UK lighthouse laboratories testing for SARS-COV-2 may have breached WHO Emergency Use Assessment and potentially violated Manufacturer Instructions for Use
UK lighthouse laboratories testing for SARS-COV-2 may have breached WHO Emergency Use Assessment and potentially violated Manufacturer Instructions for Use
wherearethenumbers.substack.com
This is an updated version of a previous post. The main findings have been published today as a rapid response in the British Medical Journal. We have recently discovered that UK laboratories have been routinely recording a significant proportion of Covid-19 test results as positive based on the presence of one target gene alone, when there should have been two or more, as required to comply with WHO rules and manufacturer instructions. Without diagnostic validation, for both the original virus and any variants, it is not clear what can be concluded from a positive test resulting from a single target gene call, especially if there was no confirmatory testing. Given this, many of the reported positive results may be inconclusive, negative or from people who suffered past infection for SARS-COV-2
UK lighthouse laboratories testing for SARS-COV-2 may have breached WHO Emergency Use Assessment and potentially violated Manufacturer Instructions for Use
UK lighthouse laboratories testing for…
UK lighthouse laboratories testing for SARS-COV-2 may have breached WHO Emergency Use Assessment and potentially violated Manufacturer Instructions for Use
This is an updated version of a previous post. The main findings have been published today as a rapid response in the British Medical Journal. We have recently discovered that UK laboratories have been routinely recording a significant proportion of Covid-19 test results as positive based on the presence of one target gene alone, when there should have been two or more, as required to comply with WHO rules and manufacturer instructions. Without diagnostic validation, for both the original virus and any variants, it is not clear what can be concluded from a positive test resulting from a single target gene call, especially if there was no confirmatory testing. Given this, many of the reported positive results may be inconclusive, negative or from people who suffered past infection for SARS-COV-2