Details

Autor(en) / Beteiligte

• He, Anna
• Fang, Cheng
• Ming, Yue
• Tan, He
• Zhang, Mengyi
• Zhang, Ruiqing
• Li, Jingyi
• Nie, Mingzhu
• Li, Fengyu
• Hu, Yaxin
• Shen, Xinxin
• Rong, Xiuge
• Ma, Xuejun

Titel

Development of field-applicable endogenous internally controlled recombinase-aided amplification (EIC-RAA) assays for the detection of human papillomavirus genotypes 6 and 11 using sample releasing agent

Ist Teil von

• Heliyon, 2022-11, Vol.8 (11), p.e11323-e11323, Article e11323

Ort / Verlag

Elsevier Ltd

Erscheinungsjahr

2022

Link zum Volltext

Quelle

Electronic Journals Library

Beschreibungen/Notizen

• Human papillomavirus (HPV) 6 and 11 are the two most common low-risk HPV subtypes, accounting for more than 90% of condyloma acuminatum. A simple, accurate and rapid screening method to be applied in community-level hospitals is in high demand. Endogenous internally controlled recombinase-assisted amplification (EIC-RAA) assays for HPV6 and 11 were performed in a single closed-tube at 39 °C within 30 min. The sensitivity and specificity of EIC-RAA were examined using recombinant plasmids and pre-tested HPV DNA. A total of 233 clinical samples were collected, and the DNA was extracted by traditional multi-step extraction, or sample releasing agent, before analysis by EIC-RAA. For comparison, HPV detection via Quantitative real-time PCR (qPCR) was also performed. The sensitivity of EIC-RAA analysis was 10 copies/reaction for HPV6, 100 copies/reaction for HPV11, and 100 copies/reaction for the human β-globin gene. No cross-reaction was observed with other HPV subtypes. Clinical performance of the EIC-RAA assay achieved a 100% of concordance rate with the commercial HPV qPCR kit. Further, the EIC-RAA assay achieved a 100% of concordance rate when using multi-step extracted DNA and sample releasing agent-processed DNA. The EIC-RAA assay for HPV6 and 11 detection possesses the advantages of accuracy, simplicity and rapidity, and demonstrates great potential to be used in community-level hospitals for field investigation. •The EIC-RAA assays for HPV6 and 11 possess high sensitivity and specificity.•The endogenous human β-globin can effectively eliminate false-negatives or invalid amplification results, increasing the reliability of the EIC-RAA assay.•The EIC-RAA assays for the detection of HPV 6 and 11 using sample releasing agent show the advantages of fast detection speed and simple operation. Human papillomavirus 6 and 11; Human β-globin gene; Endogenous internally controlled recombinase-assisted amplification; Sample releasing agent.