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. 1997 Aug;35(8):1996–2002. doi: 10.1128/jcm.35.8.1996-2002.1997

Evaluation of the semiautomated Abbott LCx Mycobacterium tuberculosis assay for direct detection of Mycobacterium tuberculosis in respiratory specimens.

V Ausina 1, F Gamboa 1, E Gazapo 1, J M Manterola 1, J Lonca 1, L Matas 1, J R Manzano 1, C Rodrigo 1, P J Cardona 1, E Padilla 1
PMCID: PMC229890  PMID: 9230369

Abstract

Five hundred twenty processed respiratory specimens from 326 patients received for the diagnosis of tuberculosis or other mycobacterial infections were tested by means of the LCx Mycobacterium tuberculosis Assay from Abbott Laboratories, which uses ligase chain reaction technology for the direct detection of M. tuberculosis complex in respiratory specimens. The results of the LCx M. tuberculosis Assay were compared with the results of culture and staining techniques. After a combination of culture results and the patient's clinical data, a total of 195 specimens were collected from 110 patients who were positively diagnosed as having pulmonary tuberculosis. Twenty-three of these 195 specimens which corresponded to 10 patients with a history of pulmonary tuberculosis (TB) and anti-TB treatment ranging from 1 to 6 months were culture negative. The other 172 specimens were culture positive for M. tuberculosis. With an overall positivity rate of 37.5% (195 of 520 specimens), the sensitivity, specificity, and positive and negative predictive values were 90.8, 100, 100, and 94.7%, respectively, for the LCx M. tuberculosis Assay; 88.2, 100, 100, and 93.4%, respectively, for culture; and 82.6, 92, 72.9, and 97.6%, respectively, for acid-fast staining. For 161 specimens (82.6%) from patients smear positive for the disease and 34 specimens (17.4%) from patients smear negative for the disease, the sensitivity values for the LCx M. tuberculosis Assay were 98.8 and 53%, respectively. There were no statistically significant differences in the sensitivities and specificities between the LCx M. tuberculosis Assay and culture (P > 0.05). Conclusively, the LCx M. tuberculosis Assay has proved to have an acceptable sensitivity and a high specificity in detecting M. tuberculosis and has the potential of reducing the diagnosis time to an 8-h working day.

