Numerator | Denominator | |
Tests for triage of HPV-positive women | ||
Sensitivity | No. HPV-positive women testing positive on triage with disease* | Primary: No. HPV-positive women with HSIL+ Secondary: No. HPV-positive women with CIN2+; No. HPV-positive women with CIN3+ |
Specificity | No. HPV-positive women testing negative on triage with no disease† | Primary: No. HPV-positive women with <HSIL Secondary: No. HPV-positive women with <CIN2 |
PPV | No. HPV-positive women testing positive on triage with disease* | No. HPV-positive testing positive on triage |
NPV | No. HPV-positive women testing negative on triage with no disease† | No. HPV-positive testing negative on triage |
Tests for primary screening | ||
Relative sensitivity (HPV/cytology) | No. HPV-positive with disease* | No. abnormal cytology with disease* |
Relative specificity (HPV/cytology) | No. HPV-negative with no disease† | No. cytology NILM with no disease† |
Relative sensitivity (HPV/cotesting) | No. HPV-positive with disease* | No. HPV-positive OR abnormal cytology with disease* |
Relative specificity (HPV/cotesting) | No. HPV-negative with no disease† | No. HPV-negative AND cytology NILM with no disease† |
*Women with disease: women with HSIL+ on review (primary endpoint) or women with local CIN2+ or CIN3+ (secondary endpoints).
†Women with no disease: women with negative, CIN1, LSIL histologic diagnosis, HPV-negative women at 18 months and women with final (18 months) negative colposcopy.
CIN2, CIN grade 2; <CIN2, histological diagnosis less than CIN2: negative, CIN1; CIN2+, CIN2 or worse lesions; CIN3, CIN3 grade 3; CIN3+, CIN3 or worse lesions; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; <HSIL, histological diagnosis less than HSIL: negative, HSIL; HSIL, high-grade squamous intraepithelial lesion on histology; HSIL+, HSIL or worse lesions; NILM, Negative for intraepithelial lesions or malignancy; NPV, negative predictive value; PPV, positive predictive value.