Questions about our Clarifi COVID-19 test? We have answers.

A simple, easy to use saliva test for COVID.

 

The Clarifi COVID-19 Saliva Test was developed by Quadrant Biosciences and SUNY Upstate Medical University.  

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.

To date, this test has been used by over 2 million students, from kindergarten to college. 

Watch this short video to see how easy it is!

What is the swab made of?

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The soft tip of the swab that goes in the mouth to collect saliva is made of polyurethane foam.

The handle is made of polypropylene homopolymer.  

Ethylene Oxide is NOT contained in or used in the manufacturing process for the OR-100/ORE-100 saliva swab.

There are NO OTHER chemicals on the swab.  

 

What is pooling, and does it work? 

Pooled testing just means grouping individual samples into one for testing. We can combine 2 to 12 individual saliva samples together to run in one test.     

From when the samples are received at the lab to when initial results are posted is about 24 hours.  

A negative result means that everyone in the pool is presumed to be negative. A positive result means that one or more of the samples in the pool are positive for SARS-Cov-2. 

Because of the way we process our test, there is still enough saliva retained in the collection tube for us to re-test each individual.  This re-test is called "Reflex" testing and it happens automatically and immediately whenever there is a positive pool.  

No waiting, no new samples required.  One swab does it all.

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

Is a PCR test accurate?

pcr machine

PCR tests are still the most sensitive tests for detecting the SARS-CoV-2 virus and will provide accurate and reliable results.  But, not all PCR tests are able to detect the same concentrations of the virus. 

The FDA requires that COVID test manufacturers measure the sensitivity of their test against their standardized SARS-CoV-2 Reference Panel².

The measure of this test sensitivity is known as Limit of Detection or LoD. LoD is reported as nucleic acid amplification test-detectable units (NDU) per milliliter or NDU/mL.

High LoDs will miss more infected patients and result in more false negatives.  Low LoDs require less of the virus to be present, meaning they are more sensitive.   

The LoD of the Clarifi COVID-19 Saliva Test is 600, which is currently the lowest LoD for a saliva test with FDA EUA according to their reference panel.

 

 

Why do I have to register my child?  

In order to use the Clarifi COVID-19 Saliva Test Kit, you have to create an account on clarifi-covid-19.com and register your child.  This is how all samples are tracked through our system and how results are reported to you.  

You only have to register once, and you can create a profile and then add your child or children under your profile.  It is VERY important that you select your exact school name for your organization when you register.  

Due to HIPPA compliance, you can't delete an account once you create it. 

Surveillance testing is diagnostic testing. Each test simply, reliably, and accurately will let you know if your child is positive for the SARS-CoV-2 virus.  That knowledge empowers you to make good choices for the health and safety of your family.  

Pooled surveillance testing means schools save money while complying with testing mandates and keeping an eye on COVID infection rates.

 

Everything under one roof.

group

Our team does it all. 

We co-developed the test with SUNY Upstate Medical University here in Syracuse. 

Orders are placed with us, samples are sent to us, our labs (staffed by our employees) process 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. 

Our families live here, our children go to school here, our communities are important to us and we are honored to be a part of helping to keep them safe and to stop the spread of COVID-19.

If you still have questions you can click the button below to email us directly or you can follow this link to our FAQ's.

 

Quadrant Biosciences Inc.

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