Veravas, Oakdale, Minn, has developed the VeraTest SARS-CoV-2 Rapid Antigen Assay, based on its 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 performed with a saliva sample, sample diluent, 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.
In early studies, the assay technology has been shown to specifically detect SARS-CoV-2 in polymerase chain reaction (PCR)-confirmed positive oral saline rinse samples with similar sensitivity as PCR. The novel alpaca-derived, single-domain antibody binds with high affinity and specificity to the SARS-CoV-2 spike protein. 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.
“A rapid test is required to address the global covid-19 testing crisis and help societies safely emerge from lockdowns,” says antibody fragment co-developer Gerald McInerney, PhD, of Karolinska Institute, Stockholm, and cofounder of Vicunab. We are happy our antibody is an important component of the VeraTest rapid antigen assay.” Veravas has agreed to an exclusive global license from Vicunab for use of the antibody in diagnostics and its assay.
“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,” says Carroll E. Streetman, Jr, CEO of Veravas. “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 [late] 2020 following FDA review and emergency use authorization.”
For more information, visit Veravas.
Featured image: This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. Note the spikes that adorn the outer surface of the virus, which impart the look of a corona surrounding the virion, when viewed electron microscopically.