登革热病毒快速检测NS1抗原和 IgG／IgM抗体的临床应用评价

摘要

目的：采用胶体金免疫层析法（ GICA）检测登革热病毒（ DENV） NS1抗原和／或IgG／IgM抗体，初步评价其临床应用效果。方法将2633例经聚合酶链反应（ PCR）-荧光探针法检测DENV核酸的血清样本分为3组：Ⅰ组为948例样本，用GICA检测NS1抗原；Ⅱ组为1156例样本，用GICA检测IgG／IgM抗体；Ⅲ组为529例样本，用GICA同时检测NS1抗原和IgG／IgM抗体。另5例流行性出血热抗体阳性样本、4例风疹／麻疹抗体阳性样本和50名健康人群样本为Ⅳ组，用GICA检测NS1抗原和IgG／IgM抗体。结果Ⅰ组结果与PCR结果相比，阳性、阴性、总体符合率分别为89．09％、92．41％、89．87％（P＜0．01）；Ⅱ组结果与PCR结果相比，阳性、阴性、总体符合率分别为64．68％、66．41％、64．88％（P＜0．01）；Ⅲ组结果与PCR结果相比，阳性、阴性、总体符合率分别为93．56％、61．82％、86．96％（P＞0．05），Ⅲ组中有419例样本经PCR检测结果为阳性， NS1抗原阳性率为85．20％，IgG／IgM抗体阳性率为63．25％，NS1抗原和／或IgG／IgM抗体阳性符合率为93．57％；Ⅳ组结果均为阴性，特异性为100％。结论 GICA对NS1抗原和IgG／IgM抗体的联合检测结果与PCR检测结果较接近，且特异性良好，可用于DENV感染的早期辅助诊断和筛查。%Objective To examine the Dengue virus (DENV) NS1 antigen and (or)the IgG/IgM antibody by gold immunochromatographic assay ( GICA) , and evaluate its preliminary clinical application effect .Methods 2 633 serum samples of which DENV nucleic acid has been tested by polymerase chain reaction ( PCR)-fluorescence probe technique were separated into 3 groups:948 samples of NS1 antigen in group Ⅰ, 1 156 samples of IgG/IgM antibody in group Ⅱ, and 529 samples of both NS1 antigen and IgG/IgM antibody in group Ⅲ have been tested by GICA.In addition, NS1 antigen and IgG/IgM antibody of 5 epidemic hemorrhagic fever antibody positive samples , 4 rubella/measles antibody positive samples as well as 50 samples of healthy subjects as group Ⅳ have also been tested by the same technique . Results The positive, negative and total coincidence rate of group Ⅰcompared to that of PCR were 89.09%, 92.41%and 89.87%respectively ( P<0.01); The positive, negative and total coincidence rate of group Ⅱ were 64.68%, 66.41%and 64.88%respectively (P<0.01);The positive, negative and total coincidence rate of group Ⅲwere 64. 68%, 66.41%and 64.88%(P>0.05).Among group Ⅲ, 419 samples showed positive by PCR .The positive rate of NS1 antigen, IgG/IgM antibody and both (or either)were 85.20%, 63.25%and 93.57%respectively.All results of groupⅣ showed negative , and the specificity was 100%.Conclusions The union test results of the DENV NS 1 antigen and the IgG/IgM antibody are comparable with those of PCR and the specificity is good .Therefore, it may be used for early auxiliary diagnosis and screening of the DENV .