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Clinical Chemistry and Laboratory Medicine (CCLM)

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Reference materials (RMs) for analysis of the human factor II (prothrombin) gene G20210A mutation

Christoph L. Klein1 / János Márki-Zay2 / Philippe Corbisier3 / David Gancberg4 / Susan Cooper5 / Donato Gemmati6 / Walter-Michael Halbmayer7 / Steve Kitchen8 / Béla Melegh9 / Michael Neumaier10 / Johannes Oldenburg11 / Elisabeth Oppliger Leibundgut12 / Pieter H. Reitsma13 / Sandra Rieger14 / Heinz G. Schimmel15 / Michael Spannagl16 / Attilia Tordai17 / Alberto Tosetto18 / Sophie Visvikis19 / Renata Zadro20 / Christine Mannhalter21






















Corresponding author: Christoph L. Klein, European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Retieseweg 111, 2440 Geel, Belgium Phone: +32-14-571634, Fax: +32-14-571548,

Citation Information: Clinical Chemical Laboratory Medicine. Volume 43, Issue 8, Pages 862–868, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2005.145, August 2005

Publication History

March 7, 2005
June 17, 2005


The Scientific Committee of Molecular Biology Techniques (C-MBT) in Clinical Chemistry of the IFCC has initiated a joint project in co-operation with the European Commission, Joint Research Centre, Institute of Reference Materials and Measurements to develop and produce plasmid-type reference materials (RMs) for the analysis of the human prothrombin gene G20210A mutation. Although DNA tests have a high impact on clinical decision-making and the number of tests performed in diagnostic laboratories is high, issues of quality and quality assurance exist, and currently only a few RMs for clinical genetic testing are available. A gene fragment chosen was produced that spans all primer annealing sites published to date. Both the wild-type and mutant alleles of this gene fragment were cloned into a pUC18 plasmid and two plasmid RMs were produced. In addition, a mixture of both plasmids was produced to mimic the heterozygous genotype. The present study describes the performance of these reference materials in a commutability study, in which they were tested by nine different methods in 13 expert laboratories. This series of plasmid RMs are, to the best of our knowledge, the first plasmid-type clinical genetic RMs introduced worldwide.

Keywords: metrological traceability; molecular diagnostic testing; mutation; polymerase chain reaction; prothrombin; recombinant DNA; reference standards

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