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. 1996 Jan;34(1):134–139. doi: 10.1128/jcm.34.1.134-139.1996

Evaluation of Roche Amplicor PCR assay for Mycobacterium tuberculosis.

W L Wobeser 1, M Krajden 1, J Conly 1, H Simpson 1, B Yim 1, M D'costa 1, M Fuksa 1, C Hian-Cheong 1, M Patterson 1, A Phillips 1, R Bannatyne 1, A Haddad 1, J L Brunton 1, S Krajden 1
PMCID: PMC228746  PMID: 8748289

Abstract

The Roche Amplicor Mycobacterium tuberculosis PCR test (RMtb-PCR) was compared with mycobacterial culture, with the BACTEC 460 system and inoculation on Lowenstein-Jensen media. Results were interpreted with an adjusted "gold standard" incorporating clinical diagnosis. A total of 1,480 clinical specimens from 1,155 patients, including tissues and fluids, as well as 141 specimens which demonstrated a positive growth index on the BACTEC 460 system were assessed. The sensitivity, specificity, and positive and negative predictive values of RMtb-PCR compared with the adjusted gold standard for clinical specimens were 79, 99, 93, and 98%, respectively. In smear-positive specimens, the sensitivity of RMtb-PCR was 98% versus 53% for smear-negative specimens. When RMtb-PCR was performed two times per week, PCR results were available an average of 21 days before the culture results. For specimens demonstrating a positive growth index on the BACTEC 460 system, RMtb-PCR had a sensitivity and specificity of 98 and 100%, respectively. This study demonstrates the value of a commercial nucleic acid amplification kit for rapid diagnosis of M. tuberculosis, particularly in smear-positive specimens or BACTEC culture-positive specimens.

