HANTAVIRUS / BUNYAVIRUS

Primary DI

06936791020061

Basic UDI-DI Code

B-06936791020061

Reference

FR0301-25

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

This product is intended for use of in vitro qualitative test of virus-specific IgM/IgG antibody for severe fever with thrombocytopenia syndrome in human serum sample. The latest research outcome published by Chinese Center for Disease Control and Prevention on March 17, 2011 showed that Chinese scientists had discovered a new type of virus named SFTSV. Since September 2010, the virus has caused the death of 36 patients in 6 provinces, namely Hubei, Henan, Shandong, Jiangsu, Anhui and Liaoning. The research result showed that the name of the virus was "severe fever with thrombocytopenia syndrome virus (SFTSV)". It is called "SFTSV" for short. In recent two years, the infection cases with main clinical symptoms of fever, gastrointestinal symptom, thrombocytopenia and leucopenia were reported in some areas in China and a few patients died because of failure of multiple organs. After infecting the host, SFTSV firstly triggered the production of specificity IgM antibody and the titer will gradually decrease when the value reaches the peak. The positive IgM antibody indicates the infection and the IgG antibody appears later in the serum and exists in the serum for a longer time. Therefore, the detection of virus-specific IgM antibody for severe fever with thrombocytopenia syndrome for the diagnosis of early (acute) infection of SFTSV and judgement of the condition, prognosis and prevention and treatment effect. The positive SFTSV specificity IgG antibody indicates a past infection. The product can be used for auxiliary diagnosis of SFTSV-infected patients by the clinical doctor.

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