COVID-19 Tests: CLIA Certified -vs- OTC COVID Rapid Antigen Tests

There is a lot of misinformation out there. Mainly when it’s a topic related to health. So, what are CLIA-certified tests? What is an over-the-counter COVID-19 rapid antigen test? Do you have to be a doctor to purchase one?

COVID-19 testing has become a large part of our daily lives. The availability and accessibility of COVID-19 tests are vital to controlling the spread of COVID-19. Knowing the difference between CLIA Certified COVID-19 tests and OTC COVID Rapid Antigen Tests can help you decide which test is best for your needs. Here’s a quick breakdown of each test.

What Is A CLIA Certified COVID-19 Test?

A Clinical Laboratory Improvement Amendments (CLIA) certified COVID-19 test is a test performed in a medical laboratory that the federal government regulates. This means that the laboratory must be registered with the Centers for Medicare and Medicaid Services (CMS).

Additionally, all lab personnel who perform the testing must have proper qualifications. CMS regulates CLIA-certified labs according to stringent quality standards and guidelines, which include standards for training lab personnel, proficiency testing, specimen handling, patient test management, quality control procedures, and more.

For this reason, CLIA-certified COVID tests tend to be more accurate than over-the-count (OTC) COVID-19 Rapid Antigen Tests. Additionally, CLIA-certified labs have been approved by CMS to submit claims for reimbursement.

To meet these standards, the COVID tests must be proven to:

  • Have a high enough sensitivity level to diagnose COVID-19 in an individual with the disease correctly.
  • Have a high enough specificity level to diagnose COVID-19 in an individual without the disease correctly.

A CLIA-certified test is a COVID-19 test that has been evaluated and approved by the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). These tests must demonstrate their accuracy, precision, and reliability to meet FDA requirements before being used in clinical laboratories. Most of these tests use a molecular (PCR) approach to detect SARS-CoV-2, the virus that causes COVID-19. These tests are considered highly accurate but may take days to receive results because they require specialized laboratory equipment and trained technicians.

Some examples of CLIA-certified tests include:

PCR

PCR tests, also known as nucleic acid amplification tests, are the most accurate type of COVID-19 test. They detect the presence of the virus’ genetic material by using a laboratory technique called polymerase chain reaction (PCR), which amplifies fragments of RNA to a level where they can be detected. The sample is collected via nasal swab and sent to a lab for analysis, with results available in as little as 24 hours or within three to five days maximum.

Antigen

Antigen tests are faster than PCR tests and cost less, but their accuracy is lower. The term “antigen” refers to any substance that can cause an immune response in your body, and antigen tests look for antigens unique to COVID-19. These tests take less time and cost less than PCR tests because they don’t have to be processed in a lab so that you can get results in minutes instead of days. You’ll know right away whether you need immediate treatment or isolation, but if you test negative, it’s still good to follow up with a PCR test to ensure the result is accurate.

What Is an Over-the-Counter COVID-19 Rapid Antigen Test?

An OTC COVID-19 rapid antigen test is a type of rapid antigen test that can detect the presence of the COVID-19 virus in your blood. These tests are designed to be used by consumers and healthcare professionals to diagnose infections more quickly than traditional testing methods.

Abbott BinaxNow COVID Test

Abbott BinaxNow COVID Test is an OTC authorized over-the-counter COVID rapid test. It is a rapid antigen test that checks for SARS-CoV-2 antigens, the proteins on the virus’s surface. The FDA issued an EUA for it. The BinaxNOW test is a lateral flow immunoassay, and this means it uses antibodies to detect the antigens in nasal swab samples. The test is simple to administer, and it delivers results in 15 minutes or less.

FlowFlex COVID Test

The FlowFlex COVID Test is a CLIA-waived, point-of-care rapid test for the detection of COVID-19. The COVID-19 Test uses proprietary technology and is now readily available to consumers.

Which COVID Test is the Right Choice for You?

In the end, if you have a half-hour to spare, go for the CLIA certified COVID-19 test. It’s more accurate and better supports a broader range of antigens. However, if time is not on your side and you need to take the test now, opt for the over-the-counter COVID-19 test.