Chiron Diagnostic Corporation

Leslie Stockman

Gurpreet S Sandhu

Bruce C Kline

Marcia E Lewis

Glenn D Roberts

The detection of the IS6110 insertion element in a clinical specimen is a rapid way of diagnosing infection by Mycobacterium tuberculosis. A reliable diagnostic test for tuberculosis based on the IS6110 DNA is described in this disclosure. A 'Universal' specimen preparation protocol that eliminates live organisms and purifies nucleic acids from all types of clinical specimens is described. Two nucleic acid primers designed to amplify IS6110 DNA with high specificity in a polymerase chain reaction are also described. The amplified IS6110 DNA is identified by a restriction endonuclease and electrophoresis based assay. The identification process also renders the DNA unamplifiable in a subsequent PCR, thereby reducing the possibility of contaminating other specimens. Time, labor and cost is minimized, while user safety and test reliability are maximized. The complete DNA extraction, amplification and analysis is accomplished with ease within an 8 hour period, with a sensitivity of 92% and a specificity approaching 100%. Testing of serially obtained samples from the same patient increases the overall rate of detection to 100%.

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Rochester, MN, United States of America

Leslie Stockman