Cervical cancer is primarily caused by persistent infection with high-risk human papillomavirus (HPV), and 70% of cases are associated with HPV16 and 18 infections. The objective of this study was to establish rapid, simple, and sensitive internally controlled recombinase-aided amplification (IC-RAA) assays for the detection of HPV16 and 18. The assays were performed at 39 ℃ and were completed within 30 min. A total of 277 clinical samples of exfoliated cervical cells were tested by IC-RAA assays and commercial HPV real-time fluorescent PCR kits using extracted DNA and samples treated with nucleic acid releasing agent. The analytical sensitivity of the IC-RAA assay was found to be 10 copies/μL for the detection of HPV16 and 18 when using recombinant plasmids as targets. The optimal concentration of the internal control (IC) plasmid and 18 was 1000 copies/μL for HPV16 and 100 copies/μL for HPV18. The clinical sensitivity of the IC-RAA assays for HPV16 using extracted DNA and samples treated with nucleic acid releasing agent was 98.73% and 97.47%, respectively, with kappa values of 0.977 (P < 0.01) and 0.955 (P < 0.01), respectively, and 100% The specificity in both cases. For HPV18, the sensitivity and specificity were 100%, and the kappa value was 1 for both samples (P < 0.01). The IC-RAA assay is a promising tool for the detection of HPV16 and HPV18, especially in resource-constrained settings.

宫颈癌主要是由持续感染高危型人乳头瘤病毒（HPV）引起的，其中70％的病例与HPV16和18感染有关。这项研究的目的是建立快速，简单，灵敏的内部控制的重组酶辅助扩增（IC-RAA）检测HPV16和18的检测。检测在39℃进行，并在30分钟内完成。使用提取的DNA和经过核酸释放剂处理的样品，通过IC-RAA分析和商业HPV实时荧光PCR试剂盒对总共277个脱落的宫颈细胞的临床样品进行了测试。当使用重组质粒作为靶标时，发现IC-RAA检测HPV16的分析灵敏度为10拷贝/μL，检测灵敏度为18个拷贝/μL。内部对照（IC）质粒和18的最佳浓度对于HPV16为1000拷贝/μL，对于HPV18为100拷贝/μL。使用提取的DNA和经核酸释放剂处理的样品对HPV16进行IC-RAA分析的临床敏感性分别为98.73％和97.47％，kappa值为0.977（P  <0.01）和0.955（P  <0.01），两种情况的特异性均为100％。对于HPV18，两个样品的敏感性和特异性均为100％，kappa值为1（P  <0.01）。IC-RAA分析是检测HPV16和HPV18的有前途的工具，尤其是在资源有限的环境中。