In-house nucleic acid amplification tests for the detection of Mycobacterium tuberculosis in sputum specimens: meta-analysis and meta-regression

Flores, Laura L; Pai, Madhukar; Colford, John M.; Riley, Lee W.

doi:10.1186/1471-2180-5-55

Cited by 158 publications

(95 citation statements)

References 59 publications

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“…Previously published reports demonstrated that the sensitivity of NAAT could be increased either by changing the target (9,11,12) or by modifying the DNA extraction protocol (13). Our multicenter study demonstrated similarly increased sensitivity by improving the sample preparation and RNA stabilization.…”

Section: Resultssupporting

confidence: 59%

“…By center, the sensitivities of TRC-2 were 90.5%, 80%, and 89.5% for Rome, Parma, and Paris, respectively. These sensitivities were in the range of recently published values for traditional commercialized PCR assays: 83 to 96.7% for the Cobas Amplicor assay (Roche Diagnostics) and 85.7 to 97.8% for the AMTD2 assay (bioMérieux-Gen-Probe) on respiratory specimens (2,11,18,19).…”

Section: Resultsmentioning

confidence: 69%

“…The only AFS-positive extrapulmonary specimen was also TRC-2 positive. The sensitivity of TRC-2 for extrapulmonary specimens was higher than the published sensitivities of in-house PCR assays for such specimens (2,11,18,19), despite the low number of specimens tested. Comparison with the BD-Probe Tec assay demonstrated that more specimens were BD-Probe Tec positive than TRC-2 positive (data not shown).…”

Section: Resultsmentioning

confidence: 70%

“…Comparison with the BD-Probe Tec assay demonstrated that more specimens were BD-Probe Tec positive than TRC-2 positive (data not shown). However, numerous specimens were culture negative, giving a specificity of 87.2%, which is lower than the specificities of TRC-2 (95.7%) and other commercialized assays (2,11,18,19).…”

Section: Resultsmentioning

confidence: 82%

“…However, NAAT developed for the rapid diagnosis of TB has never achieved the same sensitivity as culture (2,5,11,18,19). In addition, NAAT tests have been time-consuming, despite the fact that some approaches are now partially automated (Cobas Amplicor) (1,9).…”

mentioning

confidence: 99%

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Multicenter Evaluation of a Transcription-Reverse Transcription Concerted Assay for Rapid Detection of Mycobacterium tuberculosis Complex in Clinical Specimens

et al. 2009

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A European multicenter study was performed to evaluate the performance of a new method, based on the transcription-reverse transcription concerted reaction (TRC-2), which enabled one-step amplification and real-time detection of the Mycobacterium tuberculosis 16S rRNA target directly in clinical specimens. A total of 633 respiratory and nonrespiratory specimens were tested, and the results were compared with those from smears and cultures. A total of 129 patients (Paris center) were followed up in order to evaluate the clinical performance of TRC-2. By using M. tuberculosis complex strains to inoculate sterile sputa, the detection limit of TRC-2 was found to be 30 to 50 CFU/ml. A total of 548 respiratory specimens and 59 extrapulmonary specimens were assessable. For pulmonary specimens, the sensitivities of TRC-2 and acid-fast smear were 86.8% and 50.4%, respectively (P ‫؍‬ 0.002). The specificities were 97.5% and 100%, respectively. For extrapulmonary specimens, the sensitivities of TRC-2 and acid-fast smear were 83.3% and 8.3% (P < 0.0001), and the specificities were 95.8% and 100%, respectively. Fifteen of 129 patients were diagnosed with pulmonary tuberculosis (TB). The sensitivities of culture and TRC-2 were 80% (12/15) and 86.7% (13/15) (P ‫؍‬ 0.16), and the specificities were 100% and 93.9%, respectively. Based on an 11.6% incidence of TB in our population, the positive predictive values of TRC-2 and culture were 81.3% and 100%, respectively, and the negative predictive values were 98.2% and 97.4%, respectively. These results demonstrated that detection of M. tuberculosis complex in clinical specimens by TRC-2 with ready-to-use reagents was an efficient and rapid method for the diagnosis of pulmonary and extrapulmonary TB.Accurate and early diagnosis of tuberculosis (TB) remains a critical step in the management and control of TB (22). To this day, the primary rapid tool in case detection remains the microscopic examination of clinical specimens in order to detect acid-fast bacilli. The advantages and disadvantages of the acidfast smear (AFS) are well defined in the literature. Although culture is considered the gold standard, it has the major disadvantage of requiring 2 to 6 weeks to obtain a result, since mycobacteria are slow-growing organisms (5). The use of an approach combining smear microscopy and specific identification at the same time will enhance predictive values for the rapid diagnosis of TB.Nucleic acid amplification technology (NAAT) tests represent an important technical advance for microbiology laboratories. However, NAAT developed for the rapid diagnosis of TB has never achieved the same sensitivity as culture (2,5,11,18,19). In addition, NAAT tests have been time-consuming, despite the fact that some approaches are now partially automated (Cobas Amplicor) (1, 9). These systems are more rapid than culture-based methods, but they can still require up to 12 h and a series of complicated procedures to get the results. They need a high level of expertise from experienced and dedicated techni...

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Section: Resultssupporting

confidence: 59%