Evaluative analysis and guideline development of consumer-based labeling for home-use in-vitro diagnostic test kit

Abstract

At present, Thailand has neither stringent control on labeling for home-use IVDs nor requirement on user or readability test. This study thus aimed at identifying problems and necessary requirements for labeling guideline development and validation through home pregnancy test kit (HPT) labeling. The study comprised 3 phases of problems identification, home-use IVD labeling guideline development, and guideline validation. Problem identification was conducted using Diagnostic Technique on 90 novice target consumers and content analysis on 20 labeling and international regulations. The domestic problem assessment by content analysis on 20 samples of HPT product labeling revealed problems related to design quality and content. Problems on design quality included small pale prints and drawings as well as poor print quality. Content problems were found on non-indicated contents, different claims in same labeling, 2 trade names in 1 leaflet, different claims for foreign sources of 2 products having same appearance and inner label along with too many promotional claims. The Fox readability assessment demanded above 8th grade education to comprehend these labeling. The consumer Diagnostic Test confirmed that no user among 90 recruited could pass the test. Contentwise, analysis pronounced the acceptable scores for 4 out of 29 content questions including HPT name, test method, positive and negative result reading. The perceptions on utility, design quality, and comprehensibility aspects were comparable with lowest mean score on comprehensibility. The use of Q&A part, a “box”, and indirect indication for important contents was found inappropriate for Thai lay users. The comparison on labeling regulations of Australia, Canada, EU, and U.S.A suggested sufficient with valuable and visible placement under normal sale conditions of simple concise contents in official language with proper design quality. Phase II study involved labeling guideline and HPT labeling prototype development. The developed guideline evaluated by experts’ panel could be used as the standard or reference in developing the home-use IVD labeling. The outcome from phase II was used as an input into Phase III study of which purpose was to validate the developed labeling guideline by all stakeholders and adapted before consumer testing on the HPT labeling prototype. The Diagnostic Testing was conducted twice with 22 newly recruited lay consumers each. The 1st round result revealed that 50% of users failed the consumer testing whereas 13 from 29 contents did not reach the acceptable score. After revision, the improvement of labeling in the 2nd round validated the guideline. Only 4 out of 22 users could not pass the consumer test and contentwise analysis detected only 5 nonpassing contents. The user perceptions on such labeling prototype showed much improvement from the 1st round to be very high mean score in the 2nd round testing. However, Thai labeling was still emphasized as essential. The readability level of the 2nd round labeling prototype needed at least 5th grade education which was less than obligated minimum education level for Thai people. In conclusion, the policy with regulation amendment and simple reliable means for labeling quality evaluation of other home-use medical devices and health products should be strengthened and realized by all stakeholders for more consumers’ protection.