. PLoS One 2013; 8(2)e54695
[250] Clegg HW, Dallas SD, Roddey OF, et al. Presbyterian Pediatric Research Group. Extrapharyngeal group A Streptococcus infection: Diagnostic accuracy and utility of rapid antigen testing. Pediatr Infect Dis J 2003; 22(8): 726-31.
[251] Rogo T, Schwartz RH, Ascher DP. Comparison of the inverness medical acceava strep a test with the genzyme OSOM and quidel quickvue strep a tests. Clin Pediatr (Phila) 2010; 49(11): 1050-2.
[252] Herbst de Cortina S, Bristow CC, Joseph Davey D, Klausner JD. A Systematic Review of Point of Care Testing for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Infect Dis Obstet Gynecol 2016; 20164386127
[253] Gaydos CA, Van Der Pol B, Jett-Goheen M, et al. CT/NG Study Group. Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol 2013; 51(6): 1666-72.
[254] Samarawickrama A, Alexander S, Ison C. A laboratory-based evaluation of the BioStar Optical ImmunoAssay point-of-care test for diagnosing Neisseria gonorrhoeae infection. J Med Microbiol 2011; 60(Pt 12): 1779-81.
[255] Guy RJ, Causer LM, Klausner JD, et al. Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections. Sex Transm Infect 2017; 93(S4): S16-21.
[256] Martín-Díaz A, Rubio JM, Herrero-Martínez JM, et al. Study of the diagnostic accuracy of microbiological techniques in the diagnosis of malaria in the immigrant population in Madrid. Malar J 2018; 17(1): 314.
[257] van Dijk DP, Gillet P, Vlieghe E, Cnops L, Van Esbroeck M, Jacobs J. Evaluation of the Immunoquick+4 malaria rapid diagnostic test in a non-endemic setting. Eur J Clin Microbiol Infect Dis 2010; 29(5): 577-83.
[258] Mukae H, Yatera K, Noguchi S, et al. Evaluation of a rapid immunochromatographic ODK0501 assay for detecting Streptococcus pneumoniae antigens in the sputum of pneumonia patients with positive S. pneumoniae urinary antigens. J Infect Chemother 2015; 21(3): 176-81.
[259] Suzuki S, Nishimura N, Jinta T, et al. Evaluation of the rapid immunochromatographic ODK0501 assay for Streptococcus pneumoniae antigen detection with nasopharyngeal swabs: preliminary report. Multidiscip Respir Med 2016; 11: 25.
[260] Alarcón-Rivera G, Vázquez-Jiménez G, de la Cruz-Patiño E, et al. Comparative analysis between breath test, serological immunoassay and rapid-urease test for detection of Helicobacter pylori infection in Mexican patients with non-investigated dyspepsia. Rev Gastroenterol Mex 2011; 76(4): 322-9.
[261] Mansour-Ghanaei F, Joukar F, Sheykhian MR, Soati F, Rafatzand AM. Effect of gastric acidification on the (14)C-UBT HELIPROBE(®) accuracy during Pantoprazole treatment in Helicobacter pylori positive patients. Int J Clin Exp Med 2013; 6(3): 185-91.
[262] Drain PK, Gounder L, Sahid F, Moosa MY. Rapid Urine LAM Testing Improves Diagnosis of Expectorated Smear-Negative Pulmonary Tuberculosis in an HIV-endemic Region. Sci Rep 2016; 6: 19992.
[263] Swaminathan S, Rekha VV. Antigen detection as a point-of-care test for TB: the case of lipoarabinomannan. Future Microbiol 2012; 7(5): 559-64.
[264] Lawn SD, Kerkhoff AD, Burton R, et al. Diagnostic accuracy, incremental yield and prognostic value of Determine TB-LAM for routine diagnostic testing for tuberculosis in HIV-infected patients requiring acute hospital admission in South Africa: A prospective cohort. BMC Med 2017; 15(1): 67.
[265] Athlin S, Iversen A, Özenci V. Comparison of the ImmuView and the BinaxNOW antigen tests in detection of Streptococcus pneumoniae and Legionella pneumophila in urine. Eur J Clin Microbiol Infect Dis 2017; 36(10): 1933-8.
