Laboratory of Microbiology and Cell Factory.
Respiratory Infectious Diseases Unit, L Spallanzani National Institute for Infectious Diseases, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.
Int J Tuberc Lung Dis. 2019 Feb 1;23(2):260-264. doi: 10.5588/ijtld.18.0355.
Timely diagnosis of tuberculosis (TB) is essential for effectively controlling and managing the disease. Although international guidelines recommend acid-fast bacilli staining and culture as the 'gold standard', new molecular methods are available to safely and rapidly identify positive samples.
To evaluate the performance of the newer and fully automated version of a molecular assay for rRNA amplification (TRCReady M.TB) on 1028 respiratory samples collected from 378 patients for its possible use as a reliable screening method. Results were evaluated using culture as the reference test.
Of four diagnostic protocols employed, best results were obtained when TRCReady M.TB was used together with microscopy on the first respiratory sample, followed by microscopy alone on a second one. The sensitivity and specificity were respectively 97% and 100%, with a turnaround time of 24 h. We propose a possible laboratory algorithm for rapid identification of patients with TB.
TRCReady offers the advantages of full automation and avoidance of cross-contamination. As such, it should be considered as a more economical option for TB screening than other commercial assays that are currently available.
及时诊断结核病（TB）对于有效控制和管理该病至关重要。尽管国际指南推荐抗酸杆菌染色和培养作为“金标准”，但已有新的分子方法可安全、快速地鉴定阳性样本。
评估一种新的、全自动 rRNA 扩增分子检测方法（TRCReady M.TB）在 378 例患者的 1028 份呼吸道样本中的性能，评估其作为一种可靠的筛查方法的可能性。结果采用培养作为参考检测进行评估。
在使用的四种诊断方案中，当将 TRCReady M.TB 与第一份呼吸道样本的显微镜检查联合使用，随后单独对第二份呼吸道样本进行显微镜检查时，结果最佳。其灵敏度和特异性分别为 97%和 100%，周转时间为 24 小时。我们提出了一种可能的实验室算法，用于快速识别结核病患者。
TRCReady 具有全自动和避免交叉污染的优点。因此，与目前可用的其他商业检测方法相比，它应该被视为一种更经济的结核病筛查选择。
