The WHO has designated four variants as being of global concern and requiring heightened tracking and analysis. These are the B.1.1.7, B. 1.351, P.1, and B.1.617 variants.
Do These Mutations Affect PerkinElmer’s Diagnostic Coronavirus RT-PCR Assays?
The mutations in the VOC recognized by the WHO (May 14, 2021) do not affect the detection of SARS-CoV-2 by PerkinElmer RT-PCR assays. As described in the kit insert, PerkinElmer’s RT-PCR assays target two specific genomic regions of SARS-CoV-2: nucleocapsid (N) gene and ORF1ab. These mutations in the spike protein do not impact the safety and effectiveness of PerkinElmer’s diagnostic RT-PCR assays.
PerkinElmer’s Proactive Risk Management Plan:
PerkinElmer monitors SARS-CoV-2 variants database in NCBI, GISAID and SARS-CoV-2 publications (PubMed) and works closely with our government and commercial testing partners. The information is used to perform thorough bioinformatics analysis routinely. Based on in silico analysis, the performance of the kit is not impacted by the mutations.
What Should Laboratories Watch For?
On January 8, 2021, the U.S. FDA issued an alert about potential false negative results associated with commonly used COVID-19 tests due to mutations in the novel coronavirus’s genetic code. U.S. FDA’s analysis identified three molecular assays whose performance could be impacted by these SARS-CoV-2 variants. They requested and received reports from test developers that showed reduced analytical sensitivity associated with these SARS-CoV-2 molecular tests. Labs that use one of these assays should proceed with extreme caution – the extent, breadth or depth of false negative outcome is completely unknown, therefore utilizing these tests to track the new variant is unwise and unauthorized. The FDA recommends repeating the tests performed with any of these affected assays using an unaffected assay, when there is suspicion of a false negative result.
How Can PerkinElmer Help?
PerkinElmer has received many inquiries from labs that have been using kits flagged by the FDA due to the risk of false negative results. PerkinElmer can assist by ensuring a steady supply of the most-sensitive commercially available RT-PCR kit for SARS-CoV-2 detection* as established by the U.S. FDA’s Reference Panel Study
wherein the FDA developed an experiment to precisely compare the performance of the nucleic acid-based SARS-CoV-2 assays which have received Emergency use Authorization and published a comparative performance analysis. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit has the lowest Limit of Detection among all the commercially available kits tested – this means a significant reduction in false negative rate even in a world without new variants. As PerkinElmer’s assays are unaffected by the variants described above, the team continues to leverage its strong position to help.
Lowest limit of detection, and most-sensitive reflect a comparison of analytical sensitivity between Emergency Use Authorized COVID test kits as reported in FDA SARS-CoV-2 Reference Panel on Jan. 12, 2021.