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November 2, 2021

US FDA authorises Yale University’s SalivaDirect test using pooled samples

The FDA has authorised laboratories to pool five saliva samples at a time for the detection of the SARS-CoV-2 virus.

Yale University has received US Food and Drug Administration (FDA) authorisation for the SalivaDirect polymerase chain reaction (PCR) Covid-19 test to detect the SARS-CoV-2 virus in pooled samples.

Developed by the Yale School of Public Health, SalivaDirect is an open-source RT-qPCR test that uses saliva samples to detect the virus.

Laboratories designated by the Yale School of Public Health have been authorised by the FDA to use the test with pools of five saliva samples at a time for the detection of the SARS-CoV-2 virus.

With pooled testing, laboratories will be able to combine saliva samples obtained from up to five individuals in one tube and process the multiple samples as a single test.

If the pool tests negative, all individuals in the pool will be classified as negative for the virus and won’t require any further testing.

However, if a pool tests positive, the laboratories will perform additional testing to detect the positive individuals.

Yale School of Public Health research scientist and SalivaDirect principal investigator Anne Wyllie said: “Adopting frequent testing as a new public health habit will help keep us safe from infection and keep our schools, workplaces and businesses open.

“Sample pooling with SalivaDirect provides labs with an additional tool they can use to minimise testing materials, increase throughput and report faster results.”

This sample pooling process helps to maintain the clinical sensitivity that is associated with real-time reverse transcription PCR tests.

It also helps laboratories to process Covid-19 tests and provide results faster.

In August last year, SalivaDirect obtained emergency use authorisation from the FDA. It can be used on a routine basis to screen people without symptoms related to Covid-19 or for those who may have the disease.

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