Rapid Strep Test not Limited to Labs Anymore

Posted by The Evidence Blog on July 1, 2015

Red and swollen tonsils, fever, sore throat—these familiar symptoms could indicate either a viral infection or a more serious strep infection that has to be treated with antibiotics. Strep throat—medically known as group A streptococcal pharyngitis—affects millions of people each year and can be especially troubling for children (and their parents). The definitive test for strep is a throat culture with a throat swab from the patient taken at a doctor’s office and then sent to a laboratory for culturing. Although accurate, this type of testing isn’t speedy. It takes 2 or 3 days for the results, which can delay antibiotic treatment.

In an effort to speed up diagnosis and treatment in children and adults with suspected strep infections, rapid antigen diagnostic strep tests were developed. Like throat cultures, these tests require a throat swab for analysis; however, rapid strep tests can deliver results within 15 minutes rather than days and with high accuracy. Several manufacturers have developed rapid strep tests that use different molecular techniques to analyze the specimen. Each test is designed to detect only the presence of the particular streptococcal bacteria known to cause strep. The rapid strep test won’t detect other bacteria or viruses that might be the cause of the infection.

Last month, the Food and Drug Administration (FDA) for the first time granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for Roche's cobas Strep A test. The CLIA waver allows the test to be performed in a variety of clinical settings, including doctors’ offices, emergency rooms, and pharmacy clinics. Use is not restricted to clinical laboratories. A waiver from the requirements of the CLIA means that clinical studies have demonstrated that the test is accurate and poses little to no risk of incorrect results. This should be a welcome development for children (and parents) everywhere.

Topics: Hayes Blog

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