Skip Navigation
 

Variants of Concern (VOCs) and Testing

As a virus replicates in its host’s cells, small changes can occur in its genes. Sometimes these small changes, or mutations, can have significant impacts on how the virus behaves. A virus is known as a variant when it acquires enough genetic mutations to make it substantively different from the original genetic reference sequence but not enough to make it a different virus altogether. For SARS-CoV-2, the original reference sequences are generally the first ones collected in Wuhan, China, and in Washington, United States.

Variant of Concern” (VOC) is a label given to SARS-CoV-2 variants that show evidence of an ability to cause more severe disease, be more easily transmitted, or evade treatments, diagnostics, or previous immunity from vaccination or natural infection. To date, VOCs have included the Alpha, Delta, and Omicron variants, among others.

Genetic changes in variants can influence the accuracy of some COVID-19 tests when the variant’s genetic sequence is different enough from existing tests that these tests cannot detect the variant. Some COVID-19 tests look for multiple SARS-CoV-2 genes while other tests only detect a single gene. Too many changes in these target genes can reduce the ability of a test to detect the virus. Since multi-target tests look for more than one marker of infection, they tend to be less affected by genetic changes in variants. However, it is possible for a variant with enough mutations in key genes to avoid detection by even multi-target tests. This page contains information about SARS-CoV-2 Variants of Concern (VOC) and which COVID-19 tests have recorded a decreased ability to detect them. More information can be found on the FDA website.

 
Test NameManufacturerPotential failure to detect:Single vs. Multi-Target TestWill the test still detect a positive case of COVID-19?Type of TestDate EUA Received
 VariantDrop-Out Gene 
DxTerity SARS-CoV-2 RT PCR CE TestDxTerity Diagnostics, Inc.OmicronN-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR2/9/21
ViroKey SARS-CoV-2 RT-PCR Test v2.0Vela Diagnostics USA, Inc.OmicronN-Gene Multi-targetYes - can still detect other SARS-CoV-2 genesRT-PCR9/22/20
Revogene SARS-CoV-2Meridian Bioscience, Inc. OmicronN-GeneSingle targetNo - only detects N-gene targetRT-PCR11/9/21
Linea COVID-19 Assay KitApplied DNA ScienceOmicron; AlphaS-GeneMulti-targetNo - only detects S-gene targetsRT-PCR5/11/21
TaqPath COVID-19 Combo KitThermo Fisher Scientific, Inc.Omicron; AlphaS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR10/12/21
Acupath COVID-19 Real-Time (RT-PCR) AssayAcupath Laboratories, Inc.OmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR6/29/20
Aeon Global Health SARS-CoV-2 AssayAeon Global HealthOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR9/30/20
SARS-CoV-2 AssayAIT LaboratoriesOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR4/24/20
Alpha Genomix TaqPath SARS-CoV-2 Combo AssayAlpha Genomix LaboratoriesOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR8/10/20
Altru Dx SARS-CoV-2 AssayAltru Diagnostics, Inc.OmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR4/30/20
Cuur Diagnostics SARS-CoV-2 Molecular AssayBandar Enterprises, LLC dba Cuur DiagnosticsOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR10/2/20
SARS-CoV-2 AssayBiocerna LLCOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR4/28/20
Boston Heart COVID-19 RT-PCR TestBoston Heart DiagnosticsOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR7/16/20
SelfCheck COVID-19 TaqPath Multiplex PCRCleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine InstituteOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR8/9/21
Cormeum SARS-CoV-2 AssayCormeum Laboratory ServicesOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR6/12/20
DxTerity SARS-CoV-2 RT-PCR TestDxTerity Diagnostics, Inc.OmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR8/21/20
Express Gene 2019-nCoV RT-PCR Diagnostic PanelExpress Gene LLC, DBA: Express Gene Molecular Diagnostics LaboratoryOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR1/22/21
Gravity Diagnostics SARS-CoV-2 RT-PCR AssayGravity Diagnostics, LLCOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR10/15/21
Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kitsGravity Diagnostics, LLCOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR10/15/21
HealthQuest Esoterics TaqPath SARS-CoV-2 AssayHealthQuest EsotericsOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR6/23/20
Helix COVID-19 TestHelix OpCo LLCOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR10/22/20
Infinity BiologiX TaqPath SARS-CoV-2 AssayInfinity BiologiX LLCOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR8/18/21
Life Sciences Testing Center COVID-19 TestNortheastern University College of Science, Life Sciences Testing CenterOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR9/22/21
P23 Labs TaqPath SARS-CoV-2 AssayP23 Labs, LLC.OmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR4/1/21
PCL SARS-CoV-2 Real-Time RT-PCR AssayPatients Choice Laboratories, LLCOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR8/28/20
Kaiser Permanente High Throughput SARS-CoV-2 AssaySouthern California Permanente Medical GroupOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR9/21/21
iC SARS-CoV-2 TestTempus Labs, Inc.OmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR3/22/21
TaqPath COVID-19, FluA, FluB Combo KitThermo Fisher Scientific Inc.OmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR8/3/21
Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo KitThermo Fisher Scientific Inc.OmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR10/12/21
Verily COVID-19 RT-PCR TestVerily Life SciencesOmicronS-GeneMulti-targetYes - can still detect other SARS-CoV-2 genesRT-PCR11/8/21