Adelman Max W, Kurbatova Ekaterina, Wang Yun F, Leonard Michael K, White Nancy, McFarland Deborah A, Blumberg Henry M
Emory University School of Medicine, Atlanta, Georgia, United States of America.
Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, United States of America; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, Georgia, United States of America.
PLoS One. 2014 Jul 11;9(7):e100649. doi: 10.1371/journal.pone.0100649. eCollection 2014.
The Centers for Disease Control and Prevention has recommended using a nucleic acid amplification test (NAAT) for diagnosing pulmonary tuberculosis (TB) but there is a lack of data on NAAT cost-effectiveness.
We conducted a prospective cohort study that included all patients with an AFB smear-positive respiratory specimen at Grady Memorial Hospital in Atlanta, GA, USA between January 2002 and June 2008. We determined the sensitivity, specificity, and positive and negative predictive value of a commercially available and FDA-approved NAAT (amplified MTD, Gen-Probe) compared to the gold standard of culture. A cost analysis was performed and included costs related to laboratory tests, hospital charges, anti-TB medications, and contact investigations. Average cost per patient was calculated under two conditions: (1) using a NAAT on all AFB smear-postive respiratory specimens and (2) not using a NAAT. One-way sensitivity analyses were conducted to determine sensitivity of cost difference to reasonable ranges of model inputs.
During a 6 1/2 year study period, there were 1,009 patients with an AFB smear-positive respiratory specimen at our public urban hospital. We found the NAAT to be highly sensitive (99.6%) and specific (99.1%) on AFB smear-positive specimens compared to culture. Overall, the positive predictive value (PPV) of an AFB smear-positive respiratory specimen for culture-confirmed TB was 27%. The PPV of an AFB smear-positive respiratory specimen for culture-confirmed TB was significantly higher for HIV-uninfected persons compared to those who were HIV-seropositive (152/271 [56%] vs. 85/445 [19%]; RR = 2.94, 95% CI 2.36-3.65, p<0.001). The cost savings of using the NAAT was $2,003 per AFB smear-positive case.
Routine use of the NAAT on AFB smear-positive respiratory specimens was highly cost-saving in our setting at a U.S. urban public hospital with a high prevalence of TB and HIV because of the low PPV of an AFB smear for culture-confirmed TB.
美国疾病控制与预防中心推荐使用核酸扩增检测(NAAT)来诊断肺结核(TB),但缺乏关于NAAT成本效益的数据。
我们开展了一项前瞻性队列研究,纳入了2002年1月至2008年6月期间在美国佐治亚州亚特兰大市格雷迪纪念医院所有痰涂片抗酸杆菌(AFB)阳性的呼吸道标本患者。我们确定了一种市售且经美国食品药品监督管理局(FDA)批准的NAAT(扩增分枝杆菌检测,Gen-Probe)相对于培养这一金标准的敏感性、特异性、阳性预测值和阴性预测值。进行了成本分析,包括与实验室检测、医院收费、抗结核药物和接触者调查相关的成本。在两种情况下计算了每位患者的平均成本:(1)对所有痰涂片AFB阳性的呼吸道标本使用NAAT;(2)不使用NAAT。进行了单向敏感性分析,以确定成本差异对模型输入合理范围的敏感性。
在为期6年半的研究期间,我们这家城市公立医院有1009例痰涂片AFB阳性的呼吸道标本患者。我们发现,与培养相比,NAAT对痰涂片AFB阳性标本具有高度敏感性(99.6%)和特异性(99.1%)。总体而言,痰涂片AFB阳性的呼吸道标本对培养确诊肺结核的阳性预测值(PPV)为27%。与HIV血清学阳性者相比,HIV未感染者痰涂片AFB阳性的呼吸道标本对培养确诊肺结核的PPV显著更高(152/271 [56%] 对85/445 [19%];RR = 2.94,95% CI 2.36 - 3.65,p < 0.001)。使用NAAT每例痰涂片AFB阳性病例节省成本2003美元。
在我们这家肺结核和HIV患病率高的美国城市公立医院,由于痰涂片AFB对培养确诊肺结核的PPV较低,对痰涂片AFB阳性的呼吸道标本常规使用NAAT在很大程度上节省了成本。