Doing your own STI test at home is a tempting thought: No waiting room, no doctor—just you, your vagina, and a test kit. After that, it's a walk to the post box and a click on a website or app for results. But all tests are not created equal, and a top Australasian microbiologist has warned that the worst can be inaccurate, misleading, and a cause for unnecessary upset. In fact, "I'm very close to having an apoplexy over it," says Dr Collette Bromhead, a medical laboratory scientist with 20 years' experience in molecular diagnostics. "These tests seem to be a money-making scheme that exploit the well and the well-off."
A Broadly investigation has discovered at least two websites—run by the same company, Head Start Testing—are exploiting a legal loophole to import questionable HIV and STI tests into Australia and New Zealand.
But enquiries reveal the tests, billed as "98-99 percent accurate" at detecting sexually transmitted infections, are not medically approved for sale in either country.
Dr Bromhead told Broadly she is alarmed that these locally unregulated tests are allowed on the market. "[It] is horrendous... it is almost impossible for me as a microbiologist to evaluate how accurate they are, because there is no detail given."
Home testing kits have been lauded as a new way to fight the STI epidemic, paving the way for a bevy of new healthcare start-ups like GetTested and EveKit. They allow users to take a vaginal swab, a urine sample, or a blood sample, then send them to a lab for an eventual review of the results online or on an app. Other versions of home tests show results in minutes, similar to a pregnancy test.
However, in Australia, home tests are illegal unless approved by the Australian Government's Therapeutic Goods Administration, and: "As yet, the TGA has not approved any HIV self-tests for supply in Australia," a spokeswoman confirmed.
Despite this, international websites are allowed to sell tests to Australians without official approval. The Head Start Testing site is hosted in the United Kingdom, and is not a listed company in either Australia and New Zealand.
False positives or negatives can involve decisions that may seriously affect the health of a patient.
In New Zealand, their sale is not illegal under current legislation. But both the Ministry of Health and medicine approval body, Medsafe, confirmed this week that they would be investigating concerns about the company, and considering the legality and safety of these and other at-home tests as part of an upcoming review of the Medicines Act 1981.
"Because [these devices] test for serious conditions, it is critical that they give accurate results," Medsafe general manager Chris James told Broadly. "For example, false positives or negatives can involve decisions that may seriously affect the health of a patient."
Head Start Testing appear to have been selling different versions of the at-home tests since 2009, and have previously come under fire from the New Zealand Aids Foundation for "preying on the vulnerable" and lying about the accuracy of tests.
Head Start Testing did not reply to requests for comment made on the Auckland and Sydney phone numbers listed on its site, the website, and its Facebook page.
Home testing does have its benefits, providing a private, efficient service for those who don't want to visit the clinic for a straightforward test.
In the US, Planned Parenthood have launched web-based STI testing in some states for chlamydia and gonorrhoea, and companies like myLAB box offer home testing for everything from HIV to herpes and syphilis, with a full 10-test kit coming in at USD $399.
But, while both the above are FDA-approved and offer the same diagnostic accuracy as going into a laboratory, this is not the case for all kits. Dr Bromhead says inaccurate tests would return more false positives—for example, showing an STI was present when there was none—or false negatives, clearing you of a disease when there is one present. The Mayo Clinic warn of this, too.
With no doctor or counsellor present, a positive HIV result for example would be doubly crushing.
While websites can look impressive, it can be difficult to tell if the test kits for sale have been subjected to any rigorous scientific analysis as to their efficacy, Dr Bromhead said.
"And they do nothing to address the inequalities that exist within the health system—a lot of people who have an STI may not be able to pay [all that money] for a test, let alone send them off and get the results."
Even for kits that are medically approved, Dr Bromhead warns of the lack of support at home if a result comes back positive. With no doctor or counsellor present, a positive HIV result for example would be "doubly crushing," she says.
And home testing wouldn't necessarily save any time: a positive result for something like HPV would still require the patient to go into a clinic for a pelvic exam and pap smear.
Family Planning New Zealand national medical advisor Dr Christine Roke says users of at-home tests should also be aware there is a "window period" between having unprotected sex and testing for an STI when it would not show up.
For example, the incubation period for chlamydia is two weeks, while HIV and syphilis typically have a three-month window before they would be captured by a test result. At that point, it would be desirable for the test "to be put into some context by a health professional."