Table 3.
Summary of Pooled Differences in Sensitivity and Specificity Between the Wantai TB-IGRA and the QFT-GIT or the T-SPOT.TB
| Comparator/Outcome | Analysis | Studies, No. | Subjects Tested, No. | Correctly Classified (Wantai TB-IGRA), No. | Correctly Classified (Comparator), No. | Pooled Estimate Wantai TB-IGRA, % (95% CI); I2 | Pooled Estimate Comparator, % (95% CI); I2 | Difference in Sensitivity or Specificitya (Wantai TB-IGRA – Comparator), % Points (95% CI); I2 | Certainty of the Evidence (GRADE) |
|---|---|---|---|---|---|---|---|---|---|
| QFT-GIT as comparator | |||||||||
| Sensitivity | Paired comparisons (published studies)b | 0 | … | … | … | … | … | … | Very lowc,d,e ⊕○○○ |
| Paired comparisons (all studies) | 1 | 43 | 31 | 35 | 72.1 (56.3–84.7); NA | 81.4 (66.6–91.6); NA | −9.3 (−21.5 to 2.7); NA | ||
| Parallel comparisons (published studies) | 5 | 1600 | 1373 | 1321 | 86.4 (81.5–90.2); 87% | 83.2 (76.3–88.4); 93% | 3.0 (−.2 to 6.2); 32% | ||
| Parallel comparisons (all studies) | 7 | 2429 | 2041 | 1966 | 84.5 (79.8–88.4); 85% | 82.2 (76.8–86.6); 90% | 2.8 (−.3 to 5.9); 57% | ||
| Specificity | Paired comparisons (published studies)b | 0 | … | … | … | … | … | … | Lowc,e ⊕⊕○○ |
| Paired comparisons (all studies) | 0 | … | … | … | … | … | … | ||
| Parallel comparisons (published studies) | 4 | 818 | 714 | 733 | 85.9 (77.1–91.6); 90% | 88.7 (77.7–94.7); 91% | −2.6 (−4.2 to −1.0); 2% | ||
| Parallel comparisons (all studies) | 6 | 1093 | 927 | 958 | 84.3 (77.0–89.7); 87% | 86.8 (78.0–92.4); 87% | −2.8 (−4.7 to −.8); 17% | ||
| T-SPOT.TB as comparator | |||||||||
| Sensitivity | Paired comparisons (published studies)b | 1 | 68 | 66 | 66 | 97.1 (89.8–99.6); NA | 97.1 (89.8–99.6); NA | .0 (−7.0 to 7.0); NA | Very lowc,d,e ⊕○○○ |
| Paired comparisons (all studies)f | 1 | 68 | 66 | 66 | 97.1 (89.8–99.6); NA | 97.1 (89.8–99.6); NA | .0 (−7.0 to 7.0); NA | ||
| Parallel comparisons (published studies) | 6 | 1288 | 1065 | 1092 | 87.7 (80.9–92.3); 89% | 88.7 (83–92.7); 87% | −1.6 (−4.2 to 1.0); 16% | ||
| Parallel comparisons (all studies)f | 7 | 1332 | 1104 | 1132 | 87.8 (81.9–91.9); 88% | 88.9 (83.8–92.6); 85% | −1.6 (−3.9 to .6); 11% | ||
| Specificity | Paired comparisons (published studies)b | 0 | … | … | … | … | … | … | Very lowc,d,e ⊕○○○ |
| Paired comparisons (all studies) | 0 | … | … | … | … | … | … | ||
| Parallel comparisons (published studies) | 1 | 185 | 151 | 170 | 81.6 (75.3–86.9); NA | 91.9 (87–95.4); NA | −10.3 (−17.2 to −3.4); NA | ||
| Parallel comparisons (all studies) | 3 | 285 | 241 | 261 | 85.5 (77.3–91.1); 45% | 91.6 (87.7–94.3); 0% | −5.6 (−20 to 8.7); 33% | ||
A summary of each analysis, including information from individual studies, is shown in Supplementary Material Part C, Supplementary Tables 25–29 (sensitivity) and Supplementary Tables 30–32 (specificity). Forest plots of pooled sensitivities and specificities are shown in Supplementary Material Part C, Supplementary Figures 31–34 and 35–38, respectively. For a summary of the risk of bias assessment, please refer to Supplementary Figures 22–27. 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; GRADE, Grading of Recommendations Assessment, Development and Evaluation; NA, not available.
Pooled differences in sensitivity or specificity do not match exactly to the differences in the pooled sensitivities or specificities since they correspond to different meta-analytical approaches.
Primary analysis.
Downgraded because most studies were considered at either unclear or high risk of bias.
Downgraded because CIs are very wide, and consistent with both an appreciable gain and appreciable loss in diagnostic accuracy.
Downgraded because of the risk of publication bias.
No unpublished studies were included in this analysis; results are repeated from the analysis including only published studies.