Abstract

The verification of examination procedures is a responsibility for clinical laboratories in order to guarantee that their performance characteristics comply with the specifications obtained during the validation process and are congruent with the intended scope of the assay. The aim was to perform an evaluation of precision, bias, linearity, linear drift, sample carry-over, and comparability of 73 assays from Siemens Healthineers, by following the CLSI EP10-A3 guidelines. The verification was performed by measuring 72 biochemical parameters in quality control (QC) materials from Bio-Rad (except for IL6) with 73 assays installed on eight measuring systems (five Atellica^® CH 930 and three IM 1600 analyzers from Siemens Healthcare Diagnostics). The following information was collected: validation data from manufacturer, biological variation data from the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) database, and specifications for fβhCG and PAPP-A assays to meet the Fetal Medicine Foundation standards. A total of 17550 results were obtained during EP10 verification process. Out of the 73 methods, only Cl–S, Mg–S, and Na–S failed the criteria for adequate precision, trueness, and comparability. The assays did not show significant loss of linearity, linear drift, or sample carry-over. This study allowed the initial training and familiarization with the instruments and the identification of operational issues. It also represented an opportunity to evaluate the QCs and to obtain analytical performance information for application of sigma six metrics for quality assurance. Professionals are advised to adequately standardize and protocolize their verification processes to ensure laboratory competence and patient safety.

摘要

检验程序的验证是临床实验室的责任，以确保其性能特征符合在验证过程中获得的规范并与预期的测定范围一致。目的是按照 CLSI EP10-A3 指南，对 Siemens Healthineers 的 73 种检测方法的精度、偏差、线性度、线性漂移、样品残留和可比性进行评估。验证通过测量来自 Bio-Rad（IL6 除外）的质量控制 (QC) 材料中的 72 个生化参数，在八个测量系统（五个 Atellica ^®西门子医疗诊断公司的 CH 930 和三台 IM 1600 分析仪）。收集了以下信息：来自制造商的验证数据、来自欧洲临床化学和检验医学联合会 (EFLM) 数据库的生物变异数据，以及满足胎儿医学基金会标准的 fβhCG 和 PAPP-A 检测规范。在 EP10 验证过程中，总共获得了 17550 个结果。在 73 种方法中，只有 Cl-S、Mg-S 和 Na-S 未能达到足够的精密度、正确性和可比性标准。分析没有显示出显着的线性损失、线性漂移或样品残留。这项研究允许对仪器进行初步培训和熟悉，并确定操作问题。它还代表了评估 QC 并获得分析性能信息以应用 sigma 6 指标以进行质量保证的机会。建议专业人员充分标准化和规范他们的验证过程，以确保实验室能力和患者安全。