Table 3. Performance of the careHPV and INNO-LiPA assays for the diagnosis of CIN2+ lesions (n=943).
| Burkina Faso (CIN2+, n=9) | South Africa (CIN2+, n=51) | Overall (CIN2+, n=60) | ||||
|---|---|---|---|---|---|---|
| careHPV | INNO-LiPA | careHPV | INNO-LiPA | careHPV | INNO-LiPA | |
|
Performance indicators | ||||||
| No. of positive tests | 206 | 300 | 222 | 358 | 428 | 658 |
| No. of CIN2+ positive by test | 9 | 8 | 47 | 50 | 56 | 58 |
| Sensitivity % | 100 (66.4–100) | 88.9 (51.7–99.7) | 92.2 (81.1–97.8) | 98.0 (89.6–99.6) | 93.3 (83.8–98.2) | 96.7 (88.5–99.6) |
| Specificity % | 54.7 (49.9–59.5) | 32.9 (28.5–37.5) | 60.9 (56.3–65.5) | 31.3 (27.0–35.8) | 57.9 (54.5–61.2) | 32.0 (29.0–35.2) |
| PPV % | 4.4 (2.0–8.1) | 2.7 (1.2–5.2) | 21.2 (16.0–27.1) | 14.0 (10.6–18.0) | –a | – |
| NPV % | 100 (98.5–100) | 99.3 (96.2–100) | 98.6 (96.3–99.6) | 99.3 (96.1–100) | – | – |
Abbreviations: CIN=cervical intraepithelial neoplasia; HPV=human papillomavirus.
a
PPV (positive predictive value) and NPV (negative predictive value) have not been combined for the two countries as they depend on disease prevalence/incidence which are different for each country.