新型国产杂交捕获HPV检测技术在ASC-US人群分流中的应用效果评价

目的 探讨基于杂交捕获原理的DH2检测技术在未明确意义的不典型鳞状细胞(Atypical squamous cells of undetermined significance,ASC-US)人群中的分流应用效果.方法 本研究于2016年10月—2018年10月在河南省新密市招募21～64岁普通女性参加研究.所有女性在...

Performance evaluation of a new domestic hybrid capture HPV detection technology for the management of ASC-US population

Objective The of this study was to explore the performance of DH2 detection technology based on the principle of hybrid capture for the management of atypical squamous cells of undetermined significance(ASC-US)population.Methods This study recruited participants from 21 to 64 years old general women in Xinmi county,Henan province from October 2016 to October 2018.All women would be subjected to gynecological examination and cervical exfoliative cytology collection after signing informed consent form.All cytological samples were detected by DH2 for high-risk HPV testing.At the same time,all subjects underwent colposcopy and tissue biopsy if necessary.The results of colposcopy and pathological diagnosis would be used as the gold standard for performance evaluation of DH2.Results A total of 302 women were enrolled with a median age of 52 years in the study.The DH2 test results were positive in 49 women(16.2%),3(1%)women were diagnosed with cervical intraepithelial neoplasia grade 2(CIN2),and 14(4.6%)women were diagnosed with cervical intraepithelial neoplasia grade 3 or worse(CIN3+)lesions.When CIN2+ was used as the clinical endpoint,the sensitivity,specificity,positive predictive value,and negative predictive value of DH2 were 82.4%,87.7%,28.6% and 98.8% respectively;when CIN3+ was used as the clinical endpoint,the sensitivity,specificity,and positive and negative predictive values of DH2 were 85.7%,87.2%,24.5% and 99.2%,respectively.Conclusion DH2 has high sensitivity and specificity in detecting CIN2+ and CIN3+ lesions in ASC-US population.Therefore,DH2 is promising in the management of ASC-US population and could reduce the health hazards of cervical cancer by combining with cytological screening methods.