[266] Eletu SD, Sheppard CL, Thomas E, et al. Development of an extended-specificity multiplex immunoassay for detection of streptococcus pneumoniae serotype-specific antigen in urine by use of human monoclonal antibodies. Clin Vaccine Immunol 2017; 24(12)e00262-17
[267] Bristow CC, Leon SR, Huang E, et al. Field evaluation of a dual rapid immunodiagnostic test for HIV and syphilis infection in peru. Sex Transm Dis 2016; 43(1): 57-60.
[268] Ham JY, Jung J, Hwang BG, et al. Highly sensitive and novel point-of-care system, aQcare Chlamydia TRF kit for detecting Chlamydia trachomatis by using europium (Eu) (III) chelated nanoparticles. Ann Lab Med 2015; 35(1): 50-6.
[269] Abbai-Shaik NS, Reddy T, Govender S, Ramjee G. Poor performance of the chlamydia rapid test device for the detection of asymptomatic infections in south african men: A pilot study. J Sex Transm Dis 2016; 20168695146
[270] Hurly DS, Buhrer-Skinner M, Badman SG, et al. Field evaluation of the CRT and ACON chlamydia point-of-care tests in a tropical, low-resource setting. Sex Transm Infect 2014; 90(3): 179-84.
[271] Nuñez-Forero L, Moyano-Ariza L, Gaitán-Duarte H, et al. Diagnostic accuracy of rapid tests for sexually transmitted infections in symptomatic women. Sex Transm Infect 2016; 92(1): 24-8.
[272] Mahilum-Tapay L, Laitila V, Wawrzyniak JJ, et al. New point of care chlamydia rapid test-bridging the gap between diagnosis and treatment: Performance evaluation study. BMJ 2007; 335(7631): 1190-4.
[273] Nair CB, Manjula J, Subramani PA, et al. Differential diagnosis of malaria on truelab Uno®, a Portable, Real-Time, MicroPCR Device for Point-Of-Care applications. PLoS One 2016; 11(1)e0146961
[274] Nikam C, Jagannath M, Narayanan MM, et al. Rapid diagnosis of Mycobacterium tuberculosis with Truenat MTB: A near-care approach. PLoS One 2013; 8(1)e51121
[275] Kriesel JD, Bhatia AS, Barrus C, Vaughn M, Gardner J, Crisp RJ. Multiplex PCR testing for nine different sexually transmitted infections. Int J STD AIDS 2016; 27(14): 1275-82.
[276] Ruggiero P, McMillen T, Tang YW, Babady NE. Evaluation of the BioFire FilmArray respiratory panel and the GenMark eSensor respiratory viral panel on lower respiratory tract specimens. J Clin Microbiol 2014; 52(1): 288-90.
[277] Chou M, Kim S, Khim N, et al. Performance of “VIKIA Malaria Ag Pf/Pan” (IMACCESS®), a new malaria rapid diagnostic test for detection of symptomatic malaria infections. Malar J 2012; 11: 295.
[278] Gunasekera M, Narine M, Ashton M, Esfandiari J. Development of a Dual Path Platform (DPP®) immunoassay for rapid detection of Candida albicans in human whole blood and serum. J Immunol Methods 2015; 424: 7-13.
[279] Stefaniuk E, Bosacka K, Wanke-Rytt M, Hryniewicz W. The use of rapid test QuikRead go® Strep A in bacterial pharyngotonsillitis diagnosing and therapeutic decisions. Eur J Clin Microbiol Infect Dis 2017; 36(10): 1733-8.
[280] El-Ghareeb AS, Abd El Motaleb GS, Waked NM, Osman Hany Kamel N, Aly NS. Circulating cathodic antigen cassette test versus haematuria strip test in diagnosis of urinary schistosomiasis. J Parasit Dis 2016; 40(4): 1193-8.
[281] Bezerra FSM, Leal JKF, Sousa MS, et al. Evaluating a point-of-care circulating cathodic antigen test (POC-CCA) to detect Schistosoma mansoni infections in a low endemic area in north-eastern Brazil. Acta Trop 2018; 182: 264-70.
[282] Assaré RK, Tra MBI, Ouattara M, et al. Sensitivity of the Point-of-Care Circulating Cathodic Antigen Urine Cassette Test for Diagnosis of Schistosoma mansoni in Low-Endemicity Settings in Côte d’Ivoire. Am J Trop Med Hyg 2018; 99(6): 1567-72.
[283] Chesnais CB, Vlaminck J, Kunyu-Shako B, et al. Measurement of Circulating Filarial Antigen Levels in Human Blood with a Point-of-Care Test Strip and a Portable Spectrodensitometer. Am J Trop Med Hyg 2016; 94(6): 1324-9.
