Blombäck M, Kjellman H, Allain J P, Hedner U, Schimpf K, Wiechel B
Department of Clinical Chemistry and Blood Coagulation, Karolinska Hospital, Stockholm, Sweden.
Scand J Clin Lab Invest. 1987 Oct;47(6):561-6. doi: 10.1080/00365518709168469.
A multicentre study was undertaken in order to determine the reliability of the methods of assay of F VIII:C and the position of the peak value obtained after infusion of F VIII:C concentrates. Blood samples were drawn before and 10, 30 and 60 min after injection of F VIII concentrates in six haemophiliacs in one of the centres. Coded, frozen plasma samples were dispatched to the laboratories of the other four centres. F VIII:C was determined by different one-stage methods using the same international standard but with different activators. The results of the different laboratories differed widely and no agreement was reached on the existence of a lag period. To reach a valid conclusion not only the same sample has to be analysed, as in this study, but also the same laboratory technique has to be used by all participating investigators. To reach agreement on in vivo recovery and on elimination curves for different F VIII concentrates multicentre studies must be based on reliable methods of assay.
为了确定F VIII:C的检测方法的可靠性以及输注F VIII:C浓缩剂后获得的峰值位置,开展了一项多中心研究。在其中一个中心,对6名血友病患者在注射F VIII浓缩剂前以及注射后10、30和60分钟采集血样。编码后的冷冻血浆样本被送往其他四个中心的实验室。使用相同的国际标准但不同的激活剂,通过不同的一步法测定F VIII:C。不同实验室的结果差异很大,对于是否存在延迟期也未达成一致。为了得出有效的结论,不仅像本研究中那样必须分析相同的样本,而且所有参与研究的人员都必须使用相同的实验室技术。为了就不同F VIII浓缩剂的体内回收率和消除曲线达成一致,多中心研究必须基于可靠的检测方法。