Quality and use of consumer information provided with home test kits: room for improvement.

Abstract

Diagnostic self-tests (tests on body materials that are initiated by consumers with the aim of diagnosing a disorder or risk factor) are becoming increasingly available. Although the pros and cons of self-testing are currently not clear, it is an existing phenomenon that is likely to gain further popularity. To examine consumers' use of and needs for information about self-testing, and to assess the quality of consumer information provided with home test kits, as perceived by consumers and as assessed using a checklist of quality criteria. A cross-sectional Internet survey among 305 self-testers assessed their use of and needs for information and their perception of the quality of consumer information provided with self-test kits. A meta-search engine was used to identify Dutch and English consumer information for home diagnostic tests available online at the time of the study. The quality of this consumer information was evaluated using a checklist of quality criteria. The consumers' information needs were in line with the most frequently used information, and the information was perceived as being of moderate to good quality. The information was mostly in agreement with clinical practice guidelines, although information on reliability and follow-up behaviour was limited. Approximately half of the instruction leaflets did not include information on the target group of the test. Although generally of moderate to good quality, some aspects of the information provided were in many cases insufficient. European legislation concerning self-tests and accompanying information needs to be adapted and adhered to more closely.