降钙素原免疫荧光定量检测系统的性能验证和评价

The performance verification and evaluation of immune fluorescence quantitative detection system for procalcitonin

目的对降钙素原(PCT)免疫荧光定量检测系统进行方法学性能验证和评价。方法对降钙素原(PCT)免疫荧光定量检测系统的精密度、分析测量范围、检测限和参考范围进行验证,观察这些指标是否符合实验室质量目标或厂商声明的性能要求。并将该检测系统与已得到认可的罗氏E601检测系统进行相关性分析。结果 3个不同浓度的PCT样品(水平1、2、3)批内不精密度变异系数分别为7.68%、3.47%和4.13%;低高水平的质控品批间不精密度变异系数分别为7.11%和5.09%;该检测系统的分析测量范围为0.04 ng/ml^55 ng/ml;检测限为0.031 ng/ml;20例健康体检者的PCT结果中有1个超出正常参考范围;2个检测系统高度相关(r=0.993),线性回归方程为y=0.974x-0.023。结论该PCT检测系统各项性能指标良好,能够满足临床需求。

Objective To verificate and evaluate the methodology of immune fluorescence quantitative detection system for procalcitonin. Methods To assess the precision,accuracy,analytical measurement range,detection limit and reference range with the immune fluorescence quantitative detection system for procalcitonin,and we observed whether the indicators of the system was in line with the performance requirements of the laboratory quality goals or manufacturer＇s statement. By comparing this system and the well-recognized Roche E601 detection system,the correlation analysis was carried out. Results The variation coefficient for intra-batch precision of three levels of PCT samples（ level 1,2,3） was 7. 68%,3. 47% and 4. 13% respectively; the variation coefficient for inter-batch precision of low level and high level of PCT quality product was 7. 11% and5. 09% respectively; after verification,the system analysis of the measuring range was 0. 04 ng/ml-55 ng/ml,and the detection limit was 0. 031 ng/ml; there was only one PCT result of the 20 healthy cases beyond the normal reference range. The two detection systems were highly correlated（ r = 0. 993）,and the linear regression equation was y = 0. 974x-0. 023. Conclusion The various performance indicators of the PCT results of the immune fluorescence quantitative detection system for procalcitonin is good,and can meet the clinical needs.