This blog represents the most up-to-date information about the B.1.1.7 SARS-CoV-2 variant as of February 1, 2021.
A new, highly transmissible variant of SARS-CoV-2 discovered in the United Kingdom, B.1.1.7 (or VOC202012/01 or 501Y.V1) has complicated the COVID-19 situation. B.1.1.7’s markedly higher transmissibility creates challenges for COVID-19 wards, assisted-living facilities, and other situations in which close contact between potentially infected people is unavoidable, making the detection and tracking of this variant and others like it even more important to the long-term containment of SARS-CoV-2. While B.1.1.7 shows increased transmissibility, preliminary evidence suggested there was no indication it was associated with increased disease severity. However, more recent studies do indicate that there is a realistic possibility of increased risk of death in patients infected with B.1.1.7.
B.1.1.7 has a specific mutation in the S-gene which results in a deletion of two amino acids at sites 69 (histidine) and 70 (valine), commonly referred to as 69-70del. This has raised concerns about whether the B.1.1.7 variant, or other lineages and variants which include the same S-gene mutation, can be detected.
The S Gene Advantage
The Applied Biosystems TaqPath COVID-19 diagnostic tests use a multi-target design, to compensate for emerging SARS-CoV-2 variants and mutations. Furthermore, they are unique among the most commonly used molecular tests in that the multi-target design includes an S-gene target. If a sample with a variant that has the 69-70del mutation is tested using the TaqPath COVID-19 tests, it will result in an S gene dropout. Because of this, the test may signal the presence of the 69-70del mutation and, potentially, the B.1.1.7 lineage (501Y.V1 variant).
To date, the 69-70del S gene mutation has not been found to impact test results obtained using the TaqPath COVID-19 tests.
European CDC and US FDA Highlight TaqPath COVID-19 Tests for Early Identification of B.1.1.7
Per the US FDA, “Importantly, the detection pattern that appears with the TaqPath… diagnostic tests when certain genetic variants are present may help with early identification of new variants in patients to reduce further spread of infection. The recently identified B.1.1.7 variant has been associated with an increased risk of transmission, therefore early identification of this variant in patients may help reduce further spread of infection.” The European Centre for Disease Prevention and Control (ECDC) likewise reports, “only one assay targeting the S-gene [the TaqPath COVID-19 CE-IVD RT-PCR Kit] is on the list of published in-house assays listed by the WHO.” Furthermore, the ECDC notes that, “Laboratories should review the PCR performance and drop-out of the S-gene. PCR could be used as an indicator for cases with the new variant for further sequencing and investigation.”  Both the ECDC and US FDA recommend further characterizing specimens which show S-gene dropout using sequencing.
Identify Potential Variants Early to Help Curb the Spread
Being able to distinguish between different, potentially more transmissible SARS-CoV-2 variants is of value for gathering preliminary data on the appearance and spread of SARS-CoV-2 variants and lineages. Because the detection patterns of the TaqPath COVID-19 tests may differ between different variants, test results from these kits may provide initial insight into developments in SARS-CoV-2’s evolution. Further genetic surveillance studies using whole viral genome sequencing techniques should be employed to more thoroughly track this deadly pathogen. Any data is good data when the best data is yet to be gathered, so this possibility can help public health officials fill the gap between the present moment and future improvements to epidemiological surveillance around the world.
How to Learn More
Find out more about our TaqPath COVID-19 diagnostic test kits:
- The TaqPath COVID-19 Combo Kit is Emergency Use Authorized (EUA)
- The TaqPath COVID-19 CE-IVD RT-PCR Kit is CE-IVD marked
Confirmation of the variant strain may be accomplished by sequencing. There are multiple options available for sequencing of SARS-CoV-2 research isolates.
Learn how we can help your emerging SARS-CoV-2 variant and mutation surveillance efforts with our Sanger sequencing and NGS technologies.
If you have additional questions or would like to discuss your specific situation, please contact our technical support team at www.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, please check the TaqPath COVID-19 Multiplex Diagnostic Solution webpage.