TABLE 3.
The clinical performance of LA, cobas, LBC, or combinations of HPV genotypes detected by cobas and LBC for detection of AIN2 or AIN3 or AIN3 alonea
| Test and HPV statusb | Performance (%) of indicated test to detectc: |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| AIN2 or AIN3 (n = 68) |
AIN3 (n = 22) |
|||||||||
| Se | Sp | YI | PPV | NPV | Se | Sp | YI | PPV | NPV | |
| LA | ||||||||||
| HPV16 | 55.6 | 78.0 | 33.5 | 36.5 | 88.5 | 63.6 | 74.2 | 37.9 | 14.6 | 96.7 |
| HPV18 | 19.0 | 91.3 | 10.4 | 33.3 | 83.2 | 13.6 | 89.6 | 3.3 | 8.3 | 93.8 |
| HPV16 and HPV18 | 65.1 | 72.6 | 37.6 | 35.0 | 90.1 | 68.2 | 67.9 | 36.1 | 12.8 | 96.9 |
| Any carcinogenic type | 98.4 | 28.9 | 27.3 | 23.9 | 98.8 | 95.5 | 25.2 | 20.6 | 8.1 | 98.8 |
| cobas | ||||||||||
| HPV16 | 57.4 | 74.4 | 31.7 | 34.5 | 88.1 | 63.6 | 70.4 | 34.1 | 12.39 | 96.7 |
| HPV18 | 20.6 | 90.0 | 10.6 | 32.6 | 82.8 | 13.6 | 88.1 | 1.7 | 6.98 | 93.9 |
| HPV16 and HPV18 | 66.2 | 67.8 | 34.0 | 32.6 | 89.5 | 68.2 | 63.3 | 31.5 | 10.87 | 96.8 |
| Any carcinogenic type | 100.0 | 26.0 | 26.0 | 24.1 | 100.0 | 100.0 | 22.4 | 22.4 | 7.80 | 100.0 |
| LBC (T.M.D.) | ||||||||||
| ASC-US | 83.6 | 51.1 | 34.6 | 28.9 | 92.9 | 90.5 | 46.6 | 37.1 | 9.8 | 98.7 |
| HG | 40.3 | 87.2 | 27.5 | 42.9 | 86.0 | 61.9 | 84.8 | 46.7 | 20.6 | 97.2 |
| Genotypes and LBC (T.M.D.) | ||||||||||
| ≥ASC-US or HPV16 | 92.5 | 42.7 | 35.2 | 27.9 | 96.0 | 95.2 | 37.8 | 33.1 | 9.0 | 99.2 |
| ≥ASC-US or HPV16/18 | 95.5 | 40.1 | 35.7 | 27.7 | 97.4 | 95.2 | 35.1 | 30.3 | 8.7 | 99.1 |
| HG or HPV16 | 68.7 | 69.9 | 38.5 | 35.4 | 90.3 | 85.7 | 65.5 | 51.3 | 13.8 | 98.6 |
| HG or HPV16/18 | 74.6 | 64.2 | 38.8 | 33.3 | 91.3 | 85.7 | 59.4 | 45.1 | 12.0 | 98.5 |
LBC, liquid-based cytology; AIN2, anal intraepithelial neoplasia grade 2; AIN3, anal intraepithelial neoplasia grade 3.
ASC-US, atypical squamous cells of undetermined significance; ≥ASC-US, ASC-US or more severe cytology; HG, high-grade cytology (high-grade squamous intraepithelial lesion [HSIL] or atypical squamous cells cannot rule out HSIL [ASC-H] cytology).
Se, sensitivity; Sp, specificity; YI, Youden's index; PPV, positive predictive value.