Measurement of inaccuracy and imprecision of HCG methods using dilutions of the WHO 4th IS-HCG standard and a pregnant patient's serum

Clin Biochem. 2004 Feb;37(2):152-4. doi: 10.1016/j.clinbiochem.2003.10.016.

Abstract

Introduction: Differences in human chorionic gonadotropin (hCG) results obtained by seven different methods were documented by analyzing dilutions of the WHO 4th International Standard (IS) and a pregnant patient's serum.

Materials and methods: Biases of +30.9 to -37.5% and +36.8 to -36.1% from the target concentration were found for the WHO 4th IS and patient sample dilutions, respectively.

Results: Imprecision was calculated from replicate measurements of hCG on the different sample dilutions. Imprecision ranged from 1.0% to 18.9% and 1.1% to 5.3% for the WHO 4th IS and patient sample dilutions, respectively. Using a maximum allowable error of 12.5% for hCG measurements, we found that two instruments were so biased that their hCG measurements could not be interchanged with hCG values produced by any of the other systems.

Discussion: It is ideal to use only one hCG methodology for the serial monitoring of hCG; otherwise, hCG methods should be carefully chosen to minimize inter-method bias.

Publication types

  • Comparative Study

MeSH terms

  • Bias
  • Biomarkers
  • Chorionic Gonadotropin / blood*
  • Chorionic Gonadotropin / standards*
  • Female
  • Humans
  • Immunoenzyme Techniques / instrumentation
  • Male
  • Pregnancy
  • Quality Control
  • Reagent Kits, Diagnostic / standards
  • Reference Standards
  • Reference Values
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Biomarkers
  • Chorionic Gonadotropin
  • Reagent Kits, Diagnostic