A word from our founder
I have no need to tell you that COVID-19 has had a substantial impact on businesses across the globe, and Quadrant has certainly not been immune from this.
However, our team at Quadrant is nothing if not adaptable and resourceful. In March 2020, we made the decision to allocate some of our resources to directly address the pandemic. As a result, we co-developed two COVID-19 solutions. The Clarifi COVID-19 Saliva Test, currently the most sensitive saliva test on the market in the US, and Wastewater Surveillance for large-scale community testing.
Please read more about these important efforts below.
FDA EUA* saliva test for individuals
Wastewater Surveillance Testing
Detects one (1) COVID-19 case in a population of 10,000
Testing supplies for Laboratories
Clarifi 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 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, 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.
Testing services for schools, employers and individuals
Clarifi COVID-19 Saliva Test
Quadrant Laboratories, a subsidiary of Quadrant Biosciences is a high throughput, CLIA Certified lab authorized to process COVID-19 saliva samples using the Clarifi 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.
Quadrant Biosciences has partnered with several schools, organizations, and employers throughout New York State to provide on-site diagnostic testing services for students, and employees. In addition, Quadrant has partnered with New York State to provide community testing sites open to the general public. There are no out-of-pocket costs at these sites and results are typically returned within 1-2 days of receipt at Quadrant Laboratories.
Wastewater testing for the presence of COVID-19
Wastewater surveillance is used to quantify the SARS-CoV-2 viral load shed into the sewer system, by standardizing samples using CrAssphage, a common bacteriophage found in human feces.
This method of analysis is highly sensitive, it can detect one infection in a population of 10,000 allowing for large populations to be efficiently and cost-effectively screened for the presence of SARS-CoV-2.
Surveillance of wastewater is an effective tool for combating the spread of COVID-19 by assessing the levels of the in a population. This insight provides local health officials and policymakers with an early warning of emerging COVID-19 infections in their communities.
Quadrant partnered with Syracuse University, SUNY Upstate Medical University, SUNY ESF, and Arcadis to implement wastewater testing in many communities and college campuses across New York State. This has served as an early-warning solution, helping policymakers with their decision process.
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.