ArticleJournal of clinical pathology1999
Evaluation of three commercial detection systems for Mycobacterium tuberculosis where clinical diagnosis is difficult.
Article in Journal of clinical pathology, 1999. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Mycobacteriosis and Tuberculosis: Laboratory Diagnosis.The open microbiology journal · 2018Review
- Renal tuberculosis in the modern era.The American journal of tropical medicine and hygiene · 2013Review
- Performance assessment of the CapitalBio mycobacterium identification array system for identification of mycobacteria.Journal of clinical microbiology · 2012Article
- Performance assessment of the DR. MTBC Screen assay and the BD ProbeTec ET system for direct detection of Mycobacterium tuberculosis in respiratory specimens.Journal of clinical microbiology · 2006Article
- Comparison of the sodium hydroxide specimen processing method with the C18-carboxypropylbetaine specimen processing method using independent specimens with auramine smear, the MB/BacT liquid culture system, and the COBAS AMPLICOR MTB test.Journal of clinical microbiology · 2005Article
- Performance assessment of a nested-PCR assay (the RAPID BAP-MTB) and the BD ProbeTec ET system for detection of Mycobacterium tuberculosis in clinical specimens.Journal of clinical microbiology · 2004Article
- Clinical evaluation of the polymerase chain reaction for the rapid diagnosis of tuberculosis.Journal of clinical pathology · 2004Article
- Relevance of commercial amplification methods for direct detection of Mycobacterium tuberculosis complex in clinical samples.Journal of clinical microbiology · 2003Review
- Performance of an IS6110-based PCR assay and the COBAS AMPLICOR MTB PCR system for detection of Mycobacterium tuberculosis complex DNA in human lymph node samples.Journal of clinical microbiology · 2002Article
- Evaluation of Henes-PCR assay for Mycobacterium detection in different clinical specimens from patients with or without tuberculosis-associated HIV infection.Journal of clinical laboratory analysis · 2000Article
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo assess the performance of three commercially available Mycobacterium tuberculosis detection systems employing nucleic acid amplification, when applied directly to respiratory and non-respiratory specimens from patients where the diagnosis of tuberculosis is difficult using clinical and traditional bacteriological methods.
methods42 respiratory and 21 non-respiratory specimens were concentrated, examined with auramine staining, and cultured on Lowenstein-Jensen slopes. These specimens were also assayed using the Amplicor Mycobacterium tuberculosis test (AM) (Roche Diagnostic Systems), the Amplified Mycobacterium tuberculosis direct test (AMD) (Gen-Probe), and the LCx Mycobacterium tuberculosis assay (LMA) (Abbott Laboratories).
resultsAll three amplification systems used in this study gave specificities of 100% when used on respiratory specimens. When used on non-respiratory specimens, AM and LMA gave specificities of 100% and AMD 75%. With respiratory specimens the AM, AMD, and LMA systems gave sensitivities of 75%, 65.2%, and 79.2%, respectively. With non-respiratory specimens the sensitivities were 50%, 66.7%, and 60%, while with smear negative, culture positive specimens they were 33.3%, 66.7%, and 55.6%. Positive predictive values of 100% were seen with all specimens except non-respiratory specimens assayed using AMD where the value was 66.7%.
conclusionsThe manufacturers of these systems recommend that they should only be used for the direct analysis of respiratory specimens, and the US Food and Drug Administration has approved them for use only with smear positive specimens. This study confirms that sensitivities are lower for non-respiratory and smear negative specimens, but positive predictive values are high. Provided they are interpreted with caution, positive results with these tests in respiratory and non-respiratory specimens are useful in tuberculous patients who are otherwise difficult to diagnose. Each amplification has advantages and disadvantages compared with the others.
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