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Development, validation and data quality assurance of screening methods: a case study.

Roberta Galarini1, Roberta Buratti, Laura Fioroni

  • 1Department of Food Safety, Istituto Zooprofilattico, Sperimentale dell'Umbria e delle Marche, Perugia, Italy. r.galarini@izsum.it

Analytica Chimica Acta
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Summary
This summary is machine-generated.

This study details the validation and quality control of an enzyme-linked immunosorbent assay (ELISA) for detecting 19-nortestosterone isomers in bullock urine, addressing gaps in EU guidelines for screening tests.

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Area of Science:

  • Analytical Chemistry
  • Food Safety
  • Veterinary Science

Background:

  • Qualitative screening tests are crucial for EU official controls but lack detailed validation guidance compared to quantitative methods.
  • Internal quality control (IQC) for screening assays is underdeveloped, posing challenges for accreditation bodies.
  • Accurate detection of anabolic agents like 19-nortestosterone is vital for food safety and animal welfare.

Purpose of the Study:

  • To develop, validate, and implement IQC for a commercial ELISA detecting 17-α-19-nortestosterone (α-NT) and 17-β-19-nortestosterone (β-NT) isomers in bullock urine.
  • To address the validation challenges for qualitative screening methods under EU regulations.
  • To establish robust quality assurance procedures for routine laboratory analysis.

Main Methods:

  • Comparison of two solid-phase extraction (SPE) protocols for sample purification.
  • Full validation of the chosen method according to Commission Decision 2002/657/EC, assessing specificity, detection capability, and robustness.
  • Development and implementation of control charts for ongoing method verification using real samples.

Main Results:

  • A suitable SPE method was selected and the ELISA was fully validated.
  • Key performance characteristics, including detection capability, were rigorously assessed and discussed.
  • Effective IQC procedures and control charts were established for routine monitoring.

Conclusions:

  • The study provides a comprehensive approach to validating qualitative screening assays and implementing IQC, aligning with EU requirements.
  • The developed ELISA and IQC procedures offer a reliable tool for detecting 19-nortestosterone isomers in bullock urine.
  • This work contributes to improving the quality assurance of screening tests in official food control laboratories.