Aquarius Population Health, London, UK.
Department of Medical Virology, University Hospital Tübingen, Tübingen, Germany.
BMJ Open. 2020 Mar 8;10(3):e031303. doi: 10.1136/bmjopen-2019-031303.
To estimate the impact of using the Aptima messenger RNA (mRNA) high-risk human papilloma virus (HR-HPV) assay versus a DNA HR-HPV assay in a primary HPV cervical screening programme.
One hypothetical cohort followed for 3 years through HPV primary cervical screening.
England.
A hypothetical cohort of women aged 25-65 years tested in the National Health Service (NHS) Cervical Screening Programme (CSP) for first call or routine recall testing.
A decision tree parameterised with data from the CSP (2017/18) and the HORIZON study. Uncertainty analyses were conducted using data from the FOCAL and GAST studies, other DNA HPV tests in addition to one-way and probabilistic sensitivity and scenarios analyses, to test the robustness of results.
Aptima mRNA HR-HPV assay and a DNA HR-HPV assay (cobas 4800 HPV assay).
Primary: total colposcopies and total costs for the cohort. Secondary: total HPV and cytology tests, number lost to follow-up.
At baseline for a population of 2.25 million women, an estimated £15.4 million (95% credibility intervals (CI) £6.5 to 24.1 million) could be saved and 28 009 (95% CI 27 499 to 28 527) unnecessary colposcopies averted if Aptima mRNA assays are used instead of a DNA assay, with 90 605 fewer unnecessary HR-HPV and 253 477 cytology tests performed. These savings are due to a lower number of HPV positive samples in the mRNA arm. When data from other primary HPV screening trials were compared, results indicated that using the Aptima mRNA assay generated cost savings and reduced testing in every scenario.
Using the Aptima mRNA assay versus a DNA assay would almost certainly yield cost savings and reduce unnecessary testing and procedures, benefiting the NHS and women in the CSP.
评估在原发性 HPV 宫颈筛查项目中使用 Aptima 信使 RNA（mRNA）高危型人乳头瘤病毒（HR-HPV）检测与 DNA HR-HPV 检测的影响。
通过 HPV 原发性宫颈筛查对一个假想队列进行了为期 3 年的随访。
英格兰。
在国民保健服务（NHS）宫颈癌筛查计划（CSP）中接受首次电话或常规召回检测的年龄在 25-65 岁的假想队列妇女。
使用来自 CSP（2017/18 年）和 HORIZON 研究的数据对决策树进行参数化。使用来自 FOCAL 和 GAST 研究的数据、其他 DNA HPV 检测以及单向和概率敏感性和情景分析进行不确定性分析，以检验结果的稳健性。
Aptima mRNA HR-HPV 检测和 DNA HR-HPV 检测（cobas 4800 HPV 检测）。
主要指标：队列的总阴道镜检查和总费用。次要指标：总 HPV 和细胞学检查数量，失访人数。
在 225 万妇女的人群中，基线估计使用 Aptima mRNA 检测可以节省 1540 万英镑（95%可信度区间（CI）6500 万至 2410 万英镑），并避免 28009 例（95% CI 27499 至 28527）不必要的阴道镜检查，如果使用 Aptima mRNA 检测而不是 DNA 检测，可减少 90605 例不必要的 HR-HPV 和 253477 例细胞学检查。这些节省归因于 mRNA 臂中 HPV 阳性样本数量减少。当将其他原发性 HPV 筛查试验的数据进行比较时，结果表明，在每种情况下，使用 Aptima mRNA 检测都可以节省成本并减少不必要的检测和程序，使国民保健服务和 CSP 中的妇女受益。
与 DNA 检测相比，使用 Aptima mRNA 检测几乎肯定会节省成本并减少不必要的检测和程序，使 NHS 和 CSP 中的妇女受益。
