Health Policy Manag.  2023 Jun;33(2):173-184. 10.4332/KJHPA.2023.33.2.173.

Setting Priority Criteria for Classification of Self-Testing In Vitro Diagnostic Medical Devices Using Analytic Hierarchy Process Technique

• Kim SI
• Pyeon DY
• Jeong YI
• Cho J
• Noh G
• Bae G
• Kwon HY

• KMID: 2549097
• DOI: http://doi.org/10.4332/KJHPA.2023.33.2.173

Abstract

Background
The coronavirus disease 2019 pandemic has been challenging the healthcare service, i.e., the vitalization of the point of care accompanying self-testing in vitro diagnostic medical devices (IVDs). This study aims to suggest priority criteria to classify self-testing IVDs using the analytic hierarchy process technique.
Methods
Two dimensions of the characteristics embedded in the IVDs and the diseases to be diagnosed with self-testing IVDs were parallelly considered and independently investigated. In addition, three expert panels consisting of laboratory medical doctors (n=11), clinicians (n=10), and citizens (n=11) who have an interest in the selection of self-testing IVDs were asked to answer to questionnaires. Priorities were derived and compared among each expert panel.
Results
First of all, ease of specimen collection (0.241), urgency of the situation (0.224), and simplicity of device operation (0.214) were found to be the most important criteria in light of the functional characteristics of self-testing IVDs. Medical doctors valued the ease of specimen collection, but the citizen’s panel valued self-management of the disease more. Second, considering the characteristics of the diseases, the priority criteria were shown in the order of prevalence of diseases (0.421), fatality of disease (0.378), and disease with stigma (0.201). Third, medical doctors responded that self-testing IVDs were more than twice as suitable for non-communicable diseases as compared to communicable diseases (0.688 vs. 0.312), but the citizen’s group responded that self-testing IVDs were slightly more suitable for infectious diseases (0.511 vs. 0.489).
Conclusion
Our findings suggested that self-testing IVDs could be primarily classified as the items for diagnosis of non-communicable diseases for the purpose of self-management with easy specimen collection and simple operation of devices, taking into account the urgency of the situation as well as prevalence and fatality of the disease.

Keyword

Self-testing; In vitro diagnostic medical device; Priority setting; Analytic hierarchy process