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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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1437-4331
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In This Section
Volume 44, Issue 1 (Jan 2006)

Issues

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
  • Istituto di Statistica Medica e Biometria, Università degli Studi di Milano, Milan, Italy
/ Claudio Orlando
  • Unità di Biochimica Clinica, Dipartimento di Fisiopatologia Clinica, Università degli Studi di Firenze, Florence, Italy
/ Paola Rebora
  • Istituto di Statistica Medica e Biometria, Università degli Studi di Milano, Milan, Italy
/ Federico Ambrogi
  • Unità Operativa di Statistica Medica e Biometria, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy
/ Claudia Casini Raggi
  • Unità di Biochimica Clinica, Dipartimento di Fisiopatologia Clinica, Università degli Studi di Firenze, Florence, Italy
/ Paolo Verderio
  • Unità Operativa di Statistica Medica e Biometria, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy
/ Ettore Marubini
  • Istituto di Statistica Medica e Biometria, Università degli Studi di Milano, Milan, Italy
Published Online: 2005-12-23 | DOI: https://doi.org/10.1515/CCLM.2006.004

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.

Keywords: bivariate analysis; EQA program; real-time PCR; standard curves

References

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    Raggi CC, Verderio P, Pazzagli M, Marubini E, Simi L, Pinzani P, et al. An Italian program of external quality control for quantitative assays based on real-time PCR with Taq-Man™ probes. Clin Chem Lab Med 2005; 43:542–8. [Crossref]

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    Verderio P, Orlando C, Raggi CC, Marubini E. Confidence interval estimation for DNA and mRNA concentration by real-time PCR: a new environment for an old theorem. Int J Biol Markers 2004; 19:76–9. [Crossref]

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    Kaufman L, Rousseeuw PJ. Finding groups in data. New York: John Wiley, 1990.

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About the article

Corresponding author: Prof. Giuseppe Reina, Istituto di Statistica Medica e Biometria, Via G. Venezian, 1-20133 Milan, Italy Phone: +39-02-50320855, Fax +39-02-50320866,


Received: 2005-05-30

Accepted: 2005-10-16

Published Online: 2005-12-23

Published in Print: 2006-01-01



Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2006.004. Export Citation

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Paolo Verderio, Simon C. Ramsden, Claudio Orlando, Sara Pizzamiglio, Angelo Paradiso, Michael Neumaier, Mario Pazzagli, and Ettore Marubini
Clinical Chemistry and Laboratory Medicine, 2008, Volume 46, Number 5

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