Abstract: Objective To establish a universal endogenous internally controlled recombinase-aided amplification (EIC-RAA) for the detection of HPV-6 and HPV-11 method, in order to achieve simple, accurate and rapid screening of HPV-6 and HPV-11. Method The EIC-RAA method for detecting HPV-6 and HPV-11 was established by designing universal primers and probes for L1 fragment of the conserved region of HPV-6 and HPV-11, and combining RNaseP gene primers and probes as internal reference. The sensitivity, repeatability and specificity of EIC-RAA method were tested by series of concentration diluted plasmids and nucleic acids from different subtypes of HPV sample. A total of 230 clinical samples were collected and compared for EIC-RAA and commercial HPV PCR-fluorescent probe method. Result The established EIC-RAA method can detect HPV-6 and HPV-11 within 30 minutes at 39℃, with a sensitivity of 10 copies/reaction, good repeatability and high specificity. The coincidence rate between EIC-RAA and commercial HPV PCR-fluorescent probe method was 100%. Conclusion The EIC-RAA showed the advantages of simplicity, accuracy and rapidity in detecting HPV-6 and HPV-11, and has great potential application value in the field screening of HPV-6 and HPV-11.

Key words: Human papilloma virus, Ribonuclease P, Endogenous internally control, Recombinase-assisted amplification