How to evaluate the influence of blood collection systems on the international sensitivity index. Protocol applied to two new evacuated tubes and eight coagulometer/thromboplastin combinations
How to evaluate the influence of blood collection systems on the international sensitivity index. Protocol applied to two new evacuated tubes and eight coagulometer/thromboplastin combinations
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DOI：
10.1016/s0049-3848(02)00383-3
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发表时间：
2002-10-01
影响因子：
7.5
通讯作者：
Mannucci, PM
中科院分区：
文献类型：
--
作者：
Tripodi, A;Chantarangkul, V;Mannucci, PM
先前的报告表明，凝血仪/凝血活酶组合（测量系统）的国际敏感指数（ISI）可能受血液采集系统的影响。我们采用一种新的方案来评估两种新型血液采集系统（评估管）对八种广泛使用的测量系统的ISI的影响程度。评估管由塑料制成，采血量分别为1.8毫升和2.7毫升；柠檬酸盐浓度为0.109摩尔/升。成熟的采集管（来自同一制造商）由硅化玻璃制成，采血量和柠檬酸盐浓度分别为4.5毫升和0.105摩尔/升，用作对照。用评估管和对照管采集的20名健康受试者和60名口服抗凝剂患者的血浆，用八种测量系统进行凝血酶原时间（PT）检测。用对照管采集的血浆也用一种国际凝血活酶标准进行检测。结果用于计算测量系统的ISI。然后用这些ISI计算交叉国际标准化比值（INR）的差异（即，用采集到评估管中的血浆的PT比值以及用采集到对照管中的血浆确定的ISI所得到的INR）。总体而言，差异虽小但可测量，特别是对于2.7毫升采血量的评估管以及某些测量系统（平均差异≤5.50%；平均相对偏差（MRD）≤5.82%）。尽管具有统计学意义，但这些差异在临床上并不相关，因为它们不太可能影响药物处方的决策。总之，该研究表明评估管与同一制造商的对照管相比表现良好。此处描述的方案应用于其他血液采集系统的评估。（C）2002爱思唯尔科学有限公司。保留所有权利。
Previous reports indicate that the international sensitivity index (ISI) of coagulometer/thromboplast in combinations (measuring systems) may be influenced by blood collection systems. We applied a new protocol to assess the extent with which two new blood collection systems (evaluation tubes) influence the ISI of eight widely used measuring systems. The evaluation tubes were made of plastic and had draw volumes of 1.8 and 2.7 ml; citrate concentration was 0.109 M. Well-established collection tubes (from the same manufacturer)-which were made of siliconized glass with draw volume and citrate concentration of 4.5 ml and 0.105 M, respectively-served as control. Plasmas from 20 healthy subjects and 60 patients on oral anticoagulants, collected with the evaluation and control tubes, were tested for prothrombin time (PT) with the eight measuring systems. Plasmas collected with the control tubes were also tested with an international standard for thromboplastin. Results were used to calculate the ISIS of the measuring systems. These were then used to calculate the differences of the crossover international normalized ratio (INR) (i.e., the INR obtained with PT ratios of plasmas collected into the evaluation tubes and the ISI determined with plasmas collected into the control tubes). Overall, the differences were small but measurable, especially for the 2.7-ml draw evaluation tubes and with some of the measuring systems (mean difference, less than or equal to 5.50%; mean relative deviation (MRD), less than or equal to 5.82%). Although statistically significant, these differences are not clinically relevant as they are unlikely to affect decision making in drug prescription. In conclusion. the study shows that the evaluation tubes compare well with the control tubes from the same manufacturer. The protocol described here should be adopted for the evaluation of other blood collection systems. (C) 2002 Elsevier Science Ltd. All rights reserved.