LumiraDx, a point of care (POC) diagnostics testing company, has confirmed that its SARS-CoV-2 Ag Test detects major global SARS-CoV-2 variants, including Alpha, Beta, Gamma, Delta and Epsilon variants.
In a technical bulletin, the company outlines the ongoing measures it is taking to ensure it can actively detect variants of concern (VOC), as classified by global health protection agencies including the World Health Organization, due to either their increased risk of being transmissible or of causing more severe disease.
SARS-CoV-2, like other viruses, is constantly mutating, and becoming more diverse with new variants of the virus occurring over time. While some new variants may emerge and disappear, or be clinically inconsequential, others emerge and dominate and have been detected globally during this pandemic. Government regulators in the U.S., UK, and other countries have instituted guidelines that tests must meet to be able to detect the emerging variants that are driving many new COVID-19 cases globally.
LumiraDx is actively monitoring how its SARS-CoV-2 Antigen test performs against new variants of the SARS-CoV-2 virus. The company’s in-house evaluation is carried out using in silico analysis and direct testing with either recombinant nucleocapsid protein or viral isolates. In house testing results are confirmed by independent organizations such as the UK Department of Health and Social Care – COVID-19 Technologies Validation Group and the National Health Laboratory Service – South Africa.
Nigel Lindner, PhD, LumiraDx’s chief innovation officer, explains: “Since the COVID-19 virus emerged early last year, we have learned an extraordinary amount about how this virus spreads and importantly, how it can mutate. We know that testing is a critical component in the monitoring and controlling of the spread of the virus. This becomes even more important with the emergence of new, and unfamiliar variants. We are committed not only to ensuring we are following all guidelines to monitor for these variants of concern, but also to sharing this data and our monitoring program process with our customers.”
Unlike PCR, the LumiraDx SARS-CoV-2 Ag Test uses antibodies, not nucleic acid based-primers, to capture SARS-CoV-2 nucleocapsid antigen, not the spike protein. Antibodies typically recognize 8-15 amino acid target sequences which are equivalent to 24-45 nucleotide sequences. Thus, single nucleic acid point mutations are not likely to affect the performance of the LumiraDx SARS-CoV-2 Ag Test. Furthermore, mutations outside of the nucleocapsid viral coding region (ex Spike protein) are also unlikely to affect the assay performance.
More detail on the LumiraDx SARS-CoV-2 Ag test variant detection may be found in the company’s Technical Bulletin.