Yale School of Public Health offering ’open source’ protocol to labs

WASHINGTON — The FDA granted an emergency use authorization (EUA) for a fifth saliva test for Covid-19, this time from the Yale School of Public Health, called SalivaDirect.

The agency noted that, while it has seen “variable performance” with saliva tests, this one meets its EUA criteria and uses a new method for processing the saliva specimen.

The Yale test allows for the collection of a patient’s saliva in any sterile container. It is also unique, the agency noted, in that “it does not require a separate nucleic acid extraction step.” This is important given that extraction kits are often in short supply. “Being able to perform a test without these kits enhances the capacity for increased testing, while reducing the strain on available resources. Additionally, the SalivaDirect methodology has been validated and authorized for use with different combinations of commonly used reagents and instruments, meaning the test could be used broadly in most high-complexity labs,” the agency noted in its press release about the EUA.

Another test for Covid-19, particularly one not needing the extraction step — which, as STAT News reports, requires the extraction of the virus’s genetic material — could help expedite testing results.

Rapid testing and quick results may be key to getting the pandemic under control. Antigen tests that return results within 30 minutes, however, “are less accurate” than lab tests using the extraction step. “But a growing number of public health experts say trading off accuracy for speed is a gamble worth taking, as testing labs struggle to clear days-long backlogs,” Politico reports.

The FDA and Yale did not indicate the turnaround time for testing results, however.

Yale noted it is offering an “open source” protocol to labs interested in performing the saliva test. “Because this test does not rely on any proprietary equipment from Yale and can use a variety of commercially available testing components, it can be assembled and used in high-complexity labs throughout the country, provided they comply with the conditions of authorization in the EUA,” the FDA noted.

This saliva test joins the other methods of testing that are currently available to detect Covid-19, which include:

  • Diagnostic tests to detect the SARS-CoV-2, the virus that causes Covid-19 — molecular tests, such as RT-PCR tests and antigen tests. These tests use nasal or throat swabs, with results ranging from same day to up to a week. Antigen tests can deliver results within an hour or less.
  • Antibody tests that use a blood draw or finger stick; results can be had within 1-3 days and let the patient know if they have been infected with SARS-CoV-2.
  • Rapid, point-of-care tests using a nasal or throat mucus sample available in a doctor’s office or clinic with results within minutes.
  • At-home collection tests available by prescription. Patients do their own nasal swab collection and mail the specimen back to the lab.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,254,930,730,933,190,520,926,192,927,151,928,925,934