Quality assurance of genotyping array for detection and typing of human papillomavirus

Ching Yu Lin, Hui Chi Chen, Ruey Wen Lin, San Lin You, Chiou Mien You, Li Chung Chuang, Mei Hung Pan, Mei Hsuan Lee, Yi Chun Chou, Chien Jen Chen

Research output: Contribution to journalArticlepeer-review

45 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)1-9
Number of pages9
JournalJournal of Virological Methods
Issue number1-2
Publication statusPublished - Mar 2007
Externally publishedYes


  • Human papillomavirus
  • Reliability
  • Reproducibility
  • Sensitivity
  • Specificity

ASJC Scopus subject areas

  • Virology


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