Last updated on October 9th, 2020
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.
|Xpert Xpress SARS-CoV-2 test||Detection of nucleic acid (N2 and E) from the SARS-CoV-2 using GeneXpert system||Cepheid|
|Abbott RealTime SARS-CoV-2 assay||Detection of nucleic acid from SARS-CoV-2 in NP and OP swabs.||Abbott Molecular|
|PerkinElmer New Coronavirus Nucleic Acid Detection Kit||Real-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 Panel||Detection 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 Assay||Detection of nucleic acid from SARS-CoV-2 in NP and OP swab specimens.||Quidel Corporation|
|TaqPath COVID-19 Combo Kit||Multiplex 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-PCR||Detection of nucleic acid from|
|Quest Diagnostics Infectious Disease, Inc.|
|Simplexa COVID-19 Direct assay||Detection 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 specimens||Centers for Disease Control and Prevention’s (CDC)|
|cobas SARS-CoV-2||Qualitative 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 specimens||Mesa Biotech Inc.|
|Detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens.||Avellino Lab USA, Inc.|
|BioFire COVID-19 Test||Detection of the SARS-CoV-2 targeted sequences in a single-use cartridge from NP or OP specimen.||BioFire Defense, LLC|
|COV-19 IDx assay||Detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens.||Ipsum Diagnostics, LLC|
|COVID-19 RT-PCR Test||Detection of nucleic acid from|
|Laboratory Corporation of America (LabCorp)|
|ePlex SARS-CoV-2 Test||Qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swab|
specimens eluted in VTM
|GenMark Diagnostics, Inc.|
|ID NOW COVID-19||Detection of SARS-CoV-2 viral RNA (COVID-19 RdRp gene)||Abbott Diagnostics Scarborough, Inc.|
|NeuMoDx SARS-CoV-2 Assay||Qualitative 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 Assay||Detection of SARS-CoV-2 nucleic acids in nasopharyngeal swab specimens.||Luminex Molecular Diagnostics, Inc.|
|Panther Fusion SARS-CoV-2||Detection of nucleic acid from|
SARS-CoV-2 isolated and purified from NP and OP swab specimens
Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
|Detection of nucleic acid from SARS-CoV-2 in oropharyngeal|
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-nCoV||Detection 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
|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.