title: Quality assurance of genotyping array for detection and typing of human papillomavirus.
abstract: The aim of this study was to evaluate the sensitivity, specificity, reliability and reproducibility of the EasyChip HPV blot for human papillomavirus (HPV) genotyping. Type-specific sensitivity and specificity for 39 types of HPV (HPV 6, 11, 16, 18, 26, 31, 32, 33, 35, 37, 39, 42, 43, 44, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 66, 67, 68, 69, 70, 72, 74, 82, CP8061, CP8304, L1AE5, MM4, MM7 and MM8) were examined. The operating environment, reliability, reproducibility and blot interpretation were assessed by a quality assurance system. Each batch experiment contained samples from 89 cervical specimens and 7 extrinsic controls. Caski, HeLa and Jurkat cells, male human blood cell DNA and sterile water were used to assess reliability. Furthermore, pairs of sibling controls were used to assess reproducibility. The overall sensitivity of HPV detection was 1-50 copies of HPV genome equivalent. There was no cross-reactivity with amplicons of other HPV genotypes. One hundred batch experiments demonstrated that the reliability was excellent. The intra-batch and inter-batch reproducibility was 98 and 97%, respectively. It was concluded that the EasyChip HPV blot is a highly sensitive, reliable and reproducible tool for detection and identification of HPV genotypes.
authors.affiliation: Yuan-Shan Research Institute, King Car Food Industrial Co. Ltd., I-Lan, Taiwan. lcyblot@gmail.com
authors.forename: Ching-Yu
authors.initials: CY
authors.lastname: Lin
authors.forename: Hui-Chi
authors.initials: HC
authors.lastname: Chen
authors.forename: Ruey-Wen
authors.initials: RW
authors.lastname: Lin
authors.forename: San-Lin
authors.initials: SL
authors.lastname: You
authors.forename: Chiou-Mien
authors.initials: CM
authors.lastname: You
authors.forename: Li-Chung
authors.initials: LC
authors.lastname: Chuang
authors.forename: Mei-Hung
authors.initials: MH
authors.lastname: Pan
authors.forename: Mei-Hsuan
authors.initials: MH
authors.lastname: Lee
authors.forename: Yi-Chun
authors.initials: YC
authors.lastname: Chou
authors.forename: Chien-Jen
authors.initials: CJ
authors.lastname: Chen
mesh_terms: D002584:Cervix Uteri / Q000821:virology; D004247:DNA / Q000032:analysis*; D005260:Female; D016679:Genome, Viral; D006367:HeLa Cells; D006801:Humans; D019169:Jurkat Cells; D008297:Male; D020411:Oligonucleotide Array Sequence Analysis; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004247:DNA