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.

SalivaDirect is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. Positive results are indicative of the presence of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva specimens during the acute phase of infection. SalivaDirect™ test has not been cleared or approved by the FDA; it has not been authorized to detect any other viruses or pathogens. SalivaDirect™ is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19.

The SalivaDirect COVID-19 PCR-based 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.

Regularly testing large numbers of people will play a huge role in monitoring transmission of SARS-CoV-2. Quickly detecting and isolating active cases – people who can transmit the virus, whether symptomatic or asymptomatic – is the cornerstone for limiting disease spread. In addition, accurate data on the number of active cases is necessary to inform policy makers (at local, state, and federal levels) as well as individuals what the short-term risk of spread is and how safe it is to do things like return to workplaces, attend school, and see friends and family.

Ramping up testing for effective SARS-CoV-2 surveillance has faced several barriers. One of those is the reliance on nasopharyngeal swabs, or “NP swabs.” Getting these swabs can be uncomfortable, which discourages people from getting tested frequently. NP swabs also have to be collected by someone who is trained to do so, adding a logistical barrier and putting those performing the test at risk of getting sick. Because SARS-CoV-2 rapidly spread worldwide, it has put immense strain on the supply chains that provide materials for tests, including swabs and test reagents. SalivaDirect is our answer to these problems.

SalivaDirect Links
Yale School of Public Health – SalivaDirect Website
SalivaDirect Test – Fact Sheet for Health Care Providers
SalivaDirect Test – Fact Sheet for Patients
Saliva or Nasopharyngeal Swab Specimens for Detection of SARS-CoV-2

For Business inquiries please email info@advaite.com

Important Information About SalivaDirect™:

SalivaDirect™has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.