Comparison of AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR for Detection of Mycobacterium tuberculosis Complex in Routine Clinical Practice

The AdvanSure tuberculosis/non-tuberculous mycobacterium (TB/NTM) PCR (LG Life Science, Korea) and COBAS TaqMan Mycobacterium tuberculosis (MTB) PCR (Roche Diagnostics, USA) are commonly used in clinical microbiology laboratories. We aimed to evaluate these two commercial real-time PCR assays for detection of MTB in a large set of clinical samples over a two-year period. AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR were performed on 9,119 (75.2%) and 3,010 (24.8%) of 12,129 (9,728 respiratory and 2,401 non-respiratory) MTB specimens, with 361 (4.0%) and 102 (3.4%) acid-fast bacilli (AFB)-positive results, respectively. In MTB culture, 788 (6.5%) MTB and 514 (4.2%) NTM were identified. The total sensitivity and specificity of the AdvanSure assay were 67.8% (95% confidence interval [CI], 63.9-71.6) and 98.3% (95% CI, 98.0-98.6), while those of the COBAS TaqMan assay were 67.2% (95% CI, 60.0-73.8) and 98.4% (95% CI, 97.9-98.9), respectively. The sensitivities and specificities of the AdvanSure and COBAS TaqMan assays for AFB-positive and AFB-negative samples were comparable. Furthermore, the AdvanSure assay showed fewer invalid results compared with the COBAS TaqMan assay (5.0 vs. 20.4 invalid results/1,000 tests, P<0.001). AdvanSure assay represents a comparable yet more reliable method than COBAS TaqMan for the identification of mycobacteria in routine clinical microbiology.

Tuberculose / Tuberculosis

O diagnóstico laboratorial da tuberculose é de fundamental importância para o correto tratamento e controle da disseminação da doença. Dentre os principais métodos diagnósticos, os testes baseados em biologia molecular vêm ocupando cada vez mais um papel de destaque; entretanto, ainda não substituem por completo os métodos tradicionais, como a cultura e a pesquisa direta. A dosagem da adenosina deaminase (ADA) tem utilidade no diagnóstico de doença extrapulmonar e o teste de liberação de interferon gama linfocitário (IGRA) é de utilidade no diagnóstico de tuberculose latente. A utilização conjunta dos diferentes métodos disponíveis tem trazido grandes vantagens clínicas

The laboratory diagnosis of tuberculosis is of fundamental importance for the correct treatment and control the spread of the disease. Among the main diagnostic methods, the tests based on molecular biology are occupying an increasingly prominent role, however, has not yet completely replace traditional methods such as culture and direct search. The determination of adenosine deaminase (ADA) has useful in diagnosis of extrapulmonary disease and the interferon gamma release assay (IGRA) is useful in the diagnosis of latent tuberculosis. The combination use of different methods available has brought great clinical advantages