ATHENA
Evaluation of the Cobas 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening
- Population
- Women aged 25 years or older undergoing routine screening.
- Design
- Study of the cobas HPV Test as the primary screen for cervical cancer, not randomised: all enrolled women had cytology and high-risk HPV testing, so screening strategies were compared in the same women. Women with abnormal cytology (atypical squamous cells of undetermined significance or worse) and those HPV positive were referred to colposcopy; women not reaching the CIN2+ study endpoint entered a 3-year follow-up phase. The paper reports 42,209 enrolled women; ClinicalTrials.gov lists 47,208 (actual enrolment).
- Arms
- Cytology (control): Cytology alone as the screening strategy
- Hybrid strategy (control): Cytology if aged 25-29 years and cotesting with cytology and HPV if aged 30 years or older
- HPV primary (experimental): cobas HPV Test as first-line screening
- People
- Wright TC, senior author Wright TL
Δ Sensitivity+28.3 pointsΔ Specificity−3.6 points
Show the numbers
| Endpoint | Analysis | HPV primary | Cytology / Hybrid strategy | Effect |
|---|---|---|---|---|
| SensitivityWomen aged 25 years or older enrolled in ATHENA; the abstract does not state the exact analysis population of each estimateSensitivity of each screening strategy for CIN3+ in women aged 25 years or older, evaluated in the same women (not randomised arms). | finalWright 2015 | 76.1% (70.3–81.8%) | 47.8% (41.6–54.1%) | Strategies were applied to the same women. The abstract states that HPV primary screening requires significantly more colposcopies than cytology or the hybrid strategy and that the number of colposcopies needed to detect one CIN3+ is the same as for the hybrid strategy. |
| SpecificityWomen aged 25 years or older enrolled in ATHENA; the abstract does not state the exact analysis population of each estimateSpecificity of each screening strategy for CIN3+ in women aged 25 years or older, evaluated in the same women (not randomised arms). | finalWright 2015 | 93.5% (93.3–93.8%) | 97.1% (96.9–97.2%) | — |
| Endpoint | Analysis | HPV primary | Cytology / Hybrid strategy | Effect |
|---|---|---|---|---|
| SensitivityWomen aged 25 years or older enrolled in ATHENA; the abstract does not state the exact analysis population of each estimateSensitivity of each screening strategy for CIN3+ in women aged 25 years or older, evaluated in the same women (not randomised arms). | finalWright 2015 | 76.1% (70.3–81.8%) | 47.8% (41.6–54.1%) | Strategies were applied to the same women. The abstract states that HPV primary screening requires significantly more colposcopies than cytology or the hybrid strategy and that the number of colposcopies needed to detect one CIN3+ is the same as for the hybrid strategy. |
| SpecificityWomen aged 25 years or older enrolled in ATHENA; the abstract does not state the exact analysis population of each estimateSpecificity of each screening strategy for CIN3+ in women aged 25 years or older, evaluated in the same women (not randomised arms). | finalWright 2015 | 93.5% (93.3–93.8%) | 97.1% (96.9–97.2%) | — |