As STDs spread, companies are rushing to release at-home testing kits. But are they reliable?

Among the more notable legacies of the COVID-19 Pandemic is how quickly federal agencies, the healthcare industry and consumers have moved to make at-home testing a reliable tool to deal with a public health crisis.

But that quick focus is lacking in another, lesser-known epidemic: an explosion sexually transmitted diseases that can cause chronic pain and infertility in infected adults and disable or kill infected newborns. The disparity has fueled calls from researchers, public health advocates and healthcare companies for 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-test kits, which typically range from $69 to $500 depending on the brand and the type of infections they can detect.

But with the exception of HIV testing, the Food and Drug Administration hasn’t approved any STD test kits for use outside of a medical setting. That leaves consumers uncertain about their reliability even as home usage increases dramatically.

STD test kits
Unlike rapid antigen tests for COVID, the STD home kits on the market require patients to collect their own samples and then send them to a lab for analysis. The question for regulators is whether kits can be reliably adapted for home use.

Eric Harkleroad/KHN

The STD epidemic is “out of control,” said Dr. Amesh Adalja, a senior scientist at the Johns Hopkins University Center for Health Security. “We know that we lack diagnoses. We know that contact tracing comes too late or not at all. If we are really serious about the STD crisis, we need to get more people diagnosed.”

Preliminary data for 2021 showed almost 2.5 million reported cases of chlamydia, gonorrhea and syphilis in the US, according to the Centers for Disease Control and Prevention. Reported cases of syphilis and gonorrhea have been rising 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 one of eight common sexually transmitted diseases.

The push to make at-home STD testing as easy and commonplace as at-home COVID and pregnancy testing comes from multiple quarters. Public health officials say theirs overwhelmed employees cannot handle the enormous need for testing and monitoring. Diagnostics and pharmaceutical companies see a business opportunity in the unmet demand.

The medical science that underpins STD testing isn’t particularly new or mysterious. Depending on the test, it may involve collecting a urine sample, pricking a finger for blood, or dabbing the mouth, genitals, or anus for discharge or cell samples. Medical centers and community health clinics have been conducting such tests for decades.

The question for regulators is whether sampling kits can be reliably adapted for home use. not how Rapid antigen tests for COVIDyielding 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 laboratory for analysis.

Over the past three years, as the pandemic prompted clinics offering low-cost care to drastically curtail in-person services, a number of public health departments — including state agencies in Alabama, Alaskaand Maryland – have started sending out free STD test kits to residents. universities and nonprofit organizations also conduct tests at home.

And dozens of retailers are entering or increasing direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, reported sales for its suite of STD kits grew by 120% in the first half of this year compared to the first half of 2021.

CVS Health started selling his own bundled STD kit in October priced at $99.99. Unlike most home kits, CVS’ version is commercially available.

Hologic, Abbott and Molecular Testing Labs are among the companies urgently developing tests. and cue healthwhich sells antigen tests for COVID, is poised to start a clinical trial for a rapid at-home test for chlamydia and gonorrhea that would set new standards and provide results in about 20 minutes.

Alberto Gutierrez, who used to head the FDA’s office that oversees diagnostic tests, said agency officials have been concerned about the reliability of home tests for years. The FDA wants companies to demonstrate that home collection kits are as accurate as those used in clinics and that samples will not degrade during shipment.

“The agency does not believe that these tests will be legally marketed at this time,” said Gutierrez, a partner at NDA Partners, a consulting firm that advises companies looking to bring health products to market.

“CVS shouldn’t be selling this test,” he added.

In response to questions from KHN, the FDA said it considers home collection kits, which may include swabs, lancets, transport tubes and chemicals to stabilize the samples, as devices requiring regulatory review. The FDA “generally does not comment” on whether it plans to take action in a particular case, the statement said.

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,” said Gattuso.

Everly Health and other companies described their kits as tests developed in the laboratory, similar to the diagnostics that some hospitals create for internal use. And they claim their tests can be legally marketed because their labs are certified by another agency, the Centers for Medicare & Medicaid Services.

“The instruments and assays used by the labs that we use are comparable – and often identical – to those used by the labs in a doctor’s office,” said Dr. Liz Kwo, chief medical officer at Everly Health. “Our at-home sampling methods, like dried bloodstains and saliva, have been widely used for decades.”

Home Collection kits appeal to Uxmal Caldera, 27, of Miami Beach, Fla., who prefers to test in the privacy of his home. Caldera, who doesn’t have a car, said testing at home saves him the time and expense of getting to a clinic.

Caldera has been testing for HIV and other sexually transmitted diseases every three months for more than a year, part of the routine monitoring of 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 has no insurance but gets the tests for free through a community foundation. “The instructions are really clear. I get the results in maybe four days. I would definitely recommend it to other people.”

dr Leandro Mena, director of the CDC’s Division of STD Prevention, said he would like home STD testing to become as routine as home pregnancy testing. According to Mena, an estimated 16 to 20 million tests for gonorrhea and chlamydia are performed in the United States each year. The widespread use of home STD testing, he said, could double or triple that number.

He noted that physicians have years of experience using home collection sets.

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

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

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

However, Gaydos noted that their studies were limited to small sample sizes. She said she doesn’t have the millions of dollars in funding needed to conduct the kind of comprehensive study that the FDA typically requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health labs are reluctant to embrace home kits. “The public health labs aren’t going to touch it without the FDA’s blessing,” Mahn said.

Public health clinics often offer STD testing at little or no cost, while health insurance typically covers in-person testing at a private practice. But most consumers pay out of pocket for direct-to-consumer kits. Commercial prices put them out of reach for many people, especially teenagers and young adultswhich account for almost half of sexually transmitted diseases.

Johns Hopkins’ Adalja said the FDA has been slow to start home testing in the past. The agency spent seven years evaluating the First HIV test at home it approves, which entered the market in 2012.

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

KHN (Kaiser Health News) is a national newsroom producing in-depth journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the three major operational programs at KFF (Kaiser Family Foundation). KFF is a donated non-profit organization that provides information on health issues to the nation.

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