PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■肿瘤标志物是建立的实验室工具，有助于诊断，估计预后，并监测癌症的进程。为了在病人护理中做出有意义的决策，方法和分析平台必须表现出高灵敏度，特异性，精度,和可比性。实验室必须定期参加外部质量评估（EQA）计划。这里,对EQA数据进行了纵向评估,以评估肿瘤标志物测定随时间的性能.
■癌症抗原（CA）15-3（n=5,492）的纵向数据，CA19-9(n=6,802)，对2019年至2023年期间进行的14个INSTANDEQA的CA125（n=5,362）进行了评估。分别有197、244和191个实验室参加了CA15-3、CA19-9和CA125的EQA。数据评估包括制造商内部和制造商之间随时间的特定变化，测定精度，CA15-3的EQA限值为±24％，CA19-9的EQA限值为±27％，CA125的EQA限值为±36％。
■该研究显示，CA15-3的制造商依赖性差异中位数高达107%，CA125的差异为99%，甚至CA19-9的差异为549%。关于所有方法的归一化中位数，CA15-3的最偏差方法的值为0.42,CA19-9的值为7.61,CA125的值为1.82.制造商内部的可变性通常很低，中值变异系数(CV)低于10%。由于这些方法是根据特定方法的共识值进行评估的，大多数参与者在验收标准内通过了EQA。当标准始终设定为24%时，中央90％的参与者通过了CA15-3的78.6％-100％的EQA（AX除外），CA125为89.3%-100%，CA19-9为64.3%-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都是可以接受的，在整个研究期间观察到相当大的方法间差异，证明了更好的方法标准化和协调的必要性，国际参考材料的发展，和患者样本的综合可交换性研究。
■癌症抗原（CA）15-3（n=5,492）的纵向数据，CA19-9(n=6,802)，对2019年至2023年期间进行的14个INSTANDEQA的CA125（n=5,362）进行了评估。分别有197、244和191个实验室参加了CA15-3、CA19-9和CA125的EQA。数据评估包括制造商内部和制造商之间随时间的特定变化，测定精度，CA15-3的EQA限值为±24％，CA19-9的EQA限值为±27％，CA125的EQA限值为±36％。
■该研究显示，CA15-3的制造商依赖性差异中位数高达107%，CA125的差异为99%，甚至CA19-9的差异为549%。关于所有方法的归一化中位数，CA15-3的最偏差方法的值为0.42,CA19-9的值为7.61,CA125的值为1.82.制造商内部的可变性通常很低，中值变异系数(CV)低于10%。由于这些方法是根据特定方法的共识值进行评估的，大多数参与者在验收标准内通过了EQA。当标准始终设定为24%时，中央90％的参与者通过了CA15-3的78.6％-100％的EQA（AX除外），CA125为89.3%-100%，CA19-9为64.3%-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都是可以接受的，在整个研究期间观察到相当大的方法间差异，证明了更好的方法标准化和协调的必要性，国际参考材料的发展，和患者样本的综合可交换性研究。
