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FDA approves emergency use of saliva test to detect COVID-19
As the race to develop rapid testing for COVID-19 expands, the Food and Drug Administration has granted emergency approval for an approach that uses saliva as the primary test biomaterial.
According to a document provided 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. To expand on this assay, Rutgers University–based RUCDR Infinite Biologics developed a saliva collection method in partnership with Spectrum Solutions and Accurate Diagnostic Labs.
The document states that collection of saliva specimens is limited to patients with symptoms of COVID-19 and should be performed in a health care setting under the supervision of a trained health care clinician. Samples are transported for RNA extraction and are tested within 48 hours of collection. In saliva samples obtained from 60 patients evaluated by the researchers, all were in agreement with the presence of COVID-19.
If shown to be as accurate as nasopharyngeal and oropharyngeal samples, saliva as a biomatrix offers the advantage of not generating aerosols or creating as many respiratory droplets during specimen procurement, therefore decreasing the risk of transmission to the health care worker.
Also, it may be easy enough for patients to do saliva self-collection at home. However, it is important to note that SARS-CoV-2 tests on saliva have not yet undergone the more rigorous evaluation of full FDA authorization, and saliva is not a preferred specimen type of the FDA nor the [Centers for Disease Control and Prevention] for respiratory virus testing.