Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
LabGenomics Clinical Laboratories, Seongnam, Korea.
Ann Lab Med. 2019 Sep;39(5):447-453. doi: 10.3343/alm.2019.39.5.447.
The use of liquid chromatography-tandem mass spectrometry (LC-MS/MS) has substantially increased in clinical laboratories worldwide. To assess the status of clinical LC-MS/MS testing in Korean laboratories, a questionnaire survey was performed by the Clinical Mass Spectrometry Research Committee of the Korean Society of Clinical Chemistry.
The questionnaire was distributed to 19 clinical laboratories performing clinical LC-MS/MS from April to May 2018. It asked about general characteristics of the laboratory and commonly utilized clinical LC-MS/MS tests: newborn screening, tacrolimus test, vitamin D test, and plasma metanephrine test. Frequency analysis and other statistical analyses were performed.
A total of 17 laboratories responded. The median number of LC-MS/MS instruments, laboratory medicine physicians, and technicians in each laboratory was three, one, and two, respectively. Nine laboratory directors had >10 years of experience with clinical LC-MS/MS. For each LC-MS/MS test, at least two concentrations of QC materials were measured every 24 hours during clinical testing, and all laboratories used QC acceptability criteria based on their established QC means and SDs. All laboratories participated in an external quality assessment program. However, there was inter-laboratory variability in sample preparation methods, instruments, reagents, internal standards, and calibrators.
LC-MS/MS has been successfully introduced in Korean clinical laboratories and is used within a quality framework. Further efforts for harmonization on a nationwide basis could facilitate the widespread use of LC-MS/MS.
液相色谱-串联质谱法（LC-MS/MS）在世界范围内的临床实验室中的应用已大大增加。为了评估韩国实验室临床 LC-MS/MS 检测的现状，由韩国临床化学学会临床质谱研究委员会进行了问卷调查。
该问卷于 2018 年 4 月至 5 月分发给 19 家进行临床 LC-MS/MS 的临床实验室。它询问了实验室的一般特征和常用的临床 LC-MS/MS 测试：新生儿筛查、他克莫司测试、维生素 D 测试和血浆甲肾上腺素测试。进行了频率分析和其他统计分析。
共有 17 家实验室做出了回应。每家实验室的 LC-MS/MS 仪器、检验科医师和技术人员的中位数分别为三、一和二。九位实验室主任拥有 10 年以上的临床 LC-MS/MS 经验。对于每个 LC-MS/MS 测试，在临床测试期间，每 24 小时至少测量两种 QC 材料的浓度，并且所有实验室都使用基于其建立的 QC 均值和 SD 的 QC 可接受标准。所有实验室都参加了外部质量评估计划。然而，在样本制备方法、仪器、试剂、内标物和校准品方面存在实验室间的差异。
LC-MS/MS 已成功引入韩国临床实验室，并在质量框架内使用。在全国范围内进行进一步的协调努力，可以促进 LC-MS/MS 的广泛应用。
