COVID-19 Tests: Types, Strategies, and Requirements

Not CLIA Certified? View our selection of over the counter tests here

New COVID-19 tests are being approved by the FDA under Emergency Use Authorization for use at home and at the clinic weekly. As supply changes, bttn is here to deliver clear and concise information and help you find tests to keep your staff, patients, and colleagues safe.


Types of COVID-19 Tests

There are two major types of COVID-19 diagnostic tests - Antigen and Molecular (RT-PCR) tests. Both are useful and important to the multilayer approach to dealing with COVID-19.

Antigen
  • Antigen tests detect specific protein on the surface of the virus
  • The results from these tests are rapid, typically in under 30 minutes
  • These tests can be performed virtually anywhere
  • They do not require a prescription
  • The rule of thumb is to use an OTC Rapid Antigen test within 72 hours of known exposure or at the first sign of symptoms

Molecular RT-PCR tests
  • Molecular tests detect the virus’s genetic material
  • These tests are considered the “gold standard” by the medical community
  • Use saliva or sample from nasal swabs and amplify the genetic material within the sample so that even small amounts of coronavirus genes in the sample can be detected. The material is amplified using a technique called polymerase chain, PCR. PCR tests are highly sensitive and approaching 100% accuracy. PCR tests are performed using special equipment and therefore tend to be at a higher price point than Rapid Antigen tests.

OTC (over-the-counter) COVID-19 Tests - OTC COVID tests typically require the user to swab the nasal passage and wait 10-15 minutes for results. It is important to swab the nasal passage before using the regent as reagents are not meant to go into the body. The accuracy of OTC COVID tests varies but they are considered particularly accurate if the user is experiencing symptoms and their viral load is very high. If you are an employer outside healthcare, OTC COVID-19 testing is a great tool to help identify positive cases and minimize outbreaks. You can purchase OTC tests directly from bttn’s website, keep an inventory on hand and distribute tests to your employees for weekly testing.

POC (point-of-care) CLIA COVID-19 Rapid 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. If you are an employer in a healthcare setting or in a school or organization with an on-premise nurse, POC tests can be a great option to test your patients, staff, and even students.

PCR tests1 - Use saliva or sample from nasal swab and amplify the genetic material within the sample so that even small amounts of coronavirus genes in the sample can be detected. The material is amplified using a technique called polymerase chain, PCR. PCR tests are highly sensitive and approaching 100% accuracy. PCR tests require special equipment to process and therefore start at a higher price point than Rapid Antigen tests. bttn offers CUE Health Cartridge PCR tests along with the reader. This health system is considered can be ordered by your doctor and conducted in a third lab. The CUE health system is referred to by many in the tech industry as Google’s “most coveted perk.”

Card Kits and Cartridges

What Product Should I Buy? You will find test type information in the “description” portion of bttn’s products. We frequently add to our inventory so check the COVID-19 test collection for our current inventory.
NON-CLIA certified organization CLIA Certificated Organization
Symptomatic OTC - Rapid Antigen Test
PCR
POC
Non-Symptomatic OTC - Rapid Antigen Test
PCR
POC

CLIA Covid-19 Rapid Test

bttn is proud to be a supplier for CLIA certified COVID-19 Rapid Tests. Laboratories that perform screening or diagnostic testing for SARS-CoV-2 must have a Clinical Laboratory Improvement Amendments (CLIA) certificate and meet regulatory requirements. Tests that have received an EUA from FDA for point-of-care (POC) use can be performed with a CLIA certificate of waiver.


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

CLIA Certification Requirements

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

HOW TO: A Guide for the BinaxNOW COVID-19 Self Test