title: Rapid genotyping of carcinogenic human papillomavirus by loop-mediated isothermal amplification using a new automated DNA test (Clinichip HPV™).
abstract: This study was designed to evaluate the Clinichip HPV test, a new DNA test that detects carcinogenic human papillomavirus (HPV) rapidly by loop-mediated isothermal amplification and performs genotyping of all 13 carcinogenic types using automated DNA chip technology with an assay time 2.5h. Using this test, 247 Japanese women (109 with normal cytology, 43 with cervical intraepithelial neoplasia grade 1, 60 with cervical intraepithelial neoplasia grade 2/3 and 35 with invasive cervical cancer) were tested for carcinogenic HPV genotypes. The results were compared to those obtained by the polymerase chain reaction-amplified DNA sequencing using 13 type-specific primers. Overall, there was very good agreement for the detection of carcinogenic HPV between the Clinichip test and direct sequencing, with 95.5% total agreement and a kappa value of 0.91. Comparison of the detection of individual HPV types shows that the overall agreement was also high (range: 96.8-100%). In women with cervical intraepithelial neoplasia grade 2 or worse, the detection rate of carcinogenic HPV was 95.7% by both the Clinichip test and the direct-sequencing method, indicating complete agreement between the two methods. In conclusion, it was found that the Clinichip test is a promising new laboratory method for genotyping of carcinogenic HPV.
authors.affiliation: Department of Obstetrics and Gynecology, University of Tsukuba, Japan.
authors.forename: Toyomi
authors.initials: T
authors.lastname: Satoh
authors.forename: Koji
authors.initials: K
authors.lastname: Matsumoto
authors.forename: Takuma
authors.initials: T
authors.lastname: Fujii
authors.forename: Osamu
authors.initials: O
authors.lastname: Sato
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Gemma
authors.forename: Mamiko
authors.initials: M
authors.lastname: Onuki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.forename: Daisuke
authors.initials: D
authors.lastname: Aoki
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hirai
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yoshikawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057205:Automation, Laboratory / Q000379:methods; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification / Q000472:pathogenicity*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology*; D002583:Uterine Cervical Neoplasms / Q000821:virology*; D014773:Virology / Q000379:methods*; D055815:Young Adult
chemical_list: D004279:DNA, Viral