title: Human papillomavirus typing with a polymerase chain reaction-based genotyping array compared with type-specific PCR.
abstract: BACKGROUND
  Type-specific persistence of human papillomavirus (HPV) infection can cause invasive cervical cancer.
  
  
  OBJECTIVE
  To evaluate the efficacy of HPV detection and typing with a general polymerase chain reaction (PCR)-based genotyping array and to compare it with a type-specific PCR assay.
  
  
  METHODS
  Four hundred and thirty-three cervical samples were tested with a modified MY11/GP6+ PCR-based reverse-blot assay (EasyChip HPV Blot; King Car, Taiwan [hereafter HPV Blot]) and with 20 genotypes of L1-type-specific PCR (HPV-6, -11, -16, -18, -31, -33, -35, -39, -45, -51, -52, -53, -56, -58, -59, -62, -66, -68, -70, and -71 [CP8061]).
  
  
  RESULTS
  The concordance of the two tests in determining HPV positivity was 96.8% (419/433), with a Cohen's kappa=0.93 (95% CI: 0.90-0.97) and McNemar's test of P=1.0, which indicates excellent agreement. The overall concordance of the two tests in the identification of type-specific HPV was 91.0% (394/433). Sensitivity (90-100%), specificity (99.2-100%), and accuracy (98.6-100%) rates of HPV Blot against the gold standard were satisfactory for HPV-16, -18, -58, -33, -52, -39, -45, -31, -51, -70 while HPV-71 (63.6%) had suboptimal sensitivity. Though the kappa values between the two tests for many individual genotypes could not be reliably calculated because of low positivity, the kappa values for HPV-16, -52, and -58 were excellent (0.93, 0.96, and 0.95, respectively).
  
  
  CONCLUSIONS
  The modified MY11/GP6+ PCR-based HPV Blot assay is accurate and sensitive for detection and genotyping of HPV in cervical swab samples.
authors.affiliation: School of Medical Laboratory Science and Biotechnology, Taipei Medical University, Taipei, Taiwan.
authors.forename: Ching-Yu
authors.initials: CY
authors.lastname: Lin
authors.forename: Angel
authors.initials: A
authors.lastname: Chao
authors.forename: Yuh-Cheng
authors.initials: YC
authors.lastname: Yang
authors.forename: Hung-Hsueh
authors.initials: HH
authors.lastname: Chou
authors.forename: Chih-Ming
authors.initials: CM
authors.lastname: Ho
authors.forename: Ruey-Wen
authors.initials: RW
authors.lastname: Lin
authors.forename: Ting-Chang
authors.initials: TC
authors.lastname: Chang
authors.forename: Jia-Yia
authors.initials: JY
authors.lastname: Chiou
authors.forename: Fang-Yu
authors.initials: FY
authors.lastname: Chao
authors.forename: Kung-Liahng
authors.initials: KL
authors.lastname: Wang
authors.forename: Tsai-Yen
authors.initials: TY
authors.lastname: Chien
authors.forename: Swei
authors.initials: S
authors.lastname: Hsueh
authors.forename: Chu-Chun
authors.initials: CC
authors.lastname: Huang
authors.forename: Chien-Jen
authors.initials: CJ
authors.lastname: Chen
authors.forename: Chyong-Huey
authors.initials: CH
authors.lastname: Lai
mesh_terms: D002584:Cervix Uteri / Q000821:virology; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D006801:Humans; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D004279:DNA, Viral