[284] Agarwal A, Panner Selvam MK, Sharma R, et al. Home sperm testing device versus laboratory sperm quality analyzer: comparison of motile sperm concentration. Fertil Steril 2018; 110(7): 1277-84.
[285] Braunstein GD. False-positive serum human chorionic gonadotropin results: Causes, characteristics, and recognition. Am J Obstet Gynecol 2002; 187(1): 217-24.
[286] Tate J, Ward G. Interferences in immunoassay. Clin Biochem Rev 2004; 25(2): 105-20.
[287] Coppola MA, Klotz KL, Kim KA, et al. SpermCheck Fertility, an immunodiagnostic home test that detects normozoospermia and severe oligozoospermia. Hum Reprod 2010; 25(4): 853-61.
[288] Klotz KL, Coppola MA, Labrecque M, et al. Clinical and consumer trial performance of a sensitive immunodiagnostic home test that qualitatively detects low concentrations of sperm following vasectomy. J Urol 2008; 180(6): 2569-76.
[289] Schaff UY, Fredriksen LL, Epperson JG, Quebral TR, Naab S, Sarno MJ, et al. Novel centrifugal technology for measuring sperm concentration in the home. Fertil Steril 2017; 107(2): 358-64.
[290] Ledden DJ, Novamo AK, Schulman LS. Evaluation of the CLINITEST® human chorionic gonadotropin (hCG) pregnancy test for susceptibility to the hook effect by the hCG β core fragment. Clin Chem 2014; 60(12): 1578-80.
[291] Johnson S, Eapen S, Smith P, Warren G, Zinaman M. Significance of pregnancy test false negative results due to elevated levels of β-core fragment hCG. J Immunoassay Immunochem 2017; 38(4): 449-55.
[292] Knudsen UB, Kronborg CS, von Dadelszen P, et al. A single rapid point-of-care placental growth factor determination as an aid in the diagnosis of preeclampsia. Pregnancy Hypertens 2012; 2(1): 8-15.
[293] Bligh LN, Greer RM, Kumar S. The relationship between maternal placental growth factor levels and intrapartum fetal compromise. Placenta 2016; 48: 63-7.
[294] Abdelazim IA. Insulin-like growth factor binding protein-1 (Actim PROM test) for detection of premature rupture of fetal membranes. J Obstet Gynaecol Res 2014; 40(4): 961-7.
[295] Bushman ET, Theilen LH, Monson M, Hammad I, Esplin I, Esplin MS. Effect of blood contamination on amniotic fluid detection in vitro using immunoassays. J Matern Fetal Neonatal Med 2019; 1-4.
[296] Four M, Chauffour C, Delabaere A, Pereira B, Sapin V, Gallot D. Correlation between automated optical reading and double human reading for two tests of fetal membranes rupture. Gynécol Obstét Fertil Sénol 2019; 47(1): 18-22.
[297] Pollet-Villard M, Cartier R, Gaucherand P, Doret M. Detection of placental alpha microglobulin-1 versus insulin-like growth factor-binding protein-1 in amniotic fluid at term: A comparative study. Am J Perinatol 2011; 28(6): 489-94.
[298] Abdelazim IA, Makhlouf HH. Placental alpha microglobulin-1 (AmniSure test) versus insulin-like growth factor binding protein-1 (Actim PROM test) for detection of premature rupture of fetal membranes. J Obstet Gynaecol Res 2013; 39(6): 1129-36.
[299] Doret M, Cartier R, Miribel J, et al. Premature preterm rupture of the membrane diagnosis in early pregnancy: PAMG-1 and IGFBP-1 detection in amniotic fluid with biochemical tests. Clin Biochem 2013; 46(18): 1816-9.
[300] Gottlieb M, Wnek K, Moskoff J, Christian E, Bailitz J. Comparison of Result Times Between Urine and Whole Blood Point-of-care Pregnancy Testing. West J Emerg Med 2016; 17(4): 449-53.
[301] McQuivey RW, Block JE. ROM Plus(®): accurate point-of-care detection of ruptured fetal membranes. Med Devices (Auckl) 2016; 9: 69-74.
[302] Lee SM, Lee J, Seong HS, et al. The clinical significance of a positive Amnisure test in women with term labor with intact membranes. J Matern Fetal Neonatal Med 2009; 22(4): 305-10.
