Stay vigilant

COVID Testing FAQs

A simple, easy to use saliva test for COVID.

 

Regular COVID testing helps you confidently keep your business open and provides your employees with a safe workplace. 

Staying safe doesn't have to be uncomfortable or complicated.  Our saliva test is easy to use, painless, fast, and accurately detects Omicron, Delta, and all other known variants.

The Clarifi COVID-19 testing process combines the ease of self-collection with exclusive web access to results, making Clarifi perfect for businesses of all sizes!

The most sensitive COVID saliva test on the market.

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 Limit of Detection or LOD. High LODs will miss more infected patients and result in more false negatives.  

LOD is reported as nucleic acid amplification test-detectable units (NDU) per milliliter or NDU/mL.

The Clarifi COVID-19 Saliva has an LOD of 600 NDU/mL, currently making it the most sensitive saliva test on the market.1

 

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Everything under one roof.

Our team does it all. You order with us, send your samples to us, our lab (staffed by our employees) processes your samples. Results are reported by us, and we have live people in house to answer any questions you might have, every step of the way. 

Your staff deserves the best.  Implement a testing plan that works for everyone.

6+
Years in Business
100+
Team Members
3+ M
COVID tests processed
2
CLIA/CLEP Labs in NY

*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. 

 

References:

1. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#amendment