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. 2020 Apr 30;6(5):591–605. doi: 10.1021/acscentsci.0c00501

Table 1. Examples of Molecular Diagnostic Tests Used to Detect Viral Genetic Material in SARS-CoV-2.

test name test type manufacturer/organization name sample source gene or region detected test result time/additional information throughput information EUAb country of approval
ID NOW COVID-19 isothermal nucleic acid amplification technology Abbott Diagnostics Scarborough, Inc. nasal, nasopharyngeal and throat swabs RdRP gene positive results <5 min and negative results in 13 min 1 sample/run US FDA 3/27/2020 United States
iAMP COVID-19 detection kit real-time RT isothermal amplification test Atila BioSystems, Inc. D11 nasal, nasopharyngeal, and oropharyngeal swabs ORF1ab and/or N gene results <1.5 h high throughputa US FDA 4/10/2020 United States
BioFire COVID-19 test multiplex real-time RT-PCR BioFire Defense, LLC nasopharyngeal swabs ORF1ab and ORF8 results in ∼45 min 94 samples/run US FDA 3/23/2020 United States
CDC 2019- Novel Coronavirus Real-Time RT-PCR Diagnostic Panel real-time RT-PCR CDC-US nasopharyngeal or oropharyngeal aspirates/washes/swabs and bronchoalveolar lavage fluid, tracheal aspirates, sputum N gene human RNase P gene used as control 264 samples/day US FDA 2/4/2020 United States
Xpert Xpress SARS-CoV-2 test real-time RT-PCR Cepheid nasopharyngeal, nasal, and midturbinate swabs N2 and E genes results in ∼45 min with <1 min of hands-on time high throughputa US FDA 3/20/2020 Australia, Canada, Singapore, United States
CRISPR-based tests for SARS-CoV-2 CRISPR-based lateral flow assay isothermal amplification Cepheid Sherlock Biosciences respiratory samples viral RNA combines Sherlock’s Cas12 and Cas13 enzymes for nucleic acid detection with Cepheid’s GeneXpert test-processing instruments   US FDA 3/20/2020 United States
VitaPCR SARS-CoV-2 assay real-time PCR Credo Diagnostics Biomedical Pte Ltd. nasal and oropharyngeal swabs viral RNA results in 20 min with 1 min of hands-on time 2000 samples/day CE mark 3/2020 Singapore
LYRA SARS-CoV-2 assay real-time RT-PCR Diagnostic Hybrids, Inc. Quidel Corporation nasopharyngeal and oropharyngeal swabs pp1ab results in <75 min after extraction   US FDA 3/17/2020 Canada
SARS-CoV-2 assay real-time RT-PCR Diagnostic Molecular Laboratory – Northwestern Medicine nasopharyngeal, oropharyngeal, nasal, and midturbinate nasal swabs and bronchoalveolar lavage fluid N1 and RdRP genes results in <1 h without manual RNA extraction   US FDA 4/2/2020 United States
Simplexa COVID-19 Direct real-time RT-PCR DiaSorin Molecular LLC nasopharyngeal swabs OFR1ab and S gene results in ∼1 h with no RNA extraction high throughputa US FDA 3/19/2020 United States
ePlex SARS-CoV-2 test RT-PCR GenMark Diagnostics, Inc. nasopharyngeal swabs RNA <2 min hands-on time and results in ∼2 h   US FDA 3/19/2020 United States
Panther Fusion SARS-CoV-2 assay (Panther Fusion System) real time RT-PCR Hologic Inc. nasopharyngeal and oropharyngeal swabs ORF1ab regions 1 and 2 each Panther Fusion system can provide results in <3 h and process up to 1150 coronavirus tests in 24-h period 1 sample/run Australia 3/20/2020, US FDA 3/16/2020 Australia, United States
COVID-19 RT-PCR test real-time RT-PCR LabCorp Laboratory Corporation of America nasopharyngeal and oropharyngeal swabs/washes/aspirates and sputum, bronchoalveolar lavage fluid N gene results in 2–4 days 24 samples/run US FDA 3/16/2020 United States
ARIES SARS-CoV-2 assay real-time RT-PCR Luminex Corporation nasopharyngeal swabs ORF1ab and N gene minimal hands-on time and an automated workflow delivers results in ∼2 h high throughputa US FDA 4/3/2020 United States
SARS-CoV-2 DETECTR CRISPR-based lateral flow assay isothermal amplification Mammoth Biosciences respiratory samples E and N genes CRISPR Cas12a-based lateral flow assay results in 30–40 min high throughputa filed for US FDA 4/16/2020 United States
Accula SARS-CoV-2 test PCR and lateral flow technologies Mesa Biotech Inc. throat and nasal swabs N gene results in 30 min, the palm-sized device can be used in physician office or patients’ home 144 tests/day US FDA 3/23/2020 United States
MiRXES FORTITUDE KIT 2.0 real-time RT-PCR MiRXES Pte Ltd. nasopharyngeal swabs viral RNA genes less prone to mutation results in 90 min, produces 100,000 test kits/wk 96 samples in 1 run Singapore HSA 3/2020 Singapore
QIAstat-Dx Respiratory SARS-CoV-2 panel multiplex real-time RT-PCR Qiagen GmbH nasopharyngeal swabs E and RdRP genes results in ∼1 h, by differentiating novel coronavirus from 21 other bacterial and viral respiratory pathogens 1 sample/run US FDA 3/30/2020 United States
cobas SARS-CoV-2 real-time RT-PCR Roche Molecular Systems, Inc. nasopharyngeal and oropharyngeal swabs viral RNA results in ∼3.5 h, instruments can process up to 384 results (cobas 6800 System) and 1056 results (cobas 8800 System) in 8 h high throughputa Australia 2/20/20, CE mark 2020, US FDA 3/12/20 Australia, Brazil, Canada, Japan, Singapore, United States
TaqPath COVID-19 combo kit multiplex real-time RT-PCR Rutgers Clinical Genomics Laboratory ThermoFisher-Applied Biosystems oropharyngeal, nasopharyngeal, anterior nasal, midturbinate nasal swabs and saliva specimens ORF1b and N and S genes   high throughputa US FDA 3/13/2020 United States
Novel Coronavirus (2019-nCoV) Nucleic Acid diagnostic kit (PCR-fluorescence probing) real-time RT-PCR Sansure Biotech Inc. nasopharyngeal and oropharyngeal swab, serum, blood and feces ORF1ab and N gene results in 30 min   China NMPA 4/2020 China
STANDARD M nCoV RT detection kit real-Time RT-PCR SD BIOSENSOR oropharyngeal swabs E and RdRP genes results within 90 min   Korea MFDS 2/27/2020 South Korea
Allplex 2019-nCoV assay multiplex real-time RT-PCR Seegene nasopharyngeal, oropharyngeal, or anterior nasal swabs, midturbinate and sputum specimens E, N, and RdRP genes results in <2 h after extraction   CE mark 2/2020, Korea MFDS 2/12/2020, US FDA 4/21/2020 Australia, South Korea, Singapore, United States
Viracor SARS-CoV-2 assay real-time RT-PCR Viracor Eurofins Clinical Diagnostics nasopharyngeal, nasal, oropharyngeal washes/swabs and bronchoalveolar lavage fluid N gene results the same day, 12–18 h from receipt of specimen   US FDA 4/6/2020 United States
b

Emergency Use Authorization by U.S. FDA or other drug regulatory authorities.