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Clinical Reference Laboratory Gets FDA Emergency Use Authorization for COVID-19 Saliva PCR Test

NEW YORK – Clinical Reference Laboratory (CRL) said on Friday that it has received Emergency Use Authorization from the US Food and Drug Administration for a saliva-based COVID-19 RT-PCR test that allows for unsupervised self-collection of samples.

According to the company, the test, CRL Rapid Response, has shown to be more sensitive and accurate than a COVID-19 anterior nasal swab test in the firm's EUA validation study. Test results are available within 24 to 48 hours of sample receipt.

The validation study showed that the saliva test was 100 percent sensitive and specific for samples from known COVID-19-positive and -negative patients, whereas anterior nasal swabs only detected 55 percent of positive samples. The reason, according to CRL, is the presence of more viral genetic material in saliva than in anterior nasal swabs and the fact that sample collection is not technique-dependent.

However, other large-scale laboratories that have evaluated saliva-based COVID-19 testing have found anterior nasal swabs to be better suited.

Saliva for the CRL Rapid Response test is collected in DNA Genotek Omnigene Oral (OM-505) collection devices from DNA Genotek, a subsidiary of OraSure Technologies. CRL said that studies it conducted with DNA Genotek found the sample to be stable for up to 21 days post-collection.

Samples are analyzed by RT-PCR using CoPrimer probes and primers developed by CRL's partner Co-Diagnostics.

CRL, based in Lenexa, Kansans, said it plans to make the test commercially available immediately and has already lined up several unnamed partners for testing. It plans to sell the test to government agencies, universities, and businesses for testing of their employees.

"[W]e are aggressively scaling up for mass COVID-19 testing in the next two to three weeks, and expect to eventually process over 50,000 tests a day," said CRL CEO Robert Thompson in a statement.

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