TABLE 5.
Clinical accuracy of the Onclarity assay and the GP-EIAa for ≥CIN2, ≥CIN3, and <CIN1 outcomes
| Outcome (no.) | Measure | % absolute accuracy (95% CI) |
Relative accuracy of Onclarity assay vs GP-EIA (95% CI) | P value for noninferiority testb | |
|---|---|---|---|---|---|
| Onclarity assay | GP-EIA | ||||
| ≥CIN2 (122) | Sensitivity | 92.6 (86.5–96.6) | 92.6 (86.5–96.6) | 1.00 (0.97–1.04) | 0.0006 |
| ≥CIN3 (83) | Sensitivity | 96.4 (89.9–99.2) | 94.0 (86.5–98.0) | 1.03 (0.99–1.06) | <0.0001 |
| 2×NILM (897) | Specificity | 92.6 (90.7–94.3) | 89.2 (87.0–91.1) | 1.04 (1.02–1.06) | <0.0001 |
a
The GP-EIA was used as a comparator test.
b
A P value of <0.05 for the noninferiority test means that the sensitivity or specificity of the Onclarity assay is not significantly lower than that of the GP-EIA, using the benchmarks of 0.90 and 0.98 for relative sensitivity and relative specificity, respectively.