In 2021, I spent the year before starting medical school calling and counseling the patients of a busy urban emergency department on the results of their sexually transmitted infection (STI) tests.
“What exactly is gonorrhea?” some would ask. “Is there a cure?”
“No one ever taught me about this,” one older gentleman lamented when we discussed using condoms to prevent the transmission of infection.
Stories like his reflect our society’s hesitancy to discuss sex and sexual health. In fact, only thirty U.S. states require public schools to teach sex education, and only twenty-two states require that if provided, sex education must be medically, factually, or technically accurate.
Unfortunately, America’s rising STI problem is becoming hard to ignore.
Over 2.5 million Americans were diagnosed with an STI in 2021, reaching an all-time high for the 6th consecutive year in a row. Cases of syphilis in the U.S. increased by almost 70 percent between 2017 and 2021, while congenital syphilis in newborns rose by a whopping 185 percent.
COVID-19 only added fuel to the fire. As clinics shut down and the public health workforce was diverted to fight the pandemic, people struggled to find places to get tested. In 2020, the National Coalition of STD Directors reported that 66 percent of clinics saw a decrease in sexual health screening.
The availability of STI testing isn’t the only factor making it difficult for people to get screened. For most Americans, especially the 25 percent without a primary care provider, finding the time to attend a doctor’s appointment just isn’t convenient.
Privacy is also key: many people worry about the stigma associated with a visit to the local STI clinic or facing judgment from providers.
In a twist of irony, the popularization of at-home COVID-19 testing may offer a possible solution to these barriers. As the concept of self-testing gains widespread acceptance, several nonprofits have started offering free STI screening kits by mail. Online shoppers can also choose from over a dozen kits, including one from CVS that tests for seven separate infections. People collect their samples from the comfort of their homes, mail them in for analysis, and receive results within days.
The problem? Except for one HIV test, none of these STI screening kits have been approved by the Food and Drug Administration (FDA) for home use.
This is because most kits on the market are laboratory-developed tests (LDTs) or tests that are created and performed within a single laboratory. An LDT hasn’t undergone FDA review: instead, they’re regulated by a different agency, the Centers for Medicaid and Medicare Services (CMS). To get approval, the local clinical laboratory director must validate the LDT’s performance data according to CMS’s Clinical Laboratory Improvement Amendments (CLIA).
However, LDTs and FDA-reviewed tests aren’t held to the same standard. CLIA’s regulatory standards don’t require the laboratory to prove an LDT’s clinical validity or how accurately a test predicts the presence of a given condition. This increases the chance that an inaccurate test could be introduced to the market.
Furthermore, the fact that an LDT is only cleared to be run by the lab that developed it limits the number of labs capable of handling home kits.
“The public health labs won’t touch it without the FDA’s blessing,” explains Jenny Mahn, director of sexual health at the National Coalition of STD Directors.
So, does at-home STI testing actually have a future?
Yes—if kit developers and the FDA work together to increase its oversight of the at-home STI testing industry and provide reliable, FDA-approved options for consumers.
Instead of each laboratory collecting validation data and undergoing CMS inspection individually, a test developer must submit performance data to the FDA and apply for clearance of at-home specimen collection as an intended use of the test. This would allow laboratories without the resources for LDT validation to run these tests and expand the availability of at-home testing.
The introduction of FDA regulation into the at-home testing market would also set a quality standard to ensure consumers can identify reliable options in an ocean of LDTs. FDA approval would require a developer to prove a test’s clinical validity and mandate public reporting of adverse events related to an incorrect test result, among other critical standards.
In the eyes of many public health officials, widespread adoption of at-home testing could turn the tide on our battle with STIs. However, the lack of standardization in current regulation protocols creates barriers to its uptake. The FDA must begin to approve at-home STI tests to encourage the growth of this burgeoning industry.
Nikki Kasal is a medical student.
