Hsia Elizabeth C, Schluger Neil, Cush John J, Chaisson Richard E, Matteson Eric L, Xu Stephen, Beutler Anna, Doyle Mittie K, Hsu Benjamin, Rahman Mahboob U
Janssen Research & Development, LLC, Spring House, Pennsylvania 19472, USA.
Arthritis Rheum. 2012 Jul;64(7):2068-77. doi: 10.1002/art.34382.
To evaluate the performance of an interferon-γ release assay (IGRA) versus the standard tuberculin skin test (TST) as a screening tool for latent tuberculosis (TB) infection prior to the initiation of anti-tumor necrosis factor therapy in patients with autoimmune inflammatory diseases.
This integrated analysis involved screening of patients with rheumatoid arthritis, those with psoriatic arthritis, and those with ankylosing spondylitis from phase III trials of golimumab. The IGRA used to screen for latent TB was the QuantiFERON-TB Gold In-Tube test.
In this pooled analysis, 2,282 patients underwent both IGRA and TST screening prior to golimumab treatment. Among these patients, 13.8% had at least one test yielding positive findings for latent TB, including 9.4% with positive results by TST, 7.0% with positive results by IGRA, and 2.6% with positive results on both tests. The rate of indeterminate results for TB on IGRA was 1.8%. Agreement between the TST and IGRA results, measured by the kappa coefficient, was 0.22 (95% confidence interval 0.157-0.279; P=0.021). Among the patients with positive IGRA findings, 36.9% had positive TST findings. Among the patients with positive TST findings, 27.4% had positive IGRA findings. Overall, 781 (34.2%) of the 2,282 patients had previously received the bacillus Calmette-Guérin (BCG) vaccine; among this vaccinated group, the rate of positivity for latent TB by TST was 15.2% (119 of 781), compared to a rate of positivity of 9.1% (71 of 781) by IGRA (P=0.0002). Among patients who had not received the BCG vaccine, the rate of positivity by TST was 5.0% (62 of 1,248) and the rate of positivity by IGRA was 5.8% (72 of 1,248) (P=0.3745). When the IGRA was repeated in patients whose results were initially indeterminate, the rate of indeterminate IGRA findings for latent TB was much lower than has been previously reported.
In the absence of a true gold standard test for latent TB infection, results of this comparison of IGRA and TST in a large cohort of patients with rheumatic diseases suggest that the IGRA provides greater specificity and possibly greater sensitivity than the TST.
评估在自身免疫性炎症性疾病患者开始抗肿瘤坏死因子治疗之前，干扰素-γ释放试验（IGRA）与标准结核菌素皮肤试验（TST）作为潜伏性结核（TB）感染筛查工具的性能。
这项综合分析涉及从戈利木单抗的III期试验中筛选类风湿关节炎患者、银屑病关节炎患者和强直性脊柱炎患者。用于筛查潜伏性结核的IGRA是全血干扰素-γ释放试验。
在这项汇总分析中，2282例患者在接受戈利木单抗治疗前同时接受了IGRA和TST筛查。在这些患者中，13.8%的患者至少有一项试验对潜伏性结核检测呈阳性结果，其中TST阳性率为9.4%，IGRA阳性率为7.0%，两项试验均阳性率为2.6%。IGRA检测结核结果不确定的比例为1.8%。用kappa系数衡量，TST和IGRA结果之间的一致性为0.22（95%置信区间0.157 - 0.279；P = 0.021）。在IGRA检测结果为阳性的患者中，36.9%的患者TST结果为阳性。在TST检测结果为阳性的患者中，27.4%的患者IGRA结果为阳性。总体而言，2282例患者中有781例（34.2%）之前接种过卡介苗（BCG）；在这个接种疫苗的组中，TST检测潜伏性结核的阳性率为15.2%（781例中的119例），而IGRA的阳性率为9.1%（781例中的71例）（P = 0.0002）。在未接种BCG疫苗的患者中，TST阳性率为5.0%（1248例中的62例），IGRA阳性率为5.8%（1248例中的72例）（P = 0.3745）。对于初始结果不确定的患者重复进行IGRA检测时，IGRA检测潜伏性结核结果不确定的比例远低于先前报道的比例。
在缺乏用于潜伏性结核感染的真正金标准检测的情况下，在一大群风湿病患者中对IGRA和TST进行比较的结果表明，IGRA比TST具有更高的特异性，可能也具有更高的敏感性。
