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Alpha-1-Fetoprotein (AFP): international proficiency study with different test systems.

G M Oremek1, A Oertl, T Bertsch

  • 1Johann Wolfgang Goethe Universität, Fachbereich Laboratoriumsmedizin, Frankfurt am Main, Germany. oremek@gmx.net

Clinical Laboratory
|October 28, 2011
PubMed
Summary
This summary is machine-generated.

This study found significant variability in alpha-fetoprotein (AFP) test results between laboratories, even with an international standard. Laboratories should engage in external quality assessments and use independent control sera for reliable AFP measurements.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Biochemical Analysis

Background:

  • Proficiency testing is crucial for assessing the reliability of diagnostic assays.
  • Alpha-fetoprotein (AFP) is a biomarker used in various clinical contexts, including cancer screening and monitoring.

Purpose of the Study:

  • To evaluate the comparability and reliability of different commercial test systems for determining AFP concentrations.
  • To identify potential sources of variation in AFP measurements across laboratories.

Main Methods:

  • A proficiency study involving 25 laboratories over one year.
  • Utilized liquid BIOREF-AFP control serum for routine internal quality control.
  • Employed 8 different commercial test systems for AFP determination.

Main Results:

  • Significant variations in AFP results were observed among participating laboratories.
  • Deviations from the overall mean ranged from 0.1% to 26.1%, with most around 10%.
  • Individual laboratory precision showed acceptable coefficients of variation, ranging from 13% to 16.1%.

Conclusions:

  • Despite an international standard, AFP results exhibit inter-laboratory variability.
  • Participation in external proficiency testing (ring studies) is recommended for all laboratories.
  • Utilizing quality control sera independent of test kit manufacturers is advised for internal quality control.