RESUMEN
The Cobas TaqMan MTB test, based on real-time PCR technology, was evaluated for direct detection of Mycobacterium tuberculosis complex (MTBC) in respiratory specimens. A total of 1,093 samples from 446 patients, including 118 acid-fast smear-positive and 975 acid-fast smear-negative specimens, were investigated. Diagnostic cultures performed with 7H11 agar, Löwenstein-Jensen medium, and the Bactec MGIT 960 system were considered the reference methods. When discrepant results between the Cobas TaqMan MTB test and culture occurred, additional results from the BD MGIT TBc identification test and the GenoType Mycobacterium CM test performed on growth-positive and acid-fast-stain-positive MGIT tubes and review of the patient's medical history were used for discrepancy analysis. The overall sensitivity, specificity, positive predictive value, and negative predictive value for the Cobas TaqMan MTB test were 91.5%, 98.7%, 91.5%, and 98.7%, respectively. In general, the performance of the new Cobas TaqMan MTB test was comparable to that of the replaced Cobas Amplicor MTB system. The most prominent feature of the new system was its extraordinarily high sensitivity (79.5%) for detecting MTBC in smear-negative specimens; out of 44 smear-negative but culture-positive specimens, 35 were positive by the new system. The Cobas TaqMan MTB assay, including DNA extraction, can be completed within 3 h.
Asunto(s)
Técnicas Bacteriológicas/métodos , Secreciones Corporales/microbiología , Técnicas de Diagnóstico Molecular/métodos , Mycobacterium tuberculosis/aislamiento & purificación , Tuberculosis Pulmonar/diagnóstico , Humanos , Reacción en Cadena de la Polimerasa/métodos , Sensibilidad y EspecificidadRESUMEN
The sensitivity and specificity of the MGIT TBc identification (TBc ID) test for Mycobacterium tuberculosis complex (MTC) detection in positive Bactec MGIT cultures were 95.2% and 99.2%, respectively. When MTC-positive results obtained from two additional molecular methods were included, the sensitivity of the MGIT TBc ID test was 85.4%, while that of culture was 95.7%.
Asunto(s)
Técnicas Bacteriológicas/métodos , Secreciones Corporales/microbiología , Técnicas de Diagnóstico Molecular/métodos , Mycobacterium tuberculosis/aislamiento & purificación , Sistema Respiratorio/microbiología , Tuberculosis Pulmonar/diagnóstico , Humanos , Sensibilidad y EspecificidadRESUMEN
Molecular identification of mycobacteria in positive Mycobacteria Growth Indicator Tube (MGIT) cultures can accelerate mycobacterial diagnosis. A membrane hybridization array (Blue Point) was evaluated for this purpose in 284 positive MGIT cultures. Discrepant results were resolved by testing with the GenoType Mycobacterium kit, TBc ID test, sequencing of the 16S rRNA gene and internal transcribed spacer. Total recovery from culture and the array (if confirmed) was considered 100%. The sensitivity, specificity, positive, and negative predictive values of the array for detection of Mycobacterium tuberculosis complex were 99.4%, 100%, 100%, and 99.2%, respectively, while the corresponding values of culture were 95.1%, 100%, 100%, and 93.8%, respectively, with significant differences in sensitivity and negative predictive value being found between the 2 methods. The recoveries of nontuberculous mycobacteria and mixed cultures of the array were also significantly higher than those of culture. The array can be adopted in routine mycobacteriology laboratory.