오류유형 및 영향분석과 그레이 관계분석을 통한 HLA 조직형 검사의 위험도 분석

초록

Background: High-resolution HLA typing is predominantly performed using sequence-based typing (SBT) and next-generation sequencing (NGS). Risk analysis is necessary to predict and evaluate potential risks in the testing process to ensure the reliability and accuracy of test results. Methods: The risks were assessed by specialized experts, including a leader, doctors, technicians, and statistical analysts. Each expert calculat- ed the severity, occurrence, and detectability of potential failures according to the Clinical Laboratory & Standards Institutes (CLSI) guidelines (EP18). For failure mode and effects analysis (FMEA), the risk priority number (RPN) was calculated as the product of these factors. Grey relational analysis (GRA) was used to derive the grey relational grade (GRG). Results: For SBT, RPN values ranged from 4–72, with GRG from 0.44–0.76, while for NGS, RPN values ranged from 12–102, with GRG from 0.51 – 0.90. The total RPN indicated a higher risk for NGS (465 vs. 1,103). For SBT, FMEA, and GRA identified high risks in adding DNA to PCR tubes or PCR products to plates, and in interpreting and inputting the results. For NGS, high risks were found in adding DNA to the reaction mix and result interpretation. Conclusions: This is the first study to apply FMEA and GRA to risk assessment in SBT and NGS for high-resolution HLA typing. NGS presented higher risks compared to SBT. It is necessary to improve workflows or introduce automated processes to reduce risk when adding reagents or mixtures and interpreting and inputting results.

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