| * 投稿摘要： |
Rapid diagnosis by use of molecular testing is crucial in control of tuberculosis. The performance of molecular techniques in clinical use may be regularly monitored in terms of variation in prevalence, technical operation and specimens. This study assesses the performance of Amplified Mycobacterium tuberculosis Direct Test (AMTD, Gen-Probe, USA) for rapid laboratory diagnosis of Mycobacterium tuberculosis complex (MTBC) in clinical specimens. A total of 1530 specimens comprised 1468 pulmonary and 62 extrapulmonary ones were submitted for AMTD as well as MTBC culture from July 2008 to November 2012. The culture was regarded as the reference method and was performed by inoculation onto both liquid media (Mycobacterium Growth Indicator Tube, Becton Dickinson, USA) and solid Lowen-Jensen media. MTBC on positive isolates was identified by use of an immunochromatographic technique (Tibillia, Genesis, China).
The sensitivity, specificity, positive and negative predictive values (PPV and NPV) of AMTD in pulmonary specimens were found to be 95.9%, 93.3%, 89.0%, and 97.5%, respectively. For smear-positive samples (n=1282), they were 96.7%, 95.5%, 88.8%, and 97.6%, respectively. For smear-negative samples (n=189), they were 76.2%, 100%, 100%, and 97.1%, respectively. In 62 extrapulmonary specimens, the sensitivity, specificity, PPV and NPV of AMTD were 76.9%, 95.9%, 83.3%, and 94.0%, respectively. In conclusion, the performance of AMTD for rapid diagnosis of MTBC infection seems satisfactory in pulmonary specimens and may be acceptable in extrapulmonary specimens. |
2025 年 07 月
