Clinical Reference Laboratory Receives FDA Emergency Use Authorization for Best-in-Class Self-Collected COVID-19 Saliva Test
In CRL conducted studies of paired samples required for the FDA EUA, the CRL Rapid Response™ test had 100% sensitivity and specificity (higher than any other saliva-based COVID-19 molecular diagnostic test) — accurately detecting the presence or absence of the virus in known COVID-19 positive and negative patients as compared to only 55% detection using anterior nasal swabs, the common method of self-collection. The higher sensitivity and accuracy of the CRL Rapid Response™ saliva test is due to a combination of factors. First, saliva typically contains a larger sample of genetic material than what is usually collected using an anterior nasal swab. Additionally, collection of a CRL sample is not technique dependent and can be easily self-collected. The saliva is collected in a DNA Genotek OMNIgene® ORAL (OM-505) saliva collection device, specifically designed for self collection, stabilization, storage and shipment to the laboratory. Studies conducted by CRL and
"Experts agree that testing is the key to getting America back to work, but concerns about reliability and availability of testing are an impediment for many states, cities and businesses as they consider their re-opening plans," said CRL CEO
"People should not have to choose between comfort or convenience and accuracy. CRL Rapid Response™ offers convenient self testing with better sample collection, protection and transport, combined with superior testing methodology, which leads to more accurate results and, ultimately, better public health outcomes," said Dr.
CRL Rapid Response™ tests can be purchased by government agencies, universities, and businesses for their employees. The test itself is easy to use and simply requires that the individual's saliva be deposited in a collection vial provided and sent back to the CRL laboratories using the company provided prepaid one-day shipping package. Specimens are processed within 24-48 hours of receipt and individuals can access their test results online through a unique two-factor authentication protected portal. Individuals have the option to speak with a licensed physician about their results. Prior to taking the test, individuals will need to give consent for their employers and their local public health departments to receive the test results.
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Jackie Zygadlo at CRLmedia@mww.com