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

Public health clinics often provide STD testing at little to 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 pricing puts them out of reach for many people, particularly teens and young adults, who account for nearly half of STDs.

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

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

The Johns Hopkins Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases has distributed roughly 23,000 at-home STD kits since 2004, said Charlotte Gaydos, a principal investigator with the center. The FDA generally allows such use if it’s part of research overseen by medical professionals. The center’s tests are now used by the Alaska health department, 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,” said Gaydos.

But Gaydos noted that her studies have been limited to small sample sizes. She said she doesn’t have the millions of dollars in funding it would take to run the sort of comprehensive trial the FDA typically requires for approval.

Caldera has been testing himself 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.

“Doing it by yourself is not hard at all,” said Caldera, who is uninsured but receives the tests free through a community foundation. “The instructions are really clear. I get the results in maybe four days. For sure, 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. An estimated 16 million to 20 million tests for gonorrhea and chlamydia are performed in the U.S. each year, Mena said. Widespread use of at-home STD testing, he said, could double or triple that number.