Using our experience in RNA analysis, Quadrant, in partnership with SUNY Upstate Medical University, developed a COVID-19 saliva test.
In the Fall of 2020, our COVID-19 Saliva Test was granted Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) where it is currently referenced as the most sensitive COVID-19 saliva test on the market. The test is available to laboratories looking to add this test to their test menu, and to doctors looking for quality PCR testing in their practice..
Authorized kits for use in CLIA Certified Labs
Quadrant COVID-19 Saliva Test Kit
The Clarifi COVID-19 Saliva Test Kit is used for the qualitative detection of RNA from SARS-CoV-2 found in saliva collected from individuals suspected of having COVID-19.
This simple saliva test is a qPCR test that has a Limit of Detection (LoD) of 600 NDU/mL, currently making it the most sensitive saliva test on the market in the US. Please see Table 2C of the FDA reference panel for more information.
The Clarifi COVID-19 Saliva Test was granted Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) in September 2020, and in May 2021 the authorization was amended to include pooled testing of up to 12 samples.
Emergency use of this test is limited to authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
PCR Testing for Use in Healthcare Practices
COVID-19 Saliva Test
Quadrant Laboratories, is a high throughput, CLIA Certified lab authorized to process COVID-19 saliva samples using Quadrant Biosciences’ COVID-19 Saliva Test Kit that was granted EUA status from the FDA.
Using this test kit, our lab processed over 4 million COVID PCR tests throughtout the pandemic. We collaborated with state, county, and academic institutions to offer top-tier PCR testing during the Public Health Emergency (PHE). We now offer that same level of testing to healthcare practices.
Healthcare providers interested in using Quadrant Laboratories to process COVID-19 tests using the EUA saliva-based COVID-19 PCR test can request collection devices and shipping materials by emailing [email protected].
*On September 22, 2020, the Clarifi® COVID-19 Test Kit obtained Emergency User Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-COV-2. The Clarifi COVID-19 Test Letter of Authorization, along with the authorization Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and authorized labeling are available on the FDA website.
The Clarifi COVID-19 Test Kit has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. Clarifi COVID-19 has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and 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.
This test kit is not a direct to consumer test. This test kit is sold only to clinical laboratories in quantity.
Quadrant Laboratories, a subsidiary of Quadrant Biosciences, is a CLIA certified laboratory that provides individual and pooled COVID testing services ordered by a licensed healthcare provider using the Clarifi COVID Test Kit sold by Quadrant Biosciences.
Note: Testing is limited to qualified laboratories in the United States, certified under the Clinical Laboratory Improvement Amendment of 1988 (CLIA), 42 U.S.C. SS 263A, to perform high complexity testing.