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Table 4 Comparison of microfluidic POCT devices for molecular diagnostics

From: Microfluidics-based strategies for molecular diagnostics of infectious diseases

Approval time Devices Manufacturers Regulator Detection technology Targets LOD Detection time References
2007.08 Unyvero A50 Curetis CE Multiplex PCR Hospitalized pneumonia, blood culture, intra-abdominal infection, urinary tract infection, implant & tissue infection < 5 h [199]
2007.09 Verigene® Nanosphere FDA RT-PCR C. diff, enteric pathogens, respiratory pathogens, Gram bacteria 2–2.5 h [202]
2010.05 Simplexa Focus Diagnostics FDA RT-PCR SARS-CoV-2, influenza A/B & RSV, HSV 1 & 2, influenza A, H1N1 242–500 copies/ml < 80 min [182]
2011.08 Cobas® Liat® Roche FDA Multiplex real-time RT-PCR SARS-CoV-2, influenza A/B, RSV, Cdiff and strep A 10–3–10–1 TCID50/ml < 20 min [186]
2012.01 BD MAX BD FDA RT-PCR GBS, MRSA, C. diff, SA, vaginal pathogens, enteric bacterial and parasite, CT/GC/TV 45–90 min [197]
2012.11 GeneXpert® Infinity Systems Cepheid FDA RT-PCR GBS, MRSA, gastrointestinal pathogens, MTB, TV, respiratory viruses and so on [198]
2013.02 FilmArray® Biofire® Biofire FDA Nested Multiplex PCR Respiratory, blood, gastrointestinal and meningitis infection and so on 1000 TCID50/ml 45–60 min [174]
2014 Idylla Biocartis CE RT-PCR BRAF, KRAS, NRAS, EGFR genes 90–180 min [194]
2015 Alere Q Abbott CE RT-PCR HIV < 52 min [193]
2016.02 IO single module system Binx health CE PCR CT, NG and so on < 30 min [191, 192]
2017.05 Revogene® GenePOC FDA RT-PCR C. diff, GBS, GAS and CRE < 70 min [200]
2017.06 ePlex GenMark FDA RT-PCR Bloodstream infections and respiratory pathogens < 90 min [201]
2017.07 RTisochip-A CapitalBio Technology NMPA Isothermal amplification 19 respiratory viruses and 8 pathogenic bacteria 10–103 copies/run < 50 min [177]
2018.09 iChip-400 Baicare NMPA LAMP 16 pathogenic bacteria < 1 h [195]
2018.11 GenPlex® BOHUI NMPA Multiplex PCR 24 HPV and 18 respiratory viruses [175]
2019.07 RTisochip-W CapitalBio Technology NMPA NASBA 19 respiratory viruses and 8 pathogenic bacteria 50 copies/run 20–50 min [178, 179]
2020.01 WizDx F-150 Real-time PCR System Wizbiosolutions CE Ultra-fast RT-PCR SARS-CoV-2 20 copies/run < 40 min [190]
2021.01 Onestart-1000 Baicare NMPA RT-PCR 60 pathogenic bacteria 103 copies/ml < 1.5 h [196]
2021.02 DxLab-2A CapitalBio Technology NMPA Nested PCR SARS-CoV-2 500 copies/ml < 45 min [180]
2021.03 Cue Cue health FDA Isothermal amplification SARS-CoV-2 20 copies/test 20 min [181]
2021.06 iGeneTec MA3000 Superchip technology NMPA Isothermal amplification SARS-CoV-2 500 copies/ml < 45 min [187]
2021.08 Visby Medical Visby Medical FDA PCR SARS-CoV-2, chlamydia, NG, TV < 30 min [189]
Vivalytic BOSCH, Randox End-point PCR Respiratory and sexually transmitted infections viruses 30–150 min [176]
QuanPLEX IntelliBio qPCR 7 respiratory viruses [183]
AriaDNA Lumex Instruments RT-PCR SARS-CoV-2, african swine fever, cattle pathogens, fish pathogens and avian pathogens 9000 copies/ml < 50 min [184]
Novodiag® Mobidiag RT-PCR SARS-CoV-2, C. diff, enteric pathogens and so on < 1 h [185]
BINAS Tsinghua University Nested isothermal amplification SARS-CoV-2 < 400 copies/ml < 30 min [188]
  1. "–" means the information is not officially available from public data or is too complicated to be noted; LOD limits of detection, NMPA national medical products administration; CE conformite europeenne, FDA U.S. Food & Drug Administration, C. diff Clostridium difficile, CRE Carbapenem-resistant Enterobacteriaceae, GAS Group A streptococcus; GBS Group B streptococcus, HPV human papilloma virus, HSV herpes simplex virus, MRSA methicillin-resistant Staphylococcus aureus, MTB Mycobacterium tuberculosis, NG Neisseria gonorrhoeae, RSV respiratory syncytial virus, SA Staphylococcus aureus, TV Trichomonas vaginalis, SARS-CoV-2 severe acute respiratory syndrome coronavirus 2, PCR polymerase chain reaction, qPCR quantitative real-time polymerase chain reaction, LAMP loop-mediated isothermal amplification, RT-PCR reverse-transcription polymerase chain reaction, NASBA nucleic acid sequence-based amplification, TCID50 50% tissue culture infective dose