Mazurek Gerald H, Weis Stephen E, Moonan Patrick K, Daley Charles L, Bernardo John, Lardizabal Alfred A, Reves Randall R, Toney Sean R, Daniels Laura J, LoBue Philip A
Division of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Clin Infect Dis. 2007 Oct 1;45(7):837-45. doi: 10.1086/521107. Epub 2007 Aug 24.
Interferon-gamma release assays (IGRAs) are attractive alternatives to the tuberculin skin test (TST) for detecting Mycobacterium tuberculosis infection. However, the inability to definitively confirm the presence of most M. tuberculosis infections hampers assessment of IGRA accuracy. Although IGRAs are primarily indicated for the detection of latent tuberculosis infection, we sought to determine the sensitivity of the TST and 2 whole-blood IGRAs (QuantiFERON-TB assay [QFT] and QuantiFERON-TB Gold assay [QFT-G]) in situations in which infection is confirmed by recovery of M. tuberculosis by culture.
We conducted a prospective, multicenter, cross-sectional comparison study in which 148 persons suspected to have tuberculosis were tested simultaneously with the TST, QFT, and QFT-G.
M. tuberculosis was cultured from samples from 69 (47%) of 148 persons suspected to have tuberculosis; the TST induration was > or = 5 mm for 51 (73.9%) of the 69 subjects (95% confidence interval [CI], 62.5%-82.8%). The QFT indicated tuberculosis infection for 48 (69.6%) of the 69 subjects (95% CI, 57.9%-79.2%) and was indeterminate for 7 (10.1%). The QFT-G yielded positive results for 46 (66.7%) of the 69 subjects (95% CI, 54.9%-76.7%) and indeterminate results for 9 subjects (13.0%). If subjects with indeterminate QFT-G results were excluded, 46 (76.7%) of 60 subjects (95% CI, 64.6%-85.6%) had positive TST results, and the same number of subjects had positive QFT-G results. HIV infection was associated with false-negative TST results but not with false-negative QFT-G results.
The TST, QFT, and QFT-G have similar sensitivity in persons with culture-confirmed infection. As with the TST, negative QFT and QFT-G results should not be used to exclude the diagnosis of tuberculosis in persons with suggestive signs or symptoms.
γ-干扰素释放试验（IGRAs）是用于检测结核分枝杆菌感染的结核菌素皮肤试验（TST）的有吸引力的替代方法。然而，无法明确确认大多数结核分枝杆菌感染的存在妨碍了对IGRA准确性的评估。尽管IGRAs主要用于检测潜伏性结核感染，但我们试图确定在通过培养分离出结核分枝杆菌而确诊感染的情况下TST和两种全血IGRAs（QuantiFERON-TB试验[QFT]和QuantiFERON-TB Gold试验[QFT-G]）的敏感性。
我们进行了一项前瞻性、多中心、横断面比较研究，对148名疑似患有结核病的人同时进行TST、QFT和QFT-G检测。
在148名疑似患有结核病的人中，有69人（47%）的样本培养出结核分枝杆菌；在这69名受试者中，51人（73.9%）的TST硬结≥5mm（95%置信区间[CI]，62.5%-82.8%）。QFT显示69名受试者中有48人（69.6%）感染结核（95%CI，57.9%-79.2%），7人（10.1%）结果不确定。QFT-G显示69名受试者中有46人（66.7%）结果为阳性（95%CI，54.9%-76.7%），9名受试者（13.0%）结果不确定。如果排除QFT-G结果不确定的受试者，60名受试者中有46人（76.7%）TST结果为阳性（95%CI，64.6%-85.6%），QFT-G结果为阳性的受试者数量相同。HIV感染与TST假阴性结果相关，但与QFT-G假阴性结果无关。
在培养确诊感染的人群中，TST、QFT和QFT-G具有相似的敏感性。与TST一样，QFT和QFT-G阴性结果不应被用于排除有可疑体征或症状者的结核病诊断。
