Evaluation of two commercial amplification assays for detection ofMycobacterium tuberculosis complex in respiratory specimens

Žolnir-Dovč, Manca; Poljak, Mario; Seme, Katja; A, Rus; Avšič–Županc, Tatjana

doi:10.1007/bf01781200

Cited by 8 publications

(7 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[12][13][14][15] In these studies between 10.5% and 34.1% of the tested specimens were positive for M tuberculosis. The specificity of the LCx Mycobacterium tuberculosis assay has been reported by its manufacturer 9 to be 99.3% for 1971 respiratory specimens, of which 8% were culture positive.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have reported the sensitivities for both the Amplicor Mycobacterium tuberculosis test and the Amplified Mycobacterium tuberculosis direct test to be between 80% and 99% when used to test microscopy positive respiratory specimens. [12][13][14][15] The LCx Mycobacterium tuberculosis assay is claimed by its manufacturers to have a sensitivity of 93.7% 9 with similar specimens, and other reports have shown sensitivities between 90.8% and 90.2%. 8 16 In our present study, the results for the Amplicor Mycobacterium tuberculosis test for specimens that were both microscopy positive and culture positive were similar to those reported by others.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of three commercial detection systems for Mycobacterium tuberculosis where clinical diagnosis is difficult.

1999

View full text Add to dashboard Cite

Aims-To assess the performance of three commercially available Mycobacterium tuberculosis detection systems employing nucleic acid amplification, when applied directly to respiratory and nonrespiratory specimens from patients where the diagnosis of tuberculosis is difficult using clinical and traditional bacteriological methods. Methods-42 respiratory and 21 nonrespiratory 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). Results-All 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 nonrespiratory 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 nonrespiratory specimens assayed using AMD where the value was 66.7%. Conclusions-The 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 diYcult to diagnose. Each amplification has advantages and disadvantages compared with the others. (J Clin Pathol 1999;52:193-197)

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Evaluation of three commercial detection systems for Mycobacterium tuberculosis where clinical diagnosis is difficult.

1999

View full text Add to dashboard Cite

show abstract

“…A limited number of comparisons of DATs developed for the commercial market have been reported, [5][6][7] but their application in the routine laboratory setting has not been adequately addressed. The first-generation Gen-Probe Amplified Mycobacterium Tuberculosis Direct (MTD) test (Gen-Probe, San Diego, Calif) and the Roche Molecular AMPLICOR MTB system (Roche Molecular Systems, Branchburg, NJ) are approved by the US Food and Drug Administration for the detection of MTB complex (M tuberculosis, Mycobacterium bovis, including BCG strain, Mycobacterium microti, and Mycobacterium africanum) in acid-fast smear-positive respiratory specimens collected from untreated patients.…”

Section: -2 and Laboratoriesmentioning

confidence: 99%

Comprehensive Evaluation of Performance, Laboratory Application, and Clinical Usefulness of Two Direct Amplification Technologies for the Detection ofMycobacterium tuberculosisComplex

Della‐Latta

Whittier

1998

Am J Clin Pathol

View full text Add to dashboard Cite

A b s t r a c t The rapid detection of Mycobacterium tuberculosis from respiratory specimens is critical for optimal treatment of patients. Several nucleic acid amplification-based systems designed to detect3 Nevertheless, reliance on growth-dependent techniques that can be insensitive and lengthy (2-8 weeks) have placed the laboratory in a retrospective diagnostic picture. The advent of nucleic acid amplification technology and its application to the diagnostic arena promises sweeping changes that place the laboratory in a pivotal position to directly influence the clinical diagnosis of TB by providing same-day detection of the pathogen.The ultrasensitive nature of the direct amplification tests (DATs) makes them susceptible to false-positive reactions, particularly with unstandardized "home-brew" polymerase chain reaction (PCR) systems, 4 underscoring the need for assays that provide accurate reproducible results under controlled conditions. Several manufacturers have simplified and standardized molecular technology by formulating userfriendly commercial kits marketed for use in the routine clinical microbiology laboratory for the detection of MTB complex in respiratory specimens. These assays are designed to supplement, not replace, culture, which remains essential for drug susceptibility testing, detection of nontuberculous mycobacteria (NTM), and fingerprinting of MTB strains for epidemiologic investigations or documentation of specimen cross-contamination. Nevertheless, in-house PCR test systems persist, offering less costly alternatives to commercial systems in exchange for reduction in interlaboratory correlation and standardization.

show abstract

“…The Amplified Mycobacterium Tuberculosis Direct Test (AMTDT 2; Gen Probe, USA) and the Cobas Amplicor Mycobacterium Tuberculosis Test (Roche, Switzerland) are highly standardized and automated second-generation assays for detection of Mycobacterium tuberculosis, with reported sensitivities of 86-100% and 83-98%, and specificities of 94-100% and 92-100%, respectively [1,[3][4][5]. Following studies in which controversial results were obtained with various amplification assays, the role of these assays in monitoring treatment response remains undefined [6][7][8][9].…”

Section: Introductionmentioning

confidence: 99%

“…Amplification assays have been shown to enhance the rapid diagnosis of pulmonary tuberculosis [1][2][3]. The Amplified Mycobacterium Tuberculosis Direct Test (AMTDT 2; Gen Probe, USA) and the Cobas Amplicor Mycobacterium Tuberculosis Test (Roche, Switzerland) are highly standardized and automated second-generation assays for detection of Mycobacterium tuberculosis, with reported sensitivities of 86-100% and 83-98%, and specificities of 94-100% and 92-100%, respectively [1,[3][4][5].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Commercial DNA and rRNA Amplification Assays for Assessment of Treatment Outcome in Pulmonary Tuberculosis Patients

Rajalahti

Vuorinen

Liippo

et al. 2001

Eur J Clin Microbiol Infect Dis

View full text Add to dashboard Cite

To evaluate the clinical utility of the DNA and RNA amplification assays in monitoring the efficacy of tuberculosis treatment, 416 sputum specimens collected from 15 smear-positive tuberculosis patients during and after treatment were tested for the presence of Mycobacterium tuberculosis by microscopy, culture, polymerase chain reaction (Cobas Amplicor Mycobacterium Tuberculosis Test; Roche, Switzerland) and AMTDT 2 (Amplified Mycobacterium Tuberculosis Direct Test; Gen Probe, USA). All patients were cured, and no relapses were found. Results of both amplification assays re mained positive longer than results of either smear or culture. Four of 15 patients were positive by polymerase chain reaction and/or AMTDT 2 at the completion of treatment. Subsequent sputum specimens from these patients converted to negative within 2.5-12 months. The present data do not support the routine use of qualitative amplification assays for monitoring the treatment response of smear-positive tuberculosis patients.

show abstract

Evaluation of two commercial amplification assays for detection ofMycobacterium tuberculosis complex in respiratory specimens

Cited by 8 publications

References 21 publications

Evaluation of three commercial detection systems for Mycobacterium tuberculosis where clinical diagnosis is difficult.

Evaluation of three commercial detection systems for Mycobacterium tuberculosis where clinical diagnosis is difficult.

Comprehensive Evaluation of Performance, Laboratory Application, and Clinical Usefulness of Two Direct Amplification Technologies for the Detection ofMycobacterium tuberculosisComplex

Evaluation of Commercial DNA and rRNA Amplification Assays for Assessment of Treatment Outcome in Pulmonary Tuberculosis Patients

Contact Info

Product

Resources

About