Saliva Test for COVID-19 reduces health care professional risk of infection

Saliva Test for COVID-19 Approved for Emergency Use by FDA on 13 April 2020.

Saliva testing will help with the global shortage of swabs, increase possibility of people testing, and reduce risk to collect samples by health care professionals.

The saliva-based test requires saliva collection by subject spitting several times in a given plastic tube. The capped tube is then hand back to health care worker for laboratory testing.

Testing of self-collected saliva or healthcare provider-collected anterior and mid-turbinate nasal swabs is limited to patients with symptoms of COVID-19. Collection of saliva for Covid19 should also be performed in a healthcare setting under the supervision of a trained healthcare provider using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device. Negative results for Covid19 infection from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.

Negative results do not preclude Covid19 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The saliva assay for COVID19 is intended for use under the FDA’s Emergency Use Authorization.

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.

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