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KLİNİK ÖRNEKLERDEN MYCOBACTERIUM TUBERCULOSIS KOMPLEKS TANISINDA MTD (GEN-PROBE) SONUÇLARININ DEĞERLENDİRİLMESİ

Yıl 2006, Cilt: 20 Sayı: 3, 61 - 69, 01.12.2006

Öz

Bu çalışmada, pulmoner ve ekstrapulmoner örneklerden MTD (Mycobacterium tuberculosis direct test) (Gen-Probe, Inc. San Diego, A.B.D.) testi ile Mycobacterium tuberculosis kompleks (MTB) moleküler tanısının kültür sonuçları ve klinik veri ile karşılaştırılarak duyarlılık ve özgüllüğünün retrospektif olarak değerlendirilmesi amaçlandı. Hastanemiz mikrobiyoloji laboratuvarına Temmuz 2004 ve Mayıs 2005 tarihleri arasında kabul edilen toplam 764 örnek (%84 pulmoner ve %16 ekstrapulmoner) çalışmaya alındı. Tüm örneklere asido-rezistan boyama, kültür ve MTD uygulandı. MTD sonuçları üretici firma önerileri doğrultusunda değerlendirildi. 30.000 ve 499.999 RLU arasındaki değerler kuşkulu sınır olarak düşünüldü ve tüm kuşkulu sonuçlar için test yinelendi. Uyumsuz sonuçlar, klinik veri ve örneklerin yinelenen sonuçları ile beraber değerlendirildi. MTD, kültür ve yayma pozitifliği, sırasıyla, %19.1, %17.7 ve %4.3 olarak bulundu. Dört örneğin MTD sonucu kuşkulu sınır olarak saptandı. Altı örneğin kültür sonucu kontaminasyon ve dört örnek ise atipik mikobakteri olarak belirlendi. Genel olarak, örnekler için duyarlılık, özgüllük, pozitif ve negatif prediktif değerler sırasıyla, %94.1, %99.1, %99.2 ve %99.5 olarak bulundu. Pulmoner, ekstrapul-moner, yayma pozitif ve yayma negatif örnekler için duyarlılık, sırasıyla, %93.8, %80, %100 ve %91.7 olarak hesaplandı. Hem ekstrapulmoner ve hem de pulmoner örneklerin özgüllüğü %99.1 olarak bulundu. Kültür ve yayma ile negatif ve MTD ile pozitif bulunan 13 örnek, klinik veri ile tüberküloz olarak değerlendirildi. Sonuç olarak, nükleik asit amplifikasyon temelli MTD testi, klinik örneklerden MTB'in hızlı tanısında güvenilir olmakla birlikte, seçilmiş hastalarda, klinik veriler ve geleneksel tanı yöntemleri ile beraber yorumlanarak kullanılması gerektiği düşünüldü.

