ARCHETECT高敏肌钙蛋白Ⅰ试剂盒性能评价(1)
摘要：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。
关键词：高敏肌钙蛋白Ⅰ;性能;精密度;正确度;生物参考区间
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.
Key words：High-sensitivity cardiac troponin I;Performance;Precision;Accuracy;Biological reference interval
cTnⅠ因具有特異性强、灵敏度高、发病后出现较早且持续时间较长等特点，成为目前反应心肌损伤灵敏度和特异度较高的生物学标志物，广泛应用于急性心肌梗死(AMI)的早期诊断。2012年欧洲心脏病协会(ESC)、美国心脏病学会(AHA)和世界心脏联盟(WHF)联合提出将cTnⅠ作为心肌损伤的首选标志物，2018年ESC会议期间，第四版心肌梗死全球统一定义公布，新的定义中再次强调cTn的重要性，包括高敏肌钙蛋白的重要价值[1]。近年来，随着检验技术的不断进步，新一代高敏感方法检测的试剂相继问世，许多产商纷纷推出hs-cTnI检测试剂，因此，对其性能进行评估、验证是合理地选择cTnⅠ检测方法、保障临床结果准确性的重要环节。本研究根据ISO15189《医学实验室质量和能力认可》的要求，参考美国临床和实验室标准化协会(CLSI)发布的EP15-A2、EP17-A、EP6-A文件[2]及其它相关文献对雅培公司生产的高敏肌钙蛋白Ⅰ试剂盒的主要相关性能进行评价、验证。, 百拇医药(习浩 刘荣静)
关键词：高敏肌钙蛋白Ⅰ;性能;精密度;正确度;生物参考区间
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.
Key words：High-sensitivity cardiac troponin I;Performance;Precision;Accuracy;Biological reference interval
cTnⅠ因具有特異性强、灵敏度高、发病后出现较早且持续时间较长等特点，成为目前反应心肌损伤灵敏度和特异度较高的生物学标志物，广泛应用于急性心肌梗死(AMI)的早期诊断。2012年欧洲心脏病协会(ESC)、美国心脏病学会(AHA)和世界心脏联盟(WHF)联合提出将cTnⅠ作为心肌损伤的首选标志物，2018年ESC会议期间，第四版心肌梗死全球统一定义公布，新的定义中再次强调cTn的重要性，包括高敏肌钙蛋白的重要价值[1]。近年来，随着检验技术的不断进步，新一代高敏感方法检测的试剂相继问世，许多产商纷纷推出hs-cTnI检测试剂，因此，对其性能进行评估、验证是合理地选择cTnⅠ检测方法、保障临床结果准确性的重要环节。本研究根据ISO15189《医学实验室质量和能力认可》的要求，参考美国临床和实验室标准化协会(CLSI)发布的EP15-A2、EP17-A、EP6-A文件[2]及其它相关文献对雅培公司生产的高敏肌钙蛋白Ⅰ试剂盒的主要相关性能进行评价、验证。, 百拇医药(习浩 刘荣静)