Development of a Colloidal Gold Kit for the Diagnosis of Severe Fever with Thrombocytopenia Syndrome Virus Infection

Xianguo Wang,Dexin Li,Shiwen Wang,Quanfu Zhang,Minyao Liang,Shuhong Luo,Wei Wu,Fen Hao,Weiwen Xu,Zhihua Liao,Xunian Gao

doi:10.1155/2014/530621

Abstract

It is critical to develop a cost-effective detection kit for rapid diagnosis and on-site detection of severe fever with thrombocytopenia syndrome virus (SFTSV) infection. Here, an immunochromatographic assay (ICA) to detect SFTSV infection is described. The ICA uses gold nanoparticles coated with recombinant SFTSV for the simultaneous detection of IgG and IgM antibodies to SFTSV. The ICA was developed and evaluated by using positive sera samples of SFTSV infection (n = 245) collected from the CDC of China. The reference laboratory diagnosis of SFTSV infection was based on the “gold standard”. The results demonstrated that the positive coincidence rate and negative coincidence rate were determined to be 98.4% and 100% for IgM and 96.7% and 98.6% for IgG, respectively. The kit showed good selectivity for detection of SFTSV-specific IgG and IgM with no interference from positive sera samples of Japanese encephalitis virus infection, Dengue virus infection, Hantavirus infection, HIV infection, HBV surface antigen, HCV antibody, Mycobacterium tuberculosis antibody, or RF. Based on these results, the ICS test developed may be a suitable tool for rapid on-site testing for SFTSV infections.

Highlights

Severe fever with thrombocytopenia syndrome (SFTS) is an emerging infectious disease recently identified in central and northeast China
The results indicated that the best conditions of the colloidal gold-recombinant SFTS bunyavirus (SFTSV) were 0.8 μL/mm and the anti-human IgM antibody was 2 mg/mL
The immunochromatographic assay (ICA) we developed is a new detection method with gold nanoparticles coated with recombinant SFTSV for the simultaneous detection of IgG and IgM antibodies to SFTSV

Summary

Introduction

Severe fever with thrombocytopenia syndrome (SFTS) is an emerging infectious disease recently identified in central and northeast China. It is caused by a novel SFTS bunyavirus (SFTSV), in the genus of Phlebovirus, family Bunyaviridae [1,2,3]. 15 provinces in China have reported cases of SFTS. The clinical manifestations of SFTS include high fever, gastrointestinal symptoms, thrombocytopenia, leukocytopenia, multiorgan dysfunction, and hemorrhagic tendency in severe cases [2]. Clinical presentations of SFTS, are less specific and need to be differentiated from various infectious diseases, from hemorrhagic fever with renal syndrome (HFRS) caused by Hantavirus and human anaplasmosis [6]

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