title: Developmental validation of the EX20+4 system.
abstract: The EX20+4Y System is a polymerase chain reaction (PCR)-based amplification kit that enables typing of 19 autosomal short tandem repeat (STR) loci (i.e., CSF1PO, D13S317, D16S539, D18S51, D21S11, D3S1358, D5S818, D7S820, D8S1179, FGA, TH01, TPOX, vWA, Penta D, Penta E, D2S1338, D19S433, D12S391, D6S1043), four widely used Y chromosome-specific STR (Y-STR) loci (DYS458, DYS456, DYS391, DYS635), and amelogenin. In this study, this multiplex system was validated for sensitivity of detection, DNA mixtures, inhibitor tolerance, species specificity based on the Scientific Working Group on DNA Analysis methods (SWGDAM) developmental validation guidelines, and the Chinese criteria for the human fluorescent STR multiplex PCR reagent. The results show that the EX20+4 System is a robust and reliable amplification kit which can be used for human identification testing.
authors.affiliation: Guangzhou Forensic Science Institute, Guangdong Province Key Laboratory of Forensic Genetics, Guangzhou 510030, China; Department of Forensic Medicine, Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou 510089, China. Electronic address: uzhiyanzhai@126.com.
authors.forename: Shuanglin
authors.initials: S
authors.lastname: Li
authors.affiliation: Guangzhou Forensic Science Institute, Guangdong Province Key Laboratory of Forensic Genetics, Guangzhou 510030, China; Department of Forensic Medicine, Zhongshan School of Medicine, Sun Yat-sen University, Guangzhou 510089, China. Electronic address: Liuchaogaj@21cn.com.
authors.forename: Chao
authors.initials: C
authors.lastname: Liu
authors.affiliation: Guangzhou Forensic Science Institute, Guangdong Province Key Laboratory of Forensic Genetics, Guangzhou 510030, China. Electronic address: 79liuhong@163.com.
authors.forename: Hong
authors.initials: H
authors.lastname: Liu
authors.affiliation: Institute of Applied Genetics, Department of Forensic and Investigative Genetics, University of North Texas Health Science Center, Fort Worth, TX 76107, USA. Electronic address: gejianye@gmail.com.
authors.forename: Jianye
authors.initials: J
authors.lastname: Ge
authors.affiliation: Institute of Applied Genetics, Department of Forensic and Investigative Genetics, University of North Texas Health Science Center, Fort Worth, TX 76107, USA; Center of Excellence in Genomic Medicine Research (CEGMR), King Abdulaziz University, Jeddah, Saudi Arabia. Electronic address: Bruce.Budowle@unthsc.edu.
authors.forename: Bruce
authors.initials: B
authors.lastname: Budowle
authors.affiliation: Guangzhou Forensic Science Institute, Guangdong Province Key Laboratory of Forensic Genetics, Guangzhou 510030, China. Electronic address: liuchanghui2007@gmail.com.
authors.forename: Changhui
authors.initials: C
authors.lastname: Liu
authors.affiliation: AGCU ScienTch Incorporation, Wuxi 214174, China. Electronic address: zhengweiguo@agcu.cn.
authors.forename: Weiguo
authors.initials: W
authors.lastname: Zheng
authors.affiliation: AGCU ScienTch Incorporation, Wuxi 214174, China. Electronic address: lifayuan2009@163.com.
authors.forename: Fayuan
authors.initials: F
authors.lastname: Li
authors.affiliation: AGCU ScienTch Incorporation, Wuxi 214174, China. Electronic address: gebingwen@AGCU.com.
authors.forename: Binwen
authors.initials: B
authors.lastname: Ge
mesh_terms: D041322:Chromosomes, Human, Y; D004247:DNA / Q000235:genetics; D019075:Electrophoresis, Capillary; D005260:Female; D006801:Humans; D008297:Male; D018895:Microsatellite Repeats / Q000235:genetics; D016133:Polymerase Chain Reaction; D015203:Reproducibility of Results
chemical_list: D004247:DNA
keywords: DNA typing; Developmental validation; Forensic science; Multiplexing; Short tandem repeat (STR)