Cha Jaehyun, Hur Mina, Kim Hanah, Yun Seunggyu, Nam Myunghyun, Cho Yunjung, Nam Minjeong
Department of Laboratory Medicine, Korea University Anam Hospital, Seoul 02841, Republic of Korea.
Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul 05030, Republic of Korea.
Diagnostics (Basel). 2024 Aug 16;14(16):1793. doi: 10.3390/diagnostics14161793.
This study compared laboratory risk and turn-around time (TAT) between sequence-based typing (SBT) and next-generation sequencing (NGS) for human leukocyte antigen (HLA) typing. For risk assessment, we utilized the risk priority number (RPN) score based on failure mode and effect analysis (FMEA) and a risk acceptability matrix (RAM) according to the Clinical Laboratory Standards Institute (CLSI) guidelines (EP23-A). Total TAT was documented for the analytical phase, and hands-on time was defined as manual processes conducted by medical technicians. NGS showed a significantly higher total RPN score than SBT (1169 vs. 465). NGS indicated a higher mean RPN score, indicating elevated severity and detectability scores in comparison to SBT (RPN 23 vs. 12, = 0.001; severity 5 vs. 3, = 0.005; detectability 5 vs. 4, < 0.001, respectively). NGS required a greater number of steps than SBT (44 vs. 25 steps), all of which were acceptable for the RAM. NGS showed a longer total TAT, total hands-on time, and hands-on time per step than SBT (26:47:20 vs. 12:32:06, 03:59:35 vs. 00:47:39, 00:05:13 vs. 00:01:54 hh:mm:ss, respectively). Transitioning from SBT to NGS for HLA typing involves increased risk and an extended TAT. This study underscored the importance of evaluating these factors to optimize laboratory efficiency in HLA typing.
本研究比较了基于序列的分型（SBT）和下一代测序（NGS）用于人类白细胞抗原（HLA）分型时的实验室风险和周转时间（TAT）。对于风险评估，我们采用了基于失效模式与效应分析（FMEA）的风险优先数（RPN）评分以及根据临床实验室标准协会（CLSI）指南（EP23 - A）制定的风险可接受性矩阵（RAM）。记录了分析阶段的总周转时间，实操时间定义为医学技术人员进行的手工操作过程。NGS的总RPN评分显著高于SBT（1169对465）。NGS的平均RPN评分更高，表明与SBT相比，严重程度和可检测性评分升高（RPN分别为23对12，P = 0.001；严重程度5对3，P = 0.005；可检测性5对4，P < 0.001）。NGS比SBT需要更多步骤（44步对25步），所有这些步骤对于RAM都是可接受的。NGS的总周转时间、总实操时间和每步实操时间均比SBT长（分别为26:47:20对12:32:06、03:59:35对00:47:39、00:05:13对00:01:54 hh:mm:ss）。从SBT转换为NGS进行HLA分型会增加风险并延长周转时间。本研究强调了评估这些因素以优化HLA分型实验室效率的重要性。
