Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study,Clinical Chemistry

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Investigating the Current Harmonization Status of Tumor Markers Using Global External Quality Assessment Programs: A Feasibility Study
Clinical Chemistry ( IF 9.3 ) 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

Department of Laboratory Medicine, Netherlands Cancer Institute , Amsterdam , the Netherlands
Institute of Laboratory Medicine, Munich Biomarker Research Center, Deutsches Herzzentrum München, Technische Universität München , Munich , Germany
INSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories , Duesseldorf , Germany
Department of Clinical Chemistry, Leiden University Medical Center , Leiden , the Netherlands
RCPA Quality Assurance Programs , St Leonards, Sydney , Australia
Department of Laboratory Medicine, Konkuk University Medical Center , Seoul, South Korea
National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology , Beijing , China
UK NEQAS Immunology, Immunochemistry & Allergy, Northern General Hospital , Sheffield , United Kingdom
SKML , Nijmegen , the Netherlands
Department of Laboratory Medicine of the Radboud University Medical Center , Nijmegen , the Netherlands
Department of Laboratory Medicine, Seoul National University Bundang Hospital and College of Medicine , Seongnam, South Korea
UK NEQAS [Edinburgh], Department of Laboratory Medicine, Royal Infirmary of Edinburgh , Edinburgh , United Kingdom
Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention , Atlanta, GA , United States
Department of Laboratory Medicine, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing , China
Clinical Chemistry Service, Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center , New York, NY , United States
Department of Laboratory Medicine, Division of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center , Houston, TX , United States

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

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