SARS-CoV-2 PCR Assay Now Approved for Human Saliva Specimens

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Advanced Biological Laboratories (ABL) announced today the validation of its CE-IVD UltraGene® Combo2Screen SARS-CoV-2 qPCR assay to be used straight from non-invasive fluid saliva samples and allowing for broad population screening.

This optimization consisting in using saliva specimen as an input material for the SARS CoV-2 RNA extraction and qPCR detection, rather than traditional nasopharyngeal swabs, helps in improving the convenience and comfort of the test overall, target asymptomatic patients and reduce risk for nosocomial infection by healthcare professional performing nasopharyngeal or oropharyngeal collections.

Targeting two highly conserved regions of the SARS-CoV-2 genome (N gene + E Gene) in a multiplex format and an internal control, the sensitivity of the UltraGene® Combo2Screen CE-IVD assay from saliva samples remains very high and is still compatible with most automatic or manual RNA extraction methods, as well as with most qPCR instruments.

“We are proud to enhance our COVID-19 line of solutions. Converting the assay into a non-invasive fluid saliva test will significantly help to increase the number of people tested and will ease the diagnostics access to fragile people like children or asymptomatic patients” said Dr. Chalom Sayada, CEO of ABL.

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