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July 20, 2020

FDA grants EUA to sample pooling for Quest Diagnostics’ Covid-19 test

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for specimen pooling with Quest Diagnostics' Covid-19 diagnostic test.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for specimen pooling with Quest Diagnostics’ Covid-19 diagnostic test.

The approval enables the use of Quest SARS-CoV-2 rRT-PCR test with pooled samples, comprising up to four individual swab specimens.

Quest is the first company to receive FDA authorisation for specimen pooling.

Sample pooling enables quick testing of more people with fewer resources. The technique involves the collection of specimens into individual vials, which are later combined into small batches or pools by the laboratory.

A positive pool result indicates that one or more of the people tested may be infected, requiring individual retests. If the result is negative, all patients in that pool are considered negative.

The approach is considered efficient for analysing patients in regions or populations with low disease prevalence.

FDA commissioner Stephen Hahn said: “This EUA for sample pooling is an important step forward in getting more Covid-19 tests to more Americans more quickly while preserving testing supplies.

“Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”

The FDA authorisation enables the use of Quest Covid-19 diagnostic test with pooled upper respiratory specimens, including nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs.

By the end of the week, the company intends to implement the technique at its laboratories in Chantilly, Virginia, and Marlborough, Massachusetts, in the US.

Quest plans to extend the specimen pooling to other laboratories as well.

Quest Diagnostics chairman, CEO and president Steve Rusckowski said: “As Covid-19 continues to spread around the country, access to timely, quality laboratory testing is critical to patients and effective public health response.

“Pooled specimen testing is a proven technique that will help us to optimise testing capacity at this critical time for our country.”

In May, the company obtained EUA from the FDA for a self-collection kit for Covid-19.

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