Evaluation of a New IFN-γ Release Assay for Rapid Diagnosis of Active Tuberculosis in a High-Incidence Setting.
Evaluation of a New IFN-γ Release Assay for Rapid Diagnosis of Active Tuberculosis in a High-Incidence Setting.
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DOI：
10.3389/fcimb.2017.00117
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发表时间：
2017
影响因子：
5.7
通讯作者：
Fan XY
中科院分区：
文献类型：
--
作者：
Li G;Li F;Zhao HM;Wen HL;Li HC;Li CL;Ji P;Xu P;Wu K;Hu ZD;Lu SH;Lowrie DB;Lv JX;Fan XY
基于血液的干扰素-γ（IFN-γ）释放测定（IGRA）已被证明在结核分枝杆菌（Mtb）感染的诊断中是有用的。然而，由于成本密集的限制和可用临床数据的短缺，IGRA尚未被推荐用于大多数低收入环境中的临床实践。成立的T-SPOT。结核分枝杆菌特异性抗原ESAT-6和CFP 10检测法是目前广泛应用于结核分枝杆菌感染的免疫诊断方法，但其昂贵的成本是制约其在发展中国家临床应用的因素之一。最近，一种节省成本的IGRA检测方法TS-SPOT在中国获得批准。该新检测试剂盒含有额外的抗原Rv 3615 c。Rv 3615 c含有广泛识别的CD 4+和CD 8+表位，并且在Mtb感染的人和M.感染牛的牛因此，我们评估了在IGRA测定中除了ESAT-6和CFP 10之外还包括Rv 3615 c作为刺激物的可能效果，并评估了TS-SPOT与T-SPOT. TB相比诊断Mtb感染和活动性TB的性能。我们测试了155名活动性肺结核患者，90名非肺结核患者和55名健康个体。结果显示，活动性TB和Mtb感染的诊断阳性率提高，这可能归因于在刺激抗原的混合物中包含Rv 3615 c。TS-SPOT检测对活动性结核的诊断效率为：敏感性80.00%，特异性83.45%，阳性预测值（PPV）83.78%，阴性预测值（NPV）83.45%，阳性似然比（LR+）4.83，阴性似然比（LR-）0.24。结果与T-SPOT.TB的结果相似，在这两种测定法之间观察到极好的一致性（κ = 0.91，95% CI：0.85-0.95）。不同类型活动性肺结核患者TS-SPOT检测的敏感性不同，培养阳性肺结核患者的敏感性最高（92.16%），结核性脑膜炎患者的敏感性最低（50.00%）。综上所述，目前的证据表明，这种新的TS-SPOT检测是一个有用的辅助目前的测试，用于快速诊断活动性结核病和结核分枝杆菌感染在低收入和高发病率的环境中，由于其成本效益和高质量的特点。
Blood-based interferon-gamma (IFN-γ) release assays (IGRAs) have been proven to be useful in the diagnosis of Mycobacterium tuberculosis (Mtb) infection. However, IGRAs have not been recommended for clinical practice in most low-income settings due to cost-intensive limitations and shortage of clinical data available. The established T-SPOT. TB assay containing Mtb-specific antigens ESAT-6 and CFP10 are widely used for immunodiagonsis of Mtb infection, but the high cost is one of the restricting factors against its clinical application in the developing countries. More recently, a cost-saving IGRA assay, TS-SPOT, was approved in China. This new assay contains an additional antigen Rv3615c. Rv3615c contains broadly recognized CD4+ and CD8+ epitopes, and T-cell responses to Rv3615c are as specific for Mtb infection as the responses to ESAT-6 and CFP10 in both Mtb-infected humans and M. bovis-infected cattle. Therefore, we assessed the likely effect of inclusion of Rv3615c as stimulus besides ESAT-6 and CFP10 in an IGRA assay and evaluated the performance of TS-SPOT for diagnosis of Mtb infection and active TB compared with T-SPOT.TB. We tested 155 active TB patients, 90 non-TB lung disease patients, and 55 healthy individuals. The results presented an improved positive rate for diagnosis of active TB and Mtb infection, that could be attributable to inclusion of Rv3615c in the mixture of stimulatory antigens. The diagnostic efficiency of TS-SPOT assay for active TB was as follows: sensitivity 80.00%, specificity 83.45%, positive predictive value (PPV) 83.78%, negative predictive value (NPV) 83.45%, positive likelihood ratio (LR+) 4.83, and negative likelihood ratio (LR−) 0.24. The results were similar to those of T-SPOT.TB, with an excellent agreement (κ = 0.91, 95% CI: 0.85–0.95) being observed between these two assays. The sensitivities of the TS-SPOT assay varied for patients with different forms of active TB, with the highest sensitivity for patients with culture-positive pulmonary TB (92.16%) and the lowest for those with tuberculosis meningitis (50.00%). Taken together, the current evidence indicates that this new TS-SPOT assay is a useful adjunct to the current tests for rapid diagnosis of active TB and Mtb infection in low-income and high-incidence settings due to its characteristics of cost-effectiveness and high-quality.