Emma Joyce 

Self-test health kits promise quick results. But what do doctors think of them?

Australian pharmacies now offer rapid tests for perimenopause, iron, vitamin D levels and more. Experts weigh in on whether they’re worth using
  
  

Emma Joyce sits in front of home testing kits
Experts say there are upsides to home testing kits, especially for those with social or geographical barriers to accessing healthcare, but many of the over-the-counter self-test options are far less accurate than a laboratory test. Photograph: Blake Sharp-Wiggins/The Guardian

Convenient, discreet and offering results in minutes, rapid health and wellness tests are popping up on pharmacy shelves across Australia. There are pinprick blood tests for vitamin D and iron levels, urine tests for perimenopause and menopause, and multi-health kits covering urinary tract infections and a cocktail of metrics such as glucose, ketones and pH.

Most range from $5 to $30, which is cheaper than a private GP consultation fee. You don’t need to speak to a doctor or medical professional to buy one (or a whole basketful). So can a pee-on-a-stick test confirm if I’m perimenopausal? Will low ferritin (iron stores) solve the mystery of my eternal tiredness? And, if they do work, does a positive result simply mean more clinical tests down the track?

Patti Shih, senior lecturer in public health at the University of Wollongong and co-author of an Australian study on direct-to-consumer tests, says there are hundreds of self-testing kits on the market. Some offer “results in minutes”, while others require you to post samples of hair, saliva or blood to a laboratory for analysis.

There are upsides to home testing kits, says Shih, especially where they can “help someone who has social or geographic barriers to access healthcare”.

“Some people don’t feel they can access their doctors quickly. It’s also more expensive to go to the doctors,” she says. But – and it’s a big caveat – most “home testing kits are nowhere near as accurate as a laboratory test”. The chances of false positives or false negatives “are a lot higher”, which may lead to further testing, false reassurance or confusion.

“You should only do a test if you absolutely need it,” Shih says. There’s a risk of “the wrong test or the unnecessary test to the wrong consumer”, she says. Context and a full understanding of your medical history is important for interpreting results, which is why she would be wary of most health and wellness tests on the market.

Wellness has also become about “optimising” oneself, she says, which is leading to an “over-commercialised” self-testing ecosystem.

Some rapid tests, including pregnancy, sexual health tests and Covid tests, are very reliable says Prof Martha Hickey, director of the Women’s Gynaecology Research Centre at the Royal Women’s hospital in Melbourne. Shih agrees.

However, Shih believes others can be like “stabbing in the dark”.

Perimenopause tests

Hickey says there’s no evidence a urine FSH test, or any urine test, can predict when you’re going to go into perimenopause. There are a number of reasons for that, she says. “One is that it’s a hormone that fluctuates quite considerably through your cycle.”

The biggest predictor of perimenopause is age, she says, but the professor understands why there has been a gold rush in menopause products.

“There’s been a massive explosion of … direct-to-consumer products around women’s healthcare generally, but specifically around menopause and fertility,” she says. “It’s very hard for women to navigate this when there’s a gap in high-quality information for them to turn to.”

FSH rapid tests, sold in Australia by several manufacturers, including We Test Bio – whose test we chose to picture for its eye-catching packaging – measure follicle-stimulating hormone through urine tests. Hickey says FSH in your blood can be detected in urine, but it “is not a reliable way of knowing if you’re in perimenopause”.

A spokesperson for We Test Bio says the test “is not to diagnose perimenopause, but to provide an accessible indicator that hormone levels may be changing”. The word “perimenopause” doesn’t appear on its bright pink box, but it is used in its instructions inside the packet, on shelf labels in chemists and on We Test Bio’s website.

A spokesperson for TerryWhite Chemmart, the pharmacy we bought the FSH test from, says their use of “perimenopause” to describe the test is “intended to help customers identify the context in which the product may be useful, particularly given that ‘FSH’ is not a widely understood term”.

