Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2
Purpose of this notice: clarify information previously provided by WHO. This notice supersedes WHO Information Notice for In Vitro Diagnostic Medical Device (IVD) Users 2020/05 version 1, issued 14 December 2020.
Description of the problem: WHO requests users to follow the instructions for use (IFU) when interpreting results for specimens tested using PCR methodology.
Users of IVDs must read and follow the IFU carefully to determine if manual adjustment of the PCR positivity threshold is recommended by the manufacturer.
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 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.
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What does this mean? PCR testing was done with a high cycle threshold in order to ensure a high number of false positives. This misinformation was used to discredit President Trump’s policy for COVID-19, collapse the economy and destroy the middle class.
When Joe Biden was coronated on January 20th, the truth was revealed by WHO, false positives by PCR testing will be “corrected” and the COVID case numbers will drop. Joe Biden will be credited for saving the country from the pandemic and the middle class will be able to go back to work to finance the Communist regime in Washington, D.C.
David DeGerolamo
Darn now the serious causes of death will return. Can we have COVID back so we all do nto die from cancer and heart disease?
Sorry I had to do that to quell the anger in me. It was obvious from the beginning this was a lie. Now that they ruined peoples lively hoods and murdered other unwanted people. They will walk away untouched. While all those with a duty sit idle and wish it would all go away. There needs to be mass demonstrations that will not stop until all that played along with the lie are tried for murder in front of a jury of the people.