Genotyping test kit to identify, and then specifically genotype, hpv in formalinfixed, paraffinembedded tis sues. Detection and genotyping of human papillomavirus hpv from formalinfixed, paraffinembedded ffpe samples may be difficult when using assays based on. Hpv genotyping is achieved with the linear array hpv genotyping test that is based on. Clart hpv2 and linear array hpv genotyping researchgate. Amplilute liquid media extraction kit extrn 50 tests pn. Hpv genotyping is achieved with the linear array hpv genotyping test that is based on l1 consensus polymerase chain reaction pcr amplification of target dna with biotinylated pgmy primers followed by nucleic acid hybridization of amplicons for the detection of thirty seven anogenital hpv genotypes 6, 11, 16, 18, 26, 31, 33, 35, 39, 40.
To clarify the pathogenic contributing role of hpv in the development of genital sk, we have studied 40 genital sks, 20 extragenital sks, and 20 non. No hpv genotyping test is available in the quebec public healthcare system. Hpv genotyping in cervical cancer in northern thailand. Polymerase chain reaction human papillomavirus hpv. Full genotyping reverse hybridization assays genotyping type. The diagcor genoflow human papillomavirus array test genoflow is a novel hpv test based on pcr and flowthrough hybridization that can identify 33 hpv subtypes in 3 hours. Individual types cobas hpv test roche fda approved ce marked target amplification. Since the material available for this study consisted of paraffinembedded tissue samples of cervical cancer, we chose to adapt the linear array hpv genotyping test for use on this type of. Smoking and human papillomavirus hpv infection in the. This valgent study is the first to demonstrate that linear array hpv. The amplicor hpv test, the linear array hpv genotyping test, the papillocheck test, and the innolipa hpv test are examples of kits approved for use elsewhere in the world that have yet to be approved in the united states. Linear array hpv genotyping test is a qualitative test that detects 37 high and lowrisk human papillomavirus genotypes, including those considered a significant risk factor for hsil progression to cervical cancer.
An automated platform beeblot was evaluated in parallel with the recommended protocol for the hybridization and detection steps of the roche linear array human papillomavirus hpv genotyping test using dna from 143 cervical specimens. Roche linear array hpv genotyping test l1 consensus primerbased pcr with pgmy0911 primers 37 different hpv types innolipa hpv genotyping spf10 primers at the l1 region 24 low and highrisk hpv types. The linear array hpv genotyping test uses consensus pcr in combination with typespecific hybridization to detect 37 individual types. Thermocycler, waterbath, shaker, automated hybrization for high throughput cobas hpv test. Samples were amplified using perkinelmer geneamp pcr system 9700 as directed by the linear array. Of the cytologic samples, 25 were positive for a single hpv genotype, whereas the remaining 14 samples harbored a multiple infection, with the number of genotypes ranging from 2 to 7. Pdf performance of the linear array hpv genotyping test on. Persistent infection with highrisk human papillomavirus is associated with the development of cervical intraepithelial neoplasia and a key factor in progression to invasive cancer. Cervical cancer screening with hpv tests should use only clinically validated assays.
This assay is robust and can be performed routinely in. Pdf detection and genotyping of human papillomavirus hpv from formalin fixed, paraffinembedded ffpe samples may be difficult when. Comparison of the performance of carcinogenic hpv typing. Enhanced detection and typing of human papillomavirus hpv. Pdf to compare the clinical efficiency of two commercially available hpv dna detection and typing tests. For more information, go to hpv testing for cervical. Linear array human papillomavirus genotyping test amenable. Assessment of the roche linear array hpv genotyping test within.
Detection and genotyping of human papillomavirus hpv from formalinfixed, paraffinembedded ffpe samples may be difficult when using assays based on amplification of large fragments. Laboratory procedure manual centers for disease control. Hpv genotyping was performed with the linear array hpv genotyping test, and viruses were classified by the international agency for research on cancer assessment of hpv carcinogenicity. Hpv penile swab linear array laboratory procedure manual. Comparison of the diagcor genoflow human papillomavirus. Carestart hpv genotyping kitt twostep is the test which is performed at twostep procedure. Prevalence of different hpv types and estimation of prognostic risk factors based on the linear array hpv genotyping test. However, in 2009 the fda approved the first highrisk hpv dna test in more than a decade. Health, general genetic screening innovations genetic testing genotype identification and classification genotypes papillomavirus infections diagnosis genetic aspects. Evaluation of the spf10inno lipa human papillomavirus hpv. Samples were also tested using the amplