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目的评估Latex Test BL-2 P-FDP纤维蛋白(原)降解产物试剂盒分别在Sysmex CA7000和CS5100全自动凝血仪上的性能。方法根据美国临床实验室标准化研究所(CLSI)系列文件和其他相关文献的实验方案,对两套系统的不精密度、准确度、线性范围、携带污染率、参考范围、检测下限和抗干扰试验、方法学比对等性能进行验证分析。结果不精密度与准确度均在允许范围内,表明验证通过。线性验证实测均值与预测值偏离均<15%,符合要求。CA7000和CS5100 2台仪器检测FDP的携带污染率均为0%,符合要求。CA7000和CS5100分析FDP的检测下限结果分别为(2.63±0.28)μg/ml、(2.64±0.07)μg/ml,均在2μg/ml~3μg/ml,符合要求。对Latex Test BL-2 P-FDP试剂盒在CA7000和CS5100 2套检测系统的检测结果进行相关回归分析,y=0.881x+1.811,r=0.987(P>0.05),2个检测系统间结果一致性较好。结论 Latex Test BL-2 P-FDP试剂盒应用在Sysmex CA7000和CS5100全自动凝血仪测定时的主要性能指标,已达到临床检测需求。
Objective To evaluate the performance of the Latex Test BL-2 P-FDP Fibrinogen (original) Degradation Kit on the Sysmex CA7000 and CS5100 fully automated coagulation devices. Methods According to the CLSI series of documents and other related literatures, two systems of imprecision, accuracy, linear range, contamination carrying rate, reference range, detection limit and anti-interference test , Methodology than the equivalent performance verification analysis. The results of the imprecision and accuracy are within the allowable range, indicating that the verification passed. The deviation between the measured mean and the predicted value of linear verification was <15%, which met the requirements. CA7000 and CS5100 2 instruments to detect FDP carrying contamination were 0%, in line with requirements. The lower limit of detection of FDP detected by CA7000 and CS5100 was (2.63 ± 0.28) μg / ml and (2.64 ± 0.07) μg / ml respectively, both in the range of 2μg / ml ~ 3μg / ml. Correlation analysis of the test results of the two sets of detection systems of Latex Test BL-2 P-FDP with CA7000 and CS5100 y = 0.881x + 1.811, r = 0.987 (P> 0.05). The results of the two detection systems were consistent Sex is better. Conclusion The main performance index of the Latex Test BL-2 P-FDP kit used in the Sysmex CA7000 and CS5100 automatic coagulation analyzer has reached the clinical testing needs.