COVID-19 Tests: Types, Strategies, and Requirements

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

bttn is here to help you sort through the different types of COVD-19 tests. 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.

Acronyms & Vocabulary
  • OTC - over-the-counter
  • EUA - Emergency Use Authorization
  • POC - point-of-care
  • CLIA - Clinical Laboratories Improvement Amendment
  • PCR - Polymerase Chain Reaction
  • Antigen Test (Rapid test) - Type of test that looks for viral proteins.
  • NAATs - Nucleic Acid Amplification Tests - Type of test that works by amplifying virus’ genetic material. The amplification enables NAATs to detect very small amounts of SARS-CoV-2 RNA.
  • PPA* - Positive percent agreement - measures how many positives a test identifies that are in agreement with another test used on the same sample.
  • NPA* - Negative percent agreement - measures how many negatives a test identifies that are in agreement with another test used on the same sample.
  • Diagnostic Testing - Is intended to identify current infection in individuals and is performed when a person has signs or symptoms consistent with COVID-19 or when a person is asymptomatic but has a recent known or suspected exposure to SARS-CoV-2.
  • Screening tests - Are intended to identify infected people who are asymptomatic and do not have known, suspected, or reported exposure to SARS-CoV-2. Screening helps to identify unknown cases so that measures can be taken to prevent further transmission.

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.

Types of COVID-19 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, akin to waiting for the results of a pregnancy test. The accuracy of OTC COVID 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 COVID 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.

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 Rapid 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 tests 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.

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 accurate, approaching 100% accuracy. However, they require skilled laboratory technicians and special equipment and results can take an hour or more from start to finish.

NAATs2 - NAATs have been authorized for use in different settings, such as in laboratory facilities by trained personnel (laboratory-based) or in point-of-care (POC) settings. Some NAATs can even be self-administered at home or in other non-healthcare locations. Some NAATs are considered rapid tests that are performed at or near the place where the specimen is collected and can provide the result within minutes, whereas the time to complete laboratory-based NAATs ranges from less than an hour to more than a day. The level of sensitivity for the detection of SARS-CoV-2 genetic material in a specimen also varies depending on the methods and application of the NAAT. Sensitivity varies by test, but laboratory-based NAATs generally have higher sensitivity than POC tests or self-administered tests.

Card Kits and Cartridges

What Product Should I Buy? You will find test type information in the “description” portion of bttn’s products.
NON-CLIA certified organization CLIA Certificated Organization
Symptomatic OTC
Antigen (Rapid) Test
Non-Symptomatic PCR

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.

Testing Strategies

Here is some important information on how to determine which test strategy is right for your organization:

When choosing which test to use, it is important to understand the purpose of the testing (e.g., diagnostic vs. screening), analytic performance of the test within the context of the level of community transmission, need for rapid results, and other considerations. The COVID-19 Viral Testing Tool helps healthcare providers and individuals understand their COVID-19 testing options. After test results are in, the tool can help interpret results and guide next steps.

Most antigen tests that have received EUA from FDA are authorized for testing symptomatic persons within the first 5, 6, 7, 12, or 14 days of symptom onset. Accumulation of data on the performance of antigen tests in different situations has helped guide the use of these tests as screening tests in asymptomatic people to detect or exclude SARS-CoV-2 infection. See FDA’s recommendations for healthcare providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19.

Also see information from the Centers for Medicare & Medicaid Services (CMS) on Updated CLIA SARS-CoV-2 Molecular and Antigen Point of Care Test Enforcement Discretion.

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