Table 4.
Sensitivity and Specificity of the HPV MLPA-Assay when Applied to Frozen Tissue Samples
| Histology | MLPA single parameter |
MLPA multiparameter |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Type 16 and/or 18 (%) | Viral load >25 (%) | Integration (%) | TERT gain (%) | TERC gain (%) | Telom gain (%) | Viral load >25 and/or integration (%) | Viral load >25 and/or telom gain (%) | Integration and/or telom gain (%) | Viral load >25 and/or integration and/or telom gain (%) | |
| Normal | 4/7 (57) | 0/7 (0) | 0/7 (0) | 0/7 (0) | 0/7 (0) | 0/7 (0) | 0/7 (0) | 0/7 (0) | 0/7 (0) | 0/7 (0) |
| Normal adjacent to lesion | 14/20 (70) | 1/20 (5) | 1/20 (5) | 0/20 (0) | 0/20 (0) | 0/20 (0) | 2/20 (10) | 1/20 (5) | 1/20 (5) | 2/20 (10) |
| CIN1/condyloma | 7/10 (70) | 2/10 (20) | 1/10 (10) | 1/10 (10) | 1/10 (10) | 1/10 (10) | 3/10 (30) | 2/10 (20) | 2/10 (20) | 3/10 (30) |
| CIN2/3 | 13/13 (100) | 4/13 (31) | 5/13 (38) | 3/13 (23) | 6/13 (46) | 6/13 (46) | 8/13 (62) | 8/13 (62) | 8/13 (62) | 10/13 (77) |
| SCC | 16/17 (94) | 8/17 (47) | 7/17 (41) | 4/17 (24) | 9/17 (53) | 10/17 (59) | 11/17 (65) | 13/17 (76) | 12/17 (71) | 15/17 (88) |
| Sensitivity (95% CI) | 97% (80.9–99.8%) | 40% (23.2–59.2%) | 40% (23.2–59.2%) | 23% (10.6–42.7%) | 50% (31.7–68.3%) | 53% (34.6–71.2%) | 63% (43.9–79.5%) | 70% (50.4–84.6%) | 67% (47.1–82.1%) | 83% (64.5–93.6%) |
| Specificity (95% CI) | 32% (18.6–49.9%) | 92% (77.0–97.9%) | 95% (80.5–99.1%) | 97% (84.2–99.9%) | 97% (84.2–99.9%) | 97% (84.2–99.9%) | 86% (70.4–94.9%) | 92% (77.0–97.9%) | 92% (77.0–97.9%) | 86% (70.4–94.9%) |
CI, confidence interval; CIN, cervical interaepithelial neoplasia; SCC, squamous cell carcinoma; telom, telomerase gene; TERC, telomerase RNA component; TERT, telomerase reverse transcriptase; >25, more than 25 copies per cell.