RE: Private Eye20 Jan 2022 16:25
And in my non scientific opinion this is the passage the "whistleblower" and the scientific commentator are picking on, to a layman like me you can see the explanations for why some samples have been left out by Gateshead nhs
16. Clinical Performance Evaluation
An initial clinical performance validation aimed to evaluate the in vitro diagnostic performance of the genesig® COVID-19 3G assay compared with a comparator assay, TaqPath (ThermoFisher). Combined oropharyngeal/nasal swab samples were previously collected from patients suspected of having COVID-19 at the Queen Elizabeth Hospital, NHS Gateshead, both symptomatic and asymptomatic. These were analysed by TaqPath assay, and the eluates frozen at -70oC prior to the commencement of this study.
493 frozen patient sample eluates were tested, with 415 giving a concordant result with the original TaqPath assay result. The 78 discordant samples were then analysed by a resolver assay, the genesig® Real-Time PCR COVID-19 (CE-IVD) assay. 1 sample was excluded due to a lack of eluate for the resolver assay, 20 samples were excluded as they were below the LoD of the assay under investigation (Cq>34). All other samples were determined to be True Positive (2), True Negative (54), or False Negative (1).
The contingency table below illustrates the total positives and negatives that were used to calculate the Diagnostic Sensitivity (PPA), Diagnostic Specificity (NPA), and the 95% confidence interval (CI) for sensitivity and specificity. Of the 472 samples, 157 gave true positive results and 314 gave true negative results. This resulted in diagnostic sensitivity of 99.4% (95% CI 96.5% - 100%) and diagnostic specificity of 100% (95% CI 98.8%-100%).
Contingency table for genesig® COVID-19 3G Clinical Performance Evaluation – Queen Elizabeth Hospital - NHS Gateshead
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