TABLE 4.
Diagnostic Performance of Index Biomarkers (FC and FL) in Detecting Histological Disease Activity (ie, Nancy Index ≥2), With Corresponding 95% Confidence Intervals
| Nancy Index | ||||||||
|---|---|---|---|---|---|---|---|---|
| Cutoff | Positive ≥2 | Negative ≤1 | Sensitivity %* | Specificity %† | PPV %‡ | NPV %§ | Accuracy %║ | |
| FC | Positive >50 μg/g | 82 | 16 | 57.3 [48.8–65.6] | 80.7 [70.6–88.6] | 83.7 [76.4–89.1] | 52.3 [46.9–57.7] | 65.9 [59.4–72.1] |
| Negative ≤50 μg/g | 61 | 67 | ||||||
| Positive >100 μg/g | 58 | 6 | 40.6 [32.4–49.1] | 92.8 [84.9–97.3] | 90.6 [81.4–95.5] | 47.5 [43.9–51.2] | 59.7 [53.0–66.2] | |
| Negative ≤100 μg/g | 85 | 77 | ||||||
| FL | Positive ≥7.25 μg/g | 102 | 29 | 71.3 [63.2–78.6] | 65.1 [53.8–75.2] | 77.9 [72.0–82.8] | 56.8 [49.3–64.1] | 69.0 [62.6–75.0] |
| Negative <7.25 μg/g | 41 | 54 | ||||||
*Sensitivity: proportion of patients correctly diagnosed as positive using the index test (TP/[TP + FN]).
†Specificity: proportion of patients correctly diagnosed as negative using the index test (TN/[TN + FP]).
‡Positive Predictive Value (PPV): proportion of patients correctly diagnosed as positive using the index test of all patients with a positive diagnosis using the index test (TP/[TP + FP]).
§Negative Predictive Value (NPV): proportion of patients correctly diagnosed as negative using the index test of all patients with a negative diagnosis using the index test (TN/[TN + FN]).
║Accuracy: proportion of patients correctly diagnosed as either positive or negative ([TP + TN]/[TP + FP + TN + FN]).
TP, true positive; TN, true negative; FP, false positive; FN, false negative.