Abstract
Seven hundred fifty-eight processed sputum sediments received for the diagnosis of tuberculosis or other mycobacterial infections were tested by utilizing a rRNA target amplification assay and traditional culture techniques. The results from the rRNA target amplification assay (Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test), available in 5 h, were compared with the results from standard culture techniques held for 6 weeks. A total of 119 specimens (16%) were culture positive for Mycobacterium tuberculosis. Overall sensitivity, specificity, positive predictive value, and negative predictive value were 82, 99, 97, and 96%, respectively, for the Gen-Probe assay; 88, 100, 100, and 97%, respectively, for culture; and 53, 99.8, 99.6, and 91%, respectively, for fluorochrome stain. The Gen-Probe assay employs the isothermal enzymatic amplification of M. tuberculosis complex rRNA followed by detection of the amplicon with an acridinium ester-labeled DNA probe. This assay has the potential of reducing the time for diagnosis of tuberculosis to 1 day.
Full text
PDF






Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Abe C., Hosojima S., Fukasawa Y., Kazumi Y., Takahashi M., Hirano K., Mori T. Comparison of MB-Check, BACTEC, and egg-based media for recovery of mycobacteria. J Clin Microbiol. 1992 Apr;30(4):878–881. doi: 10.1128/jcm.30.4.878-881.1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Arnold L. J., Jr, Hammond P. W., Wiese W. A., Nelson N. C. Assay formats involving acridinium-ester-labeled DNA probes. Clin Chem. 1989 Aug;35(8):1588–1594. [PubMed] [Google Scholar]
- Baess I. Determination and re-examination of genome sizes and base ratios on deoxyribonucleic acid from mycobacteria. Acta Pathol Microbiol Immunol Scand B. 1984 Aug;92(4):209–211. doi: 10.1111/j.1699-0463.1984.tb02822.x. [DOI] [PubMed] [Google Scholar]
- Brisson-Noël A., Gicquel B., Lecossier D., Lévy-Frébault V., Nassif X., Hance A. J. Rapid diagnosis of tuberculosis by amplification of mycobacterial DNA in clinical samples. Lancet. 1989 Nov 4;2(8671):1069–1071. doi: 10.1016/s0140-6736(89)91082-9. [DOI] [PubMed] [Google Scholar]
- Butler W. R., Jost K. C., Jr, Kilburn J. O. Identification of mycobacteria by high-performance liquid chromatography. J Clin Microbiol. 1991 Nov;29(11):2468–2472. doi: 10.1128/jcm.29.11.2468-2472.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Böddinghaus B., Rogall T., Flohr T., Blöcker H., Böttger E. C. Detection and identification of mycobacteria by amplification of rRNA. J Clin Microbiol. 1990 Aug;28(8):1751–1759. doi: 10.1128/jcm.28.8.1751-1759.1990. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Cousins D. V., Wilton S. D., Francis B. R., Gow B. L. Use of polymerase chain reaction for rapid diagnosis of tuberculosis. J Clin Microbiol. 1992 Jan;30(1):255–258. doi: 10.1128/jcm.30.1.255-258.1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
- De Wit D., Steyn L., Shoemaker S., Sogin M. Direct detection of Mycobacterium tuberculosis in clinical specimens by DNA amplification. J Clin Microbiol. 1990 Nov;28(11):2437–2441. doi: 10.1128/jcm.28.11.2437-2441.1990. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Del Portillo P., Murillo L. A., Patarroyo M. E. Amplification of a species-specific DNA fragment of Mycobacterium tuberculosis and its possible use in diagnosis. J Clin Microbiol. 1991 Oct;29(10):2163–2168. doi: 10.1128/jcm.29.10.2163-2168.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Dille B. J., Butzen C. C., Birkenmeyer L. G. Amplification of Chlamydia trachomatis DNA by ligase chain reaction. J Clin Microbiol. 1993 Mar;31(3):729–731. doi: 10.1128/jcm.31.3.729-731.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Eisenach K. D., Cave M. D., Bates J. H., Crawford J. T. Polymerase chain reaction amplification of a repetitive DNA sequence specific for Mycobacterium tuberculosis. J Infect Dis. 1990 May;161(5):977–981. doi: 10.1093/infdis/161.5.977. [DOI] [PubMed] [Google Scholar]
