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3rd August 2020  Product update: rapidmicrobiology staff writer

Self-Collected Saliva-based COVID-19 RT-PCR Test Receives FDA EUA

The Clinical Reference Laboratory (CRL), one of the largest privately held clinical testing laboratories in the U.S., has received FDA Emergency Use Authorization (EUA) and is scaling up capacity for CRL Rapid Response™, a saliva-based COVID-19 RT-PCR test that can be self-collected at home, work or any other setting.

The test, shown in CRL's EUA studies to be more sensitive and accurate than the standard COVID-19 anterior nasal swab test, detects the presence of coronavirus in the saliva of the test taker. In addition, the test is more comfortable and easier to administer, is not "technique dependent" and virtually anyone can self-collect an adequate sample for testing, with test results available in 24-48 hours of receipt at CRL. CRL Rapid Response™ is ready for immediate commercial launch, making it the first large-scale service of its kind focused on the American workforce. Testing is critical to safely helping America get back to work, which is why CRL is offering these tests to employers in businesses, universities, government agencies, nursing homes and other organizations. CRL has already lined up several partnerships for CRL Rapid Response™ testing.

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 DNA Genotek, a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), demonstrate sample stability of up to twenty-one days post-collection, enabling at-home collection. CRL tests the saliva sample by RT-PCR technology, using Patented CoPrimer™ probes and primers developed by CRL partner Co-Diagnostics Inc. (NASDAQ: CODX) to detect SARS-CoV-2 viral RNA with high sensitivity and specificity.

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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Date Published: 3rd August 2020

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.

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