NEW YORK – The U.S. Meals and Drug Administration on Tuesday printed data for labs and healthcare suppliers detailing the affect of SARS-CoV-2 mutations on molecular, antigen and serology exams for the virus.
Whereas the company mentioned that modifications within the virus’s genome might affect the effectiveness of antigen and serology exams, it famous particularly 4 molecular exams that acquired Emergency Use Authorization whose efficiency it mentioned could possibly be negatively affected by SARS-CoV-2 mutations: Mesa Biotech’s Accula SARS-CoV-2 Check; Utilized DNA Sciences’ Linea COVID-19 Assay Equipment; Thermo Fisher Scientific’s TaqPath COVID-19 Combo Equipment; and Cepheid’s Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, and Xpert Omni SARS-CoV-2 exams.
The company famous within the case of the Accula take a look at that the affect of the variant of concern “doesn’t seem like important,” however that it has alerted healthcare suppliers “out of an abundance of warning.”
Within the case of the Utilized DNA Sciences, Thermo Fisher, and Cepheid exams, FDA mentioned that sure mutations can scale back sensitivity for targets of every of those exams, but it surely added that as a result of these exams all detect a number of genetic targets, it mustn’t lower general take a look at sensitivity. Nonetheless, the affect of SARS-CoV-2 variants on these exams might have an effect on the interpretation of outcomes.
Moreover, FDA famous that for the Thermo Fisher and Utilized DNA Sciences exams, circumstances by which the exams’ fail to detect their S-gene targets however efficiently detect their different targets might point out the presence of sure mutations together with these within the B117 variant, and labs ought to take into account having such specimens sequenced if that service is obtainable.
FDA mentioned it is going to proceed to replace the web page as new data on the affect of variants on SARS-CoV-2 testing turns into out there.
This article was initially printed on Trendy Healthcare’s sister publication, GenomeWeb.