基于人群筛查背景下 Alinity m HR HPV 与 cobas 4800 HPV 检测方法的临床和分析性能比较。

Comparison of the clinical and analytical performance of Alinity m HR HPV and cobas 4800 HPV assays in a population-based screening setting.

机构信息

Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Zaloška cesta 4, 1000 Ljubljana, Slovenia.

Medizinisches Versorgungszentrum wagnerstibbe für Laboratoriumsmedizin und Pathologie GmbH, Hannover, Germany.

出版信息

J Clin Virol. 2021 Jul;140:104851. doi: 10.1016/j.jcv.2021.104851. Epub 2021 May 10.

DOI:10.1016/j.jcv.2021.104851

PMID:34020361

Abstract

BACKGROUND

The recently launched Abbott Alinity m HR HPV (Alinity) assay separately identifies high-risk human papillomavirus (hrHPV) genotypes HPV16, HPV18, and HPV45, and reports 11 other genotypes as two aggregates.

METHODS

Clinical and analytical performance of Alinity was compared with the cobas 4800 HPV assay on 4,334 women aged 20-64 years attending routine, population-based organized cervical cancer screening during 2009/2010. After 36 months, they were invited to participate in the second screening round (2012-2014) and later followed-up through centralized national cervical cancer screening registry.

RESULTS

In women 30 and older, the clinical sensitivity for cervical intraepithelial neoplasia grade 2+ (CIN2+) was 100.0% (95% CI, 88.2-100.0%) for Alinity and 100.0% (95% CI, 88.2-100.0%) for cobas, and for CIN3+ 100.0% (95% CI, 78.9-100.0%) for both assays. The clinical specificity for ≤ CIN1 in women 30 and older was 92.4% (95% CI, 91.4-93.3%) and 92.9% (95% CI, 91.9-93.7%), respectively. The assays demonstrated excellent overall agreement for hrHPV detection (97.9%) and genotype-specific agreement for HPV16 (99.6%), HPV18 (99.8%), and other hrHPV (98.1%). Overall positive agreement and positive agreements for HPV16, HPV18, and other hrHPV genotypes were 84.3%, 89.1%, 73.2%, and 82.3%. Based on a 5-year CIN3+ risk, slightly more HPV-positive women would require referral to immediate colposcopy after testing with Alinity vs. cobas (4.1% vs. 3.8%; p = 0.470), but significantly fewer Alinity-tested women would need a 6- to 12-month follow-up visit compared with those tested with cobas (5.0% vs. 8.6%; p < 0.0001).

CONCLUSIONS

Alinity and cobas have comparable clinical performance and showed excellent overall and genotype-specific agreement. The Alinity's extended genotyping ability could help predict the 5-year CIN3+ risk and cost-saving management of HPV-screen-positive women.

摘要

背景

新推出的雅培 Alinity m HR HPV（Alinity）检测系统可分别鉴定高危型人乳头瘤病毒（HPV）HPV16、HPV18 和 HPV45 基因型，并将其他 11 种基因型报告为两个聚合体。

方法

2009/2010 年期间，在 4334 名 20-64 岁的妇女中，比较了 Alinity 和 cobas 4800 HPV 检测系统在临床和分析性能方面的差异，这些妇女参加了常规的、基于人群的有组织的宫颈癌筛查。36 个月后，她们被邀请参加第二轮筛查（2012-2014 年），并通过集中的国家宫颈癌筛查登记处进行随访。

结果

在 30 岁及以上的妇女中，Alinity 和 cobas 检测系统对宫颈上皮内瘤变 2+（CIN2+）的临床灵敏度均为 100.0%（95%可信区间，88.2-100.0%），对 CIN3+的灵敏度均为 100.0%（95%可信区间，78.9-100.0%）。在 30 岁及以上的妇女中，Alinity 和 cobas 检测系统对 ≤ CIN1 的临床特异性分别为 92.4%（95%可信区间，91.4-93.3%）和 92.9%（95%可信区间，91.9-93.7%）。这两种检测方法在 HPV 检测方面具有极好的总一致性（97.9%）和 HPV16（99.6%）、HPV18（99.8%）和其他高危型 HPV（98.1%）的基因型特异性一致。总体阳性一致率和 HPV16、HPV18 和其他高危型 HPV 基因型的阳性一致率分别为 84.3%、89.1%、73.2%和 82.3%。基于 5 年 CIN3+风险，与 cobas 检测相比，使用 Alinity 检测会导致略多的 HPV 阳性妇女需要立即进行阴道镜检查（4.1% vs. 3.8%；p=0.470），但与 cobas 检测相比，需要进行 6-12 个月随访的 Alinity 检测妇女明显减少（5.0% vs. 8.6%；p<0.0001）。