FDA authorizes at-home chlamydia and gonorrhea test for the first time
Accessible testing for the infections may help curb the STI epidemic, but there is still a long way to go.
Earlier this month, the United States Food and Drug Administration authorized the first at-home tests for chlamydia and gonorrhea. The Simple 2 Test is available over-the-counter and costs between $58 and $99 per kit. Results are returned within a week and officials with the FDA hope that it helps curb the country’s STI epidemic.
[Related: A guide to preventing, spotting, and managing STIs.]
Bacteria causes both gonorrhea and chlamydia. While HPV is a more prevalent STI, chlamydia and gonorrhea are the most commonly reported STIs in both the US and other countries. According to the FDA, roughly 1.6 million cases of chlamydia and over 700,000 cases of gonorrhea were reported in 2021. The STIs cause painful urination and bleeding between menstrual periods. They are generally easily treated with antibiotics, but if left unattended, both gonorrhea and chlamydia can cause serious health complications, including infertility.
Rates of gonorrhea, chlamydia, and syphilis have skyrocketed over the past 20 years. The increase is at least partially driven by a lack of funding of the Centers for Disease Control and Prevention’s budget to fight the spread of STIs. Public health officials believe that easy and more accessible testing for STIs is one of the necessary tools needed to combat the country’s STI crisis.
“This authorization marks an important public health milestone, giving patients more information about their health from the privacy of their own home,” Doctor Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release on November 15. “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.”
The Simple 2 Test kit can be purchased online at LetsGetChecked’s website. It comes with tools to collect urine specimens or vaginal swabs. The patient then uses a prepaid shipping label to send the specimens to a lab. Users also must complete an online questionnaire. After two to five days, the patient can view the results online. If the test is positive or the results are invalid, users can arrange a telehealth consultation with a healthcare provider.
Doctor Matthew Golden, Director of the Seattle King County public health departmen’s HIV and STI control program, told NBC News that FDA is catching up on regulating an industry that has grown since the COVID-19 pandemic began.
[Related: This ‘morning after’ pill could prevent STIs from unprotected sex.]
“At some level, the horse has left the barn,” said Golden. He noted that self-testing kits have been widely used for years, but “some of those tests, how well they perform is not well known. So cleaning this up makes sense.”
University of Hawaii STI expert and medical consultant at the Hawaii State Department of Health’s Diamond Head STI/HIV Clinic Alan Katz told Stat News that the Simple 2 Test uses the same investigative procedure that clinicians use to diagnose chlamydia and gonorrhea.
“This option is exceptionally useful for individuals who live in rural areas or are geographically distanced from a clinic where STI testing can be done and there is no telehealth option available,” Katz said. “If a person screens positive, they can then contact a healthcare provider for further evaluation and treatment.”
While unapproved home tests for chlamydia and gonorrhea have already been on the market, The Simple 2 Test is the first to go through the FDA’s approval process. The approval could potentially make it easier for future such tests to clear the FDA’s regulatory pathway.
