Table 2.
Evaluation of Lumipulse® antigen assay with 1.240 pg/mL and 1.645 pg/mL optimal cutoffs on selected cohort and screening cohort, respectively.
| Selected cohort | Screening cohort | |
|---|---|---|
| Prevalence | 42% | 5.2% |
| ROC curve’s AUC at cutoff | 91.7% (88.1–95.4) | 97.4% (96.9–97.9) |
| Sensitivity | 92.6% (85.4–97.0) | 100% (96–100) |
| Specificity | 90.8% (84.5–95.2) | 94.8% (93.6–95.8) |
| LR+ | 10.1 (5.88–17.4) | 19.2 (15.6–23.5) |
| LR- | 0.0811 (0.0397–0.166) | 0 |
| Odds Ratio | 125 (47.7–325) | n. a.a |
| PPV | 88.0% (80.0–83.6) | 51.1% (43.5–58.7) |
| NPV | 94.4% (88.9–97.7) | 100% (99.8–100) |
Values in brackets refer to 95% CI, when applicable. AUC: area under the curve; LR-: negative likelihood ratio; LR+: positive likelihood ratio; NPV: negative predictive value; PPV: positive predictive value; ROC: receiver operating characteristic
a
n. a.: not applicable.