Warning about self-test health kits

Behind the Headlines

Thursday March 31 2011

Self-testing kits should always be used with medical advice

DIY health testing kits have made headlines, with several newspapers reporting that they could do more harm than good. Home test kits designed to detect ailments from high cholesterol to cancer, can be misleading, offer false reassurance or trigger false alarms, and they use language that is often confusing, the media reported.

The stories are based on a new report by the consumer organisation Which? on six widely available home testing kits. It found many problems with the tests, including gaps in information, difficulty of use, “baffling” language, the risk of false alarms or false reassurance and misleading naming.

According to Which? people would be better off saving their money and going straight to their GP – who would have to carry out tests to confirm any ‘diagnosis’ made by such kits in any case.

It is always preferable to consult a medical practitioner if you have any health concerns. A GP will conduct an appropriate assessment and will be able to discuss any concerns that you have and advise which further examinations, investigations or further assessments – if any – are appropriate.

 

What did the research involve?

Which? asked two experts to assess a selection of home testing kits and to look at their packaging, leaflets and websites. The experts were Dr Danielle Freedman, consultant pathologist from the Royal College of Pathologists, and GP Dr Paul Singer.

The Plain English Campaign was also asked to assess the information provided with the packs.

Which? also asked 64 members of the public to look at the information available when buying a test, to see whether the average person would be able to use the kits correctly. They were then given in-depth interviews about the information available at the point of purchase.

The test kits examined were for the following medical conditions:

Bowel cancer

The Boots Home test kit, £12.25, says it may help in the early detection of bowel cancer.

Prostate problems such as prostate cancer

The Selfcheck Health Test, £15.99, says it measures blood levels of prostate specific antigen (PSA), a marker for prostate problems.

Cholesterol

Care Diagnostica Cholesterol Health Care Test, £9.99, says it can detect high cholesterol levels.

Diabetes

Boots home test kit, £12.25, claims it may help in the early detection of diabetes.

Urinary tract infection

Atlas Urinary Tract Test, £4.49, says it is an aid in the diagnosis of urinary tract infection.

Stomach ulcers

Simplicity Stomach Ulcer Screening Test, £12.00, says it is a “screen” for stomach ulcers.

 

What were the findings?

Detailed findings about the six tests are as follows:

Boots Home test kit

Which? says the kit, which tests for blood in the stools, is not as accurate as the screening test used by the NHS because it is based on only one bowel motion and “of little use as a screen for early bowel cancer”. Information is misleading – for example, it is referred to as a “diagnostic device” on the website. The pack gives no guidance on how to collect a stool sample, nor does it mention that you’re likely to need a repeat test by your GP, or that there’s a free NHS screening programme for the over-60s.

Selfcheck Health Test

Which? points out that although raised levels of PSA can indicate prostate cancer, raised PSA levels can be caused by other things (including benign enlargement, infection and inflammation of the prostate). Because of this, there is a good chance that this finger prick test could lead to false alarms, while negative results may give false reassurance. The pack fails to state that the test is unsuitable for people with certain medical conditions such as prostatitis (acute or chronic inflammation of the prostate) or, in some circumstances, unsuitable for use after sexual activity or cycling.

Consumers reported that information about the test was not always clear. Selfcheck recommends regular prostate testing for men over 40, but this is not supported by NHS screening policies. It was also difficult to use: the Which? tester “didn’t even collect half the blood needed”.

Care Diagnostica Cholesterol Health Care Test

The test involved a finger prick test that measures cholesterol in the blood, which can indicate a higher risk of heart disease. However, the Which? medical experts said there are other risk factors for heart disease, such as smoking, diabetes and obesity. They say the test results should be considered in combination with these factors to get a more accurate idea of risk, and this should be clearly explained to avoid “false reassurance”. The wording on the pack was judged to be “inappropriate for a general audience”. The Which? tester also found that the lancet which draws blood from the finger was broken and unusable.

Boots Home Test Kit

This test, which measures the level of glucose in the blood, could worry people unnecessarily as it doesn’t mention that glucose levels can be raised after a meal. The package does not clearly state who the test is unsuitable for, what might interfere with the results and when it should not be used. Which? says that although the leaflet contains some useful information in the event of an abnormal result, it also uses some confusing language. Lack of clarity over high glucose levels and an actual diagnosis of diabetes could lead to “some unduly and unnecessarily frightened people”.

Atlas Urinary Tract Test

This tests for white blood cells, red blood cells and nitrites in the urine, which can indicate a urinary tract infection (UTI). Consumers thought this test could be useful, and frequent UTI sufferers may find that the test helps to indicate when they need to visit the GP. Experts were concerned about the difficulties of interpreting the results. The Plain English Campaign said the leaflet uses “overly scientific and technical language”. Which? points out that as with many of the tests, many people would need re-testing by the GP to decide whether treatment is needed.

Simplicity Stomach Ulcer Screening Test

Which? says that this finger prick tests is misleading since it actually tests for a bacteria (helicobacter pylori) rather than stomach ulcers, and it cannot tell people if they have a current infection. Only a minority of people with the bacteria will develop an ulcer. Information with the kit is “vague” and the company’s website “unduly frightening”. Plain English Campaign called the information on the leaflet “overwhelming”. It was difficult to use: the tester only managed to get three-quarters of the blood needed after two finger pricks.

 

What does the report recommend?

Which? says that while self-test health kits could be a useful tool, the lack of clear information about how to use them could do more harm than good. Which? chief executive, Peter Vicary-Smith, says:

“As your GP may well have to carry out their own tests to confirm a positive diagnosis anyway, you may be better off saving your money and going straight to your GP.”

Which? will be contributing its report to the European review of self-testing devices.

 

What do other sources say?

Other experts are reported as agreeing that some of these tests can be misleading. The Prostate Cancer Charity said it did not encourage the use of PSA testing because this can result in false reassurance or create unnecessary anxiety. The charity Diabetes UK also advises people who are worried that they may have the condition not to use glucose test kits. Cancer Research UK said that anyone worried about the risk of cancer should see their doctor.

Boots is reported as saying that self-testing health kits should always be used with advice from a GP or pharmacist.

 

What should I do?

Many people find it difficult to see the GP or may be unwilling to talk to a doctor about their health concerns. Self-test health kits are widely available and may seem appealing by offering people the chance to test for various conditions in the comfort and privacy of their own home. However, this report, which has looked at six widely available home testing kits, concluded that they can be difficult to use, do not always give clear or adequate information, and can lead to unnecessary anxiety or false reassurance.

Although the report was limited to only six kits and they were assessed by only two experts, the findings are worth noting. The current lack of legislation for these home testing kits may mean that these problems are common among testing kits in general.

If you are considering using a home testing kit of any kind, it is worth bearing in mind these potential drawbacks, as well as the expense. The Department of Health advises people to be cautious when using home-testing kits. A spokesperson told the BBC, "anyone who is concerned that they may be suffering from an infection or illness should contact their GP practice, pharmacist or other health professional for advice.”

It is always preferable to consult a medical practitioner if you have any health concerns. A GP will conduct an appropriate assessment and can discuss any of your concerns and advise which further examinations, investigations or further assessments – if any – are appropriate. NHS Direct can also provide advice on 0845 4647.

Links to the headlines

Concern at self-test health kits. BBC News, March 31 2011

Home health tests 'could do more harm than good'. The Daily Telegraph, March 31 2011

DIY health testing kits 'could do more harm than good'. Daily Mail, March 31 2011

'Hit and miss' warning on home health tests. The Independent, March 31 2011

Links to the science

5 need to knows about home self-test health kits. Which 2011

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Analysis by Bazian

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