背景:大多数肿瘤标志物(TMs)的协调状态未知。我们报告了一项可行性研究,以确定是否可以使用外部质量评估(EQA)程序来了解肿瘤标志物α-甲胎蛋白(AFP)的当前协调状态,前列腺特异性抗原(PSA),癌胚抗原(CEA),癌抗原(CA)125、CA15-3和CA19-9。
方法:由6个EQA提供商提供的EQA样本结果(INSTAND[Germany],韩国外部质量评估服务协会[KEQAS,韩国],国家临床实验室中心[NCCL,中国],英国国家外部质量评估服务[英国NEQAS,英国],将KwaliteitswakingMedische实验室诊断[SKML,荷兰],和澳大利亚皇家病理学家学院质量保证计划[RCPAQAP,澳大利亚])在2020年至2021年之间使用。共识意味着,根据所有EQA程序中存在的测量程序计算(AbbottAlinity,BeckmanCoulterDxI,罗氏·科巴斯,和西门子Atellica),用作参考值。根据测量程序,计算每个EQA样本的一致平均值与所有基于患者池的EQA样本的平均值之间的相对差异,并与最小值进行比较,可取的,和基于生物变异的最佳允许偏差标准。
结果:最终分析包括在19040(CA15-3)和25398(PSA)之间的个体结果和56(PSA)至76(AFP)独特的EQA样品。所有测量程序的基于患者池的EQA样本与共识平均值的平均差异均在AFP的最佳偏倚标准内,PSA的理想偏差,和CEA的最小偏差准则。然而,CEA结果<8µg/L超过了最小偏差标准。对于CA125、CA15-3和CA19-9,协调状态超出了最小偏差标准,确定了系统差异。
结论:本研究提供了6种肿瘤标志物目前协调状态的相关信息。CEA的试点协调调查,CA125、CA15-3和CA19-9将是理想的。
The harmonization status of most tumor markers (TMs) is unknown. We report a feasibility
study performed to determine whether external quality assessment (EQA) programs can be used to obtain insights into the current harmonization status of the tumor markers α-fetoprotein (AFP), prostate specific antigen (PSA), carcinoembryonic antigen (CEA), cancer antigen (CA)125, CA15-3 and CA19-9.
EQA sample results provided by 6 EQA providers (INSTAND [Germany], Korean Association of External Quality Assessment Service [KEQAS, South Korea], National Center for Clinical Laboratories [NCCL, China], United Kingdom National External Quality Assessment Service [UK NEQAS, United Kingdom], Stichting Kwaliteitsbewaking Medische Laboratoriumdiagnostiek [SKML, the Netherlands], and the Royal College of Pathologists of Australasia Quality Assurance Programs [RCPAQAP, Australia]) between 2020 and 2021 were used. The consensus means, calculated from the measurement procedures present in all EQA programs (Abbott Alinity, Beckman Coulter DxI, Roche Cobas, and Siemens Atellica), was used as reference values. Per measurement procedure, the relative difference between consensus mean for each EQA sample and the mean of all patient-pool-based EQA samples were calculated and compared to minimum, desirable, and optimal allowable bias criteria based on biological variation.
Between 19040 (CA15-3) and 25398 (PSA) individual results and 56 (PSA) to 76 (AFP) unique EQA samples were included in the final analysis. The mean differences with the consensus mean of patient-pool-based EQA samples for all measurement procedures were within the optimum bias criterion for AFP, the desirable bias for PSA, and the minimum bias criterion for CEA. However, CEA results <8 µg/L exceeded the minimum bias criterion. For CA125, CA15-3, and CA19-9, the harmonization status was outside the minimum bias criterion, with systematic differences identified.
This
study provides relevant information about the current harmonization status of 6 tumor markers. A pilot harmonization investigation for CEA, CA125, CA15-3, and CA19-9 would be desirable.