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WHO Information Notice for IVD Beneficiaries 2020/05
Product type: Nucleic Acid (NAT) Testing Technologies Using Polymerase Chain Reaction (PCR) to Detect SARS-CoV-2
Date: January 13, 2021
WHO identifier: 2020/5, version 2
Targeted audience: laboratory experts and IVD users.
Purpose of this notice: clarify information previously provided by the WHO. This notice replaces the WHO Information Notice for users of in vitro diagnostic medical devices (IVD) 2020/05, version 1, issued on 14 December 2020.
Problem description: The WHO requires users to follow the Instructions for Use (IFU) when interpreting results for samples tested using the PCR methodology.
IVD users must read and followw The IFU carefully determines whether the manufacturer recommends manually adjusting the PCR positivity threshold.
WHO guidelines Diagnostic test for SARS-CoV-2 states that a careful interpretation of weak positive results is needed (1). The cycle threshold (Ct) required for virus detection is inversely proportional to the patient’s viral load. If the test results do not match the clinical presentation, a new sample should be taken and retested using the same or different NAT technology.
TKO reminds IVD users that disease prevalence changes the predictive value of test results; as the prevalence of the disease decreases, the risk of false positives increases (2). This means that the likelihood that a person with a positive result (SARS-CoV-2 detected) is truly infected with SARS-CoV-2 is reduced by a decrease in prevalence, regardless of the claimed specificity.
Most PCR tests are indicated to aid in diagnosis, so healthcare providers must consider any outcome combined with sampling time, sample type, test specifics, clinical observations, patient history, confirmed contact status, and epidemiological information.
Actions to be taken by IVD users:
- Please read the IFU carefully in its entirety.
- If there is any aspect of the IFU that is unclear to you, contact your local representative.
- Check the IFU for each incoming shipment to detect any changes in the IFU.
- Enter the Ct value in the report to your healthcare provider.
Contact person for further information:
Anita SANDS, Regulation and Prequalification, World Health Organization, e-mail: [email protected]
References:
1. Diagnostic test for SARS-CoV-2. Geneva: World Health Organization; 2020, WHO reference number WHO / 2019-nCoV / laboratory / 2020.6.
2. Altman DG, Bland JM. Diagnostic tests 2: Predictive values. BMJ. 1994 July 9; 309 (6947): 102. doi: 10.1136 / bmj.309.6947.102.
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