Among the more remarkable legacies of the COVID-19 pandemic is how quickly federal regulators, the health care industry and consumers moved to make at-home testing a reliable tool for managing a public health crisis.
But that fast-track focus is missing from another, less publicized epidemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility among infected adults and disable or kill infected newborns. The disparity has amplified calls from researchers, public health advocates and health care companies urging the federal government to greenlight at-home testing kits that could vastly multiply the number of Americans testing for STDs.
Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, depending on the brand and the variety of infections they can detect.
But, except for HIV tests, the Food and Drug Administration hasn’t approved STD test kits for use outside a medical setting. That leaves consumers unsure about their reliability even as at-home use grows dramatically.
The STD epidemic is “out of control,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security. “We know we are missing diagnoses. We know that contact tracing is happening late or not at all. If we’re really serious about tackling the STD crisis, we have to get more people diagnosed.”
Preliminary data for 2021 showed nearly 2.5 million reported cases of chlamydia, gonorrhea and syphilis in the U.S., according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been climbing for about a decade. In its most recent prevalence estimate, the agency said that on any given day, 1 in 5 Americans are infected with any of eight common STDs.
The push to make at-home testing for STDs as easy and commonplace as at-home COVID-19 and pregnancy testing is coming from several sectors. Public health officials say their overextended staffers can’t handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see a business opportunity in the unmet demand.
The medical science underpinning STD testing is not particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have performed such testing for decades.
The issue for regulators is whether sampling kits can be reliably adapted for in-home use. Unlike rapid antigen tests for COVID-19, which produce results in 15 to 20 minutes, the home STD kits on the market require patients to collect their own samples, and then package and mail them to a lab for analysis.
In the past three years, as the pandemic prompted clinics that provide low-cost care to drastically curtail in-person services, a number of public health departments — among them state agencies in Alabama, Alaska and Maryland — have started mailing free STD test kits to residents. Universities and nonprofits are also spearheading at-home testing efforts.