Kaynakça

  • 1. World Health Organization (2005) Global tuberculosis control: surveillance, planning, financing. WHO report Geneva, 2005. WHO/ HTM/TB/2005.349.
  • 2. Haas DW, Prez RM. Mycobacterium tuberculosis. In: Mandel GL, Bennett JE, Dolin R (eds), Principles and Practice of Infectious Diseases (4th ed). Vol 2. Churchill Livingstone Inc, Washington DC 1995, 2213-43. 6
  • 3. Mechock BG, Nolte FS, Wallace RJ. Mycobacterium. In: Murray PR, Baron EJ, Pfaller MA, Tenover FC, Yolken RH (eds), Manual of Clinical Microbiology (7th ed). American Society for Microbiology, Washington DC 1999, 399-437.
  • 4. Pfyffer GE, Brown-Elliott BA, Wallace RJ. Mycobacterium: General characteristics, isolation and staining procedures. Murray PR, Baron EJ, Jorgensen JH, Pfaller MA, Yolken RH (eds), Manual of Clinical Microbiology, 8th edition. ASM Pres: Washington DC 2003; 532-59.
  • 5. Scarparo C, Piccoli P, Rigon A, Ruggerio G, Ricordi P, Piersimoni C. Evaluation of the BACTEC MGIT 960 in comparison with BACTEC 460 TB for detection and recovery of mycobacteria from clinical specimens. Diagn Microbiol Infect Dis 2002; 44: 157-61.
  • 6. Özyurt M. Tüberkülozun laboratuvar tan›s›nda kullan›lan moleküler ticari tan› sistemleri. 21. Yüzy›lda Tüberküloz Sempozyumu ve II. Tüberküloz Laboratuvar Tan› Yöntemleri Kursu, Samsun, 2003.
  • 7. Kocazeybek B. Akci¤er tüberkülozu ve akci¤er d›fl› tüberküloz tan›s›nda in-house polimeraz zincir reaksiyonu yönteminin kültürle karfl›lafl- t›r›lmas›. ‹nfek Derg 2002; 16(2): 187-93.
  • 8. Kocagöz T, Y›lmaz E, Özkara fi, et al. Detection of Mycobacterium tuberculosis in sputum samples by polymerase chain reaction using a simplified procedure. J Clin Microbiol 1993; 31: 1435-8.
  • 9. Centers for Disease Control and Prevention (CDC). Update: Nucleic acid amplification tests for tuberculosis. MMWR Morb Mortal Wkly Rep 2000;49(26): 593-4.
  • 10. Gamboa F, Fernandez G, Padilla E, et al. Comparative evaluation of initial and new versions of the Gen-Probe amplified Mycobacterium tuberculosis direct test for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. J Clin Microbiol 1998; 36: 684-9.
  • 11. Bradly SP, Reed SL, Catanzaro A. Clinacal efficacy of amplified Mycobacterium tuberculosis direct test for the diagnosis of pulmonary tuberculosis. Am J Respir Crit Care Med 1996;153:1606-10.
  • 12. Piersimoni C, Callegaro A, Scarparo C, et al. Comparative evaluation of the new GenProbe Mycobacterium tuberculosis amplified direct test and semiautomated Abboth LCX M. tuberculosis assay for direct detection of M. tuberculosis complex in respiratory and nonrespiratoey specimens. J Clin Microbiol 1998; 36: 3601-4.
  • 13. Uzun M. Tüberküloz tan›s›nda Ehrlich-ZiehlNeelsen, florokrom boyama yöntemleri ile Bactec ve Löwenstein-Jensen, kültür yöntemlerinin sonuçlar›n›n de¤erlendirilmesi. (Doktora tezi). ‹stanbul T›p Fakültesi Mikrobiyoloji Anabilim Dal›, 1994.
  • 14. Shamputa IC, Rigouts And L, Portaels F. Molecular genetic methods for diagnosis and antibiotic resistance detection of mycobacteria from clinical specimens. APMIS 2004;112 (11-12): 728-52.
  • 15. Dorronsoro I, Navascues A, Gastesi C, Salicio Y, Ojer M, Ruz A. Evaluation of the MTD-2 test for the direct detection of Mycobacterium tuberculosis in specimens. An Sist Sanit Navar 2005; 28(3): 351-6.
  • 16. Smith MB, Bergmann JS, Onoroto M, Mathews G, Woods GL. Evaluation of the enhanced amplified Mycobacterium tuberculosis direct test for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. Arch Pathol Lab Med 1999; 123(11): 1101-3.
  • 17. Chedore P, Jamieson FB. Routine use of the Gen-Probe MTD2 amplification test for detection of Mycobacterium tuberculosis in clinical specimens in a large public health mycobacteriology laboratory. Diagn Microbiol Infect Dis 1999; 35(3): 185-91.
  • 18. Pounder JI, Aldous WK, Woods GL. Comparison of real-time polymerase chain reaction using the Smart Cycler and the Gen-Probe amplified Mycobacterium tuberculosis direct test for detection of M. tuberculosis complex in clinical specimens. Diagn Microbiol Infect Dis 2006; 54(3): 217-22.
  • 19. Coll P, Garrigo M, Moreno C, Marti N. Routine use of Gen-Probe Amplified Mycobacterium Tuberculosis Direct (MTD) test for detection of Mycobacterium tuberculosis with smearpositive and smear-negative specimens. Int. J. Tuberc. Lung Dis. 2003;7(9):886-91.
  • 20. Dailloux M, Laurain C. Value of nucleic acid amplification methods Amplicor (Roche) and Amplified MTD (Gen-Probe) for the rapid diagnosis of tuberculosis. Ann Biol Clin 1996; 54(7): 297-301.
  • 21. Della-Latta P, Whittier S. Comprehensive evaluation of performance, laboratory application, and clinical usefulness of two direct amplification technologies for the detection of Mycobacterium tuberculosis complex. Am J Clin Pathol 1998 ; 110(3): 301-10.
  • 22. Çavuflo¤lu C, Güneri S, Suntur M, Bilgiç A. Clinical Evaluation of the FASTPlaqueTB for the Rapid Diagnosis of Pulmonary Tuberculosis. Turk J Med Sci 2002; 32: 487-92.
  • 23. Artan MO. Tüberkülozun Tan›s›nda Kullan›- lan "Amplified Mycobacterium Tuberculosis Direct Test"’in Uygulanmas› ve Konvansiyonel Yöntemlerle Karfl›laflt›r›lmas›. C.Ü. T›p Fakültesi Dergisi 2005; 27 (1): 5-10.
  • 24. Woods GL, Bergmann JS, Williams-Bouyer N. Clinical Evaluation of the Gen-Probe amplified mycobacterium tuberculosis direct test for rapid detection of Mycobacterium tuberculosis in select nonrespiratory specimens. J Clin Microbiol 2001; 39(5): 1993-5.
  • 25. Moore DF, Curry JI, Knott CA, Jonas V. Amplification of rRNA for assessment of treatment response of pulmonary tuberculosis patients during antimicrobial therapy. J Clin Microbiol 1996; 34: 1745-9.
  • 26. Vlaspolder F, Singer P, Roggeven C. Diagnostic value of an amplification method (Gen-Probe) compared with that of culture for diagnosis of tuberculosis. J Clin Microbiol 1995; 33: 2699-703.
  • 27. Woods GL. Molecular methods in the detection and identification of mycobacterial infections. Arch Pathol Lab Med 1999; 123(11): 1002-6.
  • 28. Lim TK, Mukhopadhyay A, Gough A, Khoo KL, Khoo SM, Lee KH, Kumarasinghe G: Role of clinical judgment in the application of a nucleic acid amplification test for the rapid diagnosis of pulmonary tuberculosis. Chest 2003;124(3): 902-8.
  • 29. Dowdy DW, Maters A, Parrish N, Beyrer C, Dorman SE. Cost-Effectiveness Analysis of the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test as Used Routinely on Smear-Positive Respiratory Specimens. J Clin Microbiol 2003; 41(3): 948–53.
  • 30. Catanzaro A, Perry S, Clarridge JE, Dunbar S, Goodnight-White S, LoBue PA, Peter C, Pfyffer GE, Sierra MF, Weber R, Woods G, Mathews G, Jonas V, Smith K, Della-Latta P. The role of clinical suspicion in evaluating a new diagnostic test for active tuberculosis: results of a multicenter prospective trial. JAMA 2000; 283: 639.

