Longitudinal Evaluation of AFP and CEA External Proficiency Testing Reveals Need for Method Harmonization

Nathalie Wojtalewicz, Laura Vierbaum, Anne Kaufmann, Ingo Schellenberg, Stefan Holdenrieder

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

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.

Original languageEnglish
Article number2019
JournalDiagnostics
Volume13
Issue number12
DOIs
StatePublished - Jun 2023

Keywords

  • AFP
  • CEA
  • INSTAND
  • alpha-fetoprotein
  • assay harmonization
  • carcinoembryonic antigen
  • external quality assessment
  • proficiency testing
  • tumor marker

Fingerprint

Dive into the research topics of 'Longitudinal Evaluation of AFP and CEA External Proficiency Testing Reveals Need for Method Harmonization'. Together they form a unique fingerprint.

Cite this