Danielsen Allan Vestergaard, Fløe Andreas, Lillebaek Troels, Hoffmann Hans Jürgen, Hilberg Ole
Lungemedicinsk Afdeling, Aarhus Universitetshospital, Nørrebrogade 44, 8000 Aarhus, Denmark.
Dan Med J. 2014 Jun;61(6):A4856.
A positive interferon-gamma release assay (IGRA) is regarded as proof of latent Mycobacterium tuberculosis infection. We conducted an evaluation of the IGRA test "T-SPOT.TB" to test its performance during clinical routine use by analysing the positivity rate and odds, effect of season and sensitivity.
Data from T-SPOT.TB testing together with age and test indications (anti-tumour necrosis factor alpha (TNFα) candidate, contact investigation or suspicion of tuberculosis (TB)) were combined with mycobacteria culture results.
A total of 1,809 patients were tested. Conclusive results were achieved for 1,780 patients (98.4%). Among these, 4.6% of anti-TNFα candidates, 19.3% of contacts and 24.4% of TB suspects tested positive. Compared with anti-TNFα candidates, the odds for a positive result were significantly higher for contact investigations (odds ratio (OR), mean (95% confidence interval): 4.93 (3.11-7.81)) and TB suspects (OR: 6.83 (4.33-10.77)). Elevated odds of an inconclusive test were found during autumn and winter periods (OR: 2.53 (1.58-4.05)) and for patients > 75 years of age (OR: 2.66 (1.43-4.94)) and < 6 years of age (OR: 3.35 (1.58-7.09)). In all, 41 of 43 culture-verified M. tuberculosis infections tested positive with one false negative.
During routine testing, inconclusive tests were rare, but more frequent during autumn/winter periods and for patients < 6 and > 75 years of age. The T-SPOT.TB showed a high sensitivity in culture-verified TB, although false negative results did occur.
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γ-干扰素释放试验（IGRA）结果呈阳性被视为潜伏性结核分枝杆菌感染的证据。我们对IGRA检测“T-SPOT.TB”进行了评估，通过分析阳性率、比值、季节影响和敏感性来测试其在临床常规使用中的性能。
将T-SPOT.TB检测数据与年龄及检测指征（抗肿瘤坏死因子α（TNFα）候选者、接触者调查或疑似结核病（TB））相结合，并与分枝杆菌培养结果进行对比。
共对1809例患者进行了检测。1780例患者（98.4%）获得了确定性结果。其中，4.6%的抗肿瘤坏死因子α候选者、19.3%的接触者和24.4%的疑似结核病患者检测结果呈阳性。与抗肿瘤坏死因子α候选者相比，接触者调查（比值比（OR），均值（95%置信区间）：4.93（3.11 - 7.81））和疑似结核病患者（OR：6.83（4.33 - 10.77））检测结果呈阳性的几率显著更高。在秋季和冬季期间（OR：2.53（1.58 - 4.05））以及年龄＞75岁（OR：2.66（1.43 - 4.94））和＜6岁（OR：3.35（1.58 - 7.09））的患者中，检测结果不确定的几率升高。在43例经培养证实的结核分枝杆菌感染患者中，共有41例检测结果呈阳性，1例假阴性。
在常规检测中，检测结果不确定的情况很少见，但在秋冬季节以及年龄＜6岁和＞75岁的患者中更为常见。尽管确实出现了假阴性结果，但T-SPOT.TB在经培养证实的结核病中显示出较高的敏感性。
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