EVALUATION OF MTD (GEN-PROBE) RESULTS FOR DIRECT DETECTION OF MYCOBACTERIUM TUBERCULOSIS COMPLEX IN CLINICAL SPECIMENS

Yıl 2006, Cilt: 20 Sayı: 3, 61 - 69, 01.12.2006

Öz

Evaluation of sensitivity and specificity of the molecular detection of Mycobacterium tuberculosis complex (MTB) by MTD (Gen-Probe, Inc., USA) for diagnosis of tuberculosis in comparison with culture results and clinical outcome was intended. A total of 764 specimens submitted to the microbiology lab of our hospital between July 2004 and May 2005 were studied. Acid-fast staining, culture and MTD were performed on all samples. Among the specimens, 84% and 16% of them were pulmonary and extrapulmonary specimens, respectively. MTD results were interpreted according to the manufacturer's recommendations. The values between 30,000 and 499,999 RLU were considered as indeterminate. All indeterminate results were repeated twice. Resolution of discordant results was accomplished by incorporating clinical data and repeated specimen analysis. MTD, culture and smear positivity were 19.1%, 17.7% and 4.3%, respectively. MTD results for four specimens were indeterminate. Six of culture results were contaminated and four of them were identified as atypical mycobacterium. Overall sensitivity, specifity, positive and negative predictive values for the specimens were found as 94.1%, 99.1% 99.2% and 99.5%. Sensitivity for pulmonary, extrapulmonary,
smear positive and smear negative
specimens were 93.8%, 80%, 100% and 91.7%,
respectively. Specifities for extrapulmonary and
pulmonary specimens were found as 99.1% for
each. Thirteen MTD positive specimens which
were found as negative with culture and smear
were diagnosed as tuberculosis by incorporating
clinical data. In conclusion, MTD test can be used
as a rapid, reliable and accurate detection of MTB
in clinical specimens. However, MTD should be used
in selected patients and should be interpreted in
accordance with the clinical outcome and
conventional diagnostic techniques.

