Testing Methods for COVID-19 (SARS-CoV-2)

Rapid collection and testing of appropriate specimens from patients meeting the suspected case definition for COVID-19 is a must for outbreak control and clinical management. Molecular testing is the current recommended method for the identification of infectious cases. Serological assays and rapid test kits for antigen detection may play an important role in diagnosis, research, and surveillance but are not currently recommended.

Currently, laboratories are detecting unique gene sequences of SARS-CoV-2 using NAAT such as real-time reverse-transcription polymerase chain reaction (rRT-PCR) for the confirmation of COVID-19 cases. The viral genes targeted so far include the N, E, S and RdRP genes.

A number of manufacturers are currently developing commercial test methods for the diagnosis of COVID-19 based on unique gene detection, antigen detection or serological assays. Some of these test methods have got Emergency Use Authorization (EUA) from FDA.

So far, there are no FDA-approved diagnostics for COVID-19.

Most of these test methods detect SARS-CoV-2 nucleic acid in direct nasal, nasopharyngeal or throat swabs and nasal, nasopharyngeal or throat swabs eluted in viral transport media from individuals who are suspected of COVID-19

Recently, ABBOTT has launched rapid molecular testing for COVID-19. According to the manufacturer, ID NOW gives positive results within 5 minutes and a negative result in 13 minutes.

Some of the manufacturers are also evaluating performance using other respiratory specimens such as sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate.

commercial test for covid-19 (SARS-CoV-2)
Test nameUseManufacturer
Xpert Xpress SARS-CoV-2 testDetection of nucleic acid (N2 and E) from the SARS-CoV-2 using GeneXpert systemCepheid
Abbott RealTime SARS-CoV-2 assayDetection of nucleic acid from SARS-CoV-2 in NP and OP swabs. Abbott Molecular
PerkinElmer New Coronavirus Nucleic Acid Detection KitReal-time RT-PCR test for the qualitative detection of nucleic acid from SARS-CoV-2 in NP and OP swabs.PerkinElmer, Inc.
New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic PanelDetection of SARS-CoV-2 RNA in NP, OP and sputum sample. Wadsworth Center, New York State Department of Public Health’s (CDC)
Lyra SARS-CoV-2 AssayDetection of nucleic acid from SARS-CoV-2 in NP and OP swab specimens. Quidel Corporation
TaqPath COVID-19 Combo KitMultiplex real-time RT-PCR for the detection of nucleic acid from
SARS-CoV-2 in NP, OP and BAL specimens.
Thermo Fisher Scientific, Inc.
Quest SARS-CoV-2 rRT-PCRDetection of nucleic acid from
the SARS-CoV-2
Quest Diagnostics Infectious Disease, Inc.
Simplexa COVID-19 Direct assayDetection of nucleic acid from SARS-CoV-2.DiaSorin Molecular LLC
CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)Detection of SARS-CoV-2 RNA in upper and lower respiratory specimensCenters for Disease Control and Prevention’s (CDC)

cobas SARS-CoV-2Qualitative test, for use on the cobas 6800 System and cobas 8800 System for the detection of nucleic acid from SARS-CoV-2.Roche Molecular Systems, Inc. (RMS)

Accula SARS-Cov-2 Test
Detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimensMesa Biotech Inc.


AvellinoCoV2 test
Detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens.Avellino Lab USA, Inc.
BioFire COVID-19 TestDetection of the SARS-CoV-2 targeted sequences in a single-use cartridge from NP or OP specimen. BioFire Defense, LLC
COV-19 IDx assayDetection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens. Ipsum Diagnostics, LLC
COVID-19 RT-PCR TestDetection of nucleic acid from
SARS-CoV-2
Laboratory Corporation of America (LabCorp)
ePlex SARS-CoV-2 TestQualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swab
specimens eluted in VTM
GenMark Diagnostics, Inc.
ID NOW COVID-19Detection of SARS-CoV-2 viral RNA (COVID-19 RdRp gene)Abbott Diagnostics Scarborough, Inc.
NeuMoDx SARS-CoV-2 AssayQualitative test, for use on the NeuMoDx 288 Molecular and NeuMoDx 96 Molecular Systems for the detection of nucleic acid from SARS-CoV-2.NeuMoDx Molecular, Inc.
NxTAG CoV Extended Panel AssayDetection of SARS-CoV-2 nucleic acids in nasopharyngeal swab specimens.Luminex Molecular Diagnostics, Inc.
Panther Fusion SARS-CoV-2Detection of nucleic acid from
SARS-CoV-2 isolated and purified from NP and OP swab specimens
Hologic, Inc.

Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
Detection of nucleic acid from SARS-CoV-2 in oropharyngeal
swab specimens
Primerdesign Ltd.

QIAstat-Dx Respiratory SARS-CoV-2 Panel
Multiplexed nucleic acid real-time PCR test for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2.QIAGEN GmbH

Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoVDetection of SARS-CoV-2 nucleic acids in throat swabs and bronchoalveolar lavage fluid (BAL) BGI Genomics Co. Ltd

Tests for the detection of IgG/IgM

Test NameUse
Manufacturer
qSARS-CoV-2 IgG/IgM Rapid Test
Qualitative test for the detection of IgM and IgG antibodies against SARS-CoV-2 in blood. Cellex Inc.

As of now, World health organization (WHO) has not endorsed any of these products yet [find more] but has activated the Emergency Use Listing (EUL) of the assays for the detection of SARS-CoV-2 nucleic acids.

References and further reading

About Acharya Tankeshwar 444 Articles
Hello, thank you for visiting my blog. I am Tankeshwar Acharya. Blogging is my passion. I am working as an Asst. Professor and Microbiologist at Department of Microbiology and Immunology, Patan Academy of Health Sciences, Nepal. If you want me to write about any posts that you found confusing/difficult, please mention in the comments below.

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