登革热初筛方法的比较与应用评价

摘要

目的：比较3种不同初筛方法对登革热的诊断价值，并探讨各种方法的应用范围及应用价值。方法采用回顾性研究。收集2014年及2015年9至10月佛山市第一人民医院门诊及住院共2137例疑似登革热病毒感染者的临床资料，同时采用ELISA法和快速法检测（血清标本）登革热病毒NS1抗原，采用快速法检测登革热病毒IgM抗体，并采用卡方（χ2）检验比较这3种方法对登革热的初筛价值。另对2015年确诊的48例，分别在发病第1～3天、4～5天、6～7天及14天同时采用3种方法进行检测，观察不同时间段3种方法的灵敏度和特异度变化。结果2014年1674例疑似病例中被确诊为登革热的有957例（57.2％），2015年463例中确诊的有48例（10.4％），共计1005例（47.0％）。3种方法对登革热的检出性能比较结果显示，NS1-ELISA方法灵敏度优于NS1抗原快速检测法和IgM抗体快速检测法（χ2＝40.865，P＜0.001；χ2＝151.383，P＜0.001），3种方法特异度相当，差异无统计学意义（χ2＝0.661，P＝0.416；χ2＝0.548，P＝0.459；χ2＝2.397，P＝0.122）。检测NS1抗原的2种方法发病7 d内灵敏度均较好，而检测IgM抗体的方法则随着时间推移灵敏度上升。结论 NS1抗原检测在疾病发生早期灵敏度和特异度良好，优于IgM抗体检测，可作为登革热早期筛查的重要方法，在登革热发病7 d内可根据登革热疫情情况选择ELISA方法或快速检测法。（中华检验医学杂志，2016，39：776-779）%Objective To compare and evaluate the performance and applications of three assays in preliminary screening of dengue infections.Methods This study was designed as a retrospective study.Clinical data were obtained from 2 137 borderline cases from September to October in 2014 and 2015.Markers of dengue infections of serum samples were detected by NS1 antigen captured ELISA, dengue NS1 detect rapid test and dengue IgM detect rapid test, respectively.Chi square test was used to compare the preliminary screening value of these 3 methods.Forty-eight diagnosed patients were also examined in the 1st-3rd day, 4th-5th day, 6th-7th days and 14th day after infection to access the sensitivities and specificities of three assays.Results Nine hundred and fifty-seven ( 57.2%) cases in 2014 and 48 ( 10.4%) cases in 2015 were diagnosed to be Dengue fever of 2 137 borderline cases.The overall sensitivity of NS1-ELISA was superior to NS1 and IgM rapid detect test (χ2 =40.865,P<0.001;χ2 =151.383,P<0.001).No significant differences were found in specificity between three assays(χ2 =0.661,P=0.416;χ2 =0.548,P=0.459; χ2 =2.397,P=0.122).The NS1 detecting assays were sensitive in 7 days after infection, but the sensitivity of IgM detecting assay increased over time.Conclusions NS1 detecting assays had good sensitivities and specificities, which can be used as an important method in preliminary screening of dengue infection.ELISA or rapid test can be selected according to epidemic situation.