CA-1500全自动血凝仪的分析性能评价

Evaluation of Analytic Performance of CA-1500 Automatic Coagulometor

目的对CA-1500全自动血凝仪的分析性能进行评价,判断其分析性能是否满足临床要求。方法按照美国临床实验室标准化委员会(NCCLS)EP5-A标准,应用定值质控品,评价CA-1500全自动血凝仪凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(FIb)、出凝血10凝血因子Ⅶ活性水平(FⅧ:C)、抗凝血酶Ⅲ(AT-Ⅲ)及D-二聚体(D-dimer)的准确度、批内精密度和日间精密度、线性范围,以及检测下限、携带污染率、仪器抗干扰能力。结果PT、APTT、TT、FIb、FⅧ:C、AT-Ⅲ及D-dimer的批内精密度均小于1/4总允许误差(TEa),日间精密度低于1/3;检验结果的准确度符合要求;Fib、FⅧ:C、AT-Ⅲ、D-dimer检测的线性良好;检测下限、携带污染率和抗干扰能力均符合临床要求。结论CA-1500全自动血凝仪的分析性能符合临床要求,可用于临床病人标本的检测。

Objective To evaluate the analytical performance charaeteritics of CA-1500 automatic coagulometor. Methods According to the National Committee for Clinical Laboratory Standards（NCCLS） EPS-A document, evaluate the within-run and Day-to- day precision of PT, APTT, TT, Fib, FVII ： C, AT-III and D-dimer on CA-1500 Automatic Coagulometor. Using quality control materials determinating the accuracy of the above tests. According to NCCLS EP6-P document, the linear range of Fib, FV^I ： C, AT- ~I and D-di- mer was analyzed. The low limited detection,carryover and the antijamming capability were evaluated. Results The within-run preci- sion of PT, AFTT,TT, Fib, FVIII ：C, AT-m and D-dimer was lower than 1/4 allowable total error（ TEa）, while the between-day precision was lower than 1/3 TEa. The accuracy satisfied the laboratory requirement. Detecting of Fib, FVIII： C, AT- III and D-dimer has good linearity. The low limited detection,carryover and antijamming capability can meet the laboratory requirement. Conclusions The analytical performance characteristics of CA-1500 automatic coagulometor satisfy the laboratory performance goals. It can be used to analyze the patients＇ samples.