Nucleic acid extraction workstation for processing saliva samples for SARS-CoV2 testing. (Source: David Sokolowski/Rutgers University)
ON FRIDAY, Rutgers University announced that the United States Food and Drug Administration (FDA) has given emergency approval to testing for SARS-CoV2 on saliva samples sent by people themselves, from home. The test has been developed by Rutgers University’s RUCDR Infinite Biologics lab, in collaboration with Spectrum Solutions and Accurate Diagnostic Labs.
What is different
The standard test for SARS-CoV2 infection is done on throat or nasal swabs (RT-PCR). These look for the presence of the virus in the swabs. Various countries also have provisions for testing blood samples for antibodies, including India which allows it in certain hotspots.
Rutgers University and its collaborators have developed an approach that uses saliva as the primary test biomaterial for SARS-CoV2. The approach recently got approval of the FDA; this was for healthcare workers collecting saliva from individuals at testing sites. On Thursday, the FDA amended the emergency use authorisation for the first SARS-CoV2 test that will allow people to collect their own saliva at home and send to a lab for results, Rutgers University announced in a statement.
A company called Vault Health too has been advertising saliva tests for SARS-CoV2. The FDA has not approved it, The New York Times reported recently.
How it helps
Collection of nose and throat swabs at a healthcare facility, or testing location, requires physical interaction with a healthcare professional. The new at-home saliva self-collection assay allows for broader screening, Rutgers said.
“The approval also means that healthcare professionals need no loner be put at risk for infection by performing swab collections.” (Representational)
The RUCDR lab has also launched a genetic testing service. This can test thousands of samples daily, Rutgers said; with the new saliva tests and expanded collection strategy, that number can increase to tens of thousands of samples daily.
“Collecting a saliva sample at home mitigates the risk of exposure needed to travel to a facility or drive through and is less invasive and more comfortable and reliable than sticking a swab up your nose or down your throat. Protecting both patients and healthcare professionals from any unnecessary exposure is of paramount importance and saliva home collection addresses almost all issues around testing quality, safety and availability,” Andrew Brooks, chief operating officer and director of technology development at RUCDR, said in the statement.
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The approval also means that healthcare professionals need no loner be put at risk for infection by performing swab collections, he said.
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