Bivariate statistical approach to evaluate laboratory performance by analysis of standard curves in an External Quality Assurance program for quantitative assays based on real-time PCR with Taq-Man™ probes

Giuseppe Reina, Claudio Orlando, Paola Rebora, Federico Ambrogi, Claudia Casini Raggi, Paolo Verderio, Ettore Marubini

Research output: Contribution to journalArticle

Abstract

Recently a revolutionary technique for quantitative PCR determination was introduced in diagnostic laboratories. To determine the influence of technical variability on the reliability of the quantitative assay, it is crucial to use External Quality Assurance (EQA) programs. An EQA program was developed in Italy to check the analytical performance of real-time PCR procedures based on Taq-Man™ probes. This article suggests a new statistical approach to discriminate, using a bivariate technique, laboratory performance that appears to be questionable, by separately considering the two main features of the standard curve: analytical sensitivity and efficiency. Furthermore, specific indexes to evaluate the impact of these two features on the determination of the initial number of molecules are given to help to improve the assay procedure.

Original languageEnglish
Pages (from-to)18-22
Number of pages5
JournalClinical Chemistry and Laboratory Medicine
Volume44
Issue number1
DOIs
Publication statusPublished - Jan 2006

Keywords

  • Bivariate analysis
  • EQA program
  • Real-time PCR
  • Standard curves

ASJC Scopus subject areas

  • Clinical Biochemistry

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