Emerging COVID-19 Variants' Effect on Testing
02/15/21 - Over the course of the past year, millions of individuals around the world have been stricken with illness secondary to transmission of SARS-CoV-2. Despite significant growth in knowledge regarding the virus that causes COVID-19, healthcare providers, epidemiologists, virologists, and laboratory scientists have often found themselves fighting an uphill battle in containing the spread of and treating patients infected with COVID-19. Over the past few months, we have learned that the SARS-CoV-2 virus, like many respiratory pathogens before, has undergone mutation, potentially contributing to increased infectivity and illness. Genetic variants of the virus such as B.1.1.7 and 501Y.V2 have garnered significant attention of the public and those assisting in treatment of COVID-19 due their apparent increase in transmissibility. Additionally, concerns have arisen regarding the ability of commonly employed testing methods to identify these new genetic variants.
Aegis Sciences Corporation utilizes the Thermo Fisher Scientific TaqPath™ COVID-19 Combo Kit for COVID-19 diagnostic testing. This highly sensitive and specific testing methodology analyzes three genetic targets that are unique to SARS-CoV-2. The FDA has recognized that the sensitivity, or risk for false negative results, of the TaqPath™ COVID-19 Combo Kit is not expected to be impacted by current COVID variants (i.e. B.1.17). The FDA’s commentary is further supported by recently published findings that demonstrate because of the targeting of 3 genes in testing, the TaqPath kit has been shown not to be prone to false negative results via testing of individuals infected with COVID variants.1,2 It is possible that other testing methodologies that do not use 3 gene targets may be impacted by these new variant strains.
Aegis Sciences Corporation will continue to equip healthcare providers with highly sensitive and specific diagnostic test results within a clinically relevant turnaround time, and it has done so in performing over 3 million tests to date. As always, our team of clinical and laboratory scientists will continue to monitor the scientific literature and clinical recommendations for testing amidst ongoing change throughout the Pandemic. Our mission is to help clinicians make better decisions and we will continue to do that through rapid, accurate, and technically superior performance.
1. Bal A, Destras G, Gaymard A, et al. Two-step strategy for the identification of SARS-CoV-2 variant of concern 202012/01 and other variants with spike deletion H69-V70, France, August to December 2020. Euro Surveill. 2021;26(3):10.2807/1560-7917.ES.2021.26.3.2100008. doi:10.2807/1560-7917.ES.2021.26.3.2100008
2. Arena F, Pollini S, Rossolini GM, Margaglione M. Summary of the Available Molecular Methods for Detection of SARS-CoV-2 during the Ongoing Pandemic. Int J Mol Sci. 2021;22(3):1298. Published 2021 Jan 28. doi:10.3390/ijms22031298