AS A FUNCTION OF ETHYLENE OXIDE STERILIZATION AND STORAGE TIME.

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$50,000.00
Award Year:
1985
Program:
SBIR
Phase:
Phase I
Contract:
n/a
Award Id:
2944
Agency Tracking Number:
2944
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
20 Staniford Street, Boston, MA, 02114
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
JAMES B. HUGHES
PRINCIPAL INVESTIGATOR
(617) 742-2010
Business Contact:
() -
Research Institute:
n/a
Abstract
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

* information listed above is at the time of submission.

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