Advertisement

Clinical evaluation of a commercial ligase-based gene amplification method for detection ofMycobacterium tuberculosis

  • P. Alonso
  • A. Orduña
  • M. A. Bratos
  • A. San Miguel
  • A. Rodríguez Torres
Article

Abstract

The purpose of this study was to evaluate the clinical usefulness of a commercial ligase-based gene amplification method (LCxMycobacterium tuberculosis test; Abbott Laboratories, USA) for detection ofMycobacterium tuberculosis. The tuberculosis infection rate among clinical samples was 10.6%. The sensitivity, specificity, and positive and negative predictive values were 23.5%, 100%, 100%, and 91.7%, respectively, with the fluorochrome auramine stain; 32.4%, 100%, 100%, and 92.6%, respectively, with culture; and 76.5%, 95.8%, 68.4% and 97.2%, respectively, with the gene amplification method. When only samples from patients without current or previous treatment were studied, the sensitivity was 36.4% with the auramine stain, 63.6% with culture, and 100% with the gene amplification assay. The mean treatment time for culture-negative and assay-negative samples was greater than that of culture-negative and assay-positive samples. The LCxMycobacterium tuberculosis test is a sensitive method for detection and identification ofMycobacterium tuberculosis. It produces few false-positive results. However, as it can remain positive after the culture becomes negative, it is not recommended for evaluation of treatment efficiency.