Kaynakça

  • 1. World Health Organization (2005) Global tuberculosis control: surveillance, planning, financing. WHO report Geneva, 2005. WHO/ HTM/TB/2005.349.
  • 2. Haas DW, Prez RM. Mycobacterium tuberculosis. In: Mandel GL, Bennett JE, Dolin R (eds), Principles and Practice of Infectious Diseases (4th ed). Vol 2. Churchill Livingstone Inc, Washington DC 1995, 2213-43. 6
  • 3. Mechock BG, Nolte FS, Wallace RJ. Mycobacterium. In: Murray PR, Baron EJ, Pfaller MA, Tenover FC, Yolken RH (eds), Manual of Clinical Microbiology (7th ed). American Society for Microbiology, Washington DC 1999, 399-437.
  • 4. Pfyffer GE, Brown-Elliott BA, Wallace RJ. Mycobacterium: General characteristics, isolation and staining procedures. Murray PR, Baron EJ, Jorgensen JH, Pfaller MA, Yolken RH (eds), Manual of Clinical Microbiology, 8th edition. ASM Pres: Washington DC 2003; 532-59.
  • 5. Scarparo C, Piccoli P, Rigon A, Ruggerio G, Ricordi P, Piersimoni C. Evaluation of the BACTEC MGIT 960 in comparison with BACTEC 460 TB for detection and recovery of mycobacteria from clinical specimens. Diagn Microbiol Infect Dis 2002; 44: 157-61.
  • 6. Özyurt M. Tüberkülozun laboratuvar tan›s›nda kullan›lan moleküler ticari tan› sistemleri. 21. Yüzy›lda Tüberküloz Sempozyumu ve II. Tüberküloz Laboratuvar Tan› Yöntemleri Kursu, Samsun, 2003.
  • 7. Kocazeybek B. Akci¤er tüberkülozu ve akci¤er d›fl› tüberküloz tan›s›nda in-house polimeraz zincir reaksiyonu yönteminin kültürle karfl›lafl- t›r›lmas›. ‹nfek Derg 2002; 16(2): 187-93.
  • 8. Kocagöz T, Y›lmaz E, Özkara fi, et al. Detection of Mycobacterium tuberculosis in sputum samples by polymerase chain reaction using a simplified procedure. J Clin Microbiol 1993; 31: 1435-8.
  • 9. Centers for Disease Control and Prevention (CDC). Update: Nucleic acid amplification tests for tuberculosis. MMWR Morb Mortal Wkly Rep 2000;49(26): 593-4.
  • 10. Gamboa F, Fernandez G, Padilla E, et al. Comparative evaluation of initial and new versions of the Gen-Probe amplified Mycobacterium tuberculosis direct test for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. J Clin Microbiol 1998; 36: 684-9.
  • 11. Bradly SP, Reed SL, Catanzaro A. Clinacal efficacy of amplified Mycobacterium tuberculosis direct test for the diagnosis of pulmonary tuberculosis. Am J Respir Crit Care Med 1996;153:1606-10.
  • 12. Piersimoni C, Callegaro A, Scarparo C, et al. Comparative evaluation of the new GenProbe Mycobacterium tuberculosis amplified direct test and semiautomated Abboth LCX M. tuberculosis assay for direct detection of M. tuberculosis complex in respiratory and nonrespiratoey specimens. J Clin Microbiol 1998; 36: 3601-4.
  • 13. Uzun M. Tüberküloz tan›s›nda Ehrlich-ZiehlNeelsen, florokrom boyama yöntemleri ile Bactec ve Löwenstein-Jensen, kültür yöntemlerinin sonuçlar›n›n de¤erlendirilmesi. (Doktora tezi). ‹stanbul T›p Fakültesi Mikrobiyoloji Anabilim Dal›, 1994.
  • 14. Shamputa IC, Rigouts And L, Portaels F. Molecular genetic methods for diagnosis and antibiotic resistance detection of mycobacteria from clinical specimens. APMIS 2004;112 (11-12): 728-52.
  • 15. Dorronsoro I, Navascues A, Gastesi C, Salicio Y, Ojer M, Ruz A. Evaluation of the MTD-2 test for the direct detection of Mycobacterium tuberculosis in specimens. An Sist Sanit Navar 2005; 28(3): 351-6.
  • 16. Smith MB, Bergmann JS, Onoroto M, Mathews G, Woods GL. Evaluation of the enhanced amplified Mycobacterium tuberculosis direct test for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. Arch Pathol Lab Med 1999; 123(11): 1101-3.
  • 17. Chedore P, Jamieson FB. Routine use of the Gen-Probe MTD2 amplification test for detection of Mycobacterium tuberculosis in clinical specimens in a large public health mycobacteriology laboratory. Diagn Microbiol Infect Dis 1999; 35(3): 185-91.
