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 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!

One of the only saliva tests with FDA EUA for pooling. 

Asset 2
Asset 3

The Clarifi COVID-19 test is one of only a few saliva tests authorized by the FDA for pooling samples for testing¹

Pooled testing helps save both time and money. Pools of up to 12 people are tested, a negative result means that everyone in the pool is presumed to be negative. A positive result means the samples need to be retested, this is called reflex testing. With our test, this reflex testing occurs immediately.  No waiting, no new samples required.  One swab does it all.    

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.

Asset 5
LOD graphic

Making sense of it all.

Asset 8

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. 

Pooled testing means you save money while helping to maintain a safe working environment for your employees.  

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

 

6+
Years in Business
100+
Team Members
2+ M
COVID tests run
1,895,223
Cups of Coffee

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.

 

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

2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data#table2c

3.  https://www/ncbi.nlm.nih.gov/pmc/articles/PMC7302192/