Clarifi COVID-19 Pooled (Group) Test
Introducing the Clarifi COVID-19 Pooled Test Kit.
What is Pooled testing?
Pooled testing combines the ease and simplicity of our saliva test with the accuracy of PCR testing to allow group testing of up to 12 people at one time.
Our pooled testing process utilizes our Clarifi COVID-19 test kit, which received FDA EUA on September 22, 2020 and updated on May 6, 2021.
Using the FDA Reference Panel, this test demonstrated a Limit of Detection (LOD) of as few as 600 copies of the SARS-CoV-2 virus per mL; this LOD currently places the Clarifi COVID-19 Test Kit as the most sensitive saliva test available for sale in the United States (see Table 2C).
Tests with lower LODs are better able to detect infections at the earliest stages when individuals may be infectious but have not developed symptoms.
Why use pooled testing?
Pooled testing allows for quick and cost-effective testing of large populations. Each pool can test up to 12 individuals.
Because the individual saliva swabs are retained, immediate reflex testing of individual samples can be done if a pool comes back with a positive result.
Pooled testing has been ongoing throughout New York State at SUNY Universities and K-12 schools. It is a great option for schools, universities, employers and other organizations to conduct large-scale, cost-effective 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.
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.