Background Many human papillomavirus (HPV) types are associated with cervical cancer (CC). Therefore, HPV genotyping has both clinical and epidemiological importance. HPV 16 and 18 are two principal high-risk types responsible for more than 70% of all CC cases. Although several commercial and non-commercial genotyping assays are available, there is a need for a cost-effective and sensitive genotyping method for low- and middle-income countries. Methods The study was aimed at evaluation of loop-mediated isothermal amplification (LAMP) assay for HPV genotyping in cervical samples. A total of six primer sets for each HPV type were selected for the assay. The LAMP assay was standardised and validated with HPV control panel. Cervical biopsies were subjected to nested multiplex polymerase chain reaction (NM-PCR; as a part of routine diagnostic workup) and LAMP (HPV 16 and 18) simultaneously. Results A total of 225 clinical samples were processed during the study period. The sensitivity of the assay was determined using the 10-fold dilutions of positive controls. Both the HPV 16-LAMP and HPV 18-LAMP assays were shown to detect as low as 10 viral copies per reaction, which is similar to that of NM-PCR. The LAMP assay had a good agreement (new cases; 92%, post-chemoradiotherapy [post-CRT]; 89.1%) with NM-PCR for the detection of both HPV 16 and 18. As compared to histology (new cases; 79.8%, post-CRT; 51.3%), LAMP had better agreement with NM-PCR for detection of HPV from post-CRT cases. Conclusions We evaluated the LAMP assay for simultaneous detection and typing of HPV 16 and 18. The assay had good agreement with NM-PCR for detection of both HPV 16 and 18. The LAMP assay is a promising tool for HPV genotyping along with routine cervical cytology, especially in resource-constrained settings.

中文翻译：

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环介导等温扩增测定对宫颈内膜样本中人乳头状瘤病毒 16 和 18 的检测和分型的评估。

背景 许多人乳头瘤病毒 (HPV) 类型与宫颈癌 (CC) 相关。因此，HPV基因分型具有临床和流行病学的重要性。HPV 16 和 18 是两种主要的高危类型，占所有 CC 病例的 70% 以上。尽管有几种商业和非商业基因分型测定方法可供使用，但低收入和中等收入国家仍需要一种具有成本效益且灵敏的基因分型方法。方法 本研究旨在评估环介导等温扩增 (LAMP) 检测对宫颈样本中 HPV 基因分型的影响。每种 HPV 类型总共选择了 6 个引物组用于检测。LAMP 检测已标准化并通过 HPV 控制面板进行验证。宫颈活检同时进行巢式多重聚合酶链式反应（NM-PCR；作为常规诊断检查的一部分）和 LAMP（HPV 16 和 18）。结果 研究期间共处理了 225 份临床样本。使用阳性对照的 10 倍稀释液确定测定的灵敏度。HPV 16-LAMP 和 HPV 18-LAMP 检测均显示每次反应可检测到低至 10 个病毒拷贝，这与 NM-PCR 类似。LAMP 检测与 NM-PCR 检测 HPV 16 和 18 具有良好的一致性（新病例；92%，放化疗后 [CRT 后]；89.1%）。与组织学相比（新病例；79.8%） ，CRT 后；51.3%），LAMP 与 NM-PCR 检测 CRT 后病例中的 HPV 具有更好的一致性。结论 我们评估了 LAMP 测定法对 HPV 16 和 18 的同时检测和分型。该测定法与 NM-PCR 检测 HPV 16 和 18 的结果具有良好的一致性。LAMP 测定法与常规宫颈细胞学检查一样，是 HPV 基因分型的有前途的工具，特别是在资源有限的环境中。