A performance evaluation of a PCR assay for the detection of SARS-CoV-2.
PCR based tests are a world-wide gold standard for the detection of SARS-CoV-2 owing to their high level of sensitivity and specificity. Mass-testing played a vital role in combating Covid-19 and regular testing continues to be the norm in many parts of the world.
SpeeDx, based in Australia, has developed a new assay to detect SARS-CoV-2 using its proprietary PlexPrime® technology, which offers benefits over standard PCR tests, including increased sensitivity and potentially detecting Covid-19 earlier. When combined with appropriate test, trace, and isolation approaches, this would enable faster control of the spread of infection.
How we helped
To undertake this evaluation, we used diagnostic remnant samples from our biobank. As we record the associated high-quality metadata, including viral load and strain information, we were able to provide SpeeDx with a range of different specific samples tailored to the team’s needs, ensuring that the evaluation complied with UK Covid-test legislation.
We rapidly evaluated the SpeeDx assay as a result of the large volume of well-curated samples stored in our biobank. By using clinical samples that have previously been tested using standard methods, we were able to demonstrate the performance of the new assay in a similar environment to its intended use. This date is essential for adoption of the assay into a clinical setting.
The results from the evaluation were positive, showing favourable levels of sensitivity and specificity when compared with tests currently in use. The data will be used for regulatory submission, allowing this new test to be sold on the UK market and assuring users around the world of the test’s performance.