COVID-19: US FDA Grants Emergency Approval For Saliva Test To Detect Coronavirus

WASHINGTON DC (United States): The U.S. Food and Drug Administration (FDA) has granted accelerated and emergency approval, also known as Emergency Use authorization (EUA), for a saliva test that could detect COVID-19, the disease caused by the novel coronavirus. Currently, the tests to diagnose COVID-19 require a swab from deep in the nasal passages or the back of the throat.

The new approach, which uses saliva as the primary test biomaterial to diagnose COVID-19, was developed by Rutgers’ RUCDR Infinite Biologics with Spectrum Solutions and Accurate Diagnostic Labs (ADL).

According to the FDA, “the Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2 Assay is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal (throat) swab, nasopharyngeal swab, anterior nasal swab, mid-turbinate nasal swab from individuals suspected of COVID-19 by their health care clinicians.”

Researchers at Rutgers University developed the saliva collection method along with Spectrum Solutions and Accurate Diagnostic Labs.

“The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR.

“It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is quicker and more scalable than swab collections. All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”

The saliva test builds on the existing TaqPath SARS-CoV-2 Assay used in existing COVID-19 testing to identify RNA from the virus.

The collection of a saliva sample requires spitting into a tube, resulting in a much less invasive procedure without tying up large amounts of PPE.

Per the Food and Drug Administration’s (FDA) instructions, the testing would still occur in a healthcare setting under the supervision of a qualified professional.

The collection of saliva specimens is only limited to patients who have typical COVID-19 symptoms. It should be performed under a health care setting by a trained clinician. The samples are then transported for RNA extraction, which are then tested within 48 hours of collection.

All of the saliva samples collected from 60 patients were in agreement with the presence of new coronavirus.

The Trump administration’s COVID-19 testing task force has already contacted RUCDR about how they can help expand testing and allow labs to leverage the technology. Biopharma executives for companies involved in COVID-19 testing also contacted the group.

The saliva tests are now available to the RWJBarnabas Health network, West Orange, N.J., which has collaborated with Rutgers University.

from League of India