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covid-clia-education

COVID Testing Regulations

We know that keeping up to date with the different regulations, rules & mandates regarding Covid-19 vaccinations and testing can be a full-time job. bttn is here to deliver clear & concise information so you can have the information you need to make informed decisions on your organization's purchasing need.

Vocabulary

OTC - Over the counter

EUA - Emergency Use Authorization

POC - Point of Care

CLIA - Clinical Laboratories Improvement Amendment

Please read the information related to testing carefully. As most of the industry’s COVID tests are under EUA and there are important nuances that must be understood prior to purchasing solutions that will work for your organization. This is especially pertinent to non-healthcare organizations that have employees that want to test out of the vaccine mandates.

Types of COVID-19 Tests

OTC (Over-The-Counter) At-Home Rapid Tests - OTC tests typically require the user to swab the nasal passage and wait 10-15 minutes for results, akin to waiting for the results of a pregnancy test. The accuracy of OTC tests varies but are considered particularly accurate if the user is experiencing symptoms and their viral load is very high. 
If you are an employer outside the healthcare market with more than 100 employees, OTC At-home testing is a great option for you to confirm the health of your employees weekly. You can purchase OTC tests directly from bttn’s website, keep an inventory on hand and distribute tests to your employees for weekly testing.

CLIA Accredited Tests / POC Test - CLIA is a federal regulation that regulates how laboratories handle “human specimens,” which in the case of COVID-19 tests, is mucus from the nasal swab. CLIA based tests are considered highly accurate and are typically used at Point-of-Care health facilities, like a physician’s office or pharmacy. These POC test require machinery to read the test. 

If you are an employer within the healthcare market with more than 100 employees and have CLIA certifications, POC tests can be a great option for your patients or employees that want to test out.

Card Kits and Cartridges 

 What Product Should I Buy?

NON-CLIA certified organization 

CLIA Certificated Organization

OTC 

POC 

You will find test type information in the “description” portion of bttn’s products. 

CLIA Certified COVID-19 Tests

bttn is proud to be a supplier for CLIA certified COVID-19 tests. The federal CLIA certification program contracts with states to certify qualified laboratories to provide COVID-19 testing. We require all businesses that purchase CLIA accredited COVID-19 tests to submit proof of CLIA certifications to ensure the safety of our partners and the end-user. 

All of our vendors have received CLIA accreditation and FDA approval for selling COVID-19 Tests. Check out our vendors CLIA Certifications:

Today we offer the following CLIA certified COVID tests.

CLIA Certification Requirements

Are you an organization looking to get CLIA certified? Download PDF CLIA Instructions and CLIA Application.

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