Division of Laboratory Medicine, European Institute of Oncology IRCCS, Milan, Italy.
Department of Biomedical Sciences, University of Sassari, Sassari, Italy.
J Med Virol. 2021 Nov;93(11):6340-6346. doi: 10.1002/jmv.26862. Epub 2021 Feb 15.
Human papillomavirus (HPV) tests differ for technology, targets, and information on the genotype and viral load. In this study, we evaluated the performance of the Seegene Anyplex II HPV HR (Anyplex) assay in the detection of cervical intraepithelial lesions (CIN) and as a test-of-cure in the follow-up after surgical treatment. One hundred and sixty-seven women referred to the European Institute of Oncology, Milan, for surgical treatment of CIN2+ were enrolled. A cervical sample was taken before treatment and at the first follow-up visit: on these samples, Qiagen Hybrid Capture 2 (HC2), Roche Linear Array HPV Test (Linear Array), cytology and histology were performed at baseline, HC2, and cytology at follow-up. Anyplex genotyping HPV test was performed on a post aliquot from liquid-based cytology specimens when available. The concordance between Anyplex and HC2 was 93.6% at baseline and 76.7% at follow-up (3-9 months after treatment), respectively. The concordance between Anyplex and Linear Array was evaluable only at baseline (92.9%). No recurrence occurred in women without the persistence of the same genotype at follow-up. Seven women relapsed: six had persistence of the same genotypes (five HPV16, one HPV33, and one HPV39), while one tested negative not only with Anyplex but also with HC2 for the persistence of low-risk genotype infection (HPV73 only detected by Linear Array). Anyplex test represents a valid option for HPV detection and genotyping in order to stratify women at risk of high-grade lesions at baseline and to monitor patients treated for CIN2+ lesions during follow-up.
人乳头瘤病毒（HPV）检测在技术、靶标以及基因型和病毒载量信息方面存在差异。在这项研究中，我们评估了 Seegene Anyplex II HPV HR（Anyplex）检测在检测宫颈上皮内病变（CIN）以及在手术治疗后随访中的表现，作为治疗后检测。167 名因 CIN2+而被转诊到米兰欧洲肿瘤研究所接受手术治疗的女性入组本研究。在治疗前和第一次随访时采集宫颈样本：在这些样本上，在基线、HC2 和细胞学随访时进行 Qiagen Hybrid Capture 2（HC2）、罗氏线性阵列 HPV 检测（Linear Array）和细胞学检查。在液体细胞学标本的等分试样可用时，进行 Anyplex 基因分型 HPV 检测。Anyplex 与 HC2 的一致性分别为基线时的 93.6%和治疗后（治疗后 3-9 个月）的 76.7%。Anyplex 与 Linear Array 的一致性仅可在基线时评估（92.9%）。在随访时没有相同基因型持续存在的女性中未发生复发。7 名女性复发：6 名女性持续存在相同的基因型（5 名 HPV16、1 名 HPV33 和 1 名 HPV39），而 1 名女性不仅用 Anyplex 检测而且用 HC2 检测均未检测到低危基因型感染（仅用 Linear Array 检测到 HPV73）。Anyplex 检测是 HPV 检测和基因分型的有效选择，可在基线时对高危病变风险的女性进行分层，并在随访期间监测接受 CIN2+病变治疗的患者。
