Abstract: Hepatic status of a subject is determined by measuring the level of pi glutathione S-transferase (&pgr;GST) in a biological fluid such as bile or plasma from the subject by an immunoassay. An increased level of &pgr;GST as compared to a normal range of &pgr;GST indicates an abnormal condition of the liver. Measuring &pgr;GST level has particular application for determining the hepatic status of a liver transplant recipient because it enables detecting liver transplant rejection at a very early stage after transplantation. The immunoassay is preferably an enzyme immunoassay, and the entire immunoassay can be completed in 2.5 hours. The biological fluid may be diluted with a diluent which contains an effective amount of a protein such as serum albumin to optimize antibody-antigen reaction. When plasma is the fluid, the plasma should be collected and stored prior to the determination in the presence of an anti-coagulant under conditions which permit substantially no haemolysis.
Type:
Grant
Filed:
July 31, 1998
Date of Patent:
February 6, 2001
Assignee:
Biotrin Intellectual Properties, Ltd.
Inventors:
John Martin Doyle, Cormac Gerard Kilty, Fiona Mary Manning
Abstract: The present invention is drawn to a method for the rapid assessment of organ status, including organ damage following immunological or toxicological insult, in a subject based on the detection of one or more isoenzymes of glutathione S-transferase (GST) in diverse biological fluids comprising contacting a particle-labelled anti-GST antibody specific for said isoenzyme with a sample of a biological fluid suspected of containing said isoenzyme, said antibody having a sensitivity sufficient to detect at least a picomolar amount of said isoenzyme, and capturing the particle-labelled antibody-isoenzyme complex on an immobolised capture antibody to generate a visually detectable signal.