The Autobio collagen type IV (CIV) chemiluminescence immunoassay (CLIA) is intended for the quantitative determination of CIV concentration in serum specimens, aiding in the diagnosis, monitoring and prognosis of hepatic fibrosis.
The formation of hepatic fibrosis is resulting from the over produce or deficient degradation, or both, of the extracelular matrix, hence excessive connective tissue builds up in the liver, then fibrosis is in turn formed. Hepatic fibrosis is the common pathological basis for chronic liver disorders. Various chronic liver disorders might gradually progress to hepatic fibrosis.
Various methods exist for the diagnosis of hepatic fibrosis, such as liver biopsy, imaging tests and serologic marker assays. The most reliable means to examine the extent of fibrosis and its activity is still the liver biopsy method. Although it is the Gold standard in hepatic fibrosis diagnosis, liver biopsy has many disadvantages. e.g. it is an invasive test, hence patients are reluctant to take this test and repeated tests are not able to be conducted. It is not possible to monitor the progress of the recovery and effects of the therapy. Fibrosis is characterized by focal inflammation and fibroelastosis, so deviations exist in specimen collection. Consequently, liver biopsy is much limited in clinical practice. Modern medical imaging methods such as type B ultrasound, CT, MRI etc. could observe certain symptoms of hepatic fibrosis. However, these medical imaging methods are yet to be confirmatory and identifiable, not to mention the inability to accurately determine the extent of liver fibrosis. Serological tests are able to identify different stages of liver fibrosis with relative accuracy, which indicates various changes during the development of liver fibrosis. Additionally, the effects of anti-fibrosis therapies could be monitored.
CIV is a major component of basal membrane. Unlike other fibrous collagens, it is composed of at least two different α peptides, i.e. α1 (IV) and α2 (IV). Serum may contain 3 different major degradation fragments, i.e. amine terminal 7S collagen, carboxyl terminal NCL collagen and the main triple helix zone. Alterations in the concentrations of these substances indicate their metabolism within the body. In a normal liver, no basal membrane is present in the Disse gaps, type IV collagen concentration is very low. However, during the fibrosis process from hepatitis through to cirrhosis, the formation of basal membrane occurs in Disse gaps. Meanwhile, type IV collagen concentration in liver tissue and blood stream increases accordingly.
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