AS A FUNCTION OF ETHYLENE OXIDE STERILIZATION AND STORAGE TIME.

AS A FUNCTION OF ETHYLENE OXIDE STERILIZATION AND STORAGE TIME.PRIMARY BILIARY CIRRHOSIS (PBC) IS A DEGENERATIVE LIVER DISEASE OF UNKNOWN ETIOLOGY WHICH FREQUENTLY RESULTS IN DEATH WITHIN 5 TO 10 YEARS OF THE ONSET OF SYMPTOMS. LABORATORY DIAGNOSIS OF PBC IS CURRENTLY BASED UPON HISTOLOGICAL FINDINGS IN BIOPSY MATERIAL AND DETECTION OF SERUM ANTIMITOCHONDRIAL ANTIBODIES (AMA) BY IMMUNOFLUORESCENT STAINING OF UNFIXED TISSUE. AS CURRENTLY PERFORMED, NEITHER PROCEDURE CAN RELIABLY DIFFERENTIATE PBC FROM CHRONIC ACTIVE HEPATITIS OR OTHER AUTOIMMUNE DISORDERS. SINCE AMA ARE PRESENT IN 99% OF PBC SERA AND IN A VERY SMALL PERCENTAGE OF THE GENERAL POPULATION, THE USE OF AMA AS A DIAGNOSTIC CRITERION IS WARRANTED PROVIDED THAT APPROPRIATE LABORATORY TECHNIQUES ARE AVAILABLE. THEREFORE, IT IS PROPOSED THAT AN IMPROVED METHODOLOGY BE DEVELOPED FOR THE DETECTION OF SPECIFIC AMA WHICH ARE PRESENT IN PBC SERA BUT NOT IN CHRONIC LIVER DISEASES OR AUTOIMMUNE DISORDERS. PRELIMINARY RESULTS HAVE IDENTIFIED A MITOCHONDRIAL ANTIGEN WHICH REACTS WITH 90% OF THE PBC SERA TESTED BY IMMUNO BLOT TRANSFER. CROSS-REACTIVITY WITH OTHER CHRONIC LIVER DISEASES WAS LESS THAN 10% UNDER APPROPRIATE ASSAY CONDITIONS. FURTHER PURIFICATION OF THE PBC-SPECIFIC ANTIGEN AND OPTIMIZATION OF THE IMMUNOASSAY PROCEDURES SHOULD PROVIDE A RELIABLE DIAGNOSTIC TECHNIQUE FOR PBC WHICH CAN BE MADE AVAILABLE TO THE