- Hance A. J., Grandchamp B., Lévy-Frébault V., Lecossier D., Rauzier J., Bocart D., Gicquel B. Detection and identification of mycobacteria by amplification of mycobacterial DNA. Mol Microbiol. 1989 Jul;3(7):843–849. doi: 10.1111/j.1365-2958.1989.tb00233.x. [DOI] [PubMed] [Google Scholar]
- Hermans P. W., Schuitema A. R., Van Soolingen D., Verstynen C. P., Bik E. M., Thole J. E., Kolk A. H., van Embden J. D. Specific detection of Mycobacterium tuberculosis complex strains by polymerase chain reaction. J Clin Microbiol. 1990 Jun;28(6):1204–1213. doi: 10.1128/jcm.28.6.1204-1213.1990. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Huebner R. E., Good R. C., Tokars J. I. Current practices in mycobacteriology: results of a survey of state public health laboratories. J Clin Microbiol. 1993 Apr;31(4):771–775. doi: 10.1128/jcm.31.4.771-775.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Kaneko K., Onodera O., Miyatake T., Tsuji S. Rapid diagnosis of tuberculous meningitis by polymerase chain reaction (PCR). Neurology. 1990 Oct;40(10):1617–1618. doi: 10.1212/wnl.40.10.1617. [DOI] [PubMed] [Google Scholar]
- Manjunath N., Shankar P., Rajan L., Bhargava A., Saluja S., Shriniwas Evaluation of a polymerase chain reaction for the diagnosis of tuberculosis. Tubercle. 1991 Mar;72(1):21–27. doi: 10.1016/0041-3879(91)90020-s. [DOI] [PubMed] [Google Scholar]
- Pao C. C., Yen T. S., You J. B., Maa J. S., Fiss E. H., Chang C. H. Detection and identification of Mycobacterium tuberculosis by DNA amplification. J Clin Microbiol. 1990 Sep;28(9):1877–1880. doi: 10.1128/jcm.28.9.1877-1880.1990. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Pierre C., Lecossier D., Boussougant Y., Bocart D., Joly V., Yeni P., Hance A. J. Use of a reamplification protocol improves sensitivity of detection of Mycobacterium tuberculosis in clinical samples by amplification of DNA. J Clin Microbiol. 1991 Apr;29(4):712–717. doi: 10.1128/jcm.29.4.712-717.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Shawar R. M., el-Zaatari F. A., Nataraj A., Clarridge J. E. Detection of Mycobacterium tuberculosis in clinical samples by two-step polymerase chain reaction and nonisotopic hybridization methods. J Clin Microbiol. 1993 Jan;31(1):61–65. doi: 10.1128/jcm.31.1.61-65.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Sritharan V., Barker R. H., Jr A simple method for diagnosing M. tuberculosis infection in clinical samples using PCR. Mol Cell Probes. 1991 Oct;5(5):385–395. doi: 10.1016/s0890-8508(06)80011-3. [DOI] [PubMed] [Google Scholar]
- Victor T., du Toit R., van Helden P. D. Purification of sputum samples through sucrose improves detection of Mycobacterium tuberculosis by polymerase chain reaction. J Clin Microbiol. 1992 Jun;30(6):1514–1517. doi: 10.1128/jcm.30.6.1514-1517.1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Wilson S. M., McNerney R., Nye P. M., Godfrey-Faussett P. D., Stoker N. G., Voller A. Progress toward a simplified polymerase chain reaction and its application to diagnosis of tuberculosis. J Clin Microbiol. 1993 Apr;31(4):776–782. doi: 10.1128/jcm.31.4.776-782.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Wolcott M. J. Advances in nucleic acid-based detection methods. Clin Microbiol Rev. 1992 Oct;5(4):370–386. doi: 10.1128/cmr.5.4.370. [DOI] [PMC free article] [PubMed] [Google Scholar]