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Related Experiment Videos

Italian external quality assessment scheme in immunoassay

G Pizzocolo1, A Albertini, R Malvano

  • 1Cattedra di Chimica Applicata alle Scienze Biomediche, Università degli Studi, Brescia, Italy.

Annali Dell'Istituto Superiore Di Sanita
|January 1, 1995
PubMed
Summary

Italian external quality assessment (EQA) schemes for hormones, tumor markers, and hepatitis B markers show significant improvements in laboratory variability for many analytes. However, some markers like total T3 and T4 showed no improvement, and LH variability was high due to kit differences.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Quality Assurance

Background:

  • External Quality Assessment (EQA) schemes are crucial for monitoring laboratory performance.
  • Italian EQA programs assess a wide range of analytes, including hormones, tumor markers, and hepatitis B markers.

Purpose of the Study:

  • To report the organization, data processing, and results of Italian EQA schemes for specific biomarkers.
  • To evaluate laboratory performance and identify trends in analytical variability over time.

Main Methods:

  • Organization of EQA schemes involving approximately 250 laboratories for hormones/tumor markers and 200 for hepatitis B markers.
  • Collection and statistical analysis of laboratory results to generate periodic and end-of-period reports.
  • Assessment of imprecision and average bias for laboratories and kits.

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Main Results:

  • Significant improvements in laboratory variability observed for TSH, progesterone, estradiol, testosterone, CEA, and ferritin from 1980-1988.
  • Slight improvements noted for cortisol, FSH, prolactin, and AFP; no improvement for total T3 and T4.
  • High variability in LH results attributed to differences in monoclonal antibody-based kits.

Conclusions:

  • EQA schemes effectively track laboratory performance and analytical variability.
  • Specific analytes show marked improvement, while others require further attention or method standardization.
  • Kit-specific differences can significantly impact inter-laboratory variability for certain markers.