ARCHETECT高敏肌钙蛋白Ⅰ试剂盒性能评价

目的 评价ARCHETECT高敏肌钙蛋白Ⅰ（hs-cTnⅠ）试剂盒性能，以验证其是否符合临床实验室使用要求。方法 参考CLSI的EP15-A2文件和相关文献对ARCHETECT高敏肌钙蛋白Ⅰ试剂盒精密度、正确度进行评价，EP17-A文件和相关文献对空白检测限（LoB）进行评价，EP6-A文件和相关文献对线性范围进行评价，参考NCCLS C28-A2文件，对健康体检者血浆标本分男女验证生物参考区间。结果 实验测得hs-cTnⅠ高值样本（5.702 μg/L）的批内不精密度CV为1.56%，总不精密度CV为1.27%，低值样本（0.003 μg/L）的批内不精密度CV和总的不精密度CV均为0；hs-cTnI的回收率为 97.50%；LoB为0.001 μg/L；在检测范围内，hs-cTnI理论值与测定值的线性方程为Y=1.0006X-0.13136，R2=0.9999；生物参考区间验证结果显示男性100.00%的结果在厂家提供的生物参考区间范围内，女性96.67%的结果在厂家提供的生物参考区间范围内。结论 ARCHETECT高敏肌钙蛋白Ⅰ试剂盒性能通过验证，可为临床提供准确、可靠的hs-cTnⅠ定量检测结果，为临床对心肌损伤的诊断、治疗提供重要信息。

Performance Evaluation of ARCHETECT High-sensitivity Cardiac Troponin I Kit

Abstract:Objective To evaluate the performance of the ARCHETECT high-sensitivity cardiac troponin I (hs-cTnI) kit to verify compliance with clinical laboratory requirements.Methods The accuracy of the ARCHETECT high-sensitivity troponin I kit were evaluated with reference to the CLSI EP15-A2 document and related literature. The blank detection limit (LoB) was evaluated in EP17-A and related literature, EP6-A and The relevant literature evaluates the linear range. Referring to the NCCLS C28-A2 document, the plasma samples of healthy subjects are compared with the male and female validated biological reference intervals.Results The intra-assay imprecision CV of the hs-cTnI high value sample (5.702 μg/L) was 1.56%, the total imprecision CV was 1.27%, and the intra-assay imprecision of the low-value sample (0.003 μg/L). The CV and the total imprecision CV were both 0; the recovery of hs-cTnI was 97.50%; the LoB was 0.001 μg/L; in the detection range, the linear equation of the theoretical and measured values of hs-cTnI was Y=1.0006X-0.13136, R2=0.9999; the bio-reference interval verification results showed that 100.00% of the results were within the bio-reference interval provided by the manufacturer, and 96.67% of the results were within the bio-reference range provided by the manufacturer.Conclusion The performance of ARCHETECT high-sensitivity troponin I kit can provide accurate and reliable quantitative detection results of hs-cTnI for clinical diagnosis, and provide important information for clinical diagnosis and treatment of myocardial injury.