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WHO Notice to IVD Beneficiaries 2021/01
Product type: All in vitro diagnostic medical devices (IVD) for the detection of SARS-CoV-2
Date: January 18, 2021
WHO identifier: 2021/01, version 1
Targeted audience: Laboratory experts and IVD users.
Purpose of this notice: Require IVD users to monitor SARS-CoV-2 mutations and their impact on diagnosis.
Problem description:
Following the detection of SARS-CoV-2 versions containing mutations, including SARS-CoV-2 VOC 202012/01 and SARS-CoV-2 501Y.V2, the TKO reminds IVD users to monitor the detection rates of SARS-CoV-2 on their website place.
IVD users should routinely review test results to detect unexpected increases or decreases in test results, including positivity rate, target detection rate, invalid or irreversible rate, etc. These variations may be early indicators of impact on IVD safety, quality, or performance products. Certain mutations can increase the risk of delayed diagnosis (due to inconclusive or invalid results) and misdiagnosis.
Manufacturers of IVD on the WHO list (via the emergency list) must proactively scan the literature and other sources in case of any documented mutations that could affect the safety, quality or performance of their products. This should be included in their post-market surveillance plan and will be complemented by feedback reported by IVD users in the form of unexpected results as well as other product problems and adverse events. All information collected must be reviewed in a timely manner, using risk management principles to determine the actions required.
Tips on actions to be taken by IVD users:
IVD users should inform the IVD manufacturer in the following circumstances:
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Increased differences in cycle threshold values (Ct) between different gene targets.
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Failure to detect specific gene targets, including those containing gene sequences that match documented mutations.
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Misdiagnosis (for example, false negative).
See the WHO website for the IVD User Reporting Form to provide feedback to manufacturers
Contact person for further information:
Anita SANDS, Regulation and Prequalification, World Health Organization,
e-mail: [email protected]
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