FDA Authorizes First Chlamydia, Gonorrhea At-Home Sample Test

On Wednesday, the United States Food and Drug Administration (FDA) authorized the Simple 2 Test manufactured by LetsGetChecked. The test is the first authorized chlamydia and gonorrhea diagnostic tool that allows patients to collect samples at home instead of at the point of care.

According to the FDA release, the test will be over-the-counter without a prescription. It provides vaginal swabs and urine specimen collection tools for consumers to collect their own samples. Upon opening the kit, patients can go online to activate it and complete a health questionnaire for their provider to analyze.

Once the sample is collected, it is sent to the appropriate laboratory, which evaluates the sample for the presence of Chlamydia trachomatis and Neisseria gonorrhoeae bacteria. The labs can use the FDA-cleared Hologic Aptima 2 Combo Assay to conduct the tests.

The FDA’s authorization of this tool is based on data submitted by LetsGetChecked that proved most consumers can safely use the kit, understand the results, and follow through with the appropriate actions based on the test’s results.

Despite this data, the authorization statement notes there are still risks of false positive or negative results. False negatives are considered a public health concern as they can cause delayed treatment, increase the probability of disease spreading, and alter a patient’s health.

Considering the dangers of a false positive, the authorization emphasizes CDC guidelines recommending antibiotic treatment for any patient exposed to these infections. An article in the New England Journal of Medicine confirmed this by assessing the impact of post-exposure prophylaxis (PEP) with doxycycline on sexually transmitted infection (STI) rates. The researchers noted that doxycycline PEP in men who have sex with men (MSM) and transgender women taking human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) reduced the risk of gonorrhea and chlamydia by 55% and 88%, respectively.

Conversely, a false positive result can lead to unnecessary treatment, which may contribute to unjustified antibiotic use and subsequent antibiotic resistance. Additionally, false positives delay the appropriate diagnosis, putting patients at risk for additional complications.

As STI rates, particularly gonorrhea rates, continue to rise, having tools to detect infection and help mitigate disease spread is critical. Making at-home tests available improves accessibility and could potentially reduce STI testing stigma.

“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the press release. “We are eager to continue supporting greater consumer access to diagnostic tests, which helps further our goal of bringing more health care into the home.”