登革病毒非结构蛋白1抗原检测试剂的比较

Comparison of Dengue viral nonstructural protein 1 antigen testing kits

目的调查登革热病毒非结构蛋白1（NS1）抗原检测试剂的敏感性和特异性，为诊断标准的修订提供依据。方法于2010年5月至2016年11月，从广州、东莞和中山三地登革热监测点医院，共收集核酸检测或病毒培养物阳性者300例。同期同地采集登革病毒核酸阴性的人群血液标本308例作为对照组。采用调查问卷收集研究对象的相关信息。分别选用胶体金试剂（国产和进口）、ELISA试剂（国产和进口）在上述3个城市进行登革热抗原检测，计算并比较不同试剂的灵敏度、特异度和符合率，以中山地区作为第三方检测。结果阳性组男性为133例，女性为167例，年龄为（47.2±13.3）岁，其中登革Ⅰ型为179例，登革Ⅱ型为110例，登革Ⅲ型为11例；对照组男、女病例均为154例，年龄为（40.1±11.6）岁。国产ELISA试剂灵敏度（94.5%）低于进口试剂（99.5%），差异有统计学意义（χ2=8.59，P=0.030）；NS1抗原检测Ⅰ型登革病毒的灵敏度和特异度均高于97.0%；检测Ⅱ型登革病毒时，国产ELISA和胶体金试剂的灵敏度分别为90.0%和95.0%，特异度分别为96.8%和100%，进口ELISA和胶体金试剂的灵敏度分别为100%和98.0%，特异度分别为99.4%和100%。第三方检测结果显示国产ELISA和胶体金试剂的灵敏度分别为90.0%和98.0%，差异有统计学意义（χ2=5.67，P=0.020）。结论NS1检测试剂均具有较高的灵敏度和特异度，可以作为登革热病例的早期筛查检测。

Objective To investigate the sensitivity and specificity of commercial nonstructural protein 1 （NS1） testing kits for Dengue fever diagnose, and provide the evidence for diagnostic criteria revision.Methods 300 PCR or virus isolation positive blood samples for dengue virus were collected from sentinel hospitals for dengue surveillance in Guangzhou, Dongguang and Zhongshang from May 2015 to Nov. 2016. At the same time, 308 PCR negative samples for Dengue virus were collected as control group. The information of the sample was collected using questionnaires. These samples were tested using imported and domestic ELISA and the colloidal gold-labeled kits that were widely used for detecting dengue NS1. Sensitivity, specificity and coincidence were calculated and analyzed, and Z hongshan＇s result was regarded as the reslut of the third part.Results The positive group includes 133 males and 167 females, average ages are 47.2±13.3, 179, 110 and 11 of them is Dengue Ⅰ, Ⅱ and Ⅲ respectively. The negative group includes 154 males and 154 females, average ages are （40.1±11.6） years old. The sensitivity of domestic ELISA Kits （94.5%） is less than imported （99.5%）, and the result has statistical significance （χ2=8.59, P=0.030）, the specificity is 99.7% and 97.7% respectively; The sensitivity of imported and domestic the colloidal gold-labeled Kits is 97.5% and 96.5% respectively, both of specificities are 100%. The sensitivity and specificity of Dengue Ⅰ for NS1 test are more than 97.0%. The sensitivity of domestic ELISA and gold-labeled Kits is 90.0% and 95.0%, and the specificity is 96.8% and 100% respectively for Dengue Ⅱ test. The sensitivity of imported ELISA and gold-labeled Kits is 100% and 98.0%, and the specificity is 99.4% and 100% respectively for Dengue Ⅱ test. The result of the third party show the sensitivity and specificity of domestic ELISA and gold-labeled Kits are 90.0% and 98.0%, the differences has statistical significance （χ2=5.67, P=0.020）.Conclusion NS1 testing can be used as early dengue fever diagnose for higher sensitivity and specificity.