Line Immuno Assay (LIA) for the Detection of Autoantibodies in Autoimmune Liver Diseases

Primary DI

06924030401009

Basic UDI-DI Code

B-06924030401009

Reference

MB00180

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

HOB Biotech Group Corp., Ltd.

The HOB- LIA-Liver is for the qualitative measurement of IgG class antibodies against AMA M2, CENP-B, sp100, gp210, LKM-1, LC-1, SLA/LP, SS-A/52kDain human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of autoimmune liver disease. Autoimmune hepatitis (AIH) types 1-3, primary biliary cirrhosis (PBC), and immune cholangiopathy, regarded as the overlap syndrome between AIH and PBC, are some of the most common autoimmune liver diseases. Autoimmune hepatitis is a relatively rare disease. It is necessary to distinguish it from viral hepatitis strictly. Because of the improvement of the serological diagnosis ability, the detection rate of the autoimmune hepatitis also increases. One of the causes is the autoimmune response to liver tissue caused by the decline of the autoimmune tolerance. It is not fully understood that whether the autoantibodies generated in this autoimmune response have pathologic correlation. Perhaps, liver cell damage is caused by T cells. Autoantibodies play an important role in distinguishing viral hepatitis from three different types of autoimmune chronic active hepatitis (AIH). In AIH type I, ANA and anti-smooth muscle antibodies (ASMA)can be detected. In AIH type II, the corresponding antigen is liver and kidney microsomal antigen (LKM - 1). Soluble liver antigen antibody mainly appears in AIH type III. Autoantibodies which could be detected in the corresponding diseases are as below: AIH type I: ANA, ASMA AIH type II: LKM-1, LC-1 AIH type III: SLA/LP PBC: AMA M2, sp100, gp210, (CENP-B)

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