关键词: 心肌肌钙蛋白I, 高敏感方法, 性能评价, 分析灵敏度, 功能灵敏度, 生物参考区间

Abstract: Objective To establish and evaluate the analysis performance of high sensitive cardiac troponin I (hs-cTnI) detected by PATHFAST chemiluminescence enzyme-immunoassay system.The data included precision, the function sensitivity (FS), the limit of blank(LoB), the limit of detection(LoD), the limit of quantity(LoQ), the low-limit of detection(LLD), the biological limit of detection(BLD) and the linearity range, and the biology reference intervals offered by manufactures were verified. Methods PATHFAST was performed to detect blank samples and series low-concentration samples of hs-cTnI according to the document of Clinical and Laboratory Standards Institute (CLSI) EP17-A and EP5-A2.The corresponding statistical method was used to define the LoB,LoD, LoQ and the linearity range of hs-cTnI in plasma in accordance with the distribution of the data. Simultaneously, the LLD, BLD and FS of hs-cTnI were established by traditional method. According to National Committee for Clinical Laboratory Standards (NCCLS) C28-A2 recommendation method and the laboratory standard operation procedure (SOP), the biology reference interval was verified. Results By PATHFAST, the within-run and between-run coefficients of variation (CV) were 4.70％ and 5.05％ in high-concentration of hs-cTnI (2.65 ng/mL), were 5.16％ and 5.23％ in middle-concentration of hs-cTnI (0.65 ng/mL), and were 5.30％and 6.07％ in low-concentration of hs-cTnI (0.025 ng/mL). According to the document of CLSI EP17-A, the LoB was 0.001 ng/mL, LoD was 0.008 ng/mL, and LoQ was 0.008 ng/mL. The LLD was 0.001 ng/mL,BLD was 0.002-0.004 ng/mL, and FS was 0.019 8 ng/mL by traditional method. The equation of linearity range of the expectant value and detected value was Y＝1.015X＋0.152,r²＝0.993.The results of 95% samples were within the biology reference intervals offered by manufactures. Conclusions The imprecision is higher than the value offered by manufactures. FS is basically consistent with the value offered by manufactures. The LoB and LLD established by the 2 methods are same. The biology reference interval being used is suitable for the laboratories.

Key words: Cardiac troponin I, High sensitive method, Performance evaluation, Analysis sensitivity, Function sensitivity, Biology reference interval