title: Clinical validation of a novel real-time human papillomavirus assay for simultaneous detection of 14 high-risk HPV type and genotyping HPV type 16 and 18 in China.
abstract: In the present study, we describe the laboratory workflow and the clinical validation of a novel multiplex real-time PCR-based HPV assay in China. The cross-sectional validation analysis showed that this assay worked well for detection of 14 HR-HPV types and identification of HPV 16 and 18 in a single sensitive assay that is suitable for both clinical usage and high-throughput cervical screening purposes. We predict that this accurate, high-throughput and low-cost HPV assay can greatly reduce the heavy economic burden of HPV detection in China.
authors.affiliation: Central Laboratory, Chaozhou Central Hospital Affiliated to Southern Medical University, No. 84 Huan-Cheng-Xi Road, Chaozhou, 521021, Guangdong, People's Republic of China.
authors.forename: Hui
authors.initials: H
authors.lastname: Yang
authors.affiliation: Chaozhou Hybribio Limited Corporation, Chaozhou, Guangdong, People's Republic of China.
authors.forename: Lie-Jun
authors.initials: LJ
authors.lastname: Li
authors.affiliation: Chaozhou Hybribio Limited Corporation, Chaozhou, Guangdong, People's Republic of China.
authors.forename: Long-Xu
authors.initials: LX
authors.lastname: Xie
authors.affiliation: Central Laboratory, Chaozhou Central Hospital Affiliated to Southern Medical University, No. 84 Huan-Cheng-Xi Road, Chaozhou, 521021, Guangdong, People's Republic of China.
authors.forename: Zhao-Yun
authors.initials: ZY
authors.lastname: Luo
authors.affiliation: Chaozhou Hybribio Limited Corporation, Chaozhou, Guangdong, People's Republic of China.
authors.forename: Min
authors.initials: M
authors.lastname: Lu
authors.affiliation: Central Laboratory, Chaozhou Central Hospital Affiliated to Southern Medical University, No. 84 Huan-Cheng-Xi Road, Chaozhou, 521021, Guangdong, People's Republic of China.
authors.forename: Min
authors.initials: M
authors.lastname: Lin
authors.affiliation: Central Laboratory, Chaozhou Central Hospital Affiliated to Southern Medical University, No. 84 Huan-Cheng-Xi Road, Chaozhou, 521021, Guangdong, People's Republic of China.
authors.forename: Xiang-Bin
authors.initials: XB
authors.lastname: Zheng
authors.affiliation: Central Laboratory, Chaozhou Central Hospital Affiliated to Southern Medical University, No. 84 Huan-Cheng-Xi Road, Chaozhou, 521021, Guangdong, People's Republic of China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Central Laboratory, Chaozhou Central Hospital Affiliated to Southern Medical University, No. 84 Huan-Cheng-Xi Road, Chaozhou, 521021, Guangdong, People's Republic of China. yangleeyee@sina.com.
authors.forename: Li-Ye
authors.initials: LY
authors.lastname: Yang
mesh_terms: D002681:China; D003430:Cross-Sectional Studies; D005838:Genotype; D060005:Genotyping Techniques / Q000379:methods*; D057166:High-Throughput Screening Assays / Q000379:methods; D006801:Humans; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*