Poller L, Barrowcliffe T W, van den Besselaar A M, Jespersen J, Tripodi A, Houghton D
Department of Pathological Sciences, University of Manchester, UK.
Thromb Haemost. 1996 Dec;76(6):977-82.
Two candidate ECAA reference preparations have been calibrated in a multicentre exercise at 14 representative national laboratories to provide reference thromboplastin for a large field study in 16 European countries. Two preparations were required because of the established differences in ISI arising from the two main routes of calibration via rabbit and human IRP. To be comparable with working reagents in everyday use a human plain recombinant reagent of low ISI and a rabbit plain preparation of moderately high ISI were selected. A precise calibration of the two candidate preparations has been achieved with the manual PT technique and an ISI of 0.95 (SE 0.0078) for the human reagent and 1.67 (SE 0.0322) for the rabbit reagent.
两种候选欧洲校准品促凝血活性(ECAA)参考制剂已在14个有代表性的国家实验室进行的多中心实验中进行了校准,以提供用于16个欧洲国家大型现场研究的参考凝血活酶。由于通过兔和人国际参考制剂(IRP)这两种主要校准途径产生的国际敏感度指数(ISI)存在既定差异,所以需要两种制剂。为了与日常使用的工作试剂具有可比性,选择了低ISI的人源普通重组试剂和中等高ISI的兔源普通制剂。通过手工凝血酶原时间(PT)技术对两种候选制剂进行了精确校准,人源试剂的ISI为0.95(标准误0.0078),兔源试剂的ISI为1.67(标准误0.0322)。