“For women experiencing symptoms such as irregular cycles, hot flushes or sleep disruption, the test can provide an additional piece of information that may prompt a conversation with a healthcare professional,” says We Test Bio’s spokesperson. All its at-home tests “empower people with accessible health insights in the privacy of their own homes”, they say.

“I don’t think these self tests are empowering,” says Hickey. “To me, a test that doesn’t work – for something that you might be frightened of – is a bad combination.”

TerryWhite Chemmart’s spokesperson says the products are “positioned as a starting point, not an endpoint”.

“We recognise that perimenopause is complex and cannot be diagnosed through a single test,” they say, adding that TerryWhite Chemmart’s trained pharmacists can provide guidance and, where appropriate, refer patients to a GP or other specialist care.

The Australian Menopause Society has a free score sheet of symptoms for perimenopause and menopause, which can be used in consultation with a doctor. “Checking FSH or AMH levels or serum oestradiol and progesterone are unnecessary tests in diagnosing menopause for most women,” says the Australian Menopause Society website.

Iron and vitamin D pinprick blood tests

Rapid tests to check ferritin (stored iron) levels or vitamin D are sold by numerous manufacturers, including TouchBio, whose tests were chosen for their colourful packaging. They’re finger-prick blood tests, with cassettes that look like Covid tests. Results are ready in 10 minutes, which is quicker and more convenient than getting a referral for a blood test at a pathology practice.

Mazz Gencer, TouchBio’s general manager, says its Therapeutic Goods Administration-regulated tests are “designed as preliminary screening tools only”.

“For some people, an at-home test can provide an initial signal that prompts them to take specific health more seriously, seek medical advice, or have a more informed conversation with a healthcare professional.”

If you’re experiencing symptoms, Shih says, “The first thing you should be doing is going to the doctor. Get a full consultation to understand the situation first – it might be something else.”

“What these tests do is simply trigger more confusion and provide very little meaningful nor actionable information going forward – even if it is accurate,” says Shih. “There is a huge fitness and wellness industry driving these tests … I believe [they] drive the purchase of supplements, and the issue with supplements is that the quality varies.” Unlike a test kit, supplements are “also very expensive”.

TouchBio’s Gencer says its ferritin and vitamin D rapid rests undergo comprehensive assessment before they can be supplied in Australia. “These products are not wellness tools; they are regulated self-tests designed to support – not replace – professional medical guidance.

“Our instructions … clearly state that abnormal or repeatedly abnormal results should be discussed with a doctor or medical professional, and that results should always be interpreted in the context of symptoms, medical history and professional medical advice.”

Gencer agrees that laboratory testing remains the reference standard. The ferritin test states “an abnormal result does not in itself confirm iron-deficiency anaemia”. The benefit for consumers is “being able to check a concern early, reflect on the result in private, and decide whether consultations with a GP should happen sooner, not later,” he says.

There are thousands of biomarkers you can test on your body, says Shih. By “focusing on one biomarker, you’re not thinking of your body as a whole”.

Multi-health tests

In some cases, tests offer results for multiple parameters, including glucose, ketones, vitamin C, protein and nitrite. We Test Bio sells a multi-health and UTI home test, which is a urine strip test that provides results in 90 seconds for 11 health concerns. It’s sold for around $20, which sounds like a steal for a broad spectrum of metrics.

“Well-regulated tools like these can support early detection, which may lead to early intervention and better health outcomes,” says We Test Bio’s spokesperson. The UTI result “can help guide next steps or prioritise care, especially when GP access is limited”.

“If it is a simple and straightforward UTI, and can be treated with over-the-counter medication from the pharmacist, you don’t really need a test,” says Shih. “An at-home test, especially a false positive or negative, is going to send you on the wrong treatment pathways.

“My message to commercial companies is be really, really clear about your product,” says Shih. “Who should be taking it and when is a necessary situation to take it?”

 

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