At-Home STD Testing Kits: Closer Look into Reliability of Growing Market due to Rising Cases of STDs
The COVID-19 pandemic brought significant changes into many industries, especially within the healthcare industry. Particular notice should be taken that federal regulators, healthcare providers, and consumers moved toward at-home testing as a critical tool in taming the global health emergency. Yet it seems there has been an obvious oversight in the battle against another epidemic, one which is as pertinent, though quiet on the forefront: the rise of sexually transmitted diseases. These could result in chronic pain and infertility in adults and severe disability or death in infants.
This concern about the missed epidemic has created growing demands by researchers, public health advocates, and health care companies for allowing at-home tes
05 October 2024
6 min read
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Online STD Testing Market Booms
The online marketplace is rife with at-home STD testing kits, whose prices range from $69 to $500. The wide price discrepancy reflects various factors, which involve brand names and the number of infections a specific kit can detect. For instance, STDrapidtestkits.com is one of them. Even though they remain popular these days and their usage is becoming pervasive; nevertheless their validity is still questioned since except the test for HIV, they are not approved by the Food and Drug Administration (FDA).
Dr. Amesh Adalja, senior scholar at Johns Hopkins University's Center for Health Security, says the STD epidemic is "spiraling out of control." He says far more testing is needed to identify and treat a public health crisis in time.
In 2021's preliminary data, the Centers for Disease Control and Prevention reported close to 2.5 million cases of syphilis, gonorrhea, and chlamydia in the country. Most astounding of all, it projects that at any given moment, one in five Americans harbors one of eight most common STDs.
The Urgent Need to Test for STDs from the Comfort of One's Home
A number of industries are advocating that at-home STD testing be as easy and ubiquitous as home tests for COVID and pregnancy. Public health officials, overwhelmed by testing and follow-up needs, support the movement. Meanwhile, diagnostic and pharmaceutical companies also see a healthy business in meeting the demand.
The science behind STD testing is neither new nor complicated; tests usually involve the collection of either a urine sample, blood via finger prick, or swab samples from various body sites. Testing like this has been common in many medical centers and community health clinics for decades. What does remain a question is whether such tests can be reliably adapted for home use.
Unlike COVID rapid antigen tests, which produce a result in 15 to 20 minutes, at-home STD kits require users to collect, package and send their samples to a lab for testing. Public health departments in Alabama, Alaska and Maryland are among those now mailing free at-home STD test kits to residents due to the pandemic. Efforts are also under way from education and nonprofit advocacy groups for at-home testing.
More businesses have entered the direct-to-consumer market or increased their current offerings. Everly Health, the digital health company, saw sales of its STD kits grow by 120% in the first half of the year compared to the same time period in 2021. Even CVS Health got in on the action, selling its bundle of STD kits for $99.99 as of October.
Meanwhile, companies like Hologic, Abbott, and Molecular Testing Labs are working avidly on developing tests. Cue Health, a COVID test vendor, is preparing to launch a rapid home test for chlamydia and gonorrhea that promises results in about 20 minutes.
Yet, the accuracy of these home-testing kits has long been in question. Alberto Gutierrez, formerly of the FDA, echoed that FDA will require companies to prove that home collection kits are as accurate as those done inside the clinic and the samples do not degrade in shipping.
Regulatory Challenges and Market Credibility
None of this moves CVS. "The company is committed to ensuring the products they offer are safe, compliant, and what customers expect from them," says Mary Gattuso, a spokesperson with CVS, adding that it follows the letter of the law.
Companies like Everly Health argue that their kits qualify as laboratory-developed tests in ways similar to diagnostics some hospitals develop for use in their own facilities. They say this is legal promotion of their tests because their labs are accredited to another branch of the government, the Centers for Medicare & Medicaid Services. Everly Health's Chief Medical Officer, Dr. Liz Kwo, testified that their methods for collecting samples from home have been in wide use for decades and that the tools used in their labs are often identical to those in labs used by doctors.
Consumer Response to Home-based Tests for STDs
Despite these regulatory hurdles, at-home STD testing kits hold a certain appeal for users like Uxmal Caldera of Miami Beach, Florida. Without a car, Caldera said he values the convenience and relative privacy of at-home testing. Caldera has been self-testing every three months over the past year-plus-minimum upkeep, part of regular monitoring associated with his PrEP regimen, a once-daily medication to help ward off HIV infection. For now, Caldera, who gets free tests courtesy of a community foundation, is an enthusiastic endorser of at-home testing, and he urges others to avail themselves of the option.
The Possible Future of Home-based STD Testing
Dr. Leandro Mena, director of the CDC's Division of STD Prevention, wants at-home STD testing to be as routine as home pregnancy tests. He estimated that more pervasive deployment of at-home STD testing can easily double or even triple the estimated 16 million to 20 million tests for gonorrhea and chlamydia conducted every year in the U.S.
Promising as this may be, there are still problems. Though Dr. Charlotte Gaydos, of the Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases, is the author of a number of studies showing the accuracy and usability of at-home STD kits, she has mentioned that sample sizes need to get a little larger to truly determine just how reliable these kits are.
Public health clinics often offer free or low-cost STD testing, and most health insurance plans cover testing if it is provided in a clinical setting. However, most direct-to-consumer tests are out-of-pocket costs, that is, not covered by one's health insurance. Commercial prices may be prohibitively expensive for many individuals including teens and young adults who account for nearly half of STDs.
The Road Forward
The FDA's historic skittishness regarding home testing blocks the way to take an at-home STD test to the mainstream quickly. It wasn't until 2012 that the agency cleared the first home HIV test after seven years. But Dr. Laura Lindberg, a professor of public health at Rutgers University said "Home testing is the way of the future."
In other words, the extent of the need for efficient and reliable home-based STD tests has increasingly gained importance because the STD epidemic is continuing to spiral upwards. And while companies continue to work on such kits, only when the test kits are right on accuracy, affordability, and take the regulatory barriers to marketability will this public health crisis be seen to truly be addressed. No question, the COVID-19 pandemic opened the doors to home-based testing, and it looks like there's no turning back from here.
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