Highly sensitive saliva PCR test

for the detection

of SARS-CoV-2

 

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 (EAU) 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 in three forms, direct sale to laboratories, through community test sites and for use at large organizations and institutions.


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 individuals

COVID-19 Saliva Test

Quadrant Laboratories, is a high throughput, CLIA Certified lab authorized to process COVID-19 saliva samples using their proprietary COVID-19 Saliva Test Kit.

At just $200 per individual sample and $250 if results are returned within 48 hours¹, the Clarifi COVID-19 Saliva Test offers best-in-class PCR testing and detects all known variants of SARS-CoV-2. 

Throughout the pandemic, Quadrant has partnered with New York State to provide community testing sites open to the general public.  

PCR testing for large groups

Quadrant Laboratories has partnered with several schools, organizations, and employers throughout New York State to provide on-site diagnostic testing services for students, and employees.  

Our group testing solutions were engineered to be scalable and overcome emerging supply chain deficiencies, creating easy access to quality testing. Our web-based application makes it simple to access results and monitor positive cases across large groups of people which is why over 100 colleges and universities and 400 K-12 school districts throughout NY chose to work with our labs throughout the pandemic.


For Providers

Sample Specimen Collection Device Billing Code(s)
Saliva OR-100 87637 & 87913

 


¹ HCPCS Code U0004; if results are returned within 48 hours, addition HCPCS Code U0005

*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.