Hong Ji Young, Park So Yeong, Kim Ahreum, Cho Sang-Nae, Hur Yun-Gyoung
Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University Medical Center, Chuncheon, Gangwon-do, Republic of Korea.
Institute for Immunology and Immunological Diseases, Yonsei University College of Medicine, Seodaemun-gu, Seoul, Republic of Korea.
J Thorac Dis. 2019 Dec;11(12):5210-5217. doi: 10.21037/jtd.2019.12.11.
QFT-Plus is a recently developed next-generation QuantiFERON-TB Gold In-Tube (QFT-GIT) test. Unlike the QFT-GIT test, it includes a TB2 antigen tube with peptides that may stimulate CD8+ T cells. This study evaluated the diagnostic performance of QFT-Plus and compared it with that of QFT-GIT.
QFT-Plus and QFT-GIT tests were performed in 33 patients with active tuberculosis (TB) and 57 healthy controls including subjects with latent TB infection (LTBI). Positivity and negativity of IFN-γ responses were compared between tests, and total concordance of the outcome was analyzed.
Positive and negative outcomes of QFT-Plus and QFT-GIT tests showed substantial agreement (91.1%, kappa=0.8). The sensitivity and the specificity of QFT-Plus (93.9% sensitivity, 92.6% specificity) were similar with those of QFT-GIT (93.9% sensitivity, 100% specificity). Of eight discordant results, five (5.56%) and three (3.3%) were positive in QFT-GIT alone and QFT-plus alone, respectively. Reactivity in the TB2 tube contributes to the difference between QFT-GIT and QFT-Plus. Median IFN-γ production in TB2 (10.0 IU/mL in TB, 3.850 IU/mL in LTBI, P=0.001) is significantly higher in the TB group than the LTBI group. The QFT-Plus did not clearly discriminate between active TB and latent TB, although it showed significantly lower IFN-γ concentrations compared with the QFT-GIT in individuals with LTBI (3.850 7.205 IU/mL).
Similar accuracy of detecting infection was observed for QFT-Plus and QFT-GIT tests in immunocompetent patients and healthy controls, including those with LTBI. Improved efficacy for identifying infection was not found with the QFT-Plus, but further studies in a larger population may confirm the clinical significance of positive response in the TB2 tube of QFT-Plus.
QFT-Plus是最近开发的下一代全血γ干扰素结核菌素检测(QFT-GIT)试验。与QFT-GIT试验不同,它包含一个含有可刺激CD8+T细胞的肽的TB2抗原管。本研究评估了QFT-Plus的诊断性能,并将其与QFT-GIT的诊断性能进行比较。
对33例活动性结核病(TB)患者和57名健康对照者(包括潜伏性结核感染(LTBI)受试者)进行QFT-Plus和QFT-GIT试验。比较两种试验中IFN-γ反应的阳性和阴性情况,并分析结果的总体一致性。
QFT-Plus和QFT-GIT试验的阳性和阴性结果显示出高度一致性(91.1%,kappa=0.8)。QFT-Plus的敏感性和特异性(敏感性93.9%,特异性92.6%)与QFT-GIT的敏感性和特异性(敏感性93.9%,特异性100%)相似。在8个不一致的结果中,仅QFT-GIT阳性的有5个(5.56%),仅QFT-Plus阳性的有3个(3.3%)。TB2管中的反应性导致了QFT-GIT和QFT-Plus之间的差异。TB组TB2管中IFN-γ产生的中位数(结核病患者中为10.0 IU/mL,LTBI患者中为3.850 IU/mL,P=0.001)显著高于LTBI组。尽管与LTBI个体的QFT-GIT相比,QFT-Plus显示出显著更低的IFN-γ浓度(3.850对7.205 IU/mL),但QFT-Plus并不能明确区分活动性结核病和潜伏性结核病。
在免疫功能正常的患者和健康对照者(包括LTBI患者)中,QFT-Plus和QFT-GIT试验检测感染的准确性相似。未发现QFT-Plus在识别感染方面有更高的效能,但在更大规模人群中的进一步研究可能会证实QFT-Plus的TB2管中阳性反应的临床意义。