Over recent years access to self-testing kits (part of the direct-to-consumer testing market) has been expanding.1 These tests may be purchased online or in pharmacies and are performed without input from health professionals. Samples taken are either processed at home or sent to a laboratory, and may offer screening, diagnosis, monitoring, or information about the risk of a disease. These tests are likely to generate additional primary care consultations as they become more widely available. Here we consider the processes by which self-tests conducted at home are regulated, their accuracy and the benefits and risks of this new diagnostic process.
WHAT IS AVAILABLE AND HOW MUCH DOES IT COST?
A UK review in 2006 found 104 kits to test at home or send away, covering 24 conditions.2 These included tests for diagnosing cancer (for example, faecal occult blood and PSA); monitoring of chronic conditions (for example, diabetes); urinary tract infections; and sexually transmitted infection tests including HIV. Prices ranged from less than £1 to £76.
WHAT INFORMATION IS THERE ON HOW WELL THE TEST CAN DETECT DISEASE?
A review of the information available with self-tests found that it was ‘generally inadequate’ and ‘often restricted to little more than the prices and instructions for use.’3 Another study found that although some information was provided about the reliability of results, this was most often in the form of ‘a brief statement such as “false-positive or false-negative results may occur”.’4 It is often not possible to find out whether a self-test has the …