[303] Gronowski AM, Nerenz RD. Assessing the risk of false negative point-of-care urinary human chorionic gonadotropin device results due to beta core fragment. Clin Biochem 2015; 48(3): 97-8.
[304] Milhorn D, Korpi-Steiner N. Using a simulation model to assess risk of false negative point-of-care urinary human chorionic gonadotropin device results due to high-dose hook interference. Clin Biochem 2015; 48(3): 99-104.
[305] Kamer SM, Foley KF, Schmidt RL, Greene DN. Analytical sensitivity of four commonly used hCG point of care devices. Clin Biochem 2015; 48(6): 448-52.
[306] Pastuszek E, Lukaszuk A, Kunicki M, et al. New AMH assay allows rapid point of care measurements of ovarian reserve. Gynecol Endocrinol 2017; 33(8): 638-43.
[307] Kadehjian LJ. Performance of five non-instrumented urine drug-testing devices with challenging near-cutoff specimens. J Anal Toxicol 2001; 25(8): 670-9.
[308] Molnar A, Lewis J, Doble P, Hansen G, Prolov T, Fu S. A rapid and sensitive method for the identification of delta-9-tetrahydrocannabinol in oral fluid by liquid chromatography-tandem mass spectrometry. Forensic Sci Int 2012; 215(1-3): 92-6.
[309] Kolbrich EA, Kim I, Barnes AJ, et al. Cozart RapiScan Oral Fluid Drug Testing System: An evaluation of sensitivity, specificity, and efficiency for cocaine detection compared with ELISA and GC-MS following controlled cocaine administration. J Anal Toxicol 2003; 27(7): 407-11.
[310] Blencowe T, Vimpari K, Lillsunde P. Benzodiazepine whole blood concentrations in cases with positive oral fluid on-site screening test results using the DrugWipe(®) single for benzodiazepines. J Anal Toxicol 2011; 35(6): 349-56.
[311] Kintz P, Cirimele V, Ludes B. Codeine testing in sweat and saliva with the Drugwipe. Int J Legal Med 1998; 111(2): 82-4.
[312] Haller CA, Stone J, Burke V, Branch J, Chen K, Gross S. Comparison of an automated and point-of-care immunoassay to GC-MS for urine oxycodone testing in the clinical laboratory. J Anal Toxicol 2006; 30(2): 106-11.
[313] Greene DN, Lehman CM, McMillin GA. Evaluation of the integrated E-Z split key(®) cup II for rapid detection of twelve drug classes in urine. J Anal Toxicol 2011; 35(1): 46-53.
[314] Kim SY, Kim H, Park Y, et al. Evaluation of an automated reader and color interpretation-based immunoassays for multiplexed drug-of-abuse testing in urine. J Anal Toxicol 2017; 41(5): 412-20.
[315] Gomila I, Barceló B, Rosell A, Avella S, Sahuquillo L, Dastis M. Cross-Reactivity of pantoprazole with three commercial cannabinoids immunoassays in urine. J Anal Toxicol 2017; 41(9): 760-4.
[316] Erdmann A, Werner D, Hugli O, Yersin B. Focused use of drug screening in overdose patients increases impact on management. Swiss Med Wkly 2015; 145w14242
[317] Attema-de Jonge ME, Peeters SY, Franssen EJ. Performance of three point-of-care urinalysis test devices for drugs of abuse and therapeutic drugs applied in the emergency department. J Emerg Med 2012; 42(6): 682-91.
[318] Krotulski AJ, Mohr ALA, Friscia M, Logan BK. Field detection of drugs of abuse in oral fluid using the Alere™ DDS®2 mobile test system with confirmation by liquid chromatography tandem mass spectrometry (LC-MS/MS). J Anal Toxicol 2018; 42(3): 170-6.
[319] Herrera-Gómez F, García-Mingo M, Colás M, González-Luque JC, Álvarez FJ. Opioids in oral fluid of Spanish drivers. Drug Alcohol Depend 2018; 187: 35-9.
[320] Rohrig TP, Moore CM, Stephens K, et al. Roadside drug testing: An evaluation of the Alere DDS® 2 mobile test system. Drug Test Anal 2018; 10(4): 663-70.
[321] Veitenheimer AM, Wagner JR. Evaluation of Oral Fluid as a Specimen for DUID. J Anal Toxicol 2017; 41(6): 517-22.
