Establishment of the Ist International Genetic Reference Panel for FactorV Leiden, human gDNA

被引:11
作者
Gray, Elaine
Hawkins, J. Ross
Morrison, Marion
Hawkins, Malcolm
Byrne, Ed
Kitchen, Steve
Jennings, Ian
Makris, Mike
Preston, F. Eric
Metcalfe, Paul
机构
[1] Natl Inst Biol Stand & Controls, Div Haematol, Potters Bar EN6 3QG, Herts, England
[2] UK NEQAS Blood Coagulat, Sheffield, S Yorkshire, England
[3] Royal Hallamshire Hosp, Sheffield Haemophilia & Trombosis Ctr, Sheffield S10 2JF, S Yorkshire, England
关键词
factor V Leiden; genetic reference materials; genomic DNA; in vitro diagnostics;
D O I
10.1160/TH-05-11-0767
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Forty-one laboratories participated in an international collaborative study to assess the suitability of a panel of three genomic DNA samples as the 1(st) International Genetic Reference Panel for the Factor V Leiden (FVL) variant. The code numbers of the materials were 03/254 (FV wild type), 03/260 (FVL homozygote) and 03/248 (FVL heterozygote). The participants evaluated the panel against their in-house controls which were known patient samples and commercial controls. In total, 859 genotype tests were carried out on the panel,with an error rate of 0.7%. The errors were not related to specific samples of the panel or to any specific techniques. The findings of this study have indicated that this panel is suitable to be used as a reference material for genotyping of factor V Leiden. It was therefore recommended that the three genomic DNA samples be established as the 1(st) International Genetic Reference Panel for Factor V Leiden, Human gDNA, 04/224. This recommendation was approved by the Scientific and Standardization Committee (SSC) of the ISTH (International Society on Thrombosis and Haemostasis) in June 2004 and the Expert Committee on Biological Standardization (ECBS) of the World Health Organization (WHO) in November 2004.
引用
收藏
页码:215 / 219
页数:5
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