The test’s simple workflow and easy saliva collection reduce the workload for healthcare workers. Credit: MicroGEM / PRNewswire.

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for MicroGEM’s Sal6830 SARS-CoV-2 Saliva Test.

The test is claimed to be the nation’s first FDA approved saliva test for Covid-19 that uses polymerase chain reaction (PCR) directly at the point of care, providing results in 27 minutes.

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MicroGEM stated that the Sal6830 SARS-CoV-2 Saliva Test was clinically evaluated during the Delta and Omicron waves of the pandemic and has proven to be robust to viral mutations.

It has been designed for multiple SARS-CoV-2 gene targets, which enables robust detection of current variants and protects against obsolescence from future variants.

The MicroGEM Sal6830 SARS-CoV-2 Saliva Test’s simple workflow and easy saliva collection also reduce the workload for healthcare workers.

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MicroGEM CEO Jeff Chapman said: “The MicroGEM Sal6830 SARS-CoV-2 Saliva Test will be an essential testing tool in our ongoing efforts to get our nation’s communities and businesses back to regular operations.

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“The introduction of the MicroGEM Sal6830 Point of Care PCR System marks a historic step in our mission to democratise molecular diagnostics by moving ultra-fast, high-performance testing out of laboratories and closer to people at the point of need, thus allowing decisions to be made in real-time.”

The company stated that the small size of the new saliva test allows it to be incorporated at testing sites that include ambulatory surgical centres, Clinical Laboratory Improvement Amendments (CLIA)-waived workplace testing sites, emergency departments and mobile testing labs.

The test received authorisation to detect nucleic acid from the SARS-CoV-2 virus only, and not for any other viruses or pathogens.