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KMID : 0387320230330020173
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Korean Journal of Health Policy and Administration
2023 Volume.33 No. 2 p.173 ~ p.184
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Setting Priority Criteria for Classification of Self-Testing In Vitro Diagnostic Medical Devices Using Analytic Hierarchy Process Technique
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Kim Seol-Ihn
Pyeon Do-Yun
Jeong Yong-Ik
Cho Ja-Hyun
Noh Ga-Ya
Bae Green
Kwon Hye-Young
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Abstract
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Background: The coronavirus disease 2019 pandemic has been challenging the healthcare service, i.e., the vitalization of the pointof care accompanying self-testing in vitro diagnostic medical devices (IVDs). This study aims to suggest priority criteria to classifyself-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 wereparallelly 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 toquestionnaires. 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 theease of specimen collection, but the citizen’s panel valued self-management of the disease more. Second, considering thecharacteristics 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 suitablefor non-communicable diseases as compared to communicable diseases (0.688 vs. 0.312), but the citizen’s group responded thatself-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 ofnon-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.
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KEYWORD
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Self-testing, Self-testing in vitro diagnostic medical devices, Priority setting, Analytic hierarchy process
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