[322] Nakanishi K, Miki A, Zaitsu K, et al. Cross-reactivities of various phenethylamine-type designer drugs to immunoassays for amphetamines, with special attention to the evaluation of the one-step urine drug test Instant-View™, and the Emit® assays for use in drug enforcement. Forensic Sci Int 2012; 217(1-3): 174-81.
[323] Strano-Rossi S, Castrignanò E, Anzillotti L, et al. Evaluation of four oral fluid devices (DDS®, Drugtest 5000®, Drugwipe 5+® and RapidSTAT®) for on-site monitoring drugged driving in comparison with UHPLC-MS/MS analysis. Forensic Sci Int 2012; 221(1-3): 70-6.
[324] Pehrsson A, Blencowe T, Vimpari K, Impinen A, Gunnar T, Lillsunde P. Performance evaluation of the DrugWipe® 5/5+ on-site oral fluid screening device. Int J Legal Med 2011; 125(5): 675-83.
[325] Gentili S, Solimini R, Tittarelli R, Mannocchi G, Busardò FP. A study on the reliability of an on-site oral fluid drug test in a recreational context. J Anal Methods Chem 2016; 20161234581
[326] Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018; 68(6): 394-424.
[327] Bui HN, Bogers JP, Cohen D, Njo T, Herruer MH. Evaluation of the performance of a point-of-care method for total and differential white blood cell count in clozapine users. Int J Lab Hematol 2016; 38(6): 703-9.
[328] Karim O, Rao A, Emberton M, et al. Point-of-care PSA testing: An evaluation of PSAwatch. Prostate Cancer Prostatic Dis 2007; 10(3): 270-3.
[329] Lohsiriwat V. Accuracy of self-checked fecal occult blood testing for colorectal cancer in Thai patients. Asian Pac J Cancer Prev 2014; 15(18): 7981-4.
[330] Hwang EC, Choi HS, Jung SI, Kwon DD, Park K, Ryu SB. Use of the NMP22 BladderChek test in the diagnosis and follow-up of urothelial cancer: A cross-sectional study. Urology 2011; 77(1): 154-9.
[331] Wang Z, Que H, Suo C, et al. Evaluation of the NMP22 BladderChek test for detecting bladder cancer: A systematic review and meta-analysis. Oncotarget 2017; 8(59): 100648-56.
[332] Gleichenhagen J, Arndt C, Casjens S, et al. Evaluation of a New Survivin ELISA and UBC® Rapid for the Detection of Bladder Cancer in Urine. Int J Mol Sci 2018; 19(1)E226
[333] Lu P, Cui J, Chen K, et al. Diagnostic accuracy of the UBC® Rapid Test for bladder cancer: A meta-analysis. Oncol Lett 2018; 16(3): 3770-8.
[334] Narayan VM, Adejoro O, Schwartz I, Ziegelmann M, Elliott S, Konety BR. The Prevalence and Impact of Urinary Marker Testing in Patients with Bladder Cancer. J Urol 2018; 199(1): 74-80.
[335] Kollarik B, Zvarik M, Bujdak P, et al. Urinary fluorescence analysis in diagnosis of bladder cancer. Neoplasma 2018; 65(2): 234-41.
[336] Rausch S, Hennenlotter J, Wiesenreiter J, et al. Assessment of a new point-of-care system for detection of prostate specific antigen. BMC Urol 2016; 16: 4.
[337] Trojan J, Povse N, Schröder O, Stein J. A new immunological test strip device for the rapid, qualitative detection of faecal occult blood. Z Gastroenterol 2002; 40(11): 921-4.
[338] Hoepffner N, Shastri YM, Hanisch E, et al. Comparative evaluation of a new bedside faecal occult blood test in a prospective multicentre study. Aliment Pharmacol Ther 2006; 23(1): 145-54.
[339] Kok L, Elias SG, Witteman BJ, et al. Diagnostic accuracy of point-of-care fecal calprotectin and immunochemical occult blood tests for diagnosis of organic bowel disease in primary care: the Cost-Effectiveness of a Decision Rule for Abdominal Complaints in Primary Care (CEDAR) study. Clin Chem 2012; 58(6): 989-98.
[340] Heida A, Knol M, Kobold AM, Bootsman J, Dijkstra G, van Rheenen PF. Agreement between home-based measurement of stool calprotectin and ELISA results for monitoring inflammatory bowel disease activity. Clin Gastroenterol Hepatol 2017; 15(11): 1742-9.
