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Novel Rapid Antigen Assay Detects SARS-CoV-2 in Saliva in 10 Minutes

By LabMedica International staff writers
Posted on 06 Oct 2020
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Veravas, Inc. (Charleston, SC, USA) has developed its VeraTest SARS-CoV-2 Rapid Antigen Assay, based on the company’s patent-pending VeraPrep technology and a proprietary novel antibody fragment with high specificity to the SARS-Cov-2 spike protein.

The 10-minute assay is easily performed with a saliva sample, sample diluents and a single VeraPrep-based assay reagent. Intended for use by CLIA laboratories as well as at mobile CLIA laboratories, over 500 results can be reported per hour with a commercially-available 96-well plate imager, and over 2,000 results per hour can be reported with automation, facilitating rapid, large-scale and location-based SARS-CoV-2 antigen testing.

The performance of the assay is currently being evaluated, although it has been shown to specifically detect SARS-CoV-2 in PCR confirmed positive oral saline rinse samples with similar sensitivity as PCR in early studies. The novel alpaca-derived, single-domain antibody binds with high affinity and specificity to the SARS-CoV-2 spike protein, making it an ideal molecule for a rapid antigen test. To date, the assay has been able to correctly read PCR confirmed positive saliva samples as positive with Ct values as high as 37, and correctly read PCR negative saliva samples as negative. Higher PCR Ct values indicate a smaller amount of viral material in a given sample, signaling a more sensitive test.

“Veravas is very pleased to announce the development of a novel rapid antigen test for the detection of SARS CoV-2 infection from saliva samples in 10 minutes” said Carroll E. Streetman, Jr, CEO of Veravas, Inc. “This fast, easy to sample, inexpensive, and highly specific and sensitive antigen test will assist healthcare providers and laboratories to quickly and reliably determine whether a patient is actively infected with the COVID-19 virus. Most importantly, this test will rapidly assess if it is safe for people to return to work, return to school, travel and go about their daily lives. Plans are to commercialize this novel antigen test in Q4-2020 following FDA review and Emergency Use Authorization.”

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