Summary
The Emergency Use Authorization (EUA) granted in the US in February 2020 for the experimental CDC SARS-CoV-2 test is being withdrawn due to major concerns about the accuracy of PCR COVID tests, especially in government contract laboratories like the UK Lighthouse labs. These labs have been criticised for their poor quality, with reports of chaotic and dangerous conditions. The PCR test is deemed unsuitable for virus screening due to a high number of false positives. Accurate diagnostic testing is crucial as it informs medical treatment and public policy. The CDC has issued new guidance for clinical laboratories to transition to another FDA-authorised COVID-19 test, ideally one that includes influenza detection. Despite petitions, the government did not release the false positive rate (FPR) data, making the reported positives questionable. The high FPR, especially when testing large populations, can lead to a significant number of false cases. The UK is expected to follow the US in transitioning to new tests, which will require validation and verification to ensure accuracy. Quality control is essential, as rushed systems often compromise standards, and the UK Accreditation Service (UKAS) faces a surge in new lab applications for COVID testing.