Keywords

Internal Medicine Tuberculosis Clinical Evaluation Infection Rate Treatment Time 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    World Health Organization: Tuberculosis notification update. Weekly Epidemiological Record (1996) 71:65–69Google Scholar
  2. 2.
    Kochi A: The global tuberculosis situation and the new control strategy of the World Health Organization. Tubercle (1991) 72:1–6PubMedGoogle Scholar
  3. 3.
    Centers for Disease Control: Tuberculosis morbidity — United States 1991. Morbidity and Mortality Weekly Report (1992) 41:240Google Scholar
  4. 4.
    de March Ayuela P: Situación actual de la tuberculosis en España. Medicina Clínica (1991) 97:463–472Google Scholar
  5. 5.
    Millard FJC: The rising incidence of tuberculosis. Journal of the Royal Society of Medicine (1996) 89:497–500PubMedGoogle Scholar
  6. 6.
    Centers for Disease Control: Nosocomial transmission of multidrug-resistant tuberculosis among HIV-infected persons. Florida and New York, 1988. Morbidity and Mortality Weekly Report (1991) 40:585–591Google Scholar
  7. 7.
    Edlin BR, Tokars JI, Grieco MH, Crawford JT, Williams JN, Sordillo ME, Ong KR, Kilburn JO, Dooley SW, Castro KG: An outbreak of multidrug-resistant tuberculosis among hospitalized patients with the acquired immunodeficiency syndrome. New England Journal of Medicine (1992) 326:1514–1521PubMedGoogle Scholar
  8. 8.
    Grupo de Estudio de Tuberculosis Resistente de Madrid: Estudio transversal multihospitalario de tuberculosis y resistencias en Madrid (octubre 1993–abril 1994). Medicina Clínica (1996) 106:1–6Google Scholar
  9. 9.
    Centers for Disease Control: National action plan to combat multidrug resistant tuberculosis. Morbidity and Mortality Weekly Report (1994) 41:1–48Google Scholar
  10. 10.
    Tenover FJ, Crawford JT, Huebner RE, Geiter LJ, Harsburgh CR, Good RC: The resurgence of tuberculosis: is your laboratory ready? Journal of Clinical Microbiology (1993) 32:767–770Google Scholar
  11. 11.
    Grupo de Trabajo sobre Tuberculosis: Consenso nacional para el control de la tuberculosis en España. Medicina Clínica (1992) 98:24–31Google Scholar
  12. 12.
    Hall GS: Primary processing of specimens and isolation and cultivation of mycobacteria. In: Heifits LB (ed): Clinics in laboratory medicine. WB Saunders, Philadelphia (1996) pp. 551–567Google Scholar
  13. 13.
    Roberts GD, Böttger EC, Stockman L: Methods for the rapid identification of mycobacterial species. In: Heifits LB (ed): Clinics in laboratory medicine. WB Saunders, Philadelphia (1996) pp. 603–615Google Scholar
  14. 14.
    Nolte FS, Metchock B: Mycobacterium. In: Murray PR (ed): Manual of clinical microbiology. American Society for Microbiology, Washington DC (1995) pp. 400–437Google Scholar
  15. 15.
    Sandin LR: Polymerase chain reaction and other amplification techniques in mycobacteriology. Heifits LB (ed): Clinics in laboratory medicine. WB Saunders, Philadelphia (1996) pp. 617–639Google Scholar
  16. 16.
    Andersen AB, Hausen EB: Structure and mapping of antigenic domains of protein antigen b, a 38,000 molecular-weight protein ofMycobacterium tuberculosis. Infection and Immunity (1989) 57:2481–2488PubMedGoogle Scholar
  17. 17.
    Sjobring U, Mecklenburg M, Andersen AB, Miorner H: Polymerase chain reaction for detection ofMycobacterium tuberculosis. Journal of Clinical Microbiology (1990) 28:2200–2204PubMedGoogle Scholar
  18. 18.
    Jonas V, Longiaru M: Detection ofMycobacterium tuberculosis by molecular methods. In: Farkas DH (ed): Clinics in laboratory medicine. WB Saunders, Philadelphia (1997) pp. 119–128Google Scholar
  19. 19.
    Shinnick TM, Jonas V: Molecular approaches to the diagnosis of tuberculosis. In: Bloom BR (ed): Tuberculosis: pathogenesis, protection and control. American Society for Microbiology, Washington DC (1994) pp. 517–530Google Scholar
  20. 20.
    Brisson Noel A, Gicquel B, Lecossier D, Levy-Frebault V, Nassif X, Hance AJ: Rapid diagnosis of tuberculosis by amplification of mycobacteria! DNA in clinical samples. Lancet (1989) ii:1069–1071Google Scholar
  21. 21.
    Chiyoji A, Hirano K, Wada M, Kazumi Y, Takahashi M, Fukosawa Y, Yoshimura T, Miyagi C, Goto S: Detection ofMycobacterium tuberculosis in clinical specimens by polymerase chain reaction and Gen-Probe amplifiedMycobacterium tuberculosis direct test. Journal of Clinical Microbiology (1993) 31:3270–3274PubMedGoogle Scholar
  22. 22.
    Miller N, Hernández SG, Cleary TJ: Evaluation of Gen-Probe amplifiedMycobacterium tuberculosis direct test and PCR for direct detection ofMycobacterium tuberculosis in clinical specimens. Journal of Clinical Microbiology (1994) 32:393–397PubMedGoogle Scholar
  23. 23.
    Forbes BA, Hicks KS: Direct detection ofMycobacterium tuberculosis in respiratory specimens in a clinical laboratory by polymerase chain reaction. Journal of Clinical Microbiology (1993) 31:1688–1694PubMedGoogle Scholar
  24. 24.
    Bergmann JS, Woods GL: Clinical evaluation of the Roche Amplicor PCRMycobacterium tuberculosis test for detection ofMycobacterium tuberculosis in respiratory specimens. Journal of Clinical Microbiology (1996) 34:1083–1085PubMedGoogle Scholar
  25. 25.
    Ausina V, Gamboa F, Gazapo E, Manterola JM, Lonca J, Matas L, Manzano JR, Rodrigo C, Cardona PJ, Padilla E: Evaluation of the semiautomated Abbott LCxMycobacterium tuberculosis assay for direct detection ofMycobacterium tuberculosis in respiratory specimens. Journal of Clinical Microbiology (1997) 35:1996–2002PubMedGoogle Scholar
  26. 26.
    Schluger NW, Kinney D, Harkin TJ, Rom WN: Clinical utility of the polymerase chain reaction in the diagnosis of infections due toMycobacterium tuberculosis. Chest (1994) 105:1116–1121PubMedGoogle Scholar
  27. 27.
    Pfyffer GE, Kissling P, Wirth R, Weber R: Direct detection ofMycobacterium tuberculosis complex in respiratory specimens by a target-amplified test system. Journal of Clinical Microbiology (1994) 32:918–923PubMedGoogle Scholar
  28. 28.
    Jonas V, Alden MJ, Curry JI, Kamisango K, Knott CA, Lankford R, Wolfe JM, Moore DF: Detection and identification ofMycobacterium tuberculosis directly from sputum sediments by amplification rRNA. Journal of Clinical Microbiology (1993) 31:2410–2416PubMedGoogle Scholar
  29. 29.
    Dalovisio JR, Montenegro-James S, Kemmerly SA, Genre CF, Chambers R, Greer D, Pankey GA, Failla DM, Haydel KG, Hutchinson L, Lindley MF, Nunez BM, Praba A, Eisenach KD, Cooper ES: Comparison of the amplifiedMycobacterium tuberculosis (MTB) direct test, Amplicor MTB PCR, and IS6110-PCR for detection of MTB in respiratory specimens. Clinical Infectious Diseases (1996) 23:1099–1106PubMedGoogle Scholar
  30. 30.
    Chin DP, Yajko DM, Hadley WK, Sanders CA, Nassos PS, Madej JJ, Hopewell PC: Clinical utility of a commercial test based on the polymerase chain reaction for detectingMycobacterium tuberculosis in respiratory specimens. American Journal of Respiratory and Critical Care Medicine (1995) 151:1872–1877PubMedGoogle Scholar
  31. 31.
    Kennedy N, Gillespie SH, Saruni AO, Kisyombe G, McNerney R, Ngowi FI, Wilson S: Polymerase chain reaction for assessing treatment response in patients with pulmonary tuberculosis. Journal of Infectious Diseases (1994) 170:713–716PubMedGoogle Scholar
  32. 32.
    Van Der Vliet GME, Schepers P, Schukkink RAF: Assessment of mycobacterial viability by RNA amplification. Journal of Clinical Microbiology (1994) 38:1959–1965Google Scholar

Copyright information

© Springer-Verlag 1998

Authors and Affiliations

  • P. Alonso
    • 1
  • A. Orduña
    • 2
  • M. A. Bratos
    • 2
  • A. San Miguel
    • 1
  • A. Rodríguez Torres
    • 2
  1. 1.Central LaboratoryRegional HospitalLugoSpain
  2. 2.Microbiology ServiceUniversity Teaching Hospital, Faculty of MedicineValladolidSpain

Personalised recommendations