Van Rossum Huub H, Holdenrieder Stefan, Yun Yeo-Min, Patel Dina, Thelen Marc, Song Junghan, Unsworth Nick, Partridge Katherine, Moore Melanie, Cui Wei, Ramanathan Lakshmi, Meng Qing H, Ballieux Bart E P B, Sturgeon Catharine, Vesper Hubert
Department of Laboratory Medicine, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Institute of Laboratory Medicine, Munich Biomarker Research Center, Deutsches Herzzentrum, Munich, Germany.
Clin Chem Lab Med. 2024 Sep 20. doi: 10.1515/cclm-2024-0696.
CA 15-3 and CEA are tumor markers used in routine clinical care for breast cancer and colorectal cancer, among others. Current measurement procedures (MP) for these tumor markers are considered to be insufficiently harmonized. This study investigated the achievable harmonization for CA 15-3 and CEA by using an simulation of external quality assessment (EQA) data from multiple EQA programs using patient-pool based samples.
CA 15-3 and CEA data from SKML (2021), UK NEQAS (2020-2021) and KEQAS (2020-2021) were used. A harmonization protocol was defined in which MPs that were considered equivalent were used to value assign EQA samples, and recalibration was only required if the MP had a bias of >5 % with value assigned EQA. Harmonization status was assessed by determining the mean level of agreement and residual variation by CV (%).
Only MPs from Abbott, Beckman, Roche and Siemens were available in all EQA programs. For CA 15-3, recalibration was proposed for Beckman MP only and for CEA, recalibration was proposed for Siemens MP only. When the harmonization procedures were applied, for CA 15-3 the pre-harmonization mean bias range per MP was reduced from -29.28 to 9.86 %, into -0.09-0.12 % after harmonization. For CEA, the mean bias range per MP was reduced from -23.78 to 2.00 % pre-harmonization to -3.13-1.42 % post-harmonization.
The present study suggests that a significant improvement in the harmonization status of CA 15-3 and CEA may be achieved by recalibration of a limited number of MPs.
CA 15 - 3和癌胚抗原（CEA）是常用于乳腺癌和结直肠癌等常规临床护理的肿瘤标志物。目前这些肿瘤标志物的检测程序（MP）被认为协调不足。本研究通过使用基于患者池样本的多个外部质量评估（EQA）项目的模拟EQA数据，调查了CA 15 - 3和CEA可实现的协调情况。
使用了来自SKML（2021年）、英国NEQAS（2020 - 2021年）和KEQAS（2020 - 2021年）的CA 15 - 3和CEA数据。定义了一种协调方案，其中被认为等效的MP用于对EQA样本进行赋值，只有当MP与赋值的EQA存在>5%的偏差时才需要重新校准。通过确定一致性的平均水平和CV（%）的残余变异来评估协调状态。
所有EQA项目中仅可获得来自雅培、贝克曼、罗氏和西门子的MP。对于CA 15 - 3，仅建议对贝克曼MP进行重新校准，对于CEA，仅建议对西门子MP进行重新校准。当应用协调程序时，对于CA 15 - 3，每个MP的协调前平均偏差范围从 - 29.28%至9.86%降低到协调后的 - 0.09% - 0.12%。对于CEA，每个MP的平均偏差范围从协调前的 - 23.78%至2.00%降低到协调后的 - 3.13% - 1.42%。
本研究表明，通过对有限数量的MP进行重新校准，可显著改善CA 15 - 3和CEA的协调状态。
