沙门菌核酸检测试剂盒评价

目的评价某沙门菌核酸检测试剂盒的性能。方法研究所需196例临床粪便标本来源于复旦大学附属儿科医院细菌室,以细菌室培养结果为沙门菌检测阳性“金标准”,将试剂盒检测结果与培养结果进行对比研究,通过分析灵敏度、特异度、精密度、约登指数、Kappa值、受试者工作特征曲线(ROC曲线)的曲线下面积(AUC)及交叉反应和抗干扰能力评价沙门菌核酸检测试剂盒的性能。结果该沙门菌核酸检测试剂盒诊断灵敏度为89.33%,诊断特异度为95.04%,CV值为10.11%,精密度良好,约登指数为84.37%,Kappa值为0.85,AUC为0.93。与细菌培养的结果对比显示,此试剂盒检测结果与培养结果有极好的一致性。交叉反应结果显示此试剂盒不会与轮状病毒、诺如病毒发生交叉反应。抗干扰能力结果显示Cary-Blair氏运送培养基不会干扰该试剂盒的检测。结论沙门菌核酸检测试剂盒对检测肠道沙门菌感染有较高的病原学检测价值,其操作简便,可作为肠道沙门菌感染快速检测以及流行病调查方法学补充。

Evaluation of Salmonella nucleic acid detection kit

Objective To evaluate the performance of the Salmonella nucleic acid detection kit.Methods A total of 196 clinical stool samples required for the study were obtained from the bacteria room of the Pediatric Hospital Affiliated to Fudan University.The performance of the Salmonella nucleic acid detection kit was evaluated by sensitivity,specificity,precision,Youden index,Kappa value,AUC of the ROC curve,cross reaction and anti-interference ability.Results The diagnostic sensitivity of the Salmonella nucleic acid detection kit was 89.33%,the diagnostic specificity was 95.04%,the CV value was 10.11%,the precision was good,the Youden index was 84.37%,the Kappa value was 0.85,and the AUC of the ROC curve was 0.93.The test results of this kit are in good consistency with the culture results.The cross-reaction results show that this kit will not cross-react with rotavirus and norovirus.The anti-interference ability results show that Cary-Blair′s transport medium does not interfere with the detection of this kit.Conclusion The Salmonella nucleic acid detection kit has high pathogenic value for detecting Salmonella intestinal infection,and its operation is simple and convenient,and it can be used as a supplement to the rapid detection of Salmonella infection and the method of epidemiological investigation.