Analytical performance of the Roche Lightcycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species

Show simple item record Omar, Shaheed Vally Roth, Andreas Ismail, Nazir Ahmed Erasmus, Linda Ehlers, Marthie Magdaleen Kock, Marleen M. Paulse, Nuraan Said, H.M. (Halima Mohammed) Hoosen, Anwar Ahmed Reischl, Udo 2011-10-12T07:20:29Z 2011-10-12T07:20:29Z 2011-09-22
dc.description.abstract BACKGROUND: The LightCyclerH Mycobacterium Detection Kit based on real-time PCR technology for the detection of Mycobacterium tuberculosis, Mycobacterium avium and Mycobacterium kansasii was recently developed. This study evaluated its analytical sensitivity, specificity and reproducibility. METHODOLOGY/PRINCIPAL FINDINGS: Plasmid standards were prepared and used to determine the limit of detection. The assay was also performed against organisms other than mycobacteria, other mycobacterial strains and interfering substances to exclude cross-reactivity and interference. Reference standards were prepared and tested to assess the assay’s reproducibility. All PCR assays were performed using the LightCyclerH 2.0 Instrument. The detection limit for M. tuberculosis was 28 copies per microlitre. Neither cross-reactivity nor interference occurred with non-mycobacterial organisms and substances tested. Overall reproducibility for consecutive measurements, run-to-run, lot-to-lot, day-to-day and laboratory-to-laboratory achieved a coefficient of variance of less than two percent. SIGNIFICANCE: The LightCyclerH Mycobacterium Detection kit has shown to be a robust and accurate assay with the potential to be used as a rapid TB diagnostic test. en_US
dc.description.uri en_US
dc.identifier.citation Omar SV, Roth A, Ismail NA, Erasmus L, Ehlers MM, Kock, MM, Paulse N, Said HM, Hoosen, AA, Reischl, U (2011) Analytical Performance of the Roche LightCyclerH Mycobacterium Detection Kit for the Diagnosis of Clinically Important Mycobacterial Species. PLoS ONE 6(9): e24789. Doi: 10.1371/journal.pone.0024789 en_US
dc.identifier.issn 1932-6203
dc.identifier.other 10.1371/journal.pone.0024789
dc.language.iso en en_US
dc.publisher Public Library of Science en_US
dc.rights © 2011 Omar et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. en_US
dc.subject Roche Lightcycler® Mycobacterium Detection Kit en_US
dc.subject Mycobacterium tuberculosis en_US
dc.subject Mycobacterium avium en_US
dc.subject Mycobacterium kansasii en_US
dc.subject.lcsh Tuberculosis -- Diagnosis en
dc.title Analytical performance of the Roche Lightcycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species en_US
dc.type Article en_US

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