评价一种新的用于登革热和 Zika 病毒感染诊断的快速荧光免疫分析方法。

Evaluation of a new rapid fluorescence immunoassay for the diagnosis of dengue and Zika virus infection.

机构信息

Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy; Infectious and Tropical Diseases Unit, Careggi University and Hospital, Florence, Italy; Referral Center for Tropical Diseases of Tuscany, Infectious and Tropical Diseases Unit, Careggi University Hospital, Florence, Italy.

Clinical Microbiology and Virology Unit, Careggi University and Hospital, Florence, Italy.

出版信息

J Clin Virol. 2019 Mar;112:34-39. doi: 10.1016/j.jcv.2019.01.011. Epub 2019 Jan 29.

DOI:10.1016/j.jcv.2019.01.011

PMID:30738366

Abstract

BACKGROUND

Dengue (DENV) and Zika virus (ZIKV) are important mosquito-transmitted viruses.

OBJECTIVES

To investigate the performance of Standard F, Fluorescence Immunoassay (FIA, SD Biosensor Inc., Suwon, South Korea) providing results in 15 min to detect DENV IgG, IgM and NS1Ag, and ZIKV IgG, IgM, and Ag.

STUDY DESIGN

A well-characterized panel of patient samples (11 acute DENV, 11 acute ZIKV, 10 past DENV, 10 past ZIKV infection, 36 with other conditions) were tested with the FIA test.

RESULTS

In acute DENV infection, the combination of FIA-NS1Ag and/or IgM positivity showed a sensitivity of 100%. In past DENV, FIA-IgG test showed a sensitivity of 70%. Specificity of FIA-DENV NS1Ag, IgG, and IgM was 87.5%, 83.5%, and 91.7%, respectively. The sensitivity of FIA-ZIKV IgM and FIA-ZIKV Ag, in confirmed acute infection, was 72.7% and 9.1%, respectively. FIA-ZIKV Ag did not improve the sensitivity in detecting acute ZIKV infection, being positive only in one IgM positive sample. In past ZIKV infection (32-183 days after symptom onset), FIA-ZIKV IgG and IgM showed a sensitivity of 40% and 80% respectively, generating an overall 90% sensitivity. Specificity of FIA-ZIKV Ag, IgM, and IgG was 92.6%, 100%, and 97%, respectively.

CONCLUSION

FIA test, a rapid and easy to perform assay, showed high sensitivity to detect acute DENV infection, but lower in acute ZIKV infection. In past ZIKV infections, the best performance of FIA test is obtained by combining detection of IgG and IgM.

摘要

背景

登革热（DENV）和寨卡病毒（ZIKV）是两种重要的蚊媒传播病毒。

目的

研究 SD Biosensor Inc.（韩国水原）的 Standard F、荧光免疫分析（FIA）检测试剂盒在 15 分钟内检测 DENV IgG、IgM 和 NS1Ag 以及 ZIKV IgG、IgM 和 Ag 的性能。

研究设计

采用经过充分验证的患者样本检测试剂盒（11 例急性 DENV、11 例急性 ZIKV、10 例既往 DENV、10 例既往 ZIKV 感染、36 例其他疾病）进行 FIA 检测。

结果

在急性 DENV 感染中，FIA-NS1Ag 和/或 IgM 阳性的组合具有 100%的敏感性。在既往 DENV 中，FIA-IgG 检测的敏感性为 70%。FIA-DENV NS1Ag、IgG 和 IgM 的特异性分别为 87.5%、83.5%和 91.7%。在确诊的急性感染中，FIA-ZIKV IgM 和 FIA-ZIKV Ag 的敏感性分别为 72.7%和 9.1%。FIA-ZIKV Ag 并不能提高急性 ZIKV 感染的检测敏感性，仅在 1 例 IgM 阳性样本中呈阳性。在既往 ZIKV 感染（症状发作后 32-183 天）中，FIA-ZIKV IgG 和 IgM 的敏感性分别为 40%和 80%，总体敏感性为 90%。FIA-ZIKV Ag、IgM 和 IgG 的特异性分别为 92.6%、100%和 97%。