ArticleDiagnostics (Basel, Switzerland)2023
Longitudinal Evaluation of AFP and CEA External Proficiency Testing Reveals Need for Method Harmonization.
Article in Diagnostics (Basel, Switzerland), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Strengthening the interpretation of longitudinal EQA data through the sporadic inclusion of native human sera in general clinical chemistry.Frontiers in molecular biosciences · 2026Article
- Using native human sera to assess the suitability of external quality assessment materials based on testosterone, progesterone, and 17β-estradiol measurements.Frontiers in molecular biosciences · 2026Article
- Circulating Biomarkers in Medullary Thyroid Carcinoma: Bridging Laboratory Complexities and Clinical Application Through Algorithm Design.Journal of clinical medicine · 2025Review
- Circulating Biomarkers of Thyroid Cancer: An Appraisal.Journal of clinical medicine · 2025Review
- Exosomes in early lung cancer diagnostics: the current state of progress made and prospects.Frontiers in cell and developmental biology · 2025Review
- Clinical application of serum CST4 combined with tumor markers in the diagnosis of digestive system malignant tumors.Oncology letters · 2024Article
- Article
- Experiences and challenges for EQA providers in assessing the commutability of control materials in accuracy-based EQA programs.Frontiers in medicine · 2024Article
- Longitudinal evaluation of external quality assessment results for CA 15-3, CA 19-9, and CA 125.Frontiers in molecular biosciences · 2024Article
- Method Comparison and Clinical Performance of Breast Cancer Tumor Markers on Novel Multiplex Immunoassay and Automatized LOCI Technology Platforms.Diagnostics (Basel, Switzerland) · 2023Article
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The glycoproteins alpha-fetoprotein (AFP) and carcinoembryonic antigen (CEA) have long been approved as biomarkers for diagnosing and monitoring tumors. International Reference Preparations (IRPs) have been around since 1975. Nevertheless, manufacturer-dependent differences have been reported, indicating a lack of harmonization. This paper analyzes data from 15 external quality assessment (EQA) surveys conducted worldwide between 2018 and 2022. The aim was to gain insight into the longitudinal development of manufacturer-dependent differences for CEA and AFP. In each survey, participating laboratories received two samples with different tumor marker levels. Inter- and intra-assay variability was analyzed and the mean 80% and 90% of the manufacturer collectives were compared to the evaluation criteria of the German Medical Association (RiliBÄK). The median EQA results for CEA revealed manufacturer-dependent differences between the highest and lowest collective of up to 100%; for AFP, the median differences mostly remained below 40%. The coefficients of variation were predominantly low for both markers. We concluded that the current assays for AFP and CEA detection are better harmonized than previously reported. The assays displayed a good robustness; however, a narrowing of the current assessment limits in EQA schemes could further enhance the quality of laboratory testing.
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