当前位置:
X-MOL 学术
›
Clin. Chem.
›
论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study
Clinical Chemistry ( IF 7.1 ) Pub Date : 2024-02-22 , DOI: 10.1093/clinchem/hvae005 Huub H van Rossum 1 , Stefan Holdenrieder 2, 3 , Bart E P B Ballieux 4 , Tony C Badrick 5 , Yeo-Min Yun 6 , Chuanbao Zhang 7 , Dina Patel 8 , Marc Thelen 9, 10 , Junghan Song 11 , Nathalie Wojtalewicz 3 , Nick Unsworth 12 , Hubert W Vesper 13 , Wei Cui 14 , Lakshmi V Ramanathan 15 , Catharine Sturgeon 12 , Qing H Meng 16
Clinical Chemistry ( IF 7.1 ) Pub Date : 2024-02-22 , DOI: 10.1093/clinchem/hvae005 Huub H van Rossum 1 , Stefan Holdenrieder 2, 3 , Bart E P B Ballieux 4 , Tony C Badrick 5 , Yeo-Min Yun 6 , Chuanbao Zhang 7 , Dina Patel 8 , Marc Thelen 9, 10 , Junghan Song 11 , Nathalie Wojtalewicz 3 , Nick Unsworth 12 , Hubert W Vesper 13 , Wei Cui 14 , Lakshmi V Ramanathan 15 , Catharine Sturgeon 12 , Qing H Meng 16
Affiliation
Background 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. Methods 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. Results 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. Conclusions 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.
更新日期:2024-02-22