Prospective evaluation of BDProbeTec strand displacement amplification (SDA) system for diagnosis of tuberculosis in non-respiratory and respiratory samples
Open Access
- 1 December 2004
- journal article
- research article
- Published by Microbiology Society in Journal of Medical Microbiology
- Vol. 53 (12), 1215-1219
- https://doi.org/10.1099/jmm.0.45780-0
Abstract
Nucleic acid amplification techniques (NAATs) have been demonstrated to make significant improvements in the diagnosis of tuberculosis (TB), particularly in the time to diagnosis and the diagnosis of smear-negative TB. The BD ProbeTec strand displacement amplification (SDA) system for the diagnosis of pulmonary and non-pulmonary tuberculosis was evaluated. A total of 689 samples were analysed from patients with clinically suspected TB. Compared with culture, the sensitivity and specificity for pulmonary samples were 98 and 89 %, and against final clinical diagnosis 93 and 92 %, respectively. This assay has undergone limited evaluation for non-respiratory samples and so 331 non-respiratory samples were tested, identifying those specimens that were likely to yield a useful result. These were CSF (n = 104), fine needle aspirates (n = 64) and pus (n = 41). Pleural fluid (n = 47) was identified as a poor specimen. A concern in using the SDA assay was that low-positive samples were difficult to interpret; 7.8 % of specimens fell into this category. Indeed, 64 % of the discrepant results, when compared to final clinical diagnosis, could be assigned as low-positive samples. Specimen type did not predict likelihood of a sample being in the low-positive zone. Although the manufacturers do not describe the concept of a low-positive zone, we have found that it aids clinical diagnosis.This publication has 17 references indexed in Scilit:
- Improved Sensitivity of Nucleic Acid Amplification for Rapid Diagnosis of Tuberculous MeningitisJournal of Clinical Microbiology, 2004
- Tuberculosis: amplification-based clinical diagnostic techniquesThe International Journal of Biochemistry & Cell Biology, 2003
- Evaluation of the BDProbeTec ET System for Direct Detection of Mycobacterium tuberculosis in Pulmonary and Extrapulmonary Samples: a Multicenter StudyJournal of Clinical Microbiology, 2003
- Tuberculous pleural effusionsEuropean Journal of Internal Medicine, 2003
- An evaluation of the BD ProbeTec ET system for the direct detection of Mycobacterium tuberculosis in respiratory samplesJournal of Medical Microbiology, 2002
- A clinical, microbiological and economic analysis of a national service for the rapid molecular diagnosis of tuberculosis and rifampicin resistance in Mycobacterium tuberculosisJournal of Medical Microbiology, 2000
- Length of time to laboratory diagnosis of Mycobacterium tuberculosis infection: Comparison of in-house methods with reference laboratory resultsJournal of Infection, 1999
- Direct detection of Mycobacterium tuberculosis complex in clinical samples from patients in Norway by ligase chain reactionJournal of Clinical Microbiology, 1997
- Detection of Mycobacterium tuberculosis in respiratory specimens by strand displacement amplification of DNAJournal of Clinical Microbiology, 1996
- Evaluation of Amplicor PCR for direct detection of Mycobacterium tuberculosis from sputum specimensJournal of Clinical Microbiology, 1995