title: HPV Direct Flow CHIP: a new human papillomavirus genotyping method based on direct PCR from crude-cell extracts.
abstract: HPV Direct Flow CHIP is a newly developed test for identifying 18 high-risk and 18 low-risk human papillomavirus (HPV) genotypes. It is based on direct PCR from crude-cell extracts, automatic flow-through hybridization, and colorimetric detection. The aim of this study was to evaluate the performance of HPV Direct Flow CHIP in the analysis of 947 samples from routine cervical screening or the follow-up of abnormal Pap smears. The specimens were dry swab samples, liquid-based cytology samples, or formalin-fixed paraffin-embedded tissues. The genotype distribution was in agreement with known epidemiological data for the Spanish population. Three different subgroups of the samples were also tested by Linear Array (LA) HPV Genotyping Test (n=108), CLART HPV2 (n=82), or Digene Hybrid Capture 2 (HC2) HPV DNA Test (n=101). HPV positivity was 73.6% by HPV Direct Flow CHIP versus 67% by LA, 65.9% by HPV Direct Flow CHIP versus 59.8% by CLART, and 62.4% by HPV Direct Flow CHIP versus 42.6% by HC2. HPV Direct Flow CHIP showed a positive agreement of 88.6% with LA (k=0.798), 87.3% with CLART (k=0.818), and 68.2% with HC2 (k=0.618). In conclusion, HPV Direct Flow CHIP results were comparable with those of the other methods tested. Although further investigation is needed to compare the performance of this new test with a gold-standard reference method, these preliminary findings evidence the potential value of HPV Direct Flow CHIP in HPV vaccinology and epidemiology studies.
authors.affiliation: Master Diagnóstica, Avenida del Conocimiento, 100 Parque Tecnológico y de la Salud, 18016 Granada, Spain. elsa.herraez@vitroweb.com
authors.forename: Elsa
authors.initials: E
authors.lastname: Herraez-Hernandez
authors.forename: Martina
authors.initials: M
authors.lastname: Alvarez-Perez
authors.forename: Gloria
authors.initials: G
authors.lastname: Navarro-Bustos
authors.forename: Javier
authors.initials: J
authors.lastname: Esquivias
authors.forename: Sonia
authors.initials: S
authors.lastname: Alonso
authors.forename: Jose
authors.initials: J
authors.lastname: Aneiros-Fernandez
authors.forename: Cesar
authors.initials: C
authors.lastname: Lacruz-Pelea
authors.forename: Magdalena
authors.initials: M
authors.lastname: Sanchez-Aguera
authors.forename: Javier Saenz
authors.initials: JS
authors.lastname: Santamaria
authors.forename: Jesus Chacon
authors.initials: JC
authors.lastname: de Antonio
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Rodriguez-Peralto
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003124:Colorimetry / Q000379:methods*; D004279:DNA, Viral / Q000235:genetics*; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D009693:Nucleic Acid Hybridization / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics* / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods*; D013030:Spain; D014773:Virology / Q000379:methods; D055815:Young Adult
chemical_list: D004279:DNA, Viral
keywords: CLART HPV2; HPV Direct Flow CHIP; HPV Genotyping; Human papillomavirus; Hybrid Capture 2; Linear Array