Home Test Kits For Chlamydia And Gonorrhea Recently Approved By The FDA

Everyday Health

The U.S. Food and Drug Administration (FDA) has recently granted approval for an over-the-counter test that allows individuals to screen for chlamydia and gonorrhea in the comfort of their homes without a prescription.

This trailblazing approval marks a significant development in the realm of at-home diagnostic tests for sexually transmitted infections (STIs). According to the FDA in a statement, the Simple 2 Test, the first of its kind to receive FDA approval since tests for HIV, is designed for adults aged 18 and older, offering a convenient and accessible solution for STI detection.

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

Both chlamydia and gonorrhea, while treatable with antibiotics, can lead to severe health complications, including infertility, if left undiagnosed and untreated, as highlighted by the Centers for Disease Control and Prevention (CDC).

The at-home test aims to empower individuals to take proactive measures in managing their sexual health by providing a discreet and user-friendly option for STI screening.

Condoms Help Prevent STIs, However People Use Them Less

Chlamydia and gonorrhea stand out as the most prevalent sexually transmitted infections, with an escalating prevalence in recent years, according to the CDC. Transmission of these infections can occur through various forms of sexual contact – vaginal, anal, or oral. Condom use has traditionally been a key factor in reducing the risk of transmission, but the landscape has shifted with the advent of medications like PrEP (pre-exposure prophylaxis) that make HIV prevention more accessible.

Alan Katz, MD, MPH, a professor emeritus of public health at the University of Hawaii, attributes the rise in STIs to factors such as the widespread use of dating apps, concurrent challenges with substance abuse, inadequate federal and state funding for STI prevention programs, and limited access to healthcare and sexual health services for marginalized populations.

Higher Numbers of STIs In Those 55 and Older

Interestingly, while the highest number of STIs occurs among those aged 15 to 29, an analysis reveals a concerning trend – rates of chlamydia, gonorrhea, and syphilis infections are surging at a faster pace among individuals aged 55 and older. This demographic shift raises questions about the potential reasons behind the increase, including less awareness about safe sex practices, reluctance among healthcare providers to inquire about new sexual partners, and a decreased likelihood of condom use among seniors not concerned about pregnancy.

A report from Northwest Public Broadcasting shares that the following may be the possible reasons for the increase in these numbers:

  • Seniors may be less knowledgeable about safe sex practices than younger adults and teens, who are more likely to have received up-to-date sex education. For this same reason, seniors may underestimate their risk for infection.
  • With more pressing health concerns like heart disease and diabetes, healthcare providers may be less likely to ask seniors about new sexual partners or suggest screening.
  • Since older adults are not worried about pregnancy, they may be less inclined to use condoms.

This is How to Use the New At-Home Test for Chlamydia and Gonorrhea

The newly approved Simple 2 Test offers a user-friendly approach to STI testing. Users collect a vaginal swab or urine specimen, which is then shipped to a lab for analysis with the provided return packaging. After completing an online health questionnaire, users receive their lab test results within two to five days after the sample reaches the lab. Positive or inconclusive cases prompt follow-up from a healthcare provider, ensuring comprehensive care.

As per William Miller, MD, PhD, MPH , a professor of epidemiology at the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill, one of the biggest upside of these new at-home tests is that people can find out sooner whether they have an infection and seek treatment right away.

Dr. Miller says, “Knowing that you have an infection allows you to stop the transmission chain, as long as you don’t have sex knowing that you have an infection. It may help reduce the duration of symptoms too, if someone discovers that they have chlamydia or gonorrhea and then gets treated.”

The company behind this innovative at-home test, LetsGetChecked, makes it available online for $99, and it can also be purchased on Amazon for $59.

While the introduction of such tests marks a significant step in enhancing accessibility to STI screening, questions remain about the accessibility and affordability of these tests, especially for those at higher risk, including teens, young adults, racial and ethnic minorities, and sexual and gender minorities, according to Melissa Simon, MD, MPH, the director of the Center for Health Equity Transformation at Northwestern Medicine in Chicago.

Dr. Simon says, “While a take-home test for gonorrhea and chlamydia is great to have available, it is not clear if the tests’ availability will have a high uptake in populations most at risk. If this test is issued for free or at very low cost, it likely will have greater uptake.”