Department of Pediatrics, Kosin University College of Medicine, Busan, Republic of Korea.
Respiratory Epidemiology and Clinical Research Unit, McGill International TB Centre, McGill University, Montréal, Québec, Canada.
Clin Infect Dis. 2021 Sep 7;73(5):e1116-e1125. doi: 10.1093/cid/ciaa1822.
We conducted a review to compare the sensitivity, specificity, reproducibility, and predictive ability of QuantiFERON-TB Gold Plus (QFT-Plus) with that of QuantiFERON-TB Gold In-Tube (QFT-GIT; QIAGEN, Hilden, Germany) and other latent tuberculosis infection (LTBI) tests.
We searched MEDLINE, Embase, Web of Science, and the Cochrane Database of Systematic Reviews from January 2013 through May 2020. We included studies comparing QFT-Plus with at least one other LTBI test. We estimated sensitivity from studies of patients with active tuberculosis, and specificity from studies of healthy individuals with low risk of LTBI. Three independent reviewers evaluated eligibility, extracted data, and assessed risk of bias.
Compared with QFT-GIT, the sensitivity of QFT-Plus in patients with active TB was 1.3% higher (95% confidence interval [CI], -0.3% to 2.9%); in 2 studies of patients with very low probability of LTBI, the specificity was 0.9% lower (95% CI, -2.4% to 0.6%). These differences were not statistically significant. The agreement between QFT-Plus and QFT-GIT was high, with a pooled Cohen's kappa statistic of 0.83 (95% CI, 0.79 to 0.88). The reproducibility of QFT-GIT and QFT-Plus was similarly poor. All participants in the studies to estimate sensitivity were aged ≥15 years, and only 6 were people living with human immunodeficiency virus. We found no studies to assess predictive ability.
QFT-Plus has diagnostic performance that is very similar to that of QFT-GIT. Further studies are needed to assess the sensitivity of QFT-Plus in immunocompromised patients and younger children before concluding if this new version offers advantages.
我们进行了一项综述，比较了 QuantiFERON-TB Gold Plus（QFT-Plus）与 QuantiFERON-TB Gold In-Tube（QFT-GIT；QIAGEN，德国希尔德斯海姆）和其他潜伏性结核感染（LTBI）检测的敏感性、特异性、可重复性和预测能力。
我们检索了 MEDLINE、Embase、Web of Science 和 Cochrane 系统评价数据库，检索时间为 2013 年 1 月至 2020 年 5 月。我们纳入了比较 QFT-Plus 与至少一种其他 LTBI 检测的研究。我们从活动性结核病患者的研究中估计敏感性，从 LTBI 风险低的健康个体的研究中估计特异性。三位独立的评审员评估了纳入研究的资格、提取数据并评估了偏倚风险。
与 QFT-GIT 相比，QFT-Plus 在活动性结核病患者中的敏感性高 1.3%（95%置信区间[CI]，-0.3%至 2.9%）；在 2 项 LTBI 可能性极低的患者研究中，特异性低 0.9%（95%CI，-2.4%至 0.6%）。这些差异无统计学意义。QFT-Plus 与 QFT-GIT 的一致性较高，汇总 Cohen's kappa 统计量为 0.83（95%CI，0.79 至 0.88）。QFT-GIT 和 QFT-Plus 的可重复性均较差。估计敏感性的研究中所有参与者的年龄均≥15 岁，仅有 6 名参与者为人免疫缺陷病毒感染者。我们未发现评估预测能力的研究。
QFT-Plus 的诊断性能与 QFT-GIT 非常相似。在得出关于新版本是否具有优势的结论之前，还需要进一步的研究来评估免疫功能低下患者和年幼儿童中 QFT-Plus 的敏感性。
