Companies market at-home STD tests. But are they reliable?

One of the more notable 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 the public health crisis.

But that fast-track focus is missing from another, less publicized pandemic: an explosion in sexually transmitted diseases that can cause chronic pain and infertility in infected adults and can disable or kill infected newborns. The disparity has fueled calls from researchers, public health advocates and health care companies to urge the federal government to greenlight home testing kits that could vastly increase the number of Americans getting tested for STDs.

Online shoppers can already choose from more than a dozen self-testing kits, typically ranging in price from $69 to $500, by brand and detecting different types of infections.

But, except for HIV tests, the Food and Drug Administration has not approved STD test kits for use outside of a medical setting. This leaves consumers unsure of their reliability, even as home use increases 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’re missing diagnoses. We know contact tracing is happening late or not happening at all. If we’re really serious about tackling the STD crisis, we need to diagnose more people.” “

According to the Centers for Disease Control and Prevention, preliminary data for 2021 predicts about 2.5 million cases of chlamydia, gonorrhea and syphilis in the US. Reported cases of syphilis and gonorrhea have been on the rise for nearly a decade. In its most recent prevalence estimate, the agency said that on any given day, 1 in 5 Americans is infected with any of eight common STDs.

There is a push from many quarters to make home testing for STDs as easy and common as home testing for COVID and pregnancy. Public health officials say their overstretched staff cannot handle the staggering need for testing and surveillance. Diagnostic and pharmaceutical companies see business opportunities in unmet demand.

The medical science underpinning STD testing isn’t particularly new or arcane. Depending on the test, this may involve collecting a urine sample, pricking a finger for blood, or swabbing the mouth, genitals, or anus for a sample of discharge or cells. Medical centers and community health clinics have done such tests for decades.

The issue for regulators is whether the sampling kits can be reliably adapted for home use. Unlike rapid antigen tests for the coronavirus, which give results in 15 to 20 minutes, home STD kits on the market require patients to collect their own samples, and then package and send them to a lab for analysis. Are being given.

Over the past three years, as the pandemic has prompted clinics that provide low-cost care to drastically cut in-person services, several public health departments — among them state agencies in Alabama, Alaska and Maryland. ​- has started mailing free STD tests. Kit to the residents. Universities and nonprofits are also leading at-home testing efforts.

Keep up with Tampa Bay’s top headlines

Subscribe to our FREE Daystarter newsletter

We’ll bring you the latest news and information you need to know every weekday morning.

You are all signed up!

Want more of our free, weekly newsletters delivered to your inbox? let’s get started.

Explore All Your Options

And dozens of business ventures are jumping into or growing into direct-to-consumer sales. Avery Health, a digital health company that sells a variety of lab tests online, reported that STD kit sales increased by 120% in the first half of this year compared to the first half of 2021.

CVS Health began selling its own bundled STD kit in October, priced at $99.99. Unlike most home kits, CVS’s version is available in stores.

Hologic, Abbott and Molecular Testing Labs are among the companies developing rapid tests. And Q Health, which sells coronavirus tests, is set to launch a clinical trial for a rapid home test for chlamydia and gonorrhea that will set a new bar, providing results in about 20 minutes.

Alberto Gutierrez, who formerly led the FDA office that oversees clinical trials, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to prove that home collection kits are just as accurate as those used in clinics, and that samples do not deteriorate during shipping.

“The agency does not believe these tests are legally marketed at this time,” said Gutierrez, a partner at NDA Partners, a consulting firm that consults with companies seeking to bring health care products to market. gives advice to

“CVS shouldn’t be selling that test,” he said.

In response to KHN’s questions, the FDA said it considers home collection kits, which can include swabs, lancets, transport tubes and chemicals to freeze samples, to be equipment that requires agency review. Is. The statement said the FDA “does not comment generally” on whether it plans to take action on any specific cases.

CVS spokeswoman Mary Gattuso said the pharmacy chain is following the law. “We are committed to ensuring that the products we offer are safe, perform as intended, comply with regulations and satisfy customers,” Gattuso said.

Everly Health and other companies describe their kits as lab-developed tests, similar to diagnostics made by some hospitals for home use. And they argue that their tests can be legally marketed because their labs have been certified by a separate agency, the Centers for Medicare and Medicaid Services.

“The equipment and tests used are comparable to — and often identical to — those used by labs,” said Dr. Liz Quo, Chief Medical Officer of Everly Health. “Our at-home sample collection methods, such as dried blood spots and saliva, have been widely used for decades.”

The Home Collection kit fascinates Uxmal Caldera, 27, of Miami Beach, Florida, who prefers to test in the privacy of his own home. Caldera, who doesn’t own a car, said home testing saves the time and expense of traveling to a clinic.

Caldera has been testing herself for HIV and other STDs every three months for more than a year, part of routine monitoring for people taking PrEP, a regimen of daily pills to prevent HIV infection.

“It’s not hard at all to do it yourself,” said Caldera, who is uninsured but receives free trials through a community foundation. “The instructions are really clear. I got results in maybe four days. Definitely, I would recommend it to other people.

Dr. Leandro Mena, director of the CDC’s Division of STD Prevention, said he would like to see at-home STD testing become as routine as home pregnancy tests. Mena said an estimated 16 million to 20 million tests for gonorrhea and chlamydia are performed in the US each year. Widespread use of at-home STD testing, he said, could double or triple that number.

He said that doctors have years of experience in using home collection kits.

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed about 23,000 at-home STD kits since 2004, said Charlotte Gaydos, a principal investigator at the center. The FDA generally allows such use if it is part of research to be observed by medical professionals. The center’s tests are now used by the Alaska Department of Health, as well as Native American tribes in Arizona and Oklahoma.

Gaydos has published dozens of studies establishing that home collection kits for diseases such as chlamydia and gonorrhea are accurate and easy to use.

“There’s a huge amount of data showing that home testing works,” Gaydos said.

But Gaydos said their studies have been limited by small sample sizes. She said it doesn’t have the millions of dollars in funding it would take for the FDA to run the extensive testing typically needed for approval.

Jenny Mahan, director of clinical and sexual health at the National Coalition of STD Directors, said many public health laboratories are reluctant to handle home kits. “Public health laboratories won’t touch it without the FDA’s blessing,” Mahan said.

Public health clinics often provide STD testing at minimal cost, while health insurance usually covers individual testing at a private practice. But most consumers pay out of pocket for direct-to-consumer kits. Commercial pricing puts them out of reach for many people, especially teens and young adults, who account for about half of all STDs.

At Johns Hopkins, Adalja said the FDA has a history of moving slowly on home testing. The agency spent seven years getting the first home HIV test approved, which hit the market in 2012.

“Home testing is the way of the future,” said Laura Lindbergh, a professor of public health at Rutgers University. “The pandemic opened the door for at-home testing and treatment without a visit to a health care provider, and we won’t be able to put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that does in-depth journalism about health issues. Along with policy analysis and polling, KHN is one of the three major operational programmes. kff (Kaiser Family Foundation). KFF is a thriving non-profit organization that provides information on health issues to the nation.

Leave a Comment