FDA Seeks Input on OTC Infectious Disease Testing
Written by Editor   
Friday, August 26, 2016 12:00 AM

The benefits and risks of over-the-counter tests for infectious diseases including respiratory infections, Group A Streptococcus and certain sexually transmitted infections (STIs) was the topic of and FDA advisory committee meeting.  The FDA said it has been approached by manufacturers wishing to market OTC tests for respiratory infections such as influenza, group A strep, and the STI pathogens Chlamydia trachomatis and Neisseria gonorrhoeae, and is seeking guidance from outside experts on what data it should require from applicants.

Consumers can currently purchase diagnostic tests for influenza, group A strep and certain STIs mainly through online retailers, though none have been cleared or approved for OTC use.  FDA staff recognized the potential public health benefits of OTC tests to diagnose certain infectious diseases. Greater access to testing may lead to a patient seeking earlier treatment, as well as the potential to decrease healthcare visits. The agency also pointed to risks of these tests -- mainly that false negative results may lead to exacerbation of symptoms, and false positive results may lead to unnecessary treatment. Over-the-counter testing also has the potential to affect surveillance activities, potentially underreporting the prevalence of infectious diseases.

Currently, two over-the-counter detection tests for other infectious diseases have been approved: the OraQuick In-Home HIV Test from OraSure Technologies, and the Home Access Hepatitis C Check by Home Access Health Corporation. The latter requires the specimen to be sent to a clinical laboratory for diagnosis, whereas the OraQuick test is self-contained and delivers results on the spot.

One wonders if OTC diagnostic tests would or would not be within the scope of the chiropractic profession in Texas.


Source:  http://www.medpagetoday.com/InfectiousDisease/GeneralInfectiousDisease/59697