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胶乳增强免疫透射比浊法测定心肌肌钙蛋白Ⅰ的性能评价及其参考值范围的确定 被引量:1

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摘要 目的对血清心肌肌钙蛋白I(cardiac troponin I,cTnI)测定试剂盒进行性能评价,了解其分析性能是否满足临床要求。方法在全自动生化分析仪上建立胶乳增强免疫透射比浊法测定血清cTnI的方法,按照国家实验室认可及美国病理学家协会(College of American Pathology,CAP)认可要求,对cTnI测定方法建立本室的参考值范围。结果该分析方法批内精密度高、低值分别为2.86%和4.06%,批间精密度高、低值分别为3.49%和5.13%;准确度相对偏差1.00%~3.50%;携带污染率为0.57%;最低检测限为0.092μg/L;线性范围在0.00~50.00μg/L,各项评价指标满足试剂所提供性能指标。本室cTnI参考值范围0.00~0.86μg/L。结论胶乳增强免疫透射比浊法测定cTnI,其精密度、准确度、携带污染率、线性范围、最低检测限及其他指标均符合临床实验室要求。
出处 《右江民族医学院学报》 2013年第1期56-57,共2页 Journal of Youjiang Medical University for Nationalities
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