From the Departments of Obstetrics and Gynaecology (Haqshenas, Phillips, Balgovind, Garland, Murray).
the Centre for Women's Infectious Diseases, The Royal Women's Hospital, Melbourne, Australia (Haqshenas, Molano, Phillips, Balgovind, Garland, Machalek, Murray).
Arch Pathol Lab Med. 2024 Mar 1;148(3):353-358. doi: 10.5858/arpa.2022-0317-OA.
CONTEXT.—: Detection of human papillomavirus (HPV) in formalin-fixed, paraffin-embedded (FFPE) tissues may identify the cause of lesions and has value for the development of new diagnostic assays and epidemiologic studies. Seegene Anyplex II assays are widely used for HPV screening, but their performance using FFPE samples has not been fully explored.
OBJECTIVE.—: To validate Anyplex II HPV HR Detection (Anyplex II, Seegene) using FFPE samples.
DESIGN.—: We used 248 stored DNA extracts from cervical cancer FFPE samples collected during 2005-2015 that tested HPV positive using the RHA kit HPV SPF10-LiPA25, v1 (SPF10, Labo Biomedical Products) HPV genotyping assay, manufacturer-validated for FFPE samples.
RESULTS.—: Of the selected 248 samples, 243 were used in our analysis. Consistent with SPF10 genotyping results, Anyplex II detected all 12 oncogenic types and had an overall HPV detection rate of 86.4% (210 of 243 samples). Anyplex II and SPF10 showed very high agreement for the detection of the 2 most important oncogenic genotypes: HPV 16 (219 of 226; 96.9%; 95% CI, 93.7-98.75) and HPV 18 (221 of 226; 97.8%; 95% CI, 94.9-99.3).
CONCLUSIONS.—: Overall results showed that both platforms produced comparable HPV genotyping results, indicating the suitability of Anyplex II for FFPE samples. The Anyplex II assay has the added convenience of being an efficient, single-well semiquantitative polymerase chain reaction assay. Further optimization of Anyplex II may enhance its performance using FFPE samples by improving the detection limit.
在福尔马林固定、石蜡包埋（FFPE）组织中检测人乳头瘤病毒（HPV）可以确定病变的原因，并且对开发新的诊断检测和流行病学研究具有价值。Seegene Anyplex II 检测法广泛用于 HPV 筛查，但尚未充分探索其在 FFPE 样本中的性能。
验证 Anyplex II HPV HR 检测（Anyplex II，Seegene）在 FFPE 样本中的应用。
我们使用了 248 个存储的 DNA 提取物，这些提取物来自 2005-2015 年间收集的宫颈癌 FFPE 样本，这些样本使用 RHA 试剂盒 HPV SPF10-LiPA25，v1（SPF10，Labo Biomedical Products）HPV 基因分型检测法检测为 HPV 阳性，该检测法已通过制造商验证可用于 FFPE 样本。
在所选择的 248 个样本中，有 243 个样本用于我们的分析。与 SPF10 基因分型结果一致，Anyplex II 检测到所有 12 种致癌类型，总体 HPV 检测率为 86.4%（243 个样本中的 210 个）。Anyplex II 和 SPF10 对检测两种最重要的致癌基因型的结果非常一致：HPV 16（219 个样本中的 226 个；96.9%；95%CI，93.7-98.75）和 HPV 18（221 个样本中的 226 个；97.8%；95%CI，94.9-99.3）。
总体结果表明，两种平台都产生了可比的 HPV 基因分型结果，表明 Anyplex II 适用于 FFPE 样本。Anyplex II 检测法的附加优势在于它是一种高效、单孔半定量聚合酶链反应检测法。通过提高检测限，进一步优化 Anyplex II 可能会提高其在 FFPE 样本中的性能。
