Table 3.
Clinical performance of biomarkers.
| Test | Sensitivity | Specificity | PPV | NPV | Youden's index | Referral |
|---|---|---|---|---|---|---|
| Cobas HR-HPV | ||||||
| AIN2+ | 100% (95.6–100) | 27.7% (21.9–34.3) | 40.3% (34.3–46.6) | 100% (92.4–100) | 0.277 | 81.39% |
| AIN3 | 100% (92.1–100) | 22.7% (17.8–28.4) | 22.1% (17.3–27.8) | 100% (92.4–100) | 0.227 | |
| Cobas HPV16/18 | ||||||
| AIN2+ | 62.5% (52.4–71.6) | 74.2% (67.7–79.8) | 54.2% (44.9–63.2) | 80.2% (73.8–85.4) | 0.367 | 37.85% |
| AIN3 | 64.9% (51.1–76.8) | 68.1% (62.0–73.6) | 30.8% (22.9–40.1) | 89.8% (84.5–93.5) | 0.33 | |
| mRNA | ||||||
| AIN2+ | 79.8% (70.6–86.8) | 62.4% (55.5–68.9) | 50.9% (43.0–58.8) | 86.4% (79.7–91.2) | 0.422 | 51.42% |
| AIN3 | 80.7% (67.7–89.5) | 55.0% (48.7–61.1) | 28.2% (21.6–35.9) | 92.9% (87.3–96.2) | 0.357 | |
| p16/Ki-67 | ||||||
| AIN2+ | 92.3% (85.0–96.4) | 44.1% (37.4–51.1) | 44.7% (37.9–51.6) | 92.2% (84.7–96.3) | 0.3643 | 67.82% |
| AIN3 | 93.0% (82.2–97.8) | 37.7% (31.8–43.9) | 24.7% (19.2–31.1) | 96.1% (89.7–98.7) | 0.307 | |
Combined disease endpoints: no dysplasia, including men with a nondysplastic biopsy or without a biopsy and with <HSIL cytology; AIN1, including men with AIN1 histology and <HSIL cytology; AIN2, including men with AIN2 histology or with lower grade, normal, or no histology and with HSIL-AIN2; AIN3, including men with AIN3 histology or with lower grade, normal, or no histology and with HSIL-AIN3. AIN1, anal intraepithelial neoplasia grade 1; AIN2, anal intraepithelial neoplasia grade 2; AIN3, anal intraepithelial neoplasia grade 3; HPV, human papillomavirus; HSIL, high-grade squamous intraepithelial lesion; NPV, negative predictive value; PPV, positive predictive value.