title: [Clinical evaluation of a novel multiplex HPV genotyping reagent using the luminex xMAP technology].
abstract: Of the more than 100 strains of human papillomavirus (HPV) reported to date, 13 strains are clinically significant due to the highly associated risk of cervical cancer. HPV test reagents are currently being developed to aid detection of these strains. The present study compared a novel HPV genotyping reagent using a Luminex device, which enables simultaneous quantitation of multiple targets using fluorescent beads, and gene-specific multiplex polymerase chain reaction (Luminex method) with approved in vitro diagnostics. Subjects comprised 256 patients examined at our hospital for either secondary cervical cancer testing or follow-up (mean age, 40 years; age range, 20-85 years) and specimens were obtained using a cervical brush and lavage fluid. The HPV-positive rate with the Luminex method was 51.4%(132/256), of which single and multiple strain infections constituted 65.9% (87/132) and 34.1% (45/132), respectively. Correlation testing of 50 positive and 50 negative Luminex method specimens was conducted using the HPV DNA Hybrid Capture II (HCII), revealing high overall (97%[97/100]), positive(100% [47/47]) and negative(94.3% [50/53]) concordance rates. Correlation was also high for the Clinichip HPV (Clinichip), with overall, positive and negative concordance rates of 98% (98/100), 100%(48/48) and 96.2%(50/52), respectively. Furthermore, the detection concordance rate with the Clinichip was 95.8% (46/48). Sequencing of the seven specimens showing result discrepancies (HCII, n = 3; Clinichip, n = 4) confirmed concordance with the Luminex method results in all cases, indicating the validity of the present method. The present findings suggest that the Luminex method has sufficient response capability for clinical application.
authors.affiliation: Division of Pathology, Kanazawa University Hospital, Kanazawa 920-8641, Japan. s-ozaki@med.kanazawa-u.ac.jp
authors.forename: Satoru
authors.initials: S
authors.lastname: Ozaki
authors.forename: Seiko
authors.initials: S
authors.lastname: Kitamura
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Hara
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Shimoyama
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kubota
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Abe
authors.forename: Kana
authors.initials: K
authors.lastname: Kato
authors.forename: Masaki
authors.initials: M
authors.lastname: Inoue
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D009693:Nucleic Acid Hybridization / Q000379:methods*; D015345:Oligonucleotide Probes / Q000235:genetics; D027383:Papillomaviridae / Q000235:genetics* / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D055815:Young Adult
chemical_list: D015345:Oligonucleotide Probes; D011933:Reagent Kits, Diagnostic