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Publication Date:
December 2005
ISSN:
1437-4331
DOI:
10.1515/CCLM.2006.004

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Clinical Chemistry and Laboratory Medicine (CCLM)

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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 Reina1 / Claudio Orlando2 / Paola Rebora3 / Federico Ambrogi4 / Claudia Casini Raggi5 / Paolo Verderio6 / Ettore Marubini7

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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,

Citation Information: Clinical Chemical Laboratory Medicine. Volume 44, Issue 1, Pages 18–22, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2006.004, December 2005

Publication History:
Received:
May 30, 2005
Accepted:
October 16, 2005
Published Online:
2005-12-23

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

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