title: Specificity of the Linear Array HPV Genotyping Test for detecting human papillomavirus genotype 52 (HPV-52).
abstract: BACKGROUND
  HPV-52 is one of the most frequent human papillomavirus (HPV) genotypes causing significant cervical pathology. The most widely used HPV genotyping assay, the Roche Linear Array HPV Genotyping Test (Linear Array), is unable to identify HPV-52 status in samples containing HPV-33, HPV-35, and/or HPV-58.
  
  
  METHODS
  Linear Array HPV-52 analytical specificity was established by testing 100 specimens reactive with the Linear Array HPV-33/35/52/58 cross-reactive probe, but not with the HPV-33, HPV-35, and/or HPV-58 individual probes, using an HPV-52-specific real-time PCR assay with a detection level of 3.9 DNA copies/reaction. In addition, we established the prevalence of HPV-52 in 49 samples reactive with the Linear Array HPV-33/35/52/58 cross-reactive probe, but containing either HPV-33, HPV-35, and/or HPV-58 using the same approach.
  
  
  RESULTS
  The HPV-52-specific assay detected HPV-52 in all 100 samples reactive with the Linear Array HPV-33/35/52/58 cross-reactive probe, but not with the HPV-33, HPV-35, and/or HPV-58 probes. The presence of up to six other HPV genotypes did not influence the HPV-52 analytical performance of Linear Array. Only 6/49 (12.2%) samples reactive with the Linear Array HPV-33/35/52/58 cross-reactive probe, but containing either HPV-33, HPV-35 or/and HPV-58, were HPV-52 positive.
  
  
  CONCLUSIONS
  Linear Array is a highly reliable test for detecting HPV-52 in the absence of genotypes HPV-33, HPV-35, and HPV-58. Additional testing using an HPV-52-specific test is necessary when HPV-33, HPV-35, and/or HPV-58 are present in the sample.
authors.affiliation: Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
authors.forename: Anja
authors.initials: A
authors.lastname: Oštrbenk
authors.affiliation: Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
authors.forename: Boštjan J
authors.initials: BJ
authors.lastname: Kocjan
authors.affiliation: Institute of Microbiology and Immunology, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. Corresponding author: mario.poljak@mf.uni-lj.si.
authors.forename: Mario
authors.initials: M
authors.lastname: Poljak
mesh_terms: D052685:Alphapapillomavirus / Q000145:classification / Q000235:genetics* / Q000302:isolation & purification; D002584:Cervix Uteri / Q000821:virology; D015344:DNA Probes, HPV; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005838:Genotype; D006801:Humans; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D015344:DNA Probes, HPV; D004279:DNA, Viral