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Selected References

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  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. 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]
  3. Andersen A. B., Hansen E. B. Structure and mapping of antigenic domains of protein antigen b, a 38,000-molecular-weight protein of Mycobacterium tuberculosis. Infect Immun. 1989 Aug;57(8):2481–2488. doi: 10.1128/iai.57.8.2481-2488.1989. [DOI] [PMC free article] [PubMed] [Google Scholar]
  4. Birkenmeyer L., Armstrong A. S. Preliminary evaluation of the ligase chain reaction for specific detection of Neisseria gonorrhoeae. J Clin Microbiol. 1992 Dec;30(12):3089–3094. doi: 10.1128/jcm.30.12.3089-3094.1992. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. 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]
  6. 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]
  7. Buimer M., van Doornum G. J., Ching S., Peerbooms P. G., Plier P. K., Ram D., Lee H. H. Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by ligase chain reaction-based assays with clinical specimens from various sites: implications for diagnostic testing and screening. J Clin Microbiol. 1996 Oct;34(10):2395–2400. doi: 10.1128/jcm.34.10.2395-2400.1996. [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. COLETSOS P. J. [Media and methods of culture suitable for the reanimation and multiplication in vitro of Mycobacterium tuberculosis of reduced vitality, of ephemeral viability, or in a state of quiescence]. Ann Inst Pasteur (Paris) 1960 Oct;99:475–495. [PubMed] [Google Scholar]
  9. 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]
  10. Daniel T. M. The rapid diagnosis of tuberculosis: a selective review. J Lab Clin Med. 1990 Sep;116(3):277–282. [PubMed] [Google Scholar]
  11. 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]
  12. 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]
  13. 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]
  14. Goto M., Oka S., Okuzumi K., Kimura S., Shimada K. Evaluation of acridinium-ester-labeled DNA probes for identification of Mycobacterium tuberculosis and Mycobacterium avium-Mycobacterium intracellulare complex in culture. J Clin Microbiol. 1991 Nov;29(11):2473–2476. doi: 10.1128/jcm.29.11.2473-2476.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Hellyer T. J., Fletcher T. W., Bates J. H., Stead W. W., Templeton G. L., Cave M. D., Eisenach K. D. Strand displacement amplification and the polymerase chain reaction for monitoring response to treatment in patients with pulmonary tuberculosis. J Infect Dis. 1996 Apr;173(4):934–941. doi: 10.1093/infdis/173.4.934. [DOI] [PubMed] [Google Scholar]
  16. Jonas V., Alden M. J., Curry J. I., Kamisango K., Knott C. A., Lankford R., Wolfe J. M., Moore D. F. Detection and identification of Mycobacterium tuberculosis directly from sputum sediments by amplification of rRNA. J Clin Microbiol. 1993 Sep;31(9):2410–2416. doi: 10.1128/jcm.31.9.2410-2416.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Kox L. F., Rhienthong D., Miranda A. M., Udomsantisuk N., Ellis K., van Leeuwen J., van Heusden S., Kuijper S., Kolk A. H. A more reliable PCR for detection of Mycobacterium tuberculosis in clinical samples. J Clin Microbiol. 1994 Mar;32(3):672–678. doi: 10.1128/jcm.32.3.672-678.1994. [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. Laffler T. G., Carrino J. J., Marshall R. L. The ligase chain reaction in DNA-based diagnosis. Ann Biol Clin (Paris) 1993;51(9):821–826. [PubMed] [Google Scholar]
  19. Luquin M., Ausina V., López Calahorra F., Belda F., García Barceló M., Celma C., Prats G. Evaluation of practical chromatographic procedures for identification of clinical isolates of mycobacteria. J Clin Microbiol. 1991 Jan;29(1):120–130. doi: 10.1128/jcm.29.1.120-130.1991. [DOI] [PMC free article] [PubMed] [Google Scholar]
  20. Manterola J. M., Gamboa F., Lonca J., Matas L., Ruiz Manzano J., Rodrigo C., Ausina V. Inhibitory effect of sodium dodecyl sulfate in detection of Mycobacterium tuberculosis by amplification of rRNA. J Clin Microbiol. 1995 Dec;33(12):3338–3340. doi: 10.1128/jcm.33.12.3338-3340.1995. [DOI] [PMC free article] [PubMed] [Google Scholar]
  21. Mycobacterioses and the acquired immunodeficiency syndrome. Joint Position Paper of the American Thoracic Society and the Centers for Disease Control. Am Rev Respir Dis. 1987 Aug;136(2):492–496. doi: 10.1164/ajrccm/136.2.492. [DOI] [PubMed] [Google Scholar]
  22. 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]
  23. Noordhoek G. T., van Embden J. D., Kolk A. H. Reliability of nucleic acid amplification for detection of Mycobacterium tuberculosis: an international collaborative quality control study among 30 laboratories. J Clin Microbiol. 1996 Oct;34(10):2522–2525. doi: 10.1128/jcm.34.10.2522-2525.1996. [DOI] [PMC free article] [PubMed] [Google Scholar]
  24. 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]
  25. 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]
  26. 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]
  27. 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]
  28. Zhang Y., Young D. Molecular genetics of drug resistance in Mycobacterium tuberculosis. J Antimicrob Chemother. 1994 Sep;34(3):313–319. doi: 10.1093/jac/34.3.313. [DOI] [PubMed] [Google Scholar]
  29. deWit D., Wootton M., Allan B., Steyn L. Simple method for production of internal control DNA for Mycobacterium tuberculosis polymerase chain reaction assays. J Clin Microbiol. 1993 Aug;31(8):2204–2207. doi: 10.1128/jcm.31.8.2204-2207.1993. [DOI] [PMC free article] [PubMed] [Google Scholar]

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