There may be a whole lot of misinformation on the market. Primarily when it’s a subject associated to well being. So, what are CLIA-certified exams? What’s an over-the-counter COVID-19 speedy antigen check? Do you need to be a health care provider to buy one?
COVID-19 testing has turn out to be a big a part of our each day lives. The supply and accessibility of COVID-19 exams are very important to controlling the unfold of COVID-19. Figuring out the distinction between CLIA Certified COVID-19 exams and OTC COVID Rapid Antigen Tests may help you resolve which check is greatest to your wants. Right here’s a fast breakdown of every check.
What Is A CLIA Certified COVID-19 Check?
A Scientific Laboratory Enchancment Amendments (CLIA) licensed COVID-19 check is a check carried out in a medical laboratory that the federal authorities regulates. Which means that the laboratory should be registered with the Facilities for Medicare and Medicaid Providers (CMS).
Moreover, all lab personnel who carry out the testing should have correct {qualifications}. CMS regulates CLIA-certified labs in accordance with stringent high quality requirements and tips, which embody requirements for coaching lab personnel, proficiency testing, specimen dealing with, affected person check administration, high quality management procedures, and extra.
Because of this, CLIA-certified COVID exams are usually extra correct than over-the-count (OTC) COVID-19 Rapid Antigen Tests. Moreover, CLIA-certified labs have been authorized by CMS to submit claims for reimbursement.
To satisfy these requirements, the COVID exams should be confirmed to:
- Have a excessive sufficient sensitivity degree to diagnose COVID-19 in a person with the illness appropriately.
- Have a excessive sufficient specificity degree to diagnose COVID-19 in a person with out the illness appropriately.
A CLIA-certified check is a COVID-19 check that has been evaluated and authorized by the U.S. Meals and Drug Administration (FDA) and the Facilities for Medicare and Medicaid Providers (CMS). These exams should show their accuracy, precision, and reliability to satisfy FDA necessities earlier than being utilized in medical laboratories. Most of those exams use a molecular (PCR) method to detect SARS-CoV-2, the virus that causes COVID-19. These exams are thought-about extremely correct however could take days to obtain outcomes as a result of they require specialised laboratory gear and skilled technicians.
Some examples of CLIA-certified exams embody:
PCR
PCR exams, also referred to as nucleic acid amplification exams, are essentially the most correct sort of COVID-19 check. They detect the presence of the virus’ genetic materials by utilizing a laboratory method known as polymerase chain response (PCR), which amplifies fragments of RNA to a degree the place they are often detected. The pattern is collected by way of nasal swab and despatched to a lab for evaluation, with outcomes out there in as little as 24 hours or inside three to 5 days most.
Antigen
Antigen exams are quicker than PCR exams and value much less, however their accuracy is decrease. The time period “antigen” refers to any substance that may trigger an immune response in your physique, and antigen exams search for antigens distinctive to COVID-19. These exams take much less time and value lower than PCR exams as a result of they don’t must be processed in a lab so as to get ends in minutes as a substitute of days. You’ll know straight away whether or not you want fast therapy or isolation, however for those who check adverse, it’s nonetheless good to observe up with a PCR check to make sure the result’s correct.
What Is an Over-the-Counter COVID-19 Rapid Antigen Check?
An OTC COVID-19 speedy antigen check is a kind of speedy antigen check that may detect the presence of the COVID-19 virus in your blood. These exams are designed for use by customers and healthcare professionals to diagnose infections extra rapidly than conventional testing strategies.
Abbott BinaxNow COVID Check
Abbott BinaxNow COVID Check is an OTC licensed over-the-counter COVID speedy check. It’s a speedy antigen check that checks for SARS-CoV-2 antigens, the proteins on the virus’s floor. The FDA issued an EUA for it. The BinaxNOW check is a lateral movement immunoassay, and this implies it makes use of antibodies to detect the antigens in nasal swab samples. The check is easy to manage, and it delivers ends in quarter-hour or much less.
FlowFlex COVID Check
The FlowFlex COVID Check is a CLIA-waived, point-of-care speedy check for the detection of COVID-19. The COVID-19 Check makes use of proprietary know-how and is now available to customers.
Which COVID Check is the Proper Alternative for You?
Ultimately, when you have a half-hour to spare, go for the CLIA licensed COVID-19 check. It’s extra correct and higher helps a broader vary of antigens. Nonetheless, if time shouldn’t be in your aspect and you could take the check now, go for the over-the-counter COVID-19 check.