HANTAVIRUS / BUNYAVIRUS

Primary DI

06936791010079

Basic UDI-DI Code

B-06936791010079

Reference

FR0101-96

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 IgG antibody for severe fever with thrombocytopenia syndrome in human serum sample. From 2009 to 2010, cases of "fever with platelet syndrome" caused by tick bite were reported in six provinces such as Hubei, Shandong, Henan and Liaoning. The Chinese Center for Disease Control and Prevention confirmed that patients were infected with the severe fever with thrombocytopenia syndrome virus (SFTSV). The clinical latency of SFTSV infection is about 1-2 weeks. It is sudden onset with the main clinical manifestation of fever. The body temperature of patients often reaches above 38°C, and the severe cases have continuous high fever up to 40°C, accompanied by digestive tract symptoms such as fatigue, obvious anorexia, nausea, vomiting and diarrhea, and unilateral superficial lymphadenopathy may occur. Thrombocytopenia and leucopenia often occur clinically. Most patients suffer from impairment of multi-organ functions very soon, which is manifested by the increase of alanine aminotransferase, aspartate transaminase and lactate dehydrogenase in serum, and proteinuria and hematuria often occur. Some cases are in critical conditions, with disturbance of consciousness, skin ecchymosis and alimentary tract hemorrhage, and some patients may die of multiple organ failure such as shock, respiratory failure and disseminated intravascular coagulation (DIC). Most patients have a good prognosis. There is a high proportion of patients with previous basic diseases and the elderly with severe diseases having a poor prognosis. The test results are for clinical reference only and cannot be used alone as a basis for confirming or excluding cases.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).