Based on in silico analysis and in-house performance evaluation using recombinant nucleocapsid proteins and inactivated viruses, the mutated variants of SARS-CoV-2 should not affect performance of the CareStart™ Covid-19 Antigen test. Our tests detect the nucleocapsid protein antigen (“N-Protein”) of the virus, which are not affected by variant strains that mainly mutate in the virus’ spike proteins (S-Protein”). We will continue to monitor and analyze variants of SARS-CoV-2 and, based on the design of our test, it is highly likely that our test will continue to detect all variants of SARS-CoV-2.
We are actively monitoring and participating with agencies and organizations to ensure our test will continue to be efficacious against mutating strains. Our test has been validated against the VUI_202012/01 variant (B.1.1.7 lineage or “UK SARS-CoV-2 variant”) and the 501.V2 strain (B.1.351 lineage or “South African SARS-CoV-2 variant”).
In addition, the FDA is identifying antigen test manufacturers whose products may face negative impacts of new mutations. We have not been contacted by the FDA stating that our test is impacted. However, in order to provide our customers with up-to-date information, we will continue to assess our test’s performance as new mutations are found and work closely with the FDA to provide transparency on our product’s accuracy.
The CareStart™ COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.