TABLE 4.
Comparison of results of the Onclarity assay and the GP-EIA for ≥CIN2, ≥CIN3, and <CIN1 populations
| Study populationa (no.) and Onclarity assay result | GP-EIA result (no.) |
Total | |
|---|---|---|---|
| Positive | Negative | ||
| ≥CIN2 (122) | |||
| Positive | 111 | 2 | 113 |
| Negative | 2 | 7 | 9 |
| Total | 113 | 9 | 122 |
| ≥CIN3 (83) | |||
| Positive | 78 | 2 | 80 |
| Negative | 0 | 3 | 3 |
| Total | 78 | 5 | 83 |
| 2×NILM (897) | |||
| Positive | 60 | 6 | 66 |
| Negative | 37 | 794 | 831 |
| Total | 97 | 800 | 897 |
a
CIN, cervical intraepithelial neoplasia; ≥CIN2, CIN of grade 2 or worse; ≥CIN3, CIN of grade 3 or worse; NILM, negative for intraepithelial lesions or malignancies; 2×NILM, NILM at both the prior screening round and the index screening.