Table 4 Evaluating diagnostic accuracy of Abbott and Roche DBS vs. Abbott Plasma in VL testing
Diagnostic test(s) | Reference test (Abbott Plasma VL copies/mL) | Diagnostic accuracy measures (DAMs) | ||||
|---|---|---|---|---|---|---|
Test category | Test result | >=1000 | < 1000 | Total | Measure | Estimate (95% CI) |
M-DBS VL copies/ml | >=1000 | 213 | 26 | 239 | Sensitivity (%) | 90.3 (86.5–94.0) |
Specificity (%) | 94.9 (92.9–96.8) | |||||
< 1000 | 23 | 480 | 503 | Positive Predictive Value (PPV) (%) | 89.1 (85.2–93.1) | |
Negative Predictive Value (NPV) (%) | 95.4 (93.6–97.3) | |||||
Total | 236 | 506 | 742 | Upward Misclassification (%) | 5.1 (3.2–7.1) | |
Downward Misclassification (%) | 9.7 (6.0–13.5) | |||||
False Omission Rate (FOR) (%) | 4.6 (2.7–6.4) | |||||
False Discovery Rate (FDR) (%) | 10.9 (8.2–13.6) | |||||
Positive Likelihood Ratio (LR+) | 17.6 (12.1–25.6) | |||||
Negative Likelihood Ratio (LR-) | 0.1 (0.1–0.2) | |||||
Diagnostic Accuracy (%) | 93.4 (91.6–95.2) | |||||
Disease Prevalence (%) | 31.8 (28.5–35.2) | |||||
Diagnostic Odds Ratio (DOR) | 171.0 (95.4–306.5) | |||||
Kappa Agreement | 0.8 (0.8–0.9) | |||||
Youden’s Index | 0.9 (0.8–0.9) | |||||
F-score | 0.9 (0.9–0.9) | |||||
V-DBS VL copies/ml | >=1000 | 219 | 35 | 254 | Sensitivity (%) | 90.1 (86.4–93.9) |
Specificity (%) | 93.1 (90.9–95.3) | |||||
< 1000 | 24 | 475 | 499 | Positive Predictive Value (PPV) (%) | 86.2 (82.0–90.5) | |
Negative Predictive Value (NPV) (%) | 95.2 (93.3–97.1) | |||||
Total | 243 | 510 | 753 | Upward Misclassification (%) | 6.9 (4.7–9.1) | |
Downward Misclassification (%) | 9.9 (6.1–13.6) | |||||
False Omission Rate (FOR) (%) | 4.8 (2.9–6.7) | |||||
False Discovery Rate (FDR) (%) | 13.8 (10.8–16.8) | |||||
Positive Likelihood Ratio (LR+) | 13.1 (9.5–18.1) | |||||
Negative Likelihood Ratio (LR-) | 0.1 (0.1–0.2) | |||||
Diagnostic Accuracy (%) | 92.2 (90.2–94.1) | |||||
Disease Prevalence (%) | 32.3 (28.9–35.6) | |||||
Diagnostic Odds Ratio (DOR) | 123.8 (71.9–213.3) | |||||
Kappa Agreement | 0.8 (0.8–0.9) | |||||
Youden’s Index | 0.8 (0.8–0.9) | |||||
F-score | 0.9 (0.9–0.9) | |||||
D-DBS VL copies/ml | >=1000 | 208 | 28 | 236 | Sensitivity (%) | 88.1 (84.0–92.3) |
Specificity (%) | 94.5 (92.5–96.5) | |||||
< 1000 | 28 | 480 | 508 | Positive Predictive Value (PPV) (%) | 88.1 (84.0–92.3) | |
Negative Predictive Value (NPV) (%) | 94.5 (92.5–96.5) | |||||
Total | 236 | 508 | 744 | Upward Misclassification (%) | 5.5 (3.5–7.5) | |
Downward Misclassification (%) | 11.9 (7.7–16.0) | |||||
False Omission Rate (FOR) (%) | 5.5 (3.5–7.5) | |||||
False Discovery Rate (FDR) (%) | 11.9 (9.1–14.7) | |||||
Positive Likelihood Ratio (LR+) | 16.0 (11.1–23.0) | |||||
Negative Likelihood Ratio (LR-) | 0.1 (0.1–0.2) | |||||
Diagnostic Accuracy (%) | 92.5 (90.6–94.4) | |||||
Disease Prevalence (%) | 31.7 (28.4–35.1) | |||||
Diagnostic Odds Ratio (DOR) | 127.3 (73.6–220.4) | |||||
Kappa Agreement | 0.8 (0.8–0.9) | |||||
Youden’s Index | 0.8 (0.8–0.9) | |||||
F-score | 0.9 (0.9–0.9) | |||||
CAP/CTM V-DBS VL copies/ml | >=1000 | 219 | 343 | 562 | Sensitivity (%) | 94.4 (91.4–97.4) |
Specificity (%) | 33.0 (28.9–37.1) | |||||
< 1000 | 13 | 169 | 182 | Positive Predictive Value (PPV) (%) | 39.0 (34.9–43.0) | |
Negative Predictive Value (NPV) (%) | 92.9 (89.1–96.6) | |||||
Total | 232 | 512 | 744 | Upward Misclassification (%) | 67.0 (62.9–71.1) | |
Downward Misclassification (%) | 5.6 (2.6–8.6) | |||||
False Omission Rate (FOR) (%) | 7.1 (3.4–10.9) | |||||
False Discovery Rate (FDR) (%) | 61.0 (53.9–68.1) | |||||
Positive Likelihood Ratio (LR+) | 1.4 (1.3–1.5) | |||||
Negative Likelihood Ratio (LR-) | 0.2 (0.1–0.3) | |||||
Diagnostic Accuracy (%) | 52.2 (48.6–55.7) | |||||
Disease Prevalence (%) | 31.2 (27.9–34.5) | |||||
Diagnostic Odds Ratio (DOR) | 8.3 (4.6–15.0) | |||||
Kappa Agreement | 0.2 (0.2–0.2) | |||||
Youden’s Index | 0.3 (0.2–0.3) | |||||
F-score | 0.6 (0.5–0.6) | |||||