肿瘤标志物是已建立的实验室工具，有助于诊断、估计预后和监测癌症的病程。为了在患者护理中做出有意义的决策，方法和分析平台必须具有高灵敏度、特异性、精确度和可比性。实验室必须定期参与外部质量评估 (EQA) 计划。在这里，对 EQA 数据进行纵向评估，以评估肿瘤标志物检测随时间的变化的性能。癌症抗原 (CA) 15-3 (n = 5,492)、CA 19-9 (n = 6,802) 和 CA 19-9 (n = 6,802) 的纵向数据对 2019 年至 2023 年间进行的 14 次即时 EQA 中的 CA 125 (n = 5,362) 进行了评估。中位数分别有 197 个、244 个和 191 个实验室参加了 CA 15-3、CA 19-9 和 CA 125 的 EQA。数据评估涵盖制造商内部和制造商之间随时间变化的特定变化、测定精度以及对 CA 15-3 ±24%、CA 19-9 ±27% 和 CA 125 ±36% 的 EQA 限值的遵守情况。研究表明，在研究期间最高和最低方法之间，CA 15-3 的制造商依赖性中位数差异高达 107%，CA 125 为 99%，CA 19-9 甚至为 549%。关于所有方法的归一化中位数，最偏离方法的值为 CA 15-3 0.42、CA 19-9 7.61 和 CA 125 1.82。制造商内部变异性一般较低，变异系数中位数 ( CV）低于10%。由于方法是根据特定方法的共识值进行评估的，因此大多数参与者在验收标准内通过了 EQA。当标准始终设定在 24% 时，中央 90% 的参与者通过了 EQA，其中 CA 15-3（AX 除外）为 78.6%-100%，CA 125 为 89.3%-100%，CA 125 为 64.3%- CA 19-9 为 100%。虽然大多数分析平台的方法内精度对于所有三种肿瘤标志物来说都是可以接受的，但在整个研究期间观察到相当大的方法间变异性，这表明有必要更好地标准化和协调方法、开发国际参考材料以及患者样本的综合可互换性研究。版权所有 © 2024 Kremser、Weiss、Kaufmann-Stoeck、Vierbaum、Schmitz、Schellenberg 和 Holdenrieder。

Tumor markers are established laboratory tools that help to diagnose, estimate prognosis, and monitor the course of cancer. For meaningful decision-making in patient care, it is essential that methods and analytical platforms demonstrate high sensitivity, specificity, precision, and comparability. Regular participation at external quality assessment (EQA) schemes is mandatory for laboratories. Here, a longitudinal evaluation of EQA data was performed to assess the performance of tumor marker assays over time.Longitudinal data of the cancer antigens (CA) 15-3 (n = 5,492), CA 19-9 (n = 6,802), and CA 125 (n = 5,362) from 14 INSTAND EQAs conducted between 2019 and 2023 were evaluated. A median of 197, 244 and 191 laboratories participated at the EQAs for CA 15-3, CA 19-9 and CA 125, respectively. Data evaluation encompasses intra- and inter-manufacturer specific variations over time, assay precision, and adherence to the EQA limits of ±24% for CA 15-3, ±27% for CA 19-9 and ±36% for CA 125.The study showed median manufacturer-dependent differences of up to 107% for CA 15-3, 99% for CA 125, and even 549% for CA 19-9 between the highest and the lowest methods over the studied period. Regarding the normalized median of all methods, the values of the most deviant methods were 0.42 for CA 15-3, 7.61 for CA 19-9, and 1.82 for CA 125. Intra-manufacturer variability was generally low, with median coefficients of variation (CV) below 10%. As the methods were evaluated according to method-specific consensus values, most participants passed the EQAs within the acceptance criteria. When the criteria were consistently set at 24%, the central 90% of participants passed the EQAs in 78.6%-100% for CA 15-3 (with exception of AX), 89.3%-100% for CA 125, and 64.3%-100% for CA 19-9.While intra-method precision of most analytical platforms is acceptable for all three tumor markers, considerable inter-method variability was observed over the whole studied period demonstrating the necessity for better standardization and harmonization of the methods, development of international reference materials, and comprehensive commutability studies with patient samples.Copyright © 2024 Kremser, Weiss, Kaufmann-Stoeck, Vierbaum, Schmitz, Schellenberg and Holdenrieder.