[341] Sithambaram S, Hilmi I, Goh KL. The diagnostic accuracy of the M2 pyruvate kinase quick stool test-A rapid office based assay test for the detection of colorectal cancer. PLoS One 2015; 10(7)e0131616
[342] Cho CH, Kim J, Jang MA, Lee BJ, Park JJ, Lim CS. Evaluation of the performance of a fecal tumor M2-PK rapid kit using stool specimens for detection of colorectal tumors. Ann Clin Lab Sci 2016; 46(2): 154-60.
[343] Chung-Faye G, Hayee B, Maestranzi S, Donaldson N, Forgacs I, Sherwood R. Fecal M2-pyruvate kinase (M2-PK): A novel marker of intestinal inflammation. Inflamm Bowel Dis 2007; 13(11): 1374-8.
[344] von Fricken ME, Weppelmann TA, Eaton WT, Masse R, Beau de Rochars MV, Okech BA. Performance of the CareStart glucose-6-phosphate dehydrogenase (G6PD) rapid diagnostic test in Gressier, Haiti. Am J Trop Med Hyg 2014; 91(1): 77-80.
[345] Bancone G, Gornsawun G, Chu CS, et al. Validation of the quantitative point-of-care CareStart biosensor for assessment of G6PD activity in venous blood. PLoS One 2018; 13(5)e0196716
[346] Oo NN, Bancone G, Maw LZ, et al. Validation of G6PD Point-of-Care Tests among Healthy Volunteers in Yangon, Myanmar. PLoS One 2016; 11(4)e0152304
[347] Alam MS, Kibria MG, Jahan N, Price RN, Ley B. Spectrophotometry assays to determine G6PD activity from Trinity Biotech and Pointe Scientific G6PD show good correlation. BMC Res Notes 2018; 11(1): 855.
[348] Kanter J, Telen MJ, Hoppe C, Roberts CL, Kim JS, Yang X. Validation of a novel point of care testing device for sickle cell disease. BMC Med 2015; 13: 225.
[349] Nguyen-Khoa T, Mine L, Allaf B, et al. Sickle SCAN™ (BioMedomics) fulfills analytical conditions for neonatal screening of sickle cell disease. Ann Biol Clin (Paris) 2018; 76(4): 416-20.
[350] Segbena AY, Guindo A, Buono R, et al. Diagnostic accuracy in field conditions of the sickle SCAN® rapid test for sickle cell disease among children and adults in two West African settings: the DREPATEST study. BMC Hematol 2018; 18: 26.
[351] McGann PT, Schaefer BA, Paniagua M, Howard TA, Ware RE. Characteristics of a rapid, point-of-care lateral flow immunoassay for the diagnosis of sickle cell disease. Am J Hematol 2016; 91(2): 205-10.
[352] Marziliano N, Notarangelo MF, Cereda M, Caporale V, Coppini L, Demola MA, et al. Rapid and portable, lab-on-chip, point-of-care genotyping for evaluating clopidogrel metabolism Clin Chim Acta 2015; 451(Pt B): 240-6.
[353] Jobbagy Z, van Atta R, Murphy KM, Eshleman JR, Gocke CD. Evaluation of the Cepheid GeneXpert BCR-ABL assay. J Mol Diagn 2007; 9(2): 220-7.
[354] Buchan BW, Peterson JF, Cogbill CH, et al. Evaluation of a microarray-based genotyping assay for the rapid detection of cytochrome P450 2C19 *2 and *3 polymorphisms from whole blood using nanoparticle probes. Am J Clin Pathol 2011; 136(4): 604-8.
[355] Zhou Y, Armstead AR, Coshatt GM, Limdi NA, Harada S. Comparison of Two Point-of-Care CYP2C19 Genotyping Assays for Genotype-Guided Antiplatelet Therapy. Ann Clin Lab Sci 2017; 47(6): 738-43.
[356] Choi JL, Kim BR, Woo KS, et al. The Diagnostic Utility of the Point-of-Care CYP2C19 Genotyping Assay in Patients with Acute Coronary Syndrome Dosing Clopidogrel: Comparison with Platelet Function Test and SNP Genotyping. Ann Clin Lab Sci 2016; 46(5): 489-94.
[357] Evans RT, Klausen B, Sojar HT, et al. Immunization with Porphyromonas (Bacteroides) gingivalis fimbriae protects against periodontal destruction. Infect Immun 1992; 60(7): 2926-35.
