@article{JRC30316,
	address = {},
	year = {2005},
	author = {Klein C and Marki-Zay J and Corbisier P and Gancberg D and Cooper S and Gemmati D and Halbmayer W and Kitchen S and Melegh B and Neumaier M and Oldenburg J and Oppliger Leibundgut E and Reitsma P and Rieger S and Schimmel H and Spannagl M and Tordai A and Tosetto A and Visvikis S and Zadro R and Mannhalter C},
	abstract = {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 Measurments to develop and produce plasmidic-type reference materials (RMs) for the analysis of the human prothrombin gene G20210A mutation. Although DNA tests have a high impact on the 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 until today. Both, the wildtype and the mutant allele of this gene fragment were cloned into a pUC18 plasmid and two plasmidic RMs were produced. In addition a mixture of both plasmids was produced mimicking the heterozygous genotype. The present study describes the performance and results of these reference materials in commutability study, when they were tested by 9 different methods in 13 expert laboratories. This series of plasmidic RMs are to the best of our knowledge the world-wide first plasmidic-type clinical genetic RMs introduced.
		},
	title = {Reference Materials (RMs) for the Analysis of the Human Factor II (prothrombin) Gene G20210A Mutation},
	type = {},
	url = {},
	volume = {43},
	number = {8},
	journal = {CLINICAL CHEMISTRY AND LABORATORY MEDICINE},
	pages = {862-868},
	issn = {},
	publisher = {WALTER DE GRUYTER & CO},
	doi = {10.1515/CCLM.2005.145}
}