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Selected References

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  1. Beavis K. G., Lichty M. B., Jungkind D. L., Giger O. Evaluation of Amplicor PCR for direct detection of Mycobacterium tuberculosis from sputum specimens. J Clin Microbiol. 1995 Oct;33(10):2582–2586. doi: 10.1128/jcm.33.10.2582-2586.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Beige J., Lokies J., Schaberg T., Finckh U., Fischer M., Mauch H., Lode H., Köhler B., Rolfs A. Clinical evaluation of a Mycobacterium tuberculosis PCR assay. J Clin Microbiol. 1995 Jan;33(1):90–95. doi: 10.1128/jcm.33.1.90-95.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Bloom B. R. Tuberculosis. Back to a frightening future. Nature. 1992 Aug 13;358(6387):538–539. doi: 10.1038/358538b0. [DOI] [PubMed] [Google Scholar]
  4. Brisson-Noel A., Aznar C., Chureau C., Nguyen S., Pierre C., Bartoli M., Bonete R., Pialoux G., Gicquel B., Garrigue G. Diagnosis of tuberculosis by DNA amplification in clinical practice evaluation. Lancet. 1991 Aug 10;338(8763):364–366. doi: 10.1016/0140-6736(91)90492-8. [DOI] [PubMed] [Google Scholar]
  5. Clarridge J. E., 3rd, Shawar R. M., Shinnick T. M., Plikaytis B. B. Large-scale use of polymerase chain reaction for detection of Mycobacterium tuberculosis in a routine mycobacteriology laboratory. J Clin Microbiol. 1993 Aug;31(8):2049–2056. doi: 10.1128/jcm.31.8.2049-2056.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. D'Amato R. F., Wallman A. A., Hochstein L. H., Colaninno P. M., Scardamaglia M., Ardila E., Ghouri M., Kim K., Patel R. C., Miller A. Rapid diagnosis of pulmonary tuberculosis by using Roche AMPLICOR Mycobacterium tuberculosis PCR test. J Clin Microbiol. 1995 Jul;33(7):1832–1834. doi: 10.1128/jcm.33.7.1832-1834.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. Eisenach K. D., Sifford M. D., Cave M. D., Bates J. H., Crawford J. T. Detection of Mycobacterium tuberculosis in sputum samples using a polymerase chain reaction. Am Rev Respir Dis. 1991 Nov;144(5):1160–1163. doi: 10.1164/ajrccm/144.5.1160. [DOI] [PubMed] [Google Scholar]
  8. Ellner J. J., Hinman A. R., Dooley S. W., Fischl M. A., Sepkowitz K. A., Goldberger M. J., Shinnick T. M., Iseman M. D., Jacobs W. R., Jr Tuberculosis symposium: emerging problems and promise. J Infect Dis. 1993 Sep;168(3):537–551. doi: 10.1093/infdis/168.3.537. [DOI] [PubMed] [Google Scholar]
  9. Folgueira L., Delgado R., Palenque E., Noriega A. R. Detection of Mycobacterium tuberculosis DNA in clinical samples by using a simple lysis method and polymerase chain reaction. J Clin Microbiol. 1993 Apr;31(4):1019–1021. doi: 10.1128/jcm.31.4.1019-1021.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  10. Forbes B. A., Hicks K. E. Ability of PCR assay to identify Mycobacterium tuberculosis in BACTEC 12B vials. J Clin Microbiol. 1994 Jul;32(7):1725–1728. doi: 10.1128/jcm.32.7.1725-1728.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
  11. 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]
  12. Kennedy N., Gillespie S. H., Saruni A. O., Kisyombe G., McNerney R., Ngowi F. I., Wilson S. Polymerase chain reaction for assessing treatment response in patients with pulmonary tuberculosis. J Infect Dis. 1994 Sep;170(3):713–716. doi: 10.1093/infdis/170.3.713. [DOI] [PubMed] [Google Scholar]
  13. Levée G., Glaziou P., Gicquel B., Chanteau S. Follow-up of tuberculosis patients undergoing standard anti-tuberculosis chemotherapy by using a polymerase chain reaction. Res Microbiol. 1994 Jan;145(1):5–8. doi: 10.1016/0923-2508(94)90061-2. [DOI] [PubMed] [Google Scholar]
  14. Nolte F. S., Metchock B., McGowan J. E., Jr, Edwards A., Okwumabua O., Thurmond C., Mitchell P. S., Plikaytis B., Shinnick T. Direct detection of Mycobacterium tuberculosis in sputum by polymerase chain reaction and DNA hybridization. J Clin Microbiol. 1993 Jul;31(7):1777–1782. doi: 10.1128/jcm.31.7.1777-1782.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Noordhoek G. T., Kolk A. H., Bjune G., Catty D., Dale J. W., Fine P. E., Godfrey-Faussett P., Cho S. N., Shinnick T., Svenson S. B. Sensitivity and specificity of PCR for detection of Mycobacterium tuberculosis: a blind comparison study among seven laboratories. J Clin Microbiol. 1994 Feb;32(2):277–284. doi: 10.1128/jcm.32.2.277-284.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Pfaller M. A. Application of new technology to the detection, identification, and antimicrobial susceptibility testing of mycobacteria. Am J Clin Pathol. 1994 Mar;101(3):329–337. doi: 10.1093/ajcp/101.3.329. [DOI] [PubMed] [Google Scholar]
  17. Simor A. E., Salit I. E., Vellend H. The role of Mycobacterium xenopi in human disease. Am Rev Respir Dis. 1984 Mar;129(3):435–438. doi: 10.1164/arrd.1984.129.3.435. [DOI] [PubMed] [Google Scholar]
  18. Sjöbring U., Mecklenburg M., Andersen A. B., Miörner H. Polymerase chain reaction for detection of Mycobacterium tuberculosis. J Clin Microbiol. 1990 Oct;28(10):2200–2204. doi: 10.1128/jcm.28.10.2200-2204.1990. [DOI] [PMC free article] [PubMed] [Google Scholar]
  19. Soini H., Skurnik M., Liippo K., Tala E., Viljanen M. K. Detection and identification of mycobacteria by amplification of a segment of the gene coding for the 32-kilodalton protein. J Clin Microbiol. 1992 Aug;30(8):2025–2028. doi: 10.1128/jcm.30.8.2025-2028.1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
  20. Telenti A., Marchesi F., Balz M., Bally F., Böttger E. C., Bodmer T. Rapid identification of mycobacteria to the species level by polymerase chain reaction and restriction enzyme analysis. J Clin Microbiol. 1993 Feb;31(2):175–178. doi: 10.1128/jcm.31.2.175-178.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  21. Vuorinen P., Miettinen A., Vuento R., Hällström O. Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and Roche Amplicor Mycobacterium Tuberculosis Test. J Clin Microbiol. 1995 Jul;33(7):1856–1859. doi: 10.1128/jcm.33.7.1856-1859.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Yajko D. M., Nassos P. S., Sanders C. A., Madej J. J., Hadley W. K. High predictive value of the acid-fast smear for Mycobacterium tuberculosis despite the high prevalence of Mycobacterium avium complex in respiratory specimens. Clin Infect Dis. 1994 Aug;19(2):334–336. doi: 10.1093/clinids/19.2.334. [DOI] [PubMed] [Google Scholar]

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