US Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Clin Infect Dis. 2013 Aug;57(4):532-42. doi: 10.1093/cid/cit336. Epub 2013 May 22.
The utility of Mycobacterium tuberculosis direct nucleic acid amplification testing (MTD) for pulmonary tuberculosis disease diagnosis in the United States has not been well described.
We analyzed a retrospective cohort of reported patients with suspected active pulmonary tuberculosis in 2008-2010 from Georgia, Hawaii, Maryland, and Massachusetts to assess MTD use, effectiveness, health-system benefits, and cost-effectiveness.
Among 2140 patients in whom pulmonary tuberculosis was suspected, 799 (37%) were M. tuberculosis-culture-positive. Eighty percent (680/848) of patients having acid-fast-bacilli-smear-positive specimens had MTD performed; MTD positive-predictive value (PPV) was 98% and negative-predictive value (NPV) was 94%. Nineteen percent (240/1292) of patients having smear-negative specimens had MTD; MTD PPV was 90% and NPV was 88%. Among patients suspected of tuberculosis but not having MTD, smear PPV for lab-confirmed tuberculosis was 77% and NPV 78%. Compared with no MTD, MTD significantly decreased time to diagnosis in patients with smear-positive/MTD-positive specimens, decreased respiratory isolation for patients having smear-positive/MTD-negative/culture-negative specimens, decreased outpatient days of unnecessary tuberculosis medications, and reduced resources expended on contact investigation. While MTD generally cost more than no MTD, incremental cost savings occurred in patients with human immunodeficiency virus (HIV) or homelessness to diagnose or to exclude tuberculosis, and in patients with substance abuse having smear-negative specimens to exclude tuberculosis.
MTD improved diagnostic accuracy and timeliness and reduced unnecessary respiratory isolation, treatment, and contact investigations. It was cost saving in patients with HIV, homelessness, or substance abuse, but not in others.
分枝杆菌直接核酸扩增检测(MTD)在诊断美国肺结核疾病中的应用尚未得到充分描述。
我们分析了 2008-2010 年来自佐治亚州、夏威夷州、马里兰州和马萨诸塞州的疑似活动性肺结核患者的回顾性队列报告,以评估 MTD 的使用情况、效果、对卫生系统的益处和成本效益。
在 2140 例疑似肺结核患者中,799 例(37%)为分枝杆菌培养阳性。80%(680/848)的痰涂片阳性患者进行了 MTD 检测;MTD 阳性预测值(PPV)为 98%,阴性预测值(NPV)为 94%。19%(240/1292)的痰涂片阴性患者进行了 MTD 检测;MTD 的 PPV 为 90%,NPV 为 88%。在疑似肺结核但未进行 MTD 检测的患者中,实验室确诊肺结核的痰涂片 PPV 为 77%,NPV 为 78%。与未进行 MTD 检测相比,MTD 显著缩短了痰涂片阳性/MTD 阳性患者的诊断时间,减少了痰涂片阳性/MTD 阴性/培养阴性患者的呼吸隔离,减少了不必要的结核病药物治疗的门诊天数,并减少了接触调查所消耗的资源。尽管 MTD 的总体成本高于不进行 MTD,但对于诊断或排除 HIV 或无家可归的结核病患者,以及对于滥用药物的痰涂片阴性患者,排除结核病患者,都可以节省增量成本。
MTD 提高了诊断准确性和及时性,并减少了不必要的呼吸隔离、治疗和接触调查。对于 HIV、无家可归或药物滥用患者,它具有成本效益,但对于其他患者则不然。