Kit and method for diagnosis, prognosis or monitoring of liver disease through measurement of amount of AST

Inventors

Wang, Hong Tao • Park, Sang Yeol • Kim, Hyun Jeong • Lee, Won Hee

Assignees

Boditech Med Inc

Abstract

Disclosed are: a kit and a method for diagnosing or monitoring a liver disease, comprising a detection reagent for one or more markers of cytosolic aspartate aminotransferase (cAST) and mitochondrial aspartate aminotransferase (mAST) as biomarkers in a biological sample; and an antibody used for the detection. Compared to the conventional enzyme activity measurement method, the method according to the present application can more accurately measure diagnosis or prognosis of a liver disease with high sensitivity through measurement of the amount of mAST or cAST present in the biological sample, in particular, in a blood sample.

Core Innovation

The disclosure relates to a kit and immunological diagnostic, prognostic, and monitoring approach for liver disease. It detects cytoplasmic AST (cAST) and mitochondrial AST (mAST) separately by using detection reagents, particularly antibodies, in biological samples, notably blood such as serum, plasma, or whole blood. The disclosure emphasizes that cAST and mAST are recognized separately rather than as a combined or total signal.

The disclosed approach addresses a problem in which conventional measurement of total AST enzymatic activity does not separately determine cAST and mAST. By using separate, non-cross-reactive monoclonal antibody recognition of cAST versus mAST, the disclosure states improved sensitivity and specificity over enzymatic AST activity measurement. The method determines the concentration of at least one of cAST and mAST after incubating an antibody with a blood sample.

In some embodiments, the disclosure uses immunoassay formats including ELISA, including sandwich ELISA, as well as other immunoassays and rapid or multiplex formats. The disclosure further provides performance and biological validation described via comparisons, including ROC curve comparisons, and measured cAST/mAST levels in healthy and disease groups including chronic viral hepatitis, liver cirrhosis, and hepatocellular carcinoma. The monoclonal antibodies are specified as those deposited as KCTC 12483BP, KCTC 12484BP, and KCTC 12485BP for cAST/mAST detection.

Claims Coverage

The provided claims coverage describes 1 independent claim covering quantitative analysis of cAST and/or mAST using a monoclonal antibody incubated with a blood sample followed by determining analyte concentration.

The independent claim is directed to quantitative immunological determination of cAST and/or mAST from a blood sample using a monoclonal antibody produced by hybridoma cells deposited as KCTC 12483BP, KCTC 12484BP, or KCTC 12485BP, with the analyte concentration determined after antibody incubation.

Stated Advantages

Documented Applications