PDF(Pubmed)
Abstract：
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).
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.
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).
The QFT-Plus and the TB-IGRA have very similar sensitivity and specificity as WHO-approved IGRAs.
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.
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).
The QFT-Plus and the TB-IGRA have very similar sensitivity and specificity as WHO-approved IGRAs.
摘要：
背景：我们比较了六个新的IGRA（以下简称索引测试：QFT-Plus，QFT-PlusCLIA,QIAreach,万泰TB-IGRA,标准ETB-Feron,还有T-SPOT.TB/T细胞选择）与WHO认可的结核病感染测试（以下简称参考测试）。
方法：数据来源（2007/Jan/01-2021/Aug/18）：Medline，EMBase,WebofScience,Cochrane系统评价数据库和制造商数据。研究选择：比较指标和参考测试的诊断性能的横断面和队列研究。.数据综合：感兴趣的主要结果是指数和参考测试之间的敏感性和特异性的汇总差异。使用等级方法总结了证据的确定性(CoE)。
结果：纳入了87项研究(44项评估了QFT-Plus，4QFT-PlusCLIA，3QIAreach，26TB-IGRA,10TB-Feron[1评估QFT-Plus]，和1T-SPOT。TB/T细胞选择)。与QFT-GIT相比，QFTPlus的敏感度低0.1个百分点（95%CI，-2.8，2.6；CoE：中等），其特异性降低0.9个百分点（95%CI，-1.0，-0.9；CoE：中等）。与QFT-GIT相比，TB-IGRA的敏感性高出3.0个百分点（95%CI，-0.2，6.2；CoE：非常低），其特异性降低2.6个百分点（95%CI，-4.2，-1.0；CoE：低）。QFT-PlusCLIA和QIAreach与QFT-Plus之间的协议非常好（合并kappa统计数据为0.86[95％CI，0.78，0.94；CoE：低]；和0.96[95％CI，0.92，1.00；CoE：低]，分别)。比较TB-Feron和QFT-Plus或QFT-GIT的合并kappa统计为0.85(95%CI,0.79至0.92;CoE:低)。
结论：QFT-plus和TB-IGRA与WHO批准的IGRA具有非常相似的敏感性和特异性。
方法：数据来源（2007/Jan/01-2021/Aug/18）：Medline，EMBase,WebofScience,Cochrane系统评价数据库和制造商数据。研究选择：比较指标和参考测试的诊断性能的横断面和队列研究。.数据综合：感兴趣的主要结果是指数和参考测试之间的敏感性和特异性的汇总差异。使用等级方法总结了证据的确定性(CoE)。
结果：纳入了87项研究(44项评估了QFT-Plus，4QFT-PlusCLIA，3QIAreach，26TB-IGRA,10TB-Feron[1评估QFT-Plus]，和1T-SPOT。TB/T细胞选择)。与QFT-GIT相比，QFTPlus的敏感度低0.1个百分点（95%CI，-2.8，2.6；CoE：中等），其特异性降低0.9个百分点（95%CI，-1.0，-0.9；CoE：中等）。与QFT-GIT相比，TB-IGRA的敏感性高出3.0个百分点（95%CI，-0.2，6.2；CoE：非常低），其特异性降低2.6个百分点（95%CI，-4.2，-1.0；CoE：低）。QFT-PlusCLIA和QIAreach与QFT-Plus之间的协议非常好（合并kappa统计数据为0.86[95％CI，0.78，0.94；CoE：低]；和0.96[95％CI，0.92，1.00；CoE：低]，分别)。比较TB-Feron和QFT-Plus或QFT-GIT的合并kappa统计为0.85(95%CI,0.79至0.92;CoE:低)。
结论：QFT-plus和TB-IGRA与WHO批准的IGRA具有非常相似的敏感性和特异性。
