title: Comparative evaluation of AMPLICOR HPV PCR and Linear Array assays on SurePath liquid-based Pap samples for the detection of high-risk HPV genotypes.
abstract: BACKGROUND
  Persistent cervical infection with high-risk [HR] HPV is a causative factor for cancer. Liquid-based [L-Pap] Pap samples are convenient for HPV testing and SurePath samples have been least studied. Most HPV tests have multiple step protocols and testing laboratories experience large volumes of samples.
  
  
  OBJECTIVE
  Using SurePath L-Pap residual samples the objectives were as follows: [1] to test the performance of AMP-HPV and LA-HPV. [2] To perform an agreement study between two laboratories for the AMP-HPV test and [3] to compare agreement of results between AMP-HPV and LA-HPV and HC2.
  
  
  METHODS
  Samples from 657 women were tested for Pap cytology then assayed for HR-HPV using AMP-HPV and LA-HPV tests. AMP-HPV performance was compared between 2 laboratories and agreement studies were conducted between AMP-HPV, LA-HPV and HC2.
  
  
  RESULTS
  HR-HPV genotypes were associated with L-Pap readings as follows: HSIL 92% [23/25], LSIL 73.6% [162/220], ASCUS 70.4% [131/186], normal 31.9% [72/226]. More women less than 30 were infected with HR-HPV and multiple genotypes regardless of the L-Pap reading. AMP-HPV and LA-HPV testing had an overall raw agreement with each other of 84.2% [Kappa 0.66] and each had agreement of 94% with HC2 testing of 133 samples [Kappa 0.86/0.87]. AMP-HPV agreement between two laboratories was better at 93% [Kappa 0.84] compared to 76.1% [Kappa 0.40] when extraction was standardized.
  
  
  CONCLUSIONS
  It is feasible to perform AMP-HPV and LA-HPV on SurePath samples to detect HR-HPV genotypes. HC2, AMP-HPV and LA-HPV showed strong agreement. The extraction component of the AMP-HPV assay needs careful attention to yield consistent results.
authors.affiliation: St. Joseph's Healthcare, McMaster University, Hamilton, ON, Canada. chernesk@mcmaster.ca
authors.forename: Max
authors.initials: M
authors.lastname: Chernesky
authors.forename: Dan
authors.initials: D
authors.lastname: Jang
authors.forename: Eder
authors.initials: E
authors.lastname: Portillo
authors.forename: Marek
authors.initials: M
authors.lastname: Smieja
authors.forename: Sylvia
authors.initials: S
authors.lastname: Chong
authors.forename: Sonya
authors.initials: S
authors.lastname: Buracond
authors.forename: Michelle
authors.initials: M
authors.lastname: Klingel
authors.forename: Rami
authors.initials: R
authors.lastname: El Sebai
authors.forename: Julius
authors.initials: J
authors.lastname: Kapala
authors.forename: Jay
authors.initials: J
authors.lastname: Patel
authors.forename: Kathy
authors.initials: K
authors.lastname: Biers
authors.forename: Nancy
authors.initials: N
authors.lastname: Harroun
authors.forename: Chris
authors.initials: C
authors.lastname: Doucette
authors.forename: Jeff
authors.initials: J
authors.lastname: Sumner
mesh_terms: D000328:Adult; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009693:Nucleic Acid Hybridization / Q000379:methods; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods; D014773:Virology / Q000379:methods*
chemical_list: D004279:DNA, Viral