Comparison of the Roche AMPLICOR MYCOBACTERIUM assay and Digene SHARP Signal System with in-house PCR and culture for detection of Mycobacterium tuberculosis in respiratory specimens.

Journal of Clinical Microbiology
T S HuangD L Cheng

Abstract

Two commercial primer kits and detection systems, the Roche AMPLICOR MYCOBACTERIUM test and the Digene primer-probe kit with the SHARP Signal System, were compared to in-house PCR as well as standard culture techniques. For the 27 culture-positive specimens, the Roche AMPLICOR MYCOBACTERIUM test detected 20 specimens, the Digene system detected 19, and in-house PCR detected 21. Of the 86 culture-negative specimens, 13 were positive by the Roche AMPLICOR MYCOBACTERIUM test, 16 were positive by the Digene system, and 21 were positive by in-house PCR. When clinical situations were evaluated, 11 of 13 culture-negative Roche AMPLICOR MYCOBACTERIUM test-positive specimens, 10 of 16 culture-negative Digene system-positive specimens, and 13 of 21 culture-negative-in-house PCR-positive specimens were diagnosed as true-positive specimens. The sensitivities of Roche AMPLICOR MYCOBACTERIUM test, the Digene system, and in-house PCR were 73.81, 69.05, and 80.95%, and the specificities were 97.18, 91.55 and 88.73%, respectively. The positive predictive values were 93.94, 82.86, and 80.95%, and the negative predictive values were 86.25, 83.33, and 88.73%, respectively. For the commercial kits, the Roche AMPLICOR MYCOBACTERIUM test seems to be ...Continue Reading

References

Nov 1, 1991·The American Review of Respiratory Disease·K D EisenachJ T Crawford
Oct 1, 1990·Journal of Clinical Microbiology·U SjöbringH Miörner
Sep 1, 1994·The Journal of Infectious Diseases·N KennedyS Wilson
Jul 1, 1994·Journal of Clinical Microbiology·B A Forbes, K E Hicks

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Citations

Nov 12, 2005·European Journal of Clinical Microbiology & Infectious Diseases : Official Publication of the European Society of Clinical Microbiology·V C C ChengK Y Yuen
Mar 1, 2008·The Korean journal of laboratory medicine·Young Jin KimChulhun L Chang
Aug 5, 2009·Molecular Diagnosis & Therapy·Seetha V BalasinghamTone Tønjum
May 16, 2002·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·S BartolomeW Bartholomew
May 14, 2003·Diagnostic Microbiology and Infectious Disease·Tsi-Shu HuangYung-Ching Liu

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