This came out on December 7th, 2020 - just noticed it today. From the World Health Organization:
WHO Information Notice for IVD Users
Nucleic acid testing (NAT) technologies that use real-time polymerase chain reaction (RT-PCR) for detection of SARS-CoV-2
And this:
Purpose of this notice: To ensure users of certain nucleic acid testing (NAT) technologies are aware of certain aspects of the instructions for use (IFU) for all products.
Description of the problem: WHO has received user feedback on an elevated risk for false SARS-CoV-2 results when testing specimens using RT-PCR reagents on open systems.
As with any diagnostic procedure, the positive and negative predictive values for the product in a given testing population are important to note. As the positivity rate for SARS-CoV-2 decreases, the positive predictive value also decreases. 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 positivity rate decreases, irrespective of the assay specificity. Therefore, healthcare providers are encouraged to take into consideration testing results along with clinical signs and symptoms, confirmed status of any contacts, etc.
...yadda... ...yadda... ...yadda... Basically, they say that the RT-PCR test (swab up the nose, not the spit test or cheek swab) can deliver false positives (up to 90% in several studies) Come on guys. We knew that back in Summer. I thought that this organization was supposed to be proactive. What are we paying you for then?
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