评估新型商业干扰素-γ 释放试验在结核分枝杆菌感染中的诊断性能：系统评价和荟萃分析。
Assessing the Diagnostic Performance of New Commercial Interferon-γ Release Assays for Mycobacterium tuberculosis Infection: A Systematic Review and Meta-Analysis.
机构信息
McGill International Tuberculosis Centre, Department of Medicine, McGill University, Montreal, Quebec, Canada.
Department of Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
出版信息
Clin Infect Dis. 2023 Jun 8;76(11):1989-1999. doi: 10.1093/cid/ciad030.
BACKGROUND
We compared 6 new interferon-γ release assays (IGRAs; hereafter index tests: QFT-Plus, QFT-Plus CLIA, QIAreach, Wantai TB-IGRA, Standard E TB-Feron, and T-SPOT.TB/T-Cell Select) with World Health Organization (WHO)-endorsed tests for tuberculosis infection (hereafter reference tests).
METHODS
Data sources (1 January 2007-18 August 2021) were Medline, Embase, Web of Science, Cochrane Database of Systematic Reviews, and manufacturers' data. Cross-sectional and cohort studies comparing the diagnostic performance of index and reference tests were selected. The primary outcomes of interest were the pooled differences in sensitivity and specificity between index and reference tests. The certainty of evidence (CoE) was summarized using the GRADE approach.
RESULTS
Eighty-seven studies were included (44 evaluated the QFT-Plus, 4 QFT-Plus CLIA, 3 QIAreach, 26 TB-IGRA, 10 TB-Feron [1 assessing the QFT-Plus], and 1 T-SPOT.TB/T-Cell Select). Compared to the QFT-GIT, QFT Plus's sensitivity was 0.1 percentage points lower (95% confidence interval [CI], -2.8 to 2.6; CoE: moderate), and its specificity 0.9 percentage points lower (95% CI, -1.0 to -.9; CoE: moderate). Compared to QFT-GIT, TB-IGRA's sensitivity was 3.0 percentage points higher (95% CI, -.2 to 6.2; CoE: very low), and its specificity 2.6 percentage points lower (95% CI, -4.2 to -1.0; CoE: low). Agreement between the QFT-Plus CLIA and QIAreach with QFT-Plus was excellent (pooled κ statistics of 0.86 [95% CI, .78 to .94; CoE: low]; and 0.96 [95% CI, .92 to 1.00; CoE: low], respectively). The pooled κ statistic comparing the TB-Feron and the QFT-Plus or QFT-GIT was 0.85 (95% CI, .79 to .92; CoE: low).
CONCLUSIONS
The QFT-Plus and the TB-IGRA have very similar sensitivity and specificity as WHO-approved IGRAs.
背景
我们将 6 种新的干扰素-γ 释放检测（IGRAs；以下简称指数检测：QFT-Plus、QFT-Plus CLIA、QIAreach、万泰 TB-IGRA、标准 E TB-Feron 和 T-SPOT.TB/T-Cell Select）与世界卫生组织（WHO）推荐的结核感染检测（以下简称参考检测）进行了比较。
方法
数据来源（2007 年 1 月 1 日至 2021 年 8 月 18 日）包括 Medline、Embase、Web of Science、Cochrane 系统评价数据库和制造商数据。我们选择了比较指数检测和参考检测诊断性能的横断面和队列研究。主要结局是指数检测和参考检测之间敏感性和特异性的汇总差异。证据确定性（CoE）使用 GRADE 方法进行总结。
结果
共纳入 87 项研究（44 项评估了 QFT-Plus，4 项 QFT-Plus CLIA，3 项 QIAreach，26 项 TB-IGRA，10 项 TB-Feron[1 项评估了 QFT-Plus]和 1 项 T-SPOT.TB/T-Cell Select）。与 QFT-GIT 相比，QFT Plus 的敏感性低 0.1 个百分点（95%置信区间[CI]，-2.8 至 2.6；CoE：中度），特异性低 0.9 个百分点（95%CI，-1.0 至 -.9；CoE：中度）。与 QFT-GIT 相比，TB-IGRA 的敏感性高 3.0 个百分点（95%CI，-.2 至 6.2；CoE：非常低），特异性低 2.6 个百分点（95%CI，-4.2 至 -1.0；CoE：低）。QFT-Plus CLIA 和 QIAreach 与 QFT-Plus 的一致性非常好（汇总κ统计值分别为 0.86[95%CI，0.78 至 0.94；CoE：低]和 0.96[95%CI，0.92 至 1.00；CoE：低]）。TB-Feron 与 QFT-Plus 或 QFT-GIT 的汇总κ 统计值为 0.85（95%CI，0.79 至 0.92；CoE：低）。
结论
QFT-Plus 和 TB-IGRA 与 WHO 批准的 IGRAs 具有非常相似的敏感性和特异性。
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