[1]习 浩,刘荣静.ARCHETECT高敏肌钙蛋白Ⅰ试剂盒性能评价[J].医学信息,2019,32(17):164-166.[doi:10.3969/j.issn.1006-1959.2019.17.056]
　XI Hao,LIU Rong-jing.Performance Evaluation of ARCHETECT High-sensitivity Cardiac Troponin I Kit[J].Journal of Medical Information,2019,32(17):164-166.[doi:10.3969/j.issn.1006-1959.2019.17.056]
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ARCHETECT高敏肌钙蛋白Ⅰ试剂盒性能评价()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
32卷
期数:
2019年17期
页码:
164-166
栏目:
诊疗技术
出版日期:
2019-09-01

文章信息/Info

Title:
Performance Evaluation of ARCHETECT High-sensitivity Cardiac Troponin I Kit
文章编号:
1006-1959（2019）17-0164-03
作者:
习 浩; 刘荣静
广州医科大学附属第二医院检验科，广东 广州 510260
Author(s):
XI Hao; LIU Rong-jing
Department of Clinical Laboratory,the Second Affiliated Hospital,Guangzhou Medical University, Guangzhou 510260, Guangdong,China
关键词:
高敏肌钙蛋白Ⅰ; 性能; 精密度; 正确度; 生物参考区间
Keywords:
Key words：High-sensitivity cardiac troponin I; Performance; Precision; Accuracy; Biological reference interval
分类号:
R446.6；R541.4
DOI:
10.3969/j.issn.1006-1959.2019.17.056
文献标志码:
A
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。
Abstract:
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.

参考文献/References:

[1]刘传芬,陈红.解读：第四版心肌梗死全球统一定义[J].中华医学信息导报,2018,33(21):20. [2]中国合格评审国家认可委员会. CNAS-CL022012医学实验室质量和能力认可准则（ISO15189：2012，IDT）[S].2013． [3]张秀明,冯仁丰.正确理解和使用分析灵敏度及检出限[J].中华医学检验杂志,2014,37(9):669-671. [4]温冬梅,张秀明,吴剑杨,等.应用CLSI EP5-A2 文件评价生化检测系统的精密度性能[J].检验医学与临床,2010,7(19):2096-2098.

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更新日期/Last Update: 2019-09-01