Table 2.
Summary of Agreement Between the New or Updated Interferon-γ Release Assays and the World Health Organization–Endorsed Tests or the Tuberculin Skin Test
| Index Test/Comparator | Studies Included | Studies, No. | Subjects Tested, No. | Total Concordant, No. | Agreement Pooled κ Statistic (95% CI); I2 | Certainty of the Evidence (GRADE) |
|---|---|---|---|---|---|---|
| QFT-Plus | ||||||
| QFT-GIT | Published studies | 22 | 6586 | 6204 | 0.82 (.78–.85); 67.4% | High ⊕⊕⊕⊕ |
| All studies | 23 | 7187 | 6799 | 0.82 (.79–.86); 75.4% | ||
| T-SPOT.TB | Published studiesa | 7 | 3139 | 2767 | 0.72 (.57–.86); 97.5% | Moderateb ⊕⊕⊕○ |
| TST | Published studiesa | 7 | 1312 | 914 | 0.32 (.20–.44); 81.2% | Moderateb ⊕⊕⊕○ |
| QFT-Plus CLIAc | ||||||
| QFT-Plus | Published studiesa,d | 4 | 1173 | 1039 | 0.86 (.78–.94); 74.8% | Lowe ⊕⊕○○ |
| QIAreachc | ||||||
| QFT-Plus | Published studiesd | 2 | 289 | 279 | 0.96 (.92–1.00); 24.9% | Lowe ⊕⊕○○ |
| All studiesd | 3 | 529 | 498 | 0.95 (.92–.98); 0.0% | ||
| Wantai TB-IGRA | ||||||
| QFT-GIT | Published studies | 3 | 1127 | 950 | 0.79 (.64–.94); 92.1% | Very lowb,f,g ⊕○○○ |
| All studies | 4 | 2355 | 2043 | 0.79 (.70–.88); 90.6% | ||
| T-SPOT.TB | Published studiesa | 3 | 340 | 320 | 0.87 (.81–.93); 0.0% | Lowf,g ⊕⊕○○ |
| TST | Published studiesa | 2 | 141 | 103 | 0.37 (.05–.69); 51.6% | Very lowd,f,g ⊕○○○ |
| TB-Feron ELISAc | ||||||
| QFT-Plus or QFT-GIT | Published studies | 4 | 1062 | 1001 | 0.85 (.79–.92); 62.0% | Lowf,g ⊕⊕○○ |
| QFT-Plus or QFT-GIT or QFT-Gold | All studies | 10 | 2454 | 2326 | 0.88 (.84–.93); 73.2% | Lowf,g ⊕⊕○○ |
Forest plots of each agreement analysis included in this table are shown in the following figures: Supplementary Material Part B: Supplementary Figures 15–18 (QFT-Plus), Supplementary Figure 19 (QFT-Plus CLIA), Supplementary Figures 20 and 21 (QIAreach); Supplementary Material Part C: Figures 39–42 (Wantai TB-IGRA); and Supplementary Material Part D: Supplementary Figures 48 and 49 (TB-Feron). Only the manufacturer evaluation of the T-SPOT.TB with T-Cell Select was identified/included in this study; results are summarized in Supplementary Material Part D, Supplementary Figure 50 and Supplementary Table 38. For a summary of the risk of bias assessment, please refer to Supplementary Figures 7–9 (QFT-Plus), 28–30 (TB-IGRA), and 43–45 (TB-Feron). In line with the GRADE approach, the certainty of evidence (CoE) is categorized into four levels: very low (⊕○○○), low (⊕⊕○○), moderate (⊕⊕⊕○), and high (⊕⊕⊕⊕).
Abbreviations: CI, confidence interval; ELISA, enzyme-linked immunosorbent assay; GRADE, Grading of Recommendations Assessment, Development and Evaluation.
No unpublished studies assessing this comparison were identified/included.
Downgraded because of the wide CIs.
Insufficient studies were identified that assessed sensitivity or specificity of these tests. Hence, only measures of agreement could be pooled and are shown.
Three studies assessing QFT-Plus CLIA [73], [7], [74] and 1 study assessing the QIAreach [75] reported results by number of samples instead of per patient.
Downgraded because 3 of 4 QFT-Plus CLIA studies and 2 of 3 QIAreach studies were considered at high risk of bias.
Downgraded because most studies were considered at either unclear or high risk of bias.
Downgraded because of the risk of publication bias.