FIB-4 & LSM by VCTE (n=5159) | NFS & LSM by VCTE (n=3094) | FIB-4 & LSM by VCTE (n=5159) | NFS & LSM by VCTE (n=3094) | FIB-4 & LSM by VCTE (n=5159) | NFS & LSM by VCTE (n=3094) | |
Advanced fibrosis, % | 30 | 28 | 30 | 28 | 30 | 28 |
Thresholds for blood-based NIT | <0.88, ≥2.31* | <−2.55, ≥0.28* | <1.3, ≥2.67† | <−1.455, ≥0.676† | <1.3, ≥2.67† | <−1.455, ≥0.676† |
Thresholds for LSM by VCTE, kPa | <7.4, ≥12.1* | <7.4, ≥12.1* | <7.9, ≥9.6† | <7.9, ≥9.6† | <8.0, ≥10.0† | |
Sensitivity, % | 80 (77–83) | 77 (74–81) | 67 (64–69) | 65 (62–68) | 66 (63–68) | 64 (62–67) |
Specificity, % | 81 (79–83) | 83 (81–85) | 85 (84–87) | 86 (84–88) | 86 (84–87) | 86 (84–88) |
PPV, % | 62 (60–65) | 61 (58–64) | 66 (64–68) | 63 (61–67) | 66 (64–68) | 64 (61–67) |
NPV, % | 91 (90–92) | 91 (89–93) | 86 (85–87) | 87 (85–88) | 86 (85–87) | 86 (85–88) |
Indeterminate, % | 18 (17–19) | 20 (18–21) | 5 (4–5) | 5 (5–6) | 5 (4–6) | 5 (5–6) |
Misclassification, % | 16 (14–17) | 15 (13–17) | 19 (18–21) | 19 (17–21) | 19 (18–20) | 19 (17–21) |
Patients undergoing LSM by VCTE, % | 51 (50–53) | 56 (54–59) | 34 (32–35) | 38 (36–40) | 34 (33–35) | 38 (37–40) |
95% CIs were estimated with 500 bootstrap replicates.
*Thresholds were determined from the individual patient data study group as corresponding to 90% sensitivity (lower value) and 90% specificity (upper value)
†Threshold were determined from the literature. For LSM by VCTE, a threshold pair yielding the highest sensitivity and specificity while having the smallest proportion of indeterminate cases in diagnosing advanced fibrosis was chosen.
NIT, non-invasive test; NPV, negative predictive value; PPV, positive predictive value.