Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Patent
1995-11-01
1998-03-24
Zitomer, Stephanie W.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
435 912, 536 221, 536 243, 536 2532, C12Q 168, C12P 1934, C07H 2104, C07H 2100
Patent
active
057311501
ABSTRACT:
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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Mycobacterium tuberculosis insertion sequence IS6110, Accession X17348, M29899.
Mycobacterium smegmatis insertion sequence IS1137, Acession x70913.
Pseudomonas syringae insertion sequence IS51, Accession M14365.
Pseudomonas cepacia insertion sequence IS401, Accession L09108.
Escherichia coli transposon Tn3411, Accession M19532.
Agrobacterium tumefaciens Ti plasmid, Accession x55075.
Kline Bruce C.
Lewis Marcia E.
Roberts Glenn D.
Sandhu Gurpreet S.
Stockman Leslie
Blackburn Robert P.
Chiron Diagnostic Corporation
Kassel Mark A.
Morgenstern Arthur S.
Tung Joyce
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