Addis Ababa University, Department of Microbiology, Immunology and Parasitology, Ethiopia.
J Virol Methods. 2022 Mar;301:114435. doi: 10.1016/j.jviromet.2021.114435. Epub 2021 Dec 14.
Genital infection with certain types of human papillomaviruses (HPVs) is a major cause of premalignant dysplasia and cervical cancer globally. Identification of 14 high-risk human papillomaviruses (HR-HPV) is immensely important in elucidating molecular epidemiology, patient monitoring, and evidence-based treatment. HPVs testing has become an essential part of current clinical practice in the management of cervical cancer and precancerous lesions. Thus, HPV assays are increasingly used for primary cervical screening and HPV genotyping, for monitoring vaccination-effect and determining changes in the epidemiology of viral genotypes across the globe. Testing for high-risk HPV is more effective in primary cervical cancer screening than in the cytological examination of a Pap smear. Separate genotyping may be useful for triage in both HPV-based and cytology-based screening. It should be used only for clinically validated tests.
To evaluate the concordance of Anyplex™ II HPV HR with other HPV assays in cervical cancer screening.
Validation studies of Anyplex™ II HPV HR assay from PubMed, google scholar, google database and Scopus were used to search articles. Articles published in English from 2013 onwards were systematically searched using keywords. Besides, other databases like Google Scholar and the Google database were searched manually for grey literature. The last search was done in December 2020. Then study eligibility, extracted data, and assessed risk of bias were assessed. Due to the great clinical heterogeneity of the included articles, the diagnostic performance of the anyplex II ™ HR HPV test was unlikely to be pooled. Rather, I did a descriptive presentation of the test performance to gather the best synthesis of evidence for the anyplex II ™ HR HPV test for the detection of CIN2+. Studies that evaluate the performance of the assay in terms of its sensitivity, specificity, reproducibility and positive and negative predictive values to comparator assays and/or histology were included in this review.
Anyplex™ Ⅱ HPV HR showed consistently high absolute clinical sensitivity for CIN2+ and CIN3+, as well as comparative clinical sensitivity relative to the currently most widely used HPV test. Because of the significantly diff ;erent composition of the referral populations, Anyplex™ Ⅱ HPV HR absolute clinical specificity for CIN2+ and CIN3+ varied across studies but was comparable relative to reference assays.
Five validation studies of Anyplex™ Ⅱ HPV HR performance in cervical cancer screening settings showed its consistently high absolute clinical sensitivity for both CIN2+ and CIN3+, still comparative clinical sensitivity and specificity relative to HC2 and GP5+/6 + PCR. Anyplex™ Ⅱ has evaluated HPV HR in several settings and population groups. It is considered clinically validated for primary cervical cancer screening and triage in referral population settings.
某些类型的人乳头瘤病毒（HPV）的生殖器感染是全球导致癌前发育不良和宫颈癌的主要原因。鉴定 14 种高危型人乳头瘤病毒（HR-HPV）对于阐明分子流行病学、患者监测和基于证据的治疗非常重要。HPV 检测已成为当前宫颈癌和癌前病变管理中临床实践的重要组成部分。因此，HPV 检测越来越多地用于宫颈癌的初级筛查和 HPV 基因分型，用于监测疫苗效果并确定全球病毒基因型流行病学的变化。与巴氏涂片细胞学检查相比，高危型 HPV 检测在宫颈癌的初级筛查中更有效。单独的基因分型对于 HPV 为基础和细胞学为基础的筛查中的分流可能是有用的。它只能用于经过临床验证的测试。
评估 Anyplex Ⅱ HPV HR 与其他 HPV 检测方法在宫颈癌筛查中的一致性。
使用 Pubmed、google scholar、google 数据库和 Scopus 中的验证研究来搜索文章。系统地使用关键词搜索 2013 年以来发表的英文文章。此外，还手动搜索其他数据库，如 Google Scholar 和 Google 数据库，以查找灰色文献。最后一次搜索是在 2020 年 12 月进行的。然后评估研究的合格性、提取的数据和评估偏倚风险。由于纳入文章的临床异质性很大，Anyplex Ⅱ HR HPV 检测的诊断性能不太可能被汇总。相反，我对该测试的性能进行了描述性介绍，以汇集 Anyplex Ⅱ HR HPV 检测用于检测 CIN2+的最佳综合证据。本综述纳入了评估该检测在敏感性、特异性、重现性以及与比较检测和/或组织学的阳性和阴性预测值方面性能的研究。
Anyplex Ⅱ HPV HR 对 CIN2+和 CIN3+显示出一致的高绝对临床敏感性，以及相对于目前最广泛使用的 HPV 检测的相对临床敏感性。由于转诊人群的组成明显不同，Anyplex Ⅱ HPV HR 对 CIN2+和 CIN3+的绝对临床特异性在不同的研究中有所不同，但与参考检测方法相比是可比的。
五项关于 Anyplex Ⅱ HPV HR 在宫颈癌筛查环境中的性能验证研究表明，它对 CIN2+和 CIN3+的绝对临床敏感性均较高，与 HC2 和 GP5+/6 + PCR 相比仍具有可比性的敏感性和特异性。Anyplex Ⅱ 已在多个环境和人群中评估了 HPV HR。它被认为是原发性宫颈癌筛查和转诊人群环境中分流的临床验证。
