The benefits and risks of over-the-counter tests for infectious diseases including respiratory infections, Group A Streptococcus and certain sexually transmitted infections (STIs) — and how the FDA should evaluate them — is the topic for an agency advisory committee meeting to be held Tuesday.
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.
Currently, two over-the-counter detection tests for other infectious diseases have been approved: theOraQuick 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.
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. A prior application was submitted for a group A strep OTC test in 1989, but agency advisors voted against recommendation, in part due to the potential for improper sample collection.
In briefing documents released in advance of the meeting, 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. In addition, a prior study indicated that patients sometimes prefer home tests because they are afforded more privacy than a clinic setting.
Benefits specific to testing for sexually transmitted infections include permitting diagnosis for those who cannot readily access healthcare, and allowing for the self-collection of genital samples, which is a preferred sample collection method for many women.
But 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.
There were also unique risks associated with specific types of test:
- Influenza: Potential inaccurate results if circulating flu strains change or new ones emerge
- Group A strep: Degree of difficulty associated with proper nasopharyngeal sample collection
- Chlamydia and gonorrhea: Patient may take true negative result to mean they are free of all STIs
With an eye towards potential future applications for approval, panel members will be asked for their recommendations for appropriate clinical studies and acceptable performance criteria to measure the potential safety and efficacy of each test.
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