Home Diagnostic Kits Misleading Patients, UK
The authors¹ of the study evaluated the information provided on 168 websites marketing home diagnostic tests for conditions such as hepatitis C, HIV and prostate cancer. Their findings highlight the fact that many websites provide poor quality information to the general public, leading to the potential for misdiagnosis.
"Home diagnostic medical tests are part of a rapidly growing market of health-related products available for purchase on the internet," write the authors. "Despite their increasing popularity, there are concerns that inadequate, misleading or confusing advertisement can potentially result in inappropriate use of these tests and lead to false reassurance or unnecessary anxiety, which may have serious health consequences."
The authors looked at existing UK and international regulatory codes when assessing the quality of information accompanying the on-line marketing of home diagnostic tests.
Overall, 55.9% of the websites complied with less than half of the criteria suggested by the authors. Only one website complied with all of their criteria. Information on the accuracy of the tests was found on 51.7%, with only 8.9% providing a scientific reference (an indication of the validity of the product and whether it had been researched prior to marketing).
The authors highlighted the fact that the majority of websites marketing home diagnostic tests provided information of inadequate quality, and often failed to demonstrate any evidence of official approval or certification. Instructions for use were only found in 57.9% of all websites. As little as a quarter of the tests included what action should be taken after obtaining the test result.
Dr Adrija Kumar Datta, one of the authors of the study, says "Not all diagnostic kits marketed on-line are reliable. In my personal experience, I have seen 'sperm test kits' for home use give incorrect results. A test result of 'poor sperm count' was proven wrong by retesting the same individual's semen twice in the hospital laboratory. That caused initial frustration and subsequent confusion to the person concerned."
He went on,"It is difficult to control internet marketing by national legislation; since this business is not restricted to any political boundary. The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom and the Food and Drug Administration (FDA) in the United States, have started regulating the sale of 'over-the-counter' diagnostic kits within their own countries². On-line marketing of these kits, including the publishing of product information on the net, however, remain beyond legal control."
Dr Adrija Kumar Datta concludes, "As our study showed, the available guidance is far from being implemented and followed across the globe. There needs to be ongoing auditing and quality assurance of any guidelines."
References
1. Dr Adrija Datta, Dr Tara Selman, Dr Teresa Tang, Dr Khalid Khan
2. Food and Drug Administration (US government)> Office of In Vitro Diagnostic Device Evaluation and Safety Home and Lab test (updated March 2006) Available here.
'Quality of information accompanying on-line marketing of home diagnostic tests' is published in the January issue (Vol.101) of the Journal of the Royal Society of Medicine.
JRSM is the flagship journal of the Royal Society of Medicine. It has full editorial independence of the RSM. It has been published continuously since 1809. Its Editor is Dr Kamran Abbasi.
The January issue of the JRSM will be available free at http://www.jrsm.org shortly.
Founded in 1805, the Royal Society of Medicine is an independent organisation that promotes the exchange of knowledge, information and ideas in medical science and continued improvement in human health.
Royal Society of Medicine
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