Advaite

SalivaDirect™ Test

Advaite Inc UIC Incubator Laboratory is a designated SalivaDirect™ Laboratory

Yale University has authorized Advaite Inc to perform the SalivaDirect™ Test. The SalivaDirect test is performed at the Advaite Inc UIC Incubator Laboratory located in Chicago. Advaite’s Laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a and meets the requirements to perform high complexity tests.

SalivaDirect™ was developed by the Yale School of Public Health (YSPH) and has received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA). The FDA limits the emergency use of SalivaDirect™ testing only to high-complexity CLIA-certified laboratories formally designated as authorized laboratories by YSPH under the EUA 202097.

The SalivaDirect nucleic acid test allows 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 athletic.
SalivaDirect offers a number of other advantages. They include:

  • It is non-invasive. SalivaDirect requires only a small sample of saliva as opposed to the standard nasopharyngeal (NP) swab. The NP method requires what is essentially a long Q-tip that is inserted deep into the nostril and then rotated.
  • It is quick and safe. Because SalivaDirect only requires a small saliva sample, the time requirement for an individual is minimal, even less than a minute. People basically have to spit into a small container. The procedure is safer in that there is less risk of exposure to health care workers collecting the samples.
  • It is accurate. Results show that SalivaDirect is highly sensitive and is accurate 94% of the time, comparable to results for NP-based tests. The limit of detection as determined by blinded standards sent out by the FDA to all labs with an EUA shows that the sensitivity of SalivaDirect is comparable to many other great PCR tests out there – including those with RNA extraction.