Abstract: A method for predicting a need for Renal Replacement Therapy (RRT) in a patient comprises: determining a concentration of pi glutathione S transferase-(?GST) in a first urine sample from the patient; and wherein a need for RRT is predicted when the ?GST concentration is determined to be elevated in comparison to a patient without kidney injury. The method according to the invention can further comprise detecting for the presence of risk factors for RRT in a patient, the risk factors including elevated serum creatinine concentration, type I diabetes, type II diabetes, hypertension, dyslipidemia, hyperglycaemia, proteinuria and hypoalbuminemia.

Abstract: A method for the early identification and prediction of abrupt reduction in kidney function in a patient undergoing cardiothoracic (CT) surgery, including Cardio-Pulmonary Bypass (CPB), comprises contacting a urine sample from the patient with a capture molecule for a biomarker, especially ?GST specific for the distal region of the renal tubule and which biomarker is released from said region when there is damage to said region indicative and predictive of an abrupt reduction in kidney function, the biomarker being detectable as early as intraoperatively or in the recovery stage post CT surgery, for example prior to transfer of the patient to the Intensive Care Unit (ICU), allowing for immediate corrective medical intervention. The method can be used to detect Acute Kidney Injury (AKI) and a requirement for Renal Replacement Therapy (RRT) namely dialysis, earlier than two hours post CT surgery and as early as zero hours post or during CT surgery or CPB.

Abstract: A method for predicting a need for Renal Replacement Therapy (RRT) in a patient comprises: determining a concentration of pi glutathione S transferase-(?GST) in a first urine sample from the patient; and wherein a need for RRT is predicted when the ?GST concentration is determined to be elevated in comparison to a patient without kidney injury. The method according to the invention can further comprise detecting for the presence of risk factors for RRT in a patient, the risk factors including elevated serum creatinine concentration, type I diabetes, type II diabetes, hypertension, dyslipidemia, hyperglycaemia, proteinuria and hypoalbuminemia.

Abstract: A method of assessing kidney function in a human subject to aid in the diagnosis of renal tubule diseases or conditions specific to a particular renal tubule region, comprises contacting a urine sample from said subject with a panel of capture molecules, each capture molecule being capable of binding to a specific biomarker from at least one of the four major regions of the renal tubule, in particular the proximal, distal, collecting duct and loop of Henle regions, the detection of one or more biomarkers in the urine sample being indicative of damage in a corresponding region of the renal tubule. The method facilitates inter alia the non-invasive detection of renal tubule damage and serves as a prognostic method to determine the level of tubule damage and monitor the effectiveness of therapeutic treatment.

Abstract: A method for detecting human parvovirus/erythrovirus antigen in a sample comprises contacting a buffer having a pH in the range 3.0 to 4.0, suitably a citrate/trisodium citrate buffer, with the sample followed by the measurement of the antigen. The measurement of the antigen can be by virus capture enzyme immunoassay. The method is a good indicator of recent infection and can be used in the screening of individual plasma units or pools from which blood products are extracted.

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.

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.

Abstract: Stabilizing medium for urinary .alpha.GST contains a stabilizing amount of a non-enzyne protein, such as a mixture of equal amounts (w/v) of bovine serum albumin and gelatin hydrolysate, chelating agent and a buffer, such that the medium has a pH in the range 7.0-7.5, the medium being effective to prevent loss of .alpha.GST immunological activity. The stabilizing medium can be used to store urine samples at temperatures of the order of -20.degree. C. without any loss of .alpha.GST immunoreactivity of the type observed in samples which are stored without such a stabilizing medium. The stabilizing medium also improves the immunoreactivity of .alpha.GST when added to fresh urine which is stored temporarily at 2-8.degree. C. prior to assay for up to two hours.