On August 16, 2016, the Microbiology Devices Panel of the Medical Devices Advisory Committee of the US Food and Drug Administration (FDA) met to discuss the approval of over-the-counter (OTC) diagnostic tests for Chlamydia trachomatis
, Neisseria gonorrhoeae,
and pathogens associated with upper respiratory tract infections such as influenza and Group A Streptococcus
At present, with the exception of OTC HIV and hepatitis C tests, there are no other OTC diagnostic tests for infectious diseases commercially available in the United States. The approval and subsequent availability of these tests could be the precipitating event for a more comprehensive antimicrobial stewardship effort in the community setting; however, making these tests immediately available to the public would not be without challenges.
Much of the discussion at the FDA advisory meeting highlighted the advantages and disadvantages of such tests from a public health perspective. The most appealing benefit is the potential for these tests to curb inappropriate antimicrobial use with an obvious impact on antimicrobial resistance. The issue of resistance has become a nearly universal priority, especially given the recent “Get Smart” initiative from the Centers for Disease Control and Prevention2
and the executive order from the White House to combat antimicrobial resistance.3
What should be emphasized is that the introduction of these tests does not appear imminent, and given the conceivable shortcomings associated with each test, perhaps rightfully so.
The challenges alluded to above include issues with global and patient-specific implementation of the tests, faults associated with the accuracy of the devices, and accessibility. Without question, if these tests became available within the next week, they would almost certainly fail to yield a decrease in healthcare expenditures, and might actually lead to the opposite outcome. For example, if the test is used by the patient, would the provider rely on that finding, or conduct a repeat or confirmatory test? Furthermore, if the patient called the provider and reported their finding, would the provider not inquire more and simply prescribe? This would inevitably widen the chasm between appropriate use and inappropriate use in the community/outpatient setting; implementation and communication are critical for these tests to provide benefit.
The challenges of utilization span not only across healthcare but also down to the individual patient. Correct execution of the test might also be patient-specific, as simply using the device incorrectly could affect the result. A Group A Strep device was introduced in 1989 but approval was ultimately denied citing risks associated with inappropriate sample collection. Patients must also understand how to interpret the findings of the test.