  • 18. Pounder JI, Aldous WK, Woods GL. Comparison of real-time polymerase chain reaction using the Smart Cycler and the Gen-Probe amplified Mycobacterium tuberculosis direct test for detection of M. tuberculosis complex in clinical specimens. Diagn Microbiol Infect Dis 2006; 54(3): 217-22.
  • 19. Coll P, Garrigo M, Moreno C, Marti N. Routine use of Gen-Probe Amplified Mycobacterium Tuberculosis Direct (MTD) test for detection of Mycobacterium tuberculosis with smearpositive and smear-negative specimens. Int. J. Tuberc. Lung Dis. 2003;7(9):886-91.
  • 20. Dailloux M, Laurain C. Value of nucleic acid amplification methods Amplicor (Roche) and Amplified MTD (Gen-Probe) for the rapid diagnosis of tuberculosis. Ann Biol Clin 1996; 54(7): 297-301.
  • 21. Della-Latta P, Whittier S. Comprehensive evaluation of performance, laboratory application, and clinical usefulness of two direct amplification technologies for the detection of Mycobacterium tuberculosis complex. Am J Clin Pathol 1998 ; 110(3): 301-10.
  • 22. Çavuflo¤lu C, Güneri S, Suntur M, Bilgiç A. Clinical Evaluation of the FASTPlaqueTB for the Rapid Diagnosis of Pulmonary Tuberculosis. Turk J Med Sci 2002; 32: 487-92.
  • 23. Artan MO. Tüberkülozun Tan›s›nda Kullan›- lan "Amplified Mycobacterium Tuberculosis Direct Test"’in Uygulanmas› ve Konvansiyonel Yöntemlerle Karfl›laflt›r›lmas›. C.Ü. T›p Fakültesi Dergisi 2005; 27 (1): 5-10.
  • 24. Woods GL, Bergmann JS, Williams-Bouyer N. Clinical Evaluation of the Gen-Probe amplified mycobacterium tuberculosis direct test for rapid detection of Mycobacterium tuberculosis in select nonrespiratory specimens. J Clin Microbiol 2001; 39(5): 1993-5.
  • 25. Moore DF, Curry JI, Knott CA, Jonas V. Amplification of rRNA for assessment of treatment response of pulmonary tuberculosis patients during antimicrobial therapy. J Clin Microbiol 1996; 34: 1745-9.
  • 26. Vlaspolder F, Singer P, Roggeven C. Diagnostic value of an amplification method (Gen-Probe) compared with that of culture for diagnosis of tuberculosis. J Clin Microbiol 1995; 33: 2699-703.
  • 27. Woods GL. Molecular methods in the detection and identification of mycobacterial infections. Arch Pathol Lab Med 1999; 123(11): 1002-6.
  • 28. Lim TK, Mukhopadhyay A, Gough A, Khoo KL, Khoo SM, Lee KH, Kumarasinghe G: Role of clinical judgment in the application of a nucleic acid amplification test for the rapid diagnosis of pulmonary tuberculosis. Chest 2003;124(3): 902-8.
  • 29. Dowdy DW, Maters A, Parrish N, Beyrer C, Dorman SE. Cost-Effectiveness Analysis of the Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test as Used Routinely on Smear-Positive Respiratory Specimens. J Clin Microbiol 2003; 41(3): 948–53.
  • 30. Catanzaro A, Perry S, Clarridge JE, Dunbar S, Goodnight-White S, LoBue PA, Peter C, Pfyffer GE, Sierra MF, Weber R, Woods G, Mathews G, Jonas V, Smith K, Della-Latta P. The role of clinical suspicion in evaluating a new diagnostic test for active tuberculosis: results of a multicenter prospective trial. JAMA 2000; 283: 639.
Toplam 30 adet kaynakça vardır.

Ayrıntılar

Diğer ID JA37BR65BH
Bölüm Araştırma Makalesi
Yazarlar

Can Biçmen Bu kişi benim

Meral Coşkun Bu kişi benim

Ayriz T Gündüz Bu kişi benim

A. Kadri Çırak Bu kişi benim

Serir Aktoğu Özkan Bu kişi benim

Yayımlanma Tarihi 1 Aralık 2006
Yayımlandığı Sayı Yıl 2006 Cilt: 20 Sayı: 3

Kaynak Göster

APA Biçmen, C., Coşkun, M., Gündüz, A. T., Çırak, A. K., vd. (2006). KLİNİK ÖRNEKLERDEN MYCOBACTERIUM TUBERCULOSIS KOMPLEKS TANISINDA MTD (GEN-PROBE) SONUÇLARININ DEĞERLENDİRİLMESİ. İzmir Göğüs Hastanesi Dergisi, 20(3), 61-69.