A comparative study on dual-magnetic circuit beads and scattering nephelometry coagulometers in coagulational evaluation of blood-contact medical devices / 中国医疗器械杂志

ABSTRACT

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.