Comparison of the ScreenFire and Xpert HPV assays for the detection of human papillomavirus and cervical precancer among women living with HIV in Malawi.

IF 3.1 2区医学 Q3 IMMUNOLOGY

Infectious Agents and Cancer Pub Date : 2024-05-17 DOI:10.1186/s13027-024-00585-4

Chemtai Mungo, Anagha Guliam, Lameck Chinula, Federica Inturrisi, Lizzie Msowoya, Tawonga Mkochi, Siniya Jawadu, Silvia de Sanjosé, Mark Schiffman, Jennifer H Tang, Jennifer S Smith

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引用次数: 0

Abstract

Background: The World Health Organization recommends human papillomavirus (HPV) testing for primary cervical cancer screening, including among women living with HIV (WLWH). Low-and-middle-income countries account for 85% of the cervical cancer burden globally, yet have limited access to HPV-based screening, largely due to cost. This study aims to compare the performance of a rapid, isothermal amplification HPV assay (ScreenFire) to that of the Xpert HPV assay for the detection of HPV and cervical precancer among WLWH in Malawi.

Methods: We utilized stored self- and provider-collected specimens from a prospective cohort study of WLWH in Malawi from July 2020 to February 2022. Specimens were tested with both Xpert and ScreenFire HPV assays. The overall and within-channel non-hierarchical agreement between ScreenFire and Xpert was determined for both self- and provider-collected specimens. Hierarchical ScreenFire HPV positivity by channel was compared to Xpert for each histological diagnosis-cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared to

Results: 315 matched self- and provider-collected specimens had valid results from both Xpert and ScreenFire testing and were included in analyses, of which 279 and 36 were HPV positive and HPV negative, respectively, on Xpert self-collection. Of the 315, 245 (78%) had normal pathology, 21 CIN1 (7%), 14 CIN2 (4%), and 35 CIN3 (11%). Of the 245 with normal pathology, 213 (87%) and 188 (77%) were HPV-positive on Xpert and ScreenFire self-collected specimens, respectively. Among provider-collected specimens, the assays had 80% agreement on overall HPV positivity (unweighted kappa 0.59, 95% 0.50-0.69). ScreenFire was HPV-positive in 90% of self-collected specimens that were HPV-positive on Xpert. Channel agreement between the assays was high for both self- and provider-collected specimens, but slightly lower for HPV18/45. In hierarchical analysis, ScreenFire demonstrated high concordance with Xpert testing for detecting CIN2+ cases in all channels, missing no HPV 16 or HPV 18/45 positive CIN2+ case that was positive on Xpert, in both self- and provider-collected specimens.

Conclusion: In this study of stored specimens, the ScreenFire HPV assay performed well in the detection of HPV and CIN2+ among WLWH compared to the Xpert HPV assay. If supported by larger validation studies, ScreenFire could be an affordable alternative point-of-care HPV assay for use in LMICs.

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比较 ScreenFire 和 Xpert HPV 检测法对马拉维感染艾滋病毒妇女的人类乳头瘤病毒和宫颈癌前病变的检测效果。

背景：世界卫生组织建议将人类乳头瘤病毒（HPV）检测用于宫颈癌初筛，包括感染艾滋病毒的妇女（WLWH）。中低收入国家的宫颈癌患者占全球宫颈癌患者的 85%，但这些国家接受 HPV 筛查的机会有限，主要原因是成本问题。本研究旨在比较快速等温扩增 HPV 检测法（ScreenFire）与 Xpert HPV 检测法在马拉维 WLWH 中检测 HPV 和宫颈癌前病变的性能：我们利用了从 2020 年 7 月到 2022 年 2 月马拉维 WLWH 前瞻性队列研究中储存的自取和提供者收集的标本。标本采用 Xpert 和 ScreenFire HPV 检测法进行检测。针对自取和提供者采集的标本，确定了 ScreenFire 和 Xpert 之间的总体一致性和通道内非层次一致性。就每种组织学诊断--宫颈上皮内瘤变 2 级或更差（CIN2+）与 Xpert 的结果进行比较：315 份自行采集和医疗机构采集的匹配标本在 Xpert 和 ScreenFire 检测中均有有效结果并纳入分析，其中 279 份和 36 份在 Xpert 自行采集中分别为 HPV 阳性和 HPV 阴性。在这 315 人中，245 人（78%）病理结果正常，21 人 CIN1（7%），14 人 CIN2（4%），35 人 CIN3（11%）。在病理结果正常的 245 人中，Xpert 和 ScreenFire 自取标本中分别有 213 人（87%）和 188 人（77%）HPV 阳性。在医疗机构采集的标本中，两种检测方法在总体 HPV 阳性率上的一致性为 80%（未加权卡帕值为 0.59，95% 为 0.50-0.69）。在 Xpert 检测为 HPV 阳性的自取标本中，ScreenFire 检测的 HPV 阳性率为 90%。对于自取和提供者采集的标本，两种检测方法的通道一致性都很高，但对于 HPV18/45 的通道一致性略低。在层次分析法中，ScreenFire 与 Xpert 检测法在所有通道中检测 CIN2+ 病例的一致性都很高，无论是自取标本还是医疗机构采集的标本，都没有漏检在 Xpert 检测中呈阳性的 HPV 16 或 HPV 18/45 阳性 CIN2+ 病例：在这项储存标本的研究中，与 Xpert HPV 检测法相比，ScreenFire HPV 检测法在检测 WLWH 中的 HPV 和 CIN2+ 方面表现良好。如果能得到更大规模验证研究的支持，ScreenFire 将成为一种经济实惠的护理点 HPV 检测方法，可用于低收入国家。

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来源期刊

Infectious Agents and Cancer ONCOLOGY-IMMUNOLOGY

CiteScore

5.80

自引率

2.70%

发文量

期刊介绍： Infectious Agents and Cancer is an open access, peer-reviewed online journal that encompasses all aspects of basic, clinical, epidemiological and translational research providing an insight into the association between chronic infections and cancer. The journal welcomes submissions in the pathogen-related cancer areas and other related topics, in particular: • HPV and anogenital cancers, as well as head and neck cancers; • EBV and Burkitt lymphoma; • HCV/HBV and hepatocellular carcinoma as well as lymphoproliferative diseases; • HHV8 and Kaposi sarcoma; • HTLV and leukemia; • Cancers in Low- and Middle-income countries. The link between infection and cancer has become well established over the past 50 years, and infection-associated cancer contribute up to 16% of cancers in developed countries and 33% in less developed countries. Preventive vaccines have been developed for only two cancer-causing viruses, highlighting both the opportunity to prevent infection-associated cancers by vaccination and the gaps that remain before vaccines can be developed for other cancer-causing agents. These gaps are due to incomplete understanding of the basic biology, natural history, epidemiology of many of the pathogens that cause cancer, the mechanisms they exploit to cause cancer, and how to interrupt progression to cancer in human populations. Early diagnosis or identification of lesions at high risk of progression represent the current most critical research area of the field supported by recent advances in genomics and proteomics technologies.