The Pharmaceutical Journal
Vol 269 No 7228 p837
14 December 2002

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Which? (www.which.net)

Health Which? raises concerns over home test kits

A number of home testing kits should be withdrawn from the market, according to a report in this month's issue of Health Which?

Health Which? bought 11 home testing kits, from pharmacies or via the internet, for a range of disease areas including high cholesterol, bowel and prostate disorders, osteoporosis, diabetes and Alzheimer's disease. They recruited experts in each disease area to assess the kits and decide whether they are suitable for use at home.

The experts say that four of the tests are misleading and unreliable and recommended that they should be withdrawn from sale. The tests that were singled out were BodyWatch's osteoporosis risk assessment kit, HomeChec's early alert Alzheimer's home screening test and both the Boots and BodyWatch cholesterol tests.

Health Which? says that tests for diabetes, prostate and bowel disorders are likely to give a result of some value. However, the experts expressed concern at people being presented with a potentially shattering result without explanation, support or counselling from a health care professional.

Health Which? adds: "Overall, our experts' main concern was that although the tests are careful not to claim to diagnose a specific disease or replace seeing a GP, the user would automatically assume a connection between the result and a specific disease."

However, Boots The Chemists, whose cholesterol, diabetes and bowel tests were included in the analysis, says that although the company is realistic about the limitations of screening kits, the kits can be useful if there is a history of certain conditions and they can be used to help people who wish to monitor their own health closely. "We have always made it clear that these tests are not about providing a diagnosis, but that they can be the first trigger to take action and visit your GP," the company says.

Wellbeing Screening, a supplier of self-testing screening kits, which acquired BodyWatch last month, is currently reviewing each product. The company told The Journal: "We have never sold our products as home-use diagnostics." It advises that if the results of the screening test are found to be outside the normal range, they should be discussed with a GP.

The British In Vitro Diagnostic Association comments that the Health Which? report is unbalanced and has "ignored the huge market for pregnancy test kits which have been used successfully in this country for many years". BIVDA adds that new regulations regarding self testing are expected to come into force at the end of next year and the requirement for CE marking on packaging will prevent the sale of poor quality and unsafe tests.