As STDs become more prevalent, companies are rushing to sell at-home testing kits. But are they reliable?

among the more notable legacies of COVID-19 (new coronavirus infectious disease) The pandemic has shown how quickly federal regulators, the healthcare industry, and consumers have moved to make home testing a credible tool for managing public health crises.

But that quick focus is lacking in another less publicized epidemic. sexually transmitted disease It can cause chronic pain and infertility among infected adults. disable or kill infected newborns. This disparity fueled calls from researchers, public health advocates, and healthcare companies asking the federal government to offer at-home testing kits that could significantly increase the number of Americans tested for STDs. I am asking for a green light.

Online shoppers can choose from over ten self-test kits, typically priced between $69 and $500, depending on the brand and type of infection they can detect.

However, with the exception of HIV testing, the Food and Drug Administration does not approve STD testing kits for use outside of healthcare settings. are worried about reliability.

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

Eric Harklelord/KHN

Dr. Amesh Adalja, a senior fellow at the Center for Health Security at Johns Hopkins University, says the STD epidemic is “out of control.” “We know that we miss diagnoses. We also know that contact tracing is delayed or not done at all. If we are serious about tackling the STD crisis, we will diagnose more people. I need to get it.”

Preliminary data for 2021 is about 2.5 million According to the Centers for Disease Control and Prevention, cases of chlamydia, gonorrhea, and syphilis have been reported in the United States. Reported cases of syphilis and gonorrhea have increased for about a decade. In the latest prevalence estimates, the agency said on certain days, 1 in 5 Americans Infected with one of eight common sexually transmitted infections.

There are moves from several sectors to make at-home testing for STDs as easy and commonplace as at-home COVID and pregnancy tests. Public health authorities excessive staff It fails to keep up with the staggering needs of testing and monitoring. Diagnostics and pharmaceutical companies see opportunity in unmet demand.

The medicine behind STD testing is nothing particularly new or mysterious. Some tests require taking a urine sample, pricking a finger to obtain blood, or swabbing the mouth, genitals, or anus to obtain a sample of secretions or cells. Medical centers and community clinics have performed such tests for decades.

The question for regulators is whether sampling kits can be reliably adapted for home use.not like Rapid antigen test for COVIDAt-home STD kits, which provide results in 15-20 minutes, require patients to collect their own samples, package them, and mail them to the lab for analysis.

Over the past three years, the pandemic has forced clinics offering low-cost care to slash in-person services, prompting many public health departments to Alabama, AlaskaWhen Maryland —Started mailing out free STD test kits to residents. university When non-profit organization We are also spearheading our at-home testing efforts.

And dozens of commercial companies are jumping into or ramping up direct-to-consumer sales. Everly Health, a digital health company that sells a variety of lab tests online, has reported sales for its suite of STD kits. 120% growth First half of this year compared to first half of 2021.

Started sales of CVS Health Unique The October bundled STD kit is priced at $99.99. Unlike most home kits, the CVS version is available in stores.

Hologic, Abbott, and Molecular Testing Labs are among the companies urgently developing tests.When cue healthSell ​​COVID tests.

Alberto Gutierrez, who previously headed the FDA’s office overseeing diagnostic testing, said FDA officials have been concerned about the reliability of home testing for years. The FDA wants companies to prove that home collection kits are as accurate as those used in clinics and that the samples don’t degrade during shipping.

“Authorities do not believe these tests are being sold legally at this time,” said Gutierrez, partner at NDA Partners, a consulting firm that advises companies looking to bring healthcare products to market. said.

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

In response to KHN’s question, the FDA considers swabs, lancets, transport tubes, and home collection kits, which can contain chemicals to stabilize the sample, to be devices requiring agency review. said. The FDA “generally does not comment” on whether it plans to take action in specific cases, the statement said.

CVS spokesperson Mary Gattuso said pharmacy chains are following the law. “We are committed to ensuring that our products are safe, perform as intended, comply with regulations and satisfy our customers,” said Gattuso.

Everly Health and others describe their kits as follows: Lab-developed test, similar to the diagnoses that some hospitals create for their internal use. They also claim that their labs are accredited by another agency, the Centers for Medicare and Medicaid Services, so their tests can be legally sold.

Dr. Liz Kwo, Chief Medical Officer, Everly Health, said: “At-home sampling methods such as dried blood spots and saliva have been widely used for decades.”

The home collection kit appeals to 27-year-old Uxmal Caldera from Miami Beach, Florida. Her girlfriend, Caldera, who doesn’t have a car, said doing the test at home saves time and money on trips to the doctor’s office.

Caldera recommends testing for HIV and other sexually transmitted infections every three months for over a year as part of regular monitoring of people taking PrEP, a daily drug regimen to prevent HIV infection. I went to

“It’s not difficult at all to do it yourself,” said Caldera, who has no insurance but is taking the test for free through the Community Foundation. “The instructions are very clear. Probably in four days. I get results and would certainly recommend it to others.”

Dr. Leandro Mena, director of the CDC’s STD prevention division, said he hopes at-home STD testing will become as routine as at-home pregnancy testing. An estimated 16 million to 20 million tests for gonorrhea and chlamydia are performed each year in the United States, Mena said. That number could double or even triple with the prevalence of home STD testing, he said.

He said the doctor has many years of experience using home collection kits.

of Johns Hopkins Center About 23,000 home STD kits have been distributed since 2004 in the STD point-of-care technology study, said Charlotte Gaydos, principal investigator at the center. The FDA generally permits such uses if they are part of research overseen by a medical professional. The center’s tests are now used by Native American tribes in Arizona and Oklahoma, as well as by the Alaska Department of Health.

gaydos announced dozens of studies Establishing accurate and easy-to-use home collection kits for diseases such as chlamydia and gonorrhea.

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

However, Gaydos noted that her study was limited to small sample sizes. She said the FDA does not have the multi-million dollar funding needed to conduct the kind of comprehensive testing that it normally requires for approval.

Jenny Mahn, director of clinical and sexual health at the National Coalition of STD Directors, said many public health laboratories were reluctant to work with HomeKit. We don’t mention none,” Mahn said.

Public clinics often offer STD testing for little or no cost, but health insurance usually covers in-person testing at private clinics. The consumer pays the cost of the direct-to-consumer kit out-of-pocket.Because of the commercial price, many people, especially her teens and young adultaccounting for almost half of STDs.

Adalja of Johns Hopkins University said the FDA has a history of slowing down home trials.Agencies evaluated over seven years First home HIV test Approved and launched on the market in 2012.

“At-home testing is the way of the future,” said Laura Lindbergh, a professor of public health at Rutgers University. You can’t put the genie back in the bottle.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. KHN is one of his three major operational programs in the United States, along with policy analysis and polling KFFMore (Kaiser Family Foundation). KFF is a donated non-profit organization that provides information on health issues to the public. As STDs become more prevalent, companies are rushing to sell at-home testing kits. But are they reliable?

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