Skip to main content
PMC home page
Journal of Clinical Microbiology logoLink to Journal of Clinical Microbiology
. 1997 Sep;35(9):2424–2426. doi: 10.1128/jcm.35.9.2424-2426.1997

Evaluation of a commercial ligase chain reaction kit (Abbott LCx) for direct detection of Mycobacterium tuberculosis in pulmonary and extrapulmonary specimens.

E Tortoli 1, F Lavinia 1, M T Simonetti 1
PMCID: PMC229984  PMID: 9276432

Abstract

Direct detection of Mycobacterium tuberculosis by means of a commercial ligase chain reaction DNA amplification method (LCx M. tuberculosis; Abbott Diagnostics Division, Abbott Park, Ill.) was investigated with 511 (including 147 extrarespiratory) specimens collected from 358 patients. LCx results were compared with standard microbiological data, and conflicting cases were resolved according to the final clinical diagnosis. M. tuberculosis was detected in 45 of 358 subjects by means of the LCx test. The test was negative for all 30 specimens with mycobacteria other than M. tuberculosis. The sensitivity, specificity, and positive and negative predictive values for the LCx test, compared with culture results, were 93.90, 92.31, 70.00, and 98.75%, respectively; these values rose in resolved cases to 95.53, 99.25, 97.27, and 98.75%, respectively. With respiratory specimens, for which the LCx system is licensed, the sensitivity reached 98.97%. In patients with a final clinical diagnosis of tuberculosis the sensitivity of the LCx system was 89.36% compared to 82.98% for cultures and 78.72% for microscopy. We conclude that the LCx test is user friendly, rapid, fairly sensitive, and highly specific. It can also be effectively used on extrapulmonary specimens provided possible false-negative results are taken into account. However, the use of LCx test appears to be less appropriate for the monitoring of antituberculosis therapy, as the majority of samples from treated tuberculosis patients gave consistently positive results, despite the sterilization of cultures.

Full Text

The Full Text of this article is available as a PDF (112.4 KB).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Abe C., Hirano K., Wada M., Kazumi Y., Takahashi M., Fukasawa Y., Yoshimura T., Miyagi C., Goto S. Detection of Mycobacterium tuberculosis in clinical specimens by polymerase chain reaction and Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test. J Clin Microbiol. 1993 Dec;31(12):3270–3274. doi: 10.1128/jcm.31.12.3270-3274.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. 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]
  3. Bodmer T., Gurtner A., Schopfer K., Matter L. Screening of respiratory tract specimens for the presence of Mycobacterium tuberculosis by using the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test. J Clin Microbiol. 1994 Jun;32(6):1483–1487. doi: 10.1128/jcm.32.6.1483-1487.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
  4. Carpentier E., Drouillard B., Dailloux M., Moinard D., Vallee E., Dutilh B., Maugein J., Bergogne-Berezin E., Carbonnelle B. Diagnosis of tuberculosis by Amplicor Mycobacterium tuberculosis test: a multicenter study. J Clin Microbiol. 1995 Dec;33(12):3106–3110. doi: 10.1128/jcm.33.12.3106-3110.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. 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]
  6. Devallois A., Legrand E., Rastogi N. Evaluation of Amplicor MTB test as adjunct to smears and culture for direct detection of Mycobacterium tuberculosis in the French Caribbean. J Clin Microbiol. 1996 May;34(5):1065–1068. doi: 10.1128/jcm.34.5.1065-1068.1996. [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. 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]
  8. Fiore M., Mitchell J., Doan T., Nelson R., Winter G., Grandone C., Zeng K., Haraden R., Smith J., Harris K. The Abbott IMx automated benchtop immunochemistry analyzer system. Clin Chem. 1988 Sep;34(9):1726–1732. [PubMed] [Google Scholar]
  9. Miller N., Hernandez S. G., Cleary T. J. Evaluation of Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test and PCR for direct detection of Mycobacterium tuberculosis in clinical specimens. J Clin Microbiol. 1994 Feb;32(2):393–397. doi: 10.1128/jcm.32.2.393-397.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
  10. Moore D. F., Curry J. I. Detection and identification of Mycobacterium tuberculosis directly from sputum sediments by Amplicor PCR. J Clin Microbiol. 1995 Oct;33(10):2686–2691. doi: 10.1128/jcm.33.10.2686-2691.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  11. Moore D. F., Curry J. I., Knott C. A., Jonas V. Amplification of rRNA for assessment of treatment response of pulmonary tuberculosis patients during antimicrobial therapy. J Clin Microbiol. 1996 Jul;34(7):1745–1749. doi: 10.1128/jcm.34.7.1745-1749.1996. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Pfyffer G. E., Kissling P., Jahn E. M., Welscher H. M., Salfinger M., Weber R. Diagnostic performance of amplified Mycobacterium tuberculosis direct test with cerebrospinal fluid, other nonrespiratory, and respiratory specimens. J Clin Microbiol. 1996 Apr;34(4):834–841. doi: 10.1128/jcm.34.4.834-841.1996. [DOI] [PMC free article] [PubMed] [Google Scholar]
  13. Pfyffer G. E., Kissling P., Wirth R., Weber R. Direct detection of Mycobacterium tuberculosis complex in respiratory specimens by a target-amplified test system. J Clin Microbiol. 1994 Apr;32(4):918–923. doi: 10.1128/jcm.32.4.918-923.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Piersimoni C., Callegaro A., Nista D., Bornigia S., De Conti F., Santini G., De Sio G. Comparative evaluation of two commercial amplification assays for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. J Clin Microbiol. 1997 Jan;35(1):193–196. doi: 10.1128/jcm.35.1.193-196.1997. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Schachter J., Stamm W. E., Quinn T. C., Andrews W. W., Burczak J. D., Lee H. H. Ligase chain reaction to detect Chlamydia trachomatis infection of the cervix. J Clin Microbiol. 1994 Oct;32(10):2540–2543. doi: 10.1128/jcm.32.10.2540-2543.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Schirm J., Oostendorp L. A., Mulder J. G. Comparison of Amplicor, in-house PCR, and conventional culture for detection of Mycobacterium tuberculosis in clinical samples. J Clin Microbiol. 1995 Dec;33(12):3221–3224. doi: 10.1128/jcm.33.12.3221-3224.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Tenover F. C., Crawford J. T., Huebner R. E., Geiter L. J., Horsburgh C. R., Jr, Good R. C. The resurgence of tuberculosis: is your laboratory ready? J Clin Microbiol. 1993 Apr;31(4):767–770. doi: 10.1128/jcm.31.4.767-770.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. Vlaspolder F., Singer P., Roggeveen C. Diagnostic value of an amplification method (Gen-Probe) compared with that of culture for diagnosis of tuberculosis. J Clin Microbiol. 1995 Oct;33(10):2699–2703. doi: 10.1128/jcm.33.10.2699-2703.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  19. 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]

Articles from Journal of Clinical Microbiology are provided here courtesy of American Society for Microbiology (ASM)

RESOURCES