WHO Information Notice for IVD Users 2021/01
Product type: All in vitro diagnostic medical devices (IVDs) for detection of SARS-CoV-2 Date: 18 January 2021 WHO-identifier: 2021/01, version 1 Target audience: Laboratory professionals and users of IVDs. Purpose of this notice: To request that IVD users monitor mutations of SARS-CoV-2 and their impact on diagnosis. Description of the problem: Following the detection of SARS-CoV-2 variants containing mutations, including SARS-CoV-2 VOC 202012/01, and SARS-CoV-2 501Y.V2, WHO reminds users of IVDs to monitor detection rates for SARS-CoV-2 at their site. IVD users should routinely review test results to detect unexpected increases or decreases in…
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