摘要
目的 对比4种国产结核分枝杆菌(MTB)感染检测试剂盒(华大、普瑞康、希格、迪澳)与世界卫生组织推荐的QuantiFERON-TBGold(QFT)在MTB感染早期诊断中的应用,筛选出最适合我国MTB感染的检测方法.方法 采集2018年1月-2020年12月新疆医科大学第八附属医院招募的3 000例研究对象的血液,均接受QFT检查,且以其检测结果为参照,计算4种国产检测试剂盒的阳性检出率、特异度、灵敏度、阳性预测值、阴性预测值和Youden指数.结果 华大免疫球蛋白G(IgG)抗体检测试剂盒阳性检出率为1.37％,灵敏度为4.24％、特异度为99.20％,阳性预测值(PPV)为51.22％、阴性预测值(NPV)为83.98％,Youden指数为0.03;普瑞康IgG抗体检测试剂盒阳性检出率15.33％,灵敏度为16.36％,特异度为84.87％,PPV为17.61％,NPV为83.70％,Youden指数为0.01.希格T细胞检测试剂盒阳性检出率21.30％,灵敏度为85.86％,特异度为91.46％,PPV为66.51％,NPV为97.04％,Youden指数为0.77;迪澳T细胞检测试剂盒阳性检出率16.40％,灵敏度为68.08％,特异度为93.61％,PPV为67.81％,NPV为93.69％,Youden指数为0.62.结论 希格T细胞检测试剂盒阳性检出率、灵敏度和特异度最高.
Abstract
OBJECTIVE To compare the effectiveness of four types of domestic kits(Huada,Prekang,Xige and Di-ao)with the effectiveness of QuantiFERON-TB Gold(QFT)recommended by the World Health Organization(WHO)in the early diagnosis of Mycobacterium tuberculosis(MTB)infection and screen out the most suitable method for detection of MTB infection in China.METHODS The blood samples were collected from 3000 subjects who were recruited from the Eighth Affiliated Hospital of Xinjiang Medical University from Jan.2018 to Dec.2020.All of them were examined by QFT,and the results were used as references.The positive detection rate,specificity,sensitivity,positive predictive value(PPV),negative predictive value(NPV)and Youden index were calculated for the four types of domestic test kits.RESULTS The positive rate,sensitivity,specificity,PPV,NPV and Youden index of the Huada IgG antibody test kit were 1.37％,4.24％,99.20％,51.22％,83.98％and 0.03,respectively.The positive detection rate,sensitivity,specificity,PPV,NPV and Youden index of the Puritron IgG antibody test kit were 15.33％,16.36％,84.87％,17.61％,83.70％and 0.01,respectively.The positive de-tection rate,sensitivity,specificity,PPV,NPV and Youden index of Hige T-cell test kit were 21.30％,85.86％,91.46％,66.51％,97.04％and 0.77,respectively.The positive detection rate,sensitivity,specificity,PPV,NPV and Youden index of Diau T-cell test kit were 16.40％,68.08％,93.61％,67.81％,93.69％and 0.62,respective-ly.CONCLUSION The positive detection rate,sensitivity and specificity of Hige T-cell test kit are the highest.
维普
万方数据