Table 4 Comparison of microfluidic POCT devices for molecular diagnostics

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]