Table 6 Relative sensitivity, relative specificity, PPV and NPV of the Cervista HPV HR test and HC2 for detecting CIN3+ within various cytology groups
CERVISTA | ||||||||
|---|---|---|---|---|---|---|---|---|
Relative sensitivity | Relative specificity | PPV | NPV | |||||
CIN 3+ | % | 95% CI | % | 95% CI | % | 95% CI | % | 95% CI |
ASC-H, AGUS (Pap III) | 80.0% | (29.9-98.9) | 100.0% | (54.6-100) | 100.0% | (39.6-100) | 50.0% | (26.7-97.3) |
LSIL, HSIL (Pap IIID) | 100.0% | (80.0-100) | 17.5% | (7.9-33.4) | 37.7% | (25.1-52.1) | 100.0% | (56.1-100) |
HSIL, CIS (Pap IVa) | 96.6% | (87.0-99.4) | NA | 84.8% | (73.4-92.1) | NA | ||
HSIL, CIS, Micro (IVb) | 100.0% | (19.8-100) | NA | 100% | (19.8-100) | NA | ||
Microinvasive (Pap V) | 100.0% | (30.1-100) | NA | 100% | (30.1-100) | NA | ||
AGUS+ (≥Pap III) | 96.6% | (89.7-99.1) | 15.7% | (7.5-29.1) | 66.4% | (57.5-74.4) | 72.7% | (39.3-92.7) |
HSIL+ (≥Pap IVa) | 96.8% | (88.0-99.4) | NA | 85.9% | (75.2-92.7) | NA | ||
HR HC2 | ||||||||
Relative sensitivity | Relative specificity | PPV | NPV | |||||
CIN 3+ | % | 95% CI | % | 95% CI | % | 95% CI | % | 95% CI |
ASC-H, AGUS (Pap III) | 80.0% | (29.9-98.9) | 100.0% | (54.6-100) | 100.0% | (39.6-100) | 50.0% | (26.7-97.3) |
LSIL, HSIL (Pap IIID) | 100.0% | (80.0-100) | 10.0% | (3.3-24.6) | 35.7% | (23.7-49.7) | 100.0% | (39.6-100) |
HSIL, CIS (Pap IVa) | 100.0% | (92.3-100) | NA | 85.3% | (74.2-92.3) | NA | ||
HSIL, CIS, Micro (IVb) | 100.0% | (19.8-100) | NA | 100% | (19.8-100) | NA | ||
Microinvasive (Pap V) | 100.0% | (30.1-100) | NA | 100% | (30.1-100) | NA | ||
AGUS+ (≥Pap III) | 98.9% | (92.9-99.9) | 9.8% | (3.7-22.2) | 65.4% | (56.6-73.3) | 83.3% | (36.5-99.1) |
HSIL+ (≥Pap IVa) | 100.0% | (92.8-100) | NA | 86.3% | (75.8-92.9) | NA | ||