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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