CIV
ZECEN
DR1032
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[INTENDED USE]
The kit has been designed for the quantitative determination of Collagen Ⅳ (CⅣ) in human serum.
The method can be used for samples over the range of 20-2400 ng/mL.
[SUMMARY AND EXPLANATION OF THE TEST]
Collagen Ⅳ (hereinafter referred to as CⅣ) quantitative detection kit (CLIA) is used for the in vitro quantitative detection of CⅣ concentration in serum. It is an indicator which reflects collagen production rather than degradation, and the degree of liver fibrosis. CⅣ plays animportant role in diagnosis of liver fibrosis and cirrhosis.
CⅣ in normal liver is mainly in the base film of blood vessels and bile ducts, and there is no significant deposit in the hepatic sinusoid. When liver fibrosis occurs, Fiber hyperplasia of CⅣ may occur the earliest with high conversion rate, a large number of deposition, and finally forms a complete basement membrane with laminin through continuous deposition. It is now recognized as an indicator which reflects collagen production rather than degradation, and the degree of liver fibrosis.
CⅣ, hyaluronic acid (HA), laminin (LN) and procollagen III N-terminal peptide can beused as the indicators to reflect the degree of liver fibrosis. Their development stage consists with the development of chronic hepatitis. For the chronic severe hepatitis and cirrhosis, they are at the highest level; and also consistent with liver inflammation, tissue necrosis and fibrosis, for inflammation grade G4, fibrosis S4, they are also at the highest level. Therefore, the level of CⅣ,HA, LN and PIIINP become the indicator of liver disease, cirrhosis and predict the development.
Diagnosis of liver fibrosis has been dependent on liver biopsy diagnosis, which has a number of significant deficiencies, for example, being traumatic, being difficult to repeat biopsies, certain complications (1/3 patients with pain; 0.3% patients with serious complications, including bleeding,pneumothorax, colon and gallbladder perforation; 0.03% mortality). Lesions in the liver are uneven,and there are differences between the viewer himself and between different viewers. Sample length is not enough (length <20mm and <10 pcs of portal area) which is prone to underestimate and broken specimens or subcapsular hepatic fibrosis can cause artifacts.
[INTENDED USE]
The kit has been designed for the quantitative determination of Collagen Ⅳ (CⅣ) in human serum.
The method can be used for samples over the range of 20-2400 ng/mL.
[SUMMARY AND EXPLANATION OF THE TEST]
Collagen Ⅳ (hereinafter referred to as CⅣ) quantitative detection kit (CLIA) is used for the in vitro quantitative detection of CⅣ concentration in serum. It is an indicator which reflects collagen production rather than degradation, and the degree of liver fibrosis. CⅣ plays animportant role in diagnosis of liver fibrosis and cirrhosis.
CⅣ in normal liver is mainly in the base film of blood vessels and bile ducts, and there is no significant deposit in the hepatic sinusoid. When liver fibrosis occurs, Fiber hyperplasia of CⅣ may occur the earliest with high conversion rate, a large number of deposition, and finally forms a complete basement membrane with laminin through continuous deposition. It is now recognized as an indicator which reflects collagen production rather than degradation, and the degree of liver fibrosis.
CⅣ, hyaluronic acid (HA), laminin (LN) and procollagen III N-terminal peptide can beused as the indicators to reflect the degree of liver fibrosis. Their development stage consists with the development of chronic hepatitis. For the chronic severe hepatitis and cirrhosis, they are at the highest level; and also consistent with liver inflammation, tissue necrosis and fibrosis, for inflammation grade G4, fibrosis S4, they are also at the highest level. Therefore, the level of CⅣ,HA, LN and PIIINP become the indicator of liver disease, cirrhosis and predict the development.
Diagnosis of liver fibrosis has been dependent on liver biopsy diagnosis, which has a number of significant deficiencies, for example, being traumatic, being difficult to repeat biopsies, certain complications (1/3 patients with pain; 0.3% patients with serious complications, including bleeding,pneumothorax, colon and gallbladder perforation; 0.03% mortality). Lesions in the liver are uneven,and there are differences between the viewer himself and between different viewers. Sample length is not enough (length <20mm and <10 pcs of portal area) which is prone to underestimate and broken specimens or subcapsular hepatic fibrosis can cause artifacts.