Statement of the Tuberculosis Committee of the Infectious Diseases Society of America

Wolinsky, Emanuel

doi:10.1093/clind/16.5.627

Cited by 18 publications

(8 citation statements)

References 1 publication

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The negative results obtained by the nucleic acid amplification methods for culture-positive specimens may perhaps be explained by the presence of inhibitors of enzymatic amplification reactions, as earlier reported for different PCR applications (3,5,19). The unequal distribution of bacteria in specimens with a low target number is another possible explanation.…”

Section: Discussionmentioning

confidence: 71%

Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche Amplicor Mycobacterium Tuberculosis Test

et al. 1995

View full text Add to dashboard Cite

Two hundred and fifty-six sputum, bronchoalveolar lavage, and bronchial and tracheal aspirate specimens from 243 patients were tested for the presence of Mycobacterium tuberculosis complex by auramine fluorochrome staining, rRNA target amplification (Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test [AMTD]), and PCR (Roche Amplicor Mycobacterium Tuberculosis Test [Amplicor PCR]). The results were compared with those of conventional Löwenstein-Jensen tube culture and BACTEC radiometric liquid culture. A total of 26 specimens from 18 patients were culture positive for M. tuberculosis. In addition, seven specimens were positive by staining and by culture for other Mycobacterium species but negative by nucleic acid amplification methods and were not included in the comparison. When compared with that for culture, the sensitivities of the techniques were as follows: for staining, 80.8%; for Gen-Probe AMTD, 84.6%; and for Roche Amplicor PCR, 84.6%. The specificities were 99.1, 98.7, and 99.1%, respectively. After resolution of discrepant results by review of the patients' clinical data, 29 specimens from 21 patients were considered positive, and the overall sensitivities, specificities, and positive and negative predictive values were 89.7, 100, 100, and 98.7% for culture; 75.9, 99.5, 95.7, and 96.9% for staining; 86.2, 100, 100, and 98.2% for Gen-Probe AMTD; and 82.8, 100, 100, and 97.9% for Roche Amplicor PCR, respectively. It is concluded that both nucleic acid amplification methods are rapid, sensitive, and specific methods for the detection of M. tuberculosis in respiratory specimens.

show abstract

Section: Discussionmentioning

confidence: 71%

Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche Amplicor Mycobacterium Tuberculosis Test

et al. 1995

View full text Add to dashboard Cite

show abstract

“…The four false-negative results (three in the NALC series and one in the SDS series) may be explained by (i) the presence of possible amplification inhibitors in the sample, analogous to those reported for PCR protocols in which inhibition of the enzyme reaction is a well-known drawback (18,21,24); (ii) nonuniform distribution of microorganisms in the test suspension, since M. tuberculosis is known to form cords and clumps (14,15); and (iii) the failure of RNA synthesis due to poor viability of the cells as demonstrated by the extremely long period until detection of these particular isolates in culture (6 to 8 weeks) and their overall poor growth (one to three colonies formed on solid media). On the other hand, it is less likely that any medication led to nondetectability of the mycobacteria, as the majority of the positive specimens in this study was obtained from patients receiving standard anti-TB therapy.…”

Section: Mtdmentioning

confidence: 67%

Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by a target-amplified test system

et al. 1994

View full text Add to dashboard Cite

A total of 938 respiratory specimens (633 sputa, 249 bronchial and tracheal aspirates, and 56 bronchoalveolar lavages) from 589 patients were tested for direct detection of Mycobacterium tuberculosis complex by the Gen-Probe amplified Mycobacterium tuberculosis direct test (MTD), and the results were compared with those of the conventional methods of fluorescence microscopy and cultivation (solid and radiometric media). One series of specimens (n = 515) was decontaminated with N-acetyl-L-cysteine (NALC)-NaOH; the other one (n = 423) was decontaminated with sodium dodecyl (lauryl) sulfate (SDS)-NaOH. Of the specimens decontaminated with NALC, 39 were MTD and culture positive, 455 were MTD and culture negative, 18 were MTD positive and culture negative, and 3 were MTD negative and culture positive, indicating a sensitivity of 92.9% and a specificity of 96.2% for the MTD. Of the specimens decontaminated with SDS, 35 were MTD and culture positive, 372 were MTD and culture negative, 15 were MTD positive and culture negative, and 1 was MTD negative and culture positive, indicating a sensitivity of 97.2% and a specificity of 96.1% for the MTD. After resolution of discrepant results by review of the patients' clinical data, the sensitivity of the MTD was 93.9%, the specificity was 97.6%, the positive predictive value was 80.7%, and the negative predictive value was 99.3% for the NALC series; the corresponding values were 97.4, 96.9, 76.0, and 99.7%, respectively, for the SDS series. In conclusion, the MTD is a highly sensitive and specific technique for detecting M. tuberculosis complex within hours in both smear-positive and smear-negative respiratory specimens.

show abstract

“…The laboratory diagnosis of mycobacterial infections usually requires 2 to 8 weeks. The recent increase in new cases of tuberculosis has shown that the need for rapid, specific diagnostic assays for M. tuberculosis is urgent (3,4,18). Most of the nucleic acid amplification assays, which are predominantly based on the amplification of mycobacterial DNA by PCR, are rapid and specific; however, they are not yet suitable for use in routine clinical laboratories.…”

Section: Discussionmentioning

confidence: 99%

“…The increased incidence of tuberculosis and the recent outbreak of multidrug-resistant tuberculosis have increasing public health significance (3,4,18). The diagnosis of tuberculosis on the basis of clinical and radiological findings, the presence of acid-fast bacilli in clinical smears, and other laboratory results are presumptive.…”

mentioning

confidence: 99%

Diagnostic value of an amplification method (Gen-Probe) compared with that of culture for diagnosis of tuberculosis

1995

View full text Add to dashboard Cite

Five hundred fifty respiratory and nonrespiratory specimens from 340 patients were analyzed by comparing the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test (MTD) with conventional culture, which was the method of reference, for the detection of the Mycobacterium tuberculosis complex. After resolution of discrepant results by retesting the samples and reviewing the patients' clinical histories, a total of 60 respiratory specimens were MTD and culture positive, 347 were MTD and culture negative, 4 were MTD positive and culture negative, and 1 was MTD negative and culture positive. This results in a sensitivity of 98.4%, a specificity of 98.9%, and positive and negative predictive values of 93.8 and 99.7%, respectively. Repeatedly, clinicians asked to test specimens of nonpulmonary origin by MTD. Although, MTD is not approved for use with nonrespiratory specimens, the following results were shown. Sixty-one pleural exudate specimens showed disappointing results (sensitivity, 20%). However, MTD performed well with another 77 nonrespiratory specimens; 17 samples were positive and 57 samples were negative by both MTD and culture. No false-negative results were found by MTD. Three MTD-positive, culture-negative specimens had high sample relative light unit/cutoff relative light unit ratios, strongly suggesting true tuberculosis. Positive microscopy and positive culture with MTD-negative results occurred 12 times. Those cultures showed atypical mycobacteria 11 times and Actinomyces species once. The stability of the reagents in the MTD kit was also assessed by testing reagents, including the enzyme mixture, kept at ؊70؇C for at least 6 months. No loss of activity was seen.

show abstract

Statement of the Tuberculosis Committee of the Infectious Diseases Society of America

Cited by 18 publications

References 1 publication

Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche Amplicor Mycobacterium Tuberculosis Test

Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche Amplicor Mycobacterium Tuberculosis Test

Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by a target-amplified test system

Diagnostic value of an amplification method (Gen-Probe) compared with that of culture for diagnosis of tuberculosis

Contact Info

Product

Resources

About