Abstract

A new method using HybriBio HPV GenoArray test kit was developed for detection of human papillomavirus (HPV) in anogenital non-tumor diseases, which was compared with the real-time PCR, and sequencing for specificity and sensitivity. All initial validation studies with the control DNA proved to be type-specific. Tissue specimens were obtained from 66 patients with external genital condylomata acuminate (n = 28) and bowenoid papulosis (n = 28) and 10 negative controls. HPV 6 DNA and HPV 11 DNA were detected in 14 and 9 of 28 condylomata acuminate patients, respectively and simultaneous infection of HPV 6 and HPV 11 DNA, HPV 11 and HPV 18 DNA were detected in 3 and 1 of 28 condylomata acuminate patients. HPV 16 DNA and HPV 6 DNA were detected in 17 and 1 of 28 bowenoid papulosis patients, and the other ten bowenoid papulosis patients were detected negative. The sensitivity of HybriBio HPV GenoArray test and real-time polymerase chain reaction (PCR) were 97.8% (45/46) and 95.7% (44/46), and the specificity was 100% (20/20) and 95% (19/20). The overall agreement between HybriBio HPV GenoArray test and sequencing was 98.5% (Cohen’s kappa value = 0.96), while real-time PCR and sequencing was 95.5% (Cohen’s kappa value = 0.89). HPV genotyping was performed by using the newly commercially introduced HPV GenoArray test kit which makes use of both DNA amplification and HybriBio’s proprietary flowthrough hybridization technique to simultaneously identify 21 HPV genotypes, with 3 common subtypes of HPV 53, HPV 66 and cp8304 in Chinese, which can potentially be a valuable tool for the detection of HPV DNA.

Key words: Human papillomavirus, condylomata acuminate, bowenoid papulosis.