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

<h4>Background</h4>The LightCycler® 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 repro...

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Autores principales:	Shaheed V Omar, Andreas Roth, Nazir A Ismail, Linda Erasmus, Marthie Ehlers, Marleen Kock, Nuraan Paulse, Halima M Said, Anwar A Hoosen, Udo Reischl
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2011
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/f4ef01dd2b52451595260cb555cfa23e
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spelling	oai:doaj.org-article:f4ef01dd2b52451595260cb555cfa23e2021-11-04T06:08:04ZAnalytical performance of the Roche LightCycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species.1932-620310.1371/journal.pone.0024789https://doaj.org/article/f4ef01dd2b52451595260cb555cfa23e2011-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21961045/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>The LightCycler® 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.<h4>Methodology/principal findings</h4>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 LightCycler® 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.<h4>Significance</h4>The LightCycler® Mycobacterium Detection kit has shown to be a robust and accurate assay with the potential to be used as a rapid TB diagnostic test.Shaheed V OmarAndreas RothNazir A IsmailLinda ErasmusMarthie EhlersMarleen KockNuraan PaulseHalima M SaidAnwar A HoosenUdo ReischlPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 6, Iss 9, p e24789 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Shaheed V Omar Andreas Roth Nazir A Ismail Linda Erasmus Marthie Ehlers Marleen Kock Nuraan Paulse Halima M Said Anwar A Hoosen Udo Reischl Analytical performance of the Roche LightCycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species.
description	<h4>Background</h4>The LightCycler® 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.<h4>Methodology/principal findings</h4>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 LightCycler® 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.<h4>Significance</h4>The LightCycler® Mycobacterium Detection kit has shown to be a robust and accurate assay with the potential to be used as a rapid TB diagnostic test.
format	article
author	Shaheed V Omar Andreas Roth Nazir A Ismail Linda Erasmus Marthie Ehlers Marleen Kock Nuraan Paulse Halima M Said Anwar A Hoosen Udo Reischl
author_facet	Shaheed V Omar Andreas Roth Nazir A Ismail Linda Erasmus Marthie Ehlers Marleen Kock Nuraan Paulse Halima M Said Anwar A Hoosen Udo Reischl
author_sort	Shaheed V Omar
title	Analytical performance of the Roche LightCycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species.
title_short	Analytical performance of the Roche LightCycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species.
title_full	Analytical performance of the Roche LightCycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species.
title_fullStr	Analytical performance of the Roche LightCycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species.
title_full_unstemmed	Analytical performance of the Roche LightCycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species.
title_sort	analytical performance of the roche lightcycler® mycobacterium detection kit for the diagnosis of clinically important mycobacterial species.
publisher	Public Library of Science (PLoS)
publishDate	2011
url	https://doaj.org/article/f4ef01dd2b52451595260cb555cfa23e
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Analytical performance of the Roche LightCycler® Mycobacterium Detection Kit for the diagnosis of clinically important mycobacterial species.

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