[358] Simonson LG, Robinson PJ, Pranger RJ, Cohen ME, Morton HE. Treponema denticola and Porphyromonas gingivalis as prognostic markers following periodontal treatment. J Periodontol 1992; 63(4): 270-3.
[359] Imamura K, Takayama S, Saito A, et al. Evaluation of a novel immunochromatographic device for rapid and accurate clinical detection of Porphyromonas gingivalis in subgingival plaque. J Microbiol Methods 2015; 117: 4-10.
[360] Nakayama Y, Ogata Y, Hiromatsu Y, et al. Clinical usefulness of novel immunochromatographic detection device for porphyromonas gingivalis in evaluating effects of scaling and root planing and local antimicrobial therapy. J Periodontol 2016; 87(10): 1238-47.
[361] Zapolsky N, Zapolsky IJ, Lim CA. Point-of-Care ultrasound diagnosis of multiple mandibular fractures in an adolescent presenting to the pediatric emergency department. Pediatr Emerg Care 2017; 33(9): 652-3.
[362] Sinjari B, Murmura G, Caputi S, Ricci L, Varvara G, Scarano A. Use of Oral Chroma™ in the assessment of volatile sulfur compounds in patients with fixed protheses. Int J Immunopathol Pharmacol 2013; 26(3): 691-7.
[363] Gartia MR, Misra SK, Ye M, et al. Point-of-service, quantitative analysis of ascorbic acid in aqueous humor for evaluating anterior globe integrity. Sci Rep 2015; 5: 16011.
[364] Nakanishi K, Fukuda S, Yamashita H, et al. Detection of deep venous thrombosis using a pocket-size ultrasound examination device. JACC Cardiovasc Imaging 2016; 9(7): 897-8.
[365] Bornemann P, Johnson J, Tiglao S, et al. Assessment of primary care physicians’ use of a pocket ultrasound device to measure left ventricular mass in patients with hypertension. J Am Board Fam Med 2015; 28(6): 706-12.
[366] Kratz T, Exner M, Campo dell’Orto M, et al. A pocket-sized hand held ultrasound system for intraoperative transthoracic echocardiography by anaesthesiologists: A feasibility study. Technol Health Care 2016; 24(3): 309-15.
[367] Tapper EB, Castera L, Afdhal NH. FibroScan (vibration-controlled transient elastography): Where does it stand in the United States practice. Clin Gastroenterol Hepatol 2015; 13(1): 27-36.
[368] Özkan B, Ünlüer EE, Akyol PY, et al. Stethoscope versus point-of-care ultrasound in the differential diagnosis of dyspnea: A randomized trial. Eur J Emerg Med 2015; 22(6): 440-3.
[369] Avinadav E, Almog A, Kravarusic D, et al. Point-of-Care Ultrasound in a Department of Pediatric and Adolescent Surgery. Isr Med Assoc J 2016; 18(11): 677-9.
[370] Lavi A, Tzemah S, Hussein A, et al. A urologic stethoscope? Urologist performed sonography using a pocket-size ultrasound device in the point-of-care setting. Int Urol Nephrol 2017; 49(9): 1513-8.
[371] Sforza A, Mancusi C, Carlino MV, et al. Diagnostic performance of multi-organ ultrasound with pocket-sized device in the management of acute dyspnea. Cardiovasc Ultrasound 2017; 15(1): 16.
[372] Andersen GN, Graven T, Skjetne K, et al. Diagnostic influence of routine point-of-care pocket-size ultrasound examinations performed by medical residents. J Ultrasound Med 2015; 34(4): 627-36.
[373] Cullen MW, Geske JB, Anavekar NS, Askew JW III, Lewis BR, Oh JK. Handheld echocardiography during hospitalization for acute myocardial infarction. Clin Cardiol 2017; 40(11): 993-9.
[374] Colclough A, Nihoyannopoulos P. Pocket-sized point-of-care cardiac ultrasound devices : Role in the emergency department. Herz 2017; 42(3): 255-61.
[375] Gurbel PA, Bliden KP, Tantry US, et al. First report of the point-of-care TEG: A technical validation study of the TEG-6S system. Platelets 2016; 27(7): 642-9.
[376] Meledeo MA, Peltier GC, McIntosh CS, Voelker CR, Bynum JA, Cap AP. Functional stability of the TEG 6s hemostasis analyzer under stress. J Trauma Acute Care Surg 2018; 84(6S Suppl 1): S83-.
