胶体金法粪便隐血检测试剂的性能检测及初步临床应用评估

目的评价胶体金法粪便隐血检测试剂的性能及临床应用价值。方法随机选择150例住院患者粪便样本,分别用试验试剂[胶体金法,梅里埃(上海)生物制品有限公司生产]和对照试剂(胶体金法,上海凯创生物技术有限公司生产)对样本进行检测,并对结果进行统计。同时结合患者临床资料,对检测结果的符合程度进行综合分析,初步评估其临床应用价值。结果试验试剂敏感性可达到40 ng/mL,特异性和重复性均符合要求,与对照试剂结果基本相符,且检测结果与临床病情相符合。结论胶体金法粪便隐血检测试剂方法简便,结果可靠,可进一步应用于临床。

Performance analysis on colloidal gold immunoassay for fecal occult blood test kit and its primary evaluation of clinical application

Objective To evaluate the performance and clinical application of the fecal occult blood test kit by colloidal gold immunoassay.Methods A total of 150 stool samples were collected randomly from inpatients.The comparative determination of these samples were performed by experimental kit（bioMerieux Co.,Ltd.） and control kit（Shanghai Chemtron Biotech Co.,Ltd.）.The results were statistically analyzed.The primary clinical application was evaluated.Results The experimental kit had a good sensitivity（40 ng/mL）,and its specificity and repeatability met the needs of clinical application.The determination results suggested that it could be consistent with control kit results and clinical pathogenetic condition.Conclusions The fecal occult blood test kit by colloidal gold immunoassay is simple,reliable,and suitable for clinical application.