COVID-19 projects page

COVID-19 projects page

COVID-19 Projects

COVID-19 Projects

A word from our Founder and CEO

Founder, Chief Executive Officer, CEO, Rich Uhlig

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.  So, in March 2020, we made the decision to pivot and allocate some of our resources to directly address this serious pandemic.  As a result, we co-developed the Clarifi COVID-19 saliva test kit, currently the most sensitive saliva test on the market in the US.  Today, we are part of three exciting COVID-19 projects.

Please read more about these important efforts below.

Thank you,

Rich Uhlig

We now offer three ways to detect COVID-19

Wastewater surveillance testing

Wastewater testing for the whole community, estimated ability to detect 1 COVID-19 case per 10,000 population.

Pooled (group) saliva testing

Group pooled testing for up to 12 samples in one test.

Individual saliva testing

FDA EUA* saliva swab test for individuals.

Why Wastewater surveillance?

Wastewater surveillance allows for large populations to be efficiently and cost-effectively screened for the presence of the COVID-19 virus by detecting viral RNA shed into the sewer systems.  Our analysis of wastewater samples provides local health officials and policymakers early warning of emerging SARS-CoV-2 infections in their communities.  Wastewater Surveillance testing can have a sensitivity of one infection per 10,000 individuals.

Quadrant partnered with Syracuse University, SUNY Upstate Medical Unversity, SUNY ESF, and Arcadis to implement testing wastewater in many communities and on many college campuses across New York State.  This has served as an early-warning solution, helping policy-makers with their decision process.

Why pooled testing?

Pooled testing can combine up to 12 individual samples into one pooled test, allowing for more people to be tested at one time.  The individual saliva samples are combined into one pooled sample which is run through a real-time qRT-PCR test.

The individual saliva collection devices are retained which means that reflex testing can be done immediately if the pooled test is returned with a positive result.

This can be a more cost-effective option for organizations, schools, employers, and other clubs and groups.  When combined with Wastewater surveillance testing, pooled testing is an effective measure.

Our pooled testing process utilizes our Clarifi COVID-19 test kit, which received FDA EUA on September 22. 2020.  An amendment to include pooling is currently under review through the FDA EUA process.  This test is currently authorized for use by the New York State Department of Health.

Why pooled testing?

Pooled testing can combine up to 12 individual samples into one pooled test, allowing for more people to be tested at one time.  The individual saliva samples are combined into one pooled sample which is run through a real-time qRT-PCR test.

The individual saliva collection devices are retained which means that reflex testing can be done immediately if the pooled test is returned with a positive result.

This can be a more cost-effective option for organizations, schools, employers, and other clubs and groups.  When combined with Wastewater surveillance testing, pooled testing is an effective measure.

This test is currently authorized for use by the New York State Department of Health.

An individual saliva test for COVID-19?

The Clarifi COVID-19 test kit is a saliva test for the qualitative detection of RNA from SARS-CoV-2 in saliva collected from individuals suspected of COVID-19 by their healthcare provider (HCP).

This simple saliva test is a qPCR test that has a Limit of Detection (LoD) of 600, 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.

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.

Additional Resources

This test kit is not a direct to consumer test, nor a testing service for health care providers.  This test kit is sold only to clinical laboratories in quantity.  There are no single kit sales of this product at this time.
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.
*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.