[377] Hartmann K. Clinical aspects of feline retroviruses: A review. Viruses 2012; 4(11): 2684-710.
[378] Westman ME, Malik R, Hall E, Sheehy PA, Norris JM. Determining the feline immunodeficiency virus (FIV) status of FIV-vaccinated cats using point-of-care antibody kits. Comp Immunol Microbiol Infect Dis 2015; 42: 43-52.
[379] Hartmann K, Griessmayr P, Schulz B, et al. Quality of different in-clinic test systems for feline immunodeficiency virus and feline leukaemia virus infection. J Feline Med Surg 2007; 9(6): 439-45.
[380] Levy JK, Crawford PC, Tucker SJ. Performance of 4 Point-of-care screening tests for feline leukemia virus and feline immunodeficiency virus. J Vet Intern Med 2017; 31(2): 521-6.
[381] Liu J, O’Connor T, Beall M, Chandrashekar R, Lappin M. Evaluation of rapid diagnostic test kits for feline leukemia virus infection using samples from naturally infected cats. JFMS Open Rep 2016; 2(2)2055116916667757
[382] Miño S, Kern A, Barrandeguy M, Parreño V. Comparison of two commercial kits and an in-house ELISA for the detection of equine rotavirus in foal feces. J Virol Methods 2015; 222: 1-10.
[383] Neuerer FF, Horlacher K, Truyen U, Hartmann K. Comparison of different in-house test systems to detect parvovirus in faeces of cats. J Feline Med Surg 2008; 10(3): 247-51.
[384] Ceplecha V, Svoboda M, Cepička I, Husník R, Horáčková K, Svobodová V. InPouch™ TF-Feline medium is not specific for Tritrichomonas foetus. Vet Parasitol 2013; 196(3-4): 503-5.
[385] Nye CJ, Mariani CL. Validation of a portable monitor for assessment of cerebrospinal fluid lactate in dogs. Vet Clin Pathol 2018; 47(1): 108-14.
[386] Rudinsky AJ, Guillaumin J, Gilor C. Sensitivity of fecal occult blood testing in the cat. J Feline Med Surg 2017; 19(6): 603-8.
[387] Shire J, Gordon JL, Karcher EL. Short communication: The effect of temperature on performance of milk ketone test strips. J Dairy Sci 2013; 96(3): 1677-80.
[388] Karapinar T, Kaynar O, Hayirli A, Kom M. Evaluation of 4 point-of-care units for the determination of blood l-lactate concentration in cattle. J Vet Intern Med 2013; 27(6): 1596-603.
[389] Gilroy CV, Burton SA, Horney BS, Mackenzie AL. Validation of the Nova CRT8 for the measurement of ionized magnesium in feline serum. Vet Clin Pathol 2005; 34(2): 124-31.
[390] Unterer S, Gerber B, Glaus TM, Hässig M, Reusch CE. Evaluation of an electrolyte analyser for measurement of concentrations of ionized calcium and magnesium in cats. Vet Res Commun 2005; 29(8): 647-59.
[391] Stevenson CK, Kidney BA, Duke T, Snead EC, Jackson ML. Evaluation of the Accutrend for lactate measurement in dogs. Vet Clin Pathol 2007; 36(3): 261-6.
[392] Yamanaka T, Nemoto M, Bannai H, et al. Evaluation of twenty-two rapid antigen detection tests in the diagnosis of Equine Influenza caused by viruses of H3N8 subtype. Influenza Other Respir Viruses 2016; 10(2): 127-33.
[393] Bauer N, Rettig S, Moritz A. Evaluation the Clinitek status automated dipstick analysis device for semiquantitative testing of canine urine. Res Vet Sci 2008; 85(3): 467-72.
[394] Di Cerbo A, Pezzuto F, Canello S, Guidetti G, Palmieri B. Therapeutic Effectiveness of a Dietary Supplement for Management of Halitosis in Dogs. J Vis Exp 2015; (101): e52717
[395] Available from:
[396] Available from:
[397] National Institute of Biomedical Imaging and Bioengineering/National Heart LaBINSFWF Price CP, Kricka LJ. Improving healthcare accessibility through point-of-care technologies Clinical chemistry 2007.
[398] St John A, Price CP. Economic evidence and point-of-care testing. Clin Biochem Rev 2013; 34(2): 61-74.
[399] Schilling M. The economic benefits of point-of-care testing 2015.