(RTTNews) - Quest Diagnostics received emergency use approval from the U.S. Food and Drug Administration for a new laboratory technique to coronavirus testing that combines test samples in batches instead of running them one by one, speeding up the process.
The FDA said it reissued an emergency use authorization to the company to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.
In pooling, specimens must be collected into individual vials, but then are combined into small batches or pools by the laboratory. A negative result for a batch means that all patients in that pool are considered negative. But, a positive result would require each specimen to be individually retested, Quest Diagnostics said in statement.
The company stated that the technique is an efficient way to evaluate patients in regions or populations with low rates of disease. Pooling is used routinely in blood banking to screen donated blood for a variety of viruses.
The company expects to deploy the technique at its laboratories in Chantilly, Virginia, and Marlborough, Massachusetts by the end of next week with additional laboratories to follow.
Meanwhile, the FDA also granted three emergency use authorizations to Quest Diagnostics for the use of its Quest Diagnostics Self-Collection Kit with the Hologic Panther Fusion, Hologic Aptima and Roche cobas molecular platforms, the company said.
The new new emergency use authorizations expand the use of the self-collection kit beyond the emergency use authorization, granted on May 27th, for the use of the kit on the Quest SARS-CoV-2 rRT-PCR test.
The company expects the new emergency use authorizations will allow it to use self-collection more broadly on behalf of clients and patients in the United States. Self-collected specimens that were not observed by a healthcare professional are not eligible for pooling.
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