双磁路磁珠法与散射比浊法血凝仪用于医疗器械PT与PTT试验评价中的比较研究

A Comparative Study on Dual-Magnetic Circuit Beads and Scattering Nephelometry Coagulometers in Coagulational Evaluation of Blood-Contact Medical Devices

以GB/T16886.4-2003标准为基础,利用双磁路磁珠法与散射比浊法半自动血凝仪对5种以金属与高分子为主要材质的血液接触医疗器械的部分凝血激活酶时间(PTT)试验和凝血酶原时间(PT)试验进行了研究。结果提示两种测量方法的血凝仪的组内变异系数(CV)均在同一数量级。在PTT试验中,两种血凝仪得到了相似的结果。在进行平均凝固时间基数较小的PT试验时,两种不同原理的血凝仪得到的结果具有较高的符合率。根据研究的结果,选择双磁路磁珠法或散射比浊法血凝仪来进行医疗器械凝血相关评价均为可行,检验机构可根据自身条件灵活选择,但须注意对基值较小的试验,如PT试验的结果解释和分析。

Dual-magnetic circuit beads and scattering nephelometry dual channel semiautomatic coagulometers are used for the coagulational evaluation of the 5 blood contact medical devices which consist of metals and polymers. The partial thromboplastin time（PTT） and prothrombin time（PT） tests are made based on the GB/T 16886.4-2003 standard. The results indicate that the coefficient of variation in the two groups is in the identical order of magnitude. In the PTT tests, they give the similar evaluational results. With the smaller numerical values of the PT tests, the different coagulometers give the high consilience results. So, both of dual-magnetic circuit beads and scattering nephelometry coagulometers are acceptable in the medical devices＇ coagulational evaluations. But the interpretation and analysis of the results of the small numerical value tests, PT tests for example, should be noticed.