Make the Clarifi® COVID-19 Saliva Test part of your ELC reopening plan.
Everything You Need Under One Roof
When you work with Quadrant Biosciences, you're working directly with the same team from distribution, to lab processing, to delivering results.
A simple saliva test for COVID.
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 a time. Unlike nasal swabs, this is non-invasive, easy, and quick to use.
A cost-effective solution.
The Clarifi COVID-19 test is one of only a few tests authorized by the FDA to pool individual samples for testing.
Pooled testing allows multiple samples to be run at a time, which in turn means lower costs.
An accurate test matters.
The FDA requires that manufacturers measure the sensitivity of their test against a standardized SARS-CoV-2 Reference Panel. The measure of this test sensitivity is known as the Limit of Detection (LOD). High LODs will miss more infected patients and result in more false negatives.
The Clarifi® COVID-19 Saliva Test has the lowest LOD of any saliva test currently on the market, and remains effective for COVID variants.
Quadrant's pooled saliva screening test has received FDA Emergency Use Authorization and has been used to test more than 100 universities, K-12 Schools, Nursing Homes, Municipalities and other employers.
The collection process is quick and easy.
*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.