普利生C2000-A全自动血凝仪的性能验证

目的对全自动血凝仪普利生C2000-A进行性能验证,以确定其是否符合临床检测要求。方法参照美国临床实验室标准化委员会（NCCLS）标准,应用定值质控血浆或（和）定标血浆,选择凝血常规项目D-二聚体（DD）、血浆凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、凝血酶原时间测定（TT）、纤维蛋白原（FIB）]对仪器分析系统的精密度、正确度、携带污染率、线性范围、抗干扰能力（干扰物为血红蛋白、直接胆红素和三酰甘油）以及通道一致性等性能进行验证和初步评价。结果所有凝血检测项目中,批内精密度均小于3%,批间精密度均小于5%;定值质控品或者定值校准品的结果与各自靶值相比其偏差均少于8%;线性验证标本按一定比例稀释后将所得理论值与实测值进行回归分析,a值均介于0.97-1.03范围内,r均大于0.975,符合线性相关要求;携带污染率均小于3%;干扰试验的偏离值均小于3%;在4个通道上各项目的测定结果差异均无统计学意义（P〉0.05）,说明其通道一致性良好。结论国产血凝仪普利生C2000-A全自动血凝仪具有良好的分析性能,其准确度、精密度、线性范围、携带污染率等指标均符合质量管理要求,特别是其对溶血、黄疸以及脂浊标本具有较强的抗干扰能力,可完全满足临床检测要求。

Performance Verification of Precil C2000-A Automatic Blood Coagulation Instrument

Objective To verify the performance of the full automatic blood coagulation analyzer precil C2000-A,and to determine whether it meets the requirements of clinical detection.Methods According to American Committee for Clinical Laboratory Standards,the precision,accuracy,carryover,linear range,anti-interference capability（interfering agents included hemoglobin,direct bilirubin and triacylglycerol）and channel consistency were verified and evaluated.Results Of the all blood coagulation detection projects,within-run precision was less than 3%and between-run precision was less than 5%.The deviations of constant quality control products and calibration results from the target values were less than 8%,respectively.After dilution,theoretical values and measured values of linear test specimens were measured for regression analysis.The a values ranged from 0.97to 1.03and the r values were greater than 0.975,which were in accordance with the requirements of the linear correlation.The carryover rate and deviation of interference test were less than 3%.The full automatic blood coagulation analyzer precil C2000-A showed a good channel consistency with no significant differences in measuring results among the four channels（P〉0.05）.Conclusion Domestic automatic blood coagulation analyzer precil C2000-A has a good analytical performance.The accuracy,precision,linear range,carryover and other indicators are in accordance with the requirements of the quality management.Especially,anti-interference capability against hemolysis,jaundice and lipid turbidity can fully meet the requirements of clinical detection.