This blog represents the most up-to-date information as of April 8, 2021.
Since viruses are constantly evolving, new genetic variants with various mutations appear all the time, and SARS-CoV-2 is no different. Currently, there are multiple SARS-CoV-2 variants circulating globally. While variants of SARS-CoV-2 are not new (throughout the global crisis, SARS-CoV-2 has been mutating at a rate of 1–2 mutations per month1), there has been a drastic change in the number of mutations the virus has accumulated in short periods of time, causing concern around the world2.
Several new SARS-CoV-2 variants have emerged that range from having increased transmissibility to comparable or even potentially increased severity of disease3. New information is rapidly emerging, and scientists are working to learn more about these variants to better understand how easily they might be transmitted, whether they may confer increased virulence, the effectiveness of currently authorized vaccines against them, and more. Additionally, COVID-19 testing labs may have questions about the potential impact of the mutations on current molecular diagnostic tests.
Mutations and the TaqPath COVID-19 portfolio of tests
We are committed to providing our customers with gold-standard molecular diagnostic technology. The TaqPath COVID-19 portfolio of diagnostic tests use a multi-target assay design to compensate for emerging SARS-CoV-2 mutations. Additionally, we actively monitor post-market reports, publications, and public genomic databases to ensure our coronavirus assays continue to meet the highest quality standards. As part of our post-market surveillance efforts, we collect, review, and analyze data on the performance of our tests, including assessing whether any emerging mutations overlap with our assay design.
As our TaqPath COVID-19 portfolio of assays are all designed to detect multiple genetic targets, the overall test sensitivity should not be affected by the currently known SARS-CoV-2 variants.*
Reference guide to notable SARS-CoV-2 variants and the TaqPath COVID-19 tests
|Variant name(s)||Potential concerns||Currently known impact on our tests*|
|Transmissibility||Virulence (disease severity)||Vaccine efficacy or immune evasion|
|B.1.1.7, 501Y.V1, VOC-202012/01 (UK variant)||Increased transmissibility4||Some evidence of potential increased disease severity5||Little to no concern of vaccine efficacy4||No known impact on overall test sensitivity
• Decreased sensitivity of only S gene (S gene dropout) due to 69-70del
• S gene advantage: S gene dropout may signal presence of 69-70del & potentially B.1.1.7
|B.1.351, 501Y.V2 (South African variant)||Increased transmissibility4||No evidence of increased disease severity4||Potential for immune escape and possible effect on vaccine efficacy4||No known impact on overall test sensitivity|
|P.1, P.2 (Brazilian / Amazonas variants)||Potentially more transmissible6||No evidence of increased disease severity4||Increased propensity for reinfection6, but potential for immune escape unknown4||No known impact on overall test sensitivity|
|B.1.429, B.1.427, CAL.20C (California or West Coast variants)||Potentially more transmissible7||Effect on virulence requires more investigation7||Effect on vaccine requires more investigation7||No known impact on overall test sensitivity|
|B.1.1.207 (Nigerian variant)||No evidence of increased transmissibility4||No evidence of increased disease severity4||Effect on vaccine efficacy or immune escape unknown||No known impact on overall test sensitivity|
|A.23.1 (Ugandan variant)||Effect on transmissibility unknown8||Effect on disease severity unknown8||Potential for immune escape being investigated8||No known impact on overall test sensitivity|
|COH.20G/501Y (Columbus or Ohio variant)||No evidence of increased transmissibility4||No evidence of increased disease severity4||Effect on vaccine efficacy or immune escape unknown4||No known impact on overall test sensitivity|
|B.1.525, B.1.526 (New York variants)||Potentially more transmissible9||Potentially more virulent9||Concerns about vaccine efficacy and immune escape9||No known impact on overall test sensitivity|
|P.3 (variant originating in the Philippines)||Potentially more transmissible10||No evidence of increased disease severity10||Effect on vaccine efficacy or immune escape requires investigation10||No known impact on overall test sensitivity|
* As of April 8, 2021
Visit our emerging mutations and variants webpage for more information. If you have questions about the emerging variants and their impact on the efficacy of our portfolio, or if you would like to discuss your specific situation, please contact our technical support team at thermofisher.com/contactus.
Intended use and regulatory statements of products vary. For specific intended use and regulatory statements please refer to the Instructions for Use (IFU). Product availability by country varies. For product availability in your country, check the associated product webpages.