Department of Clinical Laboratory, Beijing Chaoyang Hospital, Beijing Center for Clinical Laboratories, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China.
Department of Clinical Laboratory, Wangjing Hospital, China Academy of Traditional Chinese Medicine, Beijing, P.R. China.
PLoS One. 2021 Jun 15;16(6):e0253324. doi: 10.1371/journal.pone.0253324. eCollection 2021.
This study aimed to assess the comparability among assays using freshly frozen human sera and external quality assessment (EQA) data in China.
Twenty-nine serum samples and two commercial EQA materials, obtained from the National Center for Clinical Laboratories (NCCL), were analyzed in triplicate using eight routine TSH assays. The commutability of commercial EQA materials (NCCL materials) was evaluated in accordance with the CLSI EP30-A and IFCC bias analysis. Median values obtained for the NCCL EQA materials were used to determine the systematic and commutability-related biases among immunoassays through back-calculation. The comparability of TSH measurements from a panel of clinical samples and NCCL EQA data was determined on the basis of Passing-Bablok regression. Furthermore, human serum pools were used to perform commutable EQA.
NCCL EQA materials displayed commutability among three or five of seven assay combinations according CLSI or IFCC approach, respectively. The mean of systematic bias ranged from -13.78% to 9.85% for the eight routine TSH assays. After correcting for systematic bias, averaged commutability-related biases ranged between -42.26% and 12.19%. After correction for systematic and commutability -related biases, the slopes indicating interassay relatedness ranged from 0.801 to 1.299 using individual human sera, from 0.735 to 1.254 using NCCL EQA data, and from 0.729 to 1.115 using pooled human serum EQA(the commutable EQA).
The harmonization of TSH measurement is challenging; hence, systematic and commutability-related biases should be determined and corrected for accurate comparisons among assays when using human individual serum and the commercial EQA materials.
本研究旨在评估使用新鲜冷冻人血清和中国外部质量评估（EQA）数据的测定之间的可比性。
使用 8 种常规 TSH 测定法，对来自国家临床检验中心（NCCL）的 29 份血清样本和两种商业 EQA 材料进行了三次重复分析。根据 CLSI EP30-A 和 IFCC 偏差分析评估了商业 EQA 材料（NCCL 材料）的互换性。通过反算，使用 NCCL EQA 材料的中位数确定免疫测定之间的系统和互换相关偏差。基于通过回归的 Passing-Bablok 确定了来自临床样本和 NCCL EQA 数据的 TSH 测量之间的可比性。此外，使用人血清池进行可互换的 EQA。
根据 CLSI 或 IFCC 方法，NCCL EQA 材料在七种测定组合中的三种或五种组合中显示出互换性。八个常规 TSH 测定的系统偏差平均值范围为-13.78%至 9.85%。在校正系统偏差后，平均互换相关偏差范围在-42.26%至 12.19%之间。在校正系统和互换相关偏差后，使用个体人血清时，指示测定间相关性的斜率范围为 0.801 至 1.299，使用 NCCL EQA 数据时为 0.735 至 1.254，使用混合人血清 EQA（可互换 EQA）时为 0.729 至 1.115。
TSH 测量的协调具有挑战性；因此，在使用人个体血清和商业 EQA 材料进行测定之间的准确比较时，应确定和校正系统和互换相关的偏差。
