Evaluation of Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche PCR-microwell plate hybridization method (AMPLICOR MYCOBACTERIUM) for direct detection of mycobacteria

Ichiyama, Satoshi; Iinuma, Yoshitsugu; Tawada, Yukio; Yamori, Sadaaki; Hasegawa, Yoshinori; Shimokata, Kaoru; Nakashima, Naoki

doi:10.1128/jcm.34.1.130-133.1996

Cited by 62 publications

(16 citation statements)

References 31 publications

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“…The high sensitivity (94%) and specificity (100%) are similar to results reported in other studies. Ichiyama et al reported 97% sensitivity and 98.7% specificity, however Vuorinen et al reported slightly lower sensitivity of 84.6% and specificity of 99.1% using similar commercially available PCR (Amplicor) with IS6110 as a target site for laboratory diagnosis 17,18 .…”

Section: Discussionmentioning

confidence: 99%

The Role of Polymerase Chain Reaction (PCR) in Diagnosis of Spine Tuberculosis after Pre-operative Anti-tuberculosis Treatment

Rudresha¹,

Ibrahim²,

Cc³

et al. 2011

MOJ

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Objective:The aim of this study was to evaluate the role of polymerase chain reaction (PCR) in the diagnosis of spinal tuberculosis after 2 weeks of preoperative anti-tuberculosis treatment and to compare PCR to the Löwenstein -Jensen Culture (LJC) and histopathological examination (HPE) methods. Methods: Twenty-five patients were included in this study. Sixteen patients were diagnosed and treated for spinal tuberculosis based on clinical and radiological evidence. Nine patients were controls. The LJC method and HPE of the specimen were performed according to hospital protocol. PCR was performed using primer encoding insertion of sequences IS6110 for mycobacterium tuberculosis complex. Clinical findings and radiological features were the gold standard for comparison. Results: PCR results were 15 positive and one negative. The sensitivity and specificity of PCR was 94% and 100% respectively (with 95% confidence interval [CI] 67% to 99% and 63% to 100%, respectively). HPE results showed 13 were positive and 3 negative in the spinal tuberculosis group; for the control group, all were negative. Sensitivity and specificity value of HPE was 82 % and 100% respectively (with 95% confidence interval [CI] 54% to 95% and 63% to 100%, respectively). Use of LJC showed only one was positive and 15 were negative in the spinal tuberculosis group whole all nine in the control group were negative. Sensitivity and specificity value of LJC was 6% and 100% respectively (with 95% confidence interval [CI] 0.3% to 32% and 63% to 100%, respectively). Conclusion: Our findings showed that the PCR for Mycobacterium tuberculosis is reliable as a method for diagnosis of spinal tuberculosis, even after of 2 weeks of anti-TB treatment, with an overall sensitivity of 94% and specificity of 100%.

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Section: Discussionmentioning

confidence: 99%

The Role of Polymerase Chain Reaction (PCR) in Diagnosis of Spine Tuberculosis after Pre-operative Anti-tuberculosis Treatment

Rudresha¹,

Ibrahim²,

Cc³

et al. 2011

MOJ

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“…The sensitivities and specificities of these products have been reported to be similar, i.e., ranging from approximately 67 to 94% sensitivity and from 94 to 100% specificity. As has recently been noted, very few studies have provided a direct comparison of these two products (22,52). Evaluation of the published studies is therefore difficult given the wide range of protocols, reference methods, and study populations (19).…”

Section: Discussionmentioning

confidence: 99%

“…The PCR for the detec-tion of M. tuberculosis has been directed at both genomic DNA (46) and species-specific regions of 16S rRNA (Roche Amplicor) (13,14,34). Recently, several investigators have evaluated the Mycobacterium Tuberculosis Direct test (MTD; Gen-Probe, Inc., San Diego, Calif.), which couples transcriptionmediated amplification to Accuprobe detection technology (8,22,23,35). The U.S. Food and Drug Administration (FDA) has recently approved both Amplicor and MTD for testing of smear-positive specimens.…”

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confidence: 99%

Performance of an automated Q-beta replicase amplification assay for Mycobacterium tuberculosis in a clinical trial

