This is a medical product alert.
"... WHO guidance Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed. The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology.
WHO reminds IVD [In Vitro Diagnostic Medical Device] users that disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases. This means that the probability that a person who has a positive result (SARS-CoV-2 detected) is truly infected with SARS-CoV-2 decreases as prevalence decreases, irrespective of the claimed specificity.
Most PCR assays are indicated as an aid for diagnosis, therefore, health care providers must consider any result in combination with timing of sampling, specimen type, assay specifics, clinical observations, patient history, confirmed status of any contacts, and epidemiological information.
Actions to be taken by IVD users: ...
4. Provide the Ct value in the report to the requesting health care provider."
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