Advaite, a biotech company, announced that its high complexity CLIA laboratory has been authorised to offer Yale University’s SalivaDirect test.

SalivaDirect is a qualitative test designed for the detection of nucleic acid from SARS-CoV-2 in saliva collected from individuals suspected of having Covid-19.

The saliva sample needs to be collected in sterile container and doesn’t require use of any preservatives.

The Yale School of Public Health (YSPH) has developed the SalivaDirect, and the US Food and Drug Administration (FDA) has granted the Emergency Use Authorization (EUA) for the test in August.

According to the YSPH, the SalivaDirect methodology has also been validated and authorised for use with different combinations of commonly used reagents and instruments.

The FDA EUA allows the emergency use of SalivaDirect testing only in high-complexity CLIA-certified laboratories. YSPH designated Advaite’s Chicago Laboratory as authorised laboratory to perform the test.

SalivaDirect offers 99% analytical sensitivity and 94% specificity

SalivaDirect is said to offer 99% analytical sensitivity, and 94% specificity, establishing itself among the gold standard for Covid-19 testing, said the company.

A pilot programme led by the YSPH, the National Basketball Association (NBA), and the National Basketball Players Association (NBPA), the SalivaDirect test was used in testing asymptomatic individuals.

Advaite is a biotech company engaged in developing advanced therapeutics and diagnostics for patients suffering from different serious diseases.

The company is currently focused on developing novel point-of-care assays and deploy them to help combat the Covid-19 pandemic.

Advaite chief scientific officer and co-founder Sandeep Jain said: “The SalivaDirect COVID-19 PCR-based nucleic acid test will allow us to shift away from a defensive symptom-based strategy to a proactive surveillance-based strategy that enables communities and businesses to stay open safely during the pandemic.

“As an example of success of this strategy, mandatory saliva testing programs are currently being used in public universities to allow safe student and staff participation in campus housing, performing arts and athletics.”