Smith¹,

Radcliffe²,

Rigby³

et al. 1997

J Clin Microbiol

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We present data from a clinical trial study in which an automated version (Galileo) of a previously described Q-Beta replicase-amplified probe assay (J. S. Shah et al., J. Clin. Microbiol. 33:1435-1441, 1995) was used for the direct detection of Mycobacterium tuberculosis complex in sputum. The assay was designed to target specific regions of 23S rRNA found in M. tuberculosis, Mycobacterium bovis, Mycobacterium africanum, and Mycobacterium microti and had a sensitivity ranging from approximately <10 to 300 CFU. The assay was tested for cross-hybridization by using large numbers (e.g., 10 5 to 10 10 CFU/assay) of 133 other organisms commonly found in respiratory tract samples, including non-M. tuberculosis Mycobacterium spp., other bacteria, fungi, and viruses. All of these competitors tested negative by the assay. Automated assay results for 780 respiratory tract samples (sputum or bronchoalveolar lavage specimens) collected and tested at three trial sites in the United States) were compared with the results of culture and acid-fast microscopy. Aliquots of conventionally digested and decontaminated sputum pellets were heated at 100°C and mechanically disrupted prior to hybridization and background reduction, amplification, and detection in a closed disposable test pack. Pertinent elements of individual patient histories relating to tuberculosis exposure, previous active disease, antituberculosis therapy status, etc., were considered in the resolution of discrepant results for 48 (assay false-positive) samples. Seventy-one of 90 (78.9%) culture-positive samples were positive when tested in the Galileo assay, while 7% of culture-negative samples were assay positive, corresponding to a sensitivity of 79% and a specificity of 93%. Following resolution of discrepant results by chart review, the sensitivity and specificity for the Q-Beta replicase amplification assay with the Galileo analyzer were 84 and 97%, respectively. A total of 69.2% of smear-negative (culture positive) samples were detected by the assay. Ten test packs at a time were automatically processed by the Galileo analyzer without operator intervention following loading of samples. The first result was reported in approximately 3 h, and the last result was available in 6.5 h. To our knowledge, this is the first report of a clinical study with a fully automated amplification probe hybridization assay for the detection of pathogens directly from a clinical specimen.

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“…The addition of nucleic acid amplification technology to the microbiology laboratories has resolved many of these problems. The exquisite sensitivity and specificity of these methods allow the accurate detection of very small number of microorganisms (Ichiyama et al, 1996and Jackson et al, 1996and Whelen et al, 1995. In selected situations, the limitation imposed by the inability of an organism to be cultured and the selection of appropriate media and culture conditions may be replaced by the use of nucleic acid amplification.…”

Section: Application Of Nucleic Acid Amplification Technologymentioning

confidence: 99%

<b>Nucleic Acid Amplification as used in the Diagnosis and Management of Viral Diseases: A <i>Review</i></b>

Auwal¹

2014

Bayero J. Pure App. Sci.

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Diagnostic virology is of great importance particularly in disease management and for epidemiological purposes, but is slow and results are obtained when the patient has recovered or succumbed to the infection. In addition, consideration of antiviral chemotherapy is in short supply even where preliminary investigation results are available. Some viruses are highly unculturable, fastidious or hazardous to the laboratory personnel and diagnosis depends on serological methods or culture in an expensive bio-safety level. Molecular diagnostic techniques do not depend on pathogen isolation or growth or on the detection of an immune response to the pathogen, rather uses genotypic characteristics to identify specific pathogen. Nucleic acid of a given pathogen is unique, and therefore nucleic acid analysis can be used for unequivocal identification via amplification to increase the amount of material available for analysis. Nucleic acid-based diagnostic methods are extremely sensitive, reliable and to some extent affordable, and are widely used for clinical microbiology to detect pathogen.

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Evaluation of Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche PCR-microwell plate hybridization method (AMPLICOR MYCOBACTERIUM) for direct detection of mycobacteria

Cited by 62 publications

References 31 publications

The Role of Polymerase Chain Reaction (PCR) in Diagnosis of Spine Tuberculosis after Pre-operative Anti-tuberculosis Treatment

The Role of Polymerase Chain Reaction (PCR) in Diagnosis of Spine Tuberculosis after Pre-operative Anti-tuberculosis Treatment

Performance of an automated Q-beta replicase amplification assay for Mycobacterium tuberculosis in a clinical trial

<b>Nucleic Acid Amplification as used in the Diagnosis and Management of Viral Diseases: A <i>Review</i></b>

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