Self-testing proves contagious

Is the future of diagnosis one of 'patient, test thyself'? Ciarán Brennan looks at the pros and cons of home diagnosis.

Is the future of diagnosis one of 'patient, test thyself'? Ciarán Brennan looks at the pros and cons of home diagnosis.

No fuss, no waiting, no embarrassment of bumping into a neighbour as you emerge from a clinic - relatively cheap home testing seems to provide the answer for a busy generation who value their privacy. And it's on the rise.

The home self-testing diagnostic market has been identified as a candidate for exceptionally high annual growth rates over the next five years in the over-the-counter (OTC) marketplace.

The now ubiquitous pregnancy-testing kit may have been the mammy of them all, but the market has advanced enormously since it was launched decades ago. You can now buy home-testing kits to diagnose a vast array of illness and conditions - glucose monitoring, cholesterol testing, drug testing, right up to kits for testing for prostate cancer and even infectious diseases such as hepatitis and HIV.

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But is it about empowering people or is it a dangerous development that might lead to people misdiagnosing their illnesses?

The medical profession is not opposed to home testing in general, but many diagnoses are not as straightforward as pregnancy testing, according to Dr Ronan Boland, vice-chairman of the GP committee of the Irish Medical Organisation (IMO) and editor of website mygp.ie.

"Certainly, I would take the view that, in the case of pregnancy testing, it is a useful addition and can give an anxious woman a quick answer." But he warns against taking some tests in isolation, particularly for cholesterol or prostate cancer.

"Doctors do not carry out these tests in isolation," he says. "We carry them out as part of a holistic approach looking at all the factors that may impact on somebody's risk of developing a major illness."

Tests carried out at home in isolation from other factors could give somebody false reassurance, says Boland.

Cholesterol is only one of five or six significant risk factors for heart disease, and ignoring or not testing for things such as weight, blood pressure, lifestyle habits, diabetes or family history could leave you at risk. On the other hand, a relatively high cholesterol reading could be unnecessarily worrying for someone who maintains a healthy lifestyle, does not smoke, has normal blood pressure and is not overweight, he says.

Dr Niall O'Cleirigh, chairman of the communications and publications committee of the Irish College of General Practitioners, says that while home-testing kits have their merits, he is apprehensive about some of the tests on the market today.

"We are all for the basic issue of empowering patients, but we would have concerns about home tests that are becoming available now for HIV or hepatitis and other serious conditions.

"These are major public health issues and, if people were just testing themselves at home and not seeking medical attention, that would be a cause for concern."

There are other issues such as the effect a positive HIV test would have on a person - which is why GPs offer pre- and post- counselling, says O'Cleirigh.

Boland agrees: "If someone does a HIV test at home and they have a positive result, it is a fairly calamitous outcome for the patient. Where a doctor or healthcare professional is carrying out a HIV test, it is not simply a matter of taking a blood test.

"You have to counsel the patient. You have to counsel them as regards the possibility of a positive result, what's going to happen immediately if you have a positive result, the possible implication of things like insurance and so on."

The issue of accuracy of some home tests has been highlighted, particularly for those ordered over the internet, where the buyer may not be aware of the quality of the manufacturer or the standards demanded in the country of origin.

But Rory Nealon, chief financial officer with Irish company Trinity Biotech - which has met the US Food and Drug Administration (FDA) to discuss the conditions under which the FDA might grant marketing clearance for over the counter sales of its UniGold HIV test - argues products coming on to the market today are made to the highest standard and are rigorously tested.

"Our product is every bit as good as a laboratory-based test. It has what is called 100 per cent sensitivity, which means 100 times out of 100 it will pick up a positive result where the patient is positive.

"The objective of these trials that the FDA will submit products like ours to is exactly how will people perform that test in the home environment and will they get it right every time.

If there is any doubt whatsoever, the FDA would not release it into an OTC market," he says.

Boland says he is realistic enough to know that the rise in popularity of home-testing kits shows that the public is becoming increasingly comfortable with them.

"I have no doubt that people will continue to avail of the tests that are out there. The ultimate message is buyer beware."