In:
Clinical Chemistry and Laboratory Medicine (CCLM), Walter de Gruyter GmbH, Vol. 43, No. 8 ( 2005-01-1)
Kurzfassung:
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.
Materialart:
Online-Ressource
ISSN:
1434-6621
,
1437-4331
DOI:
10.1515/CCLM.2005.145
Sprache:
Unbekannt
Verlag:
Walter de Gruyter GmbH
Publikationsdatum:
2005
ZDB Id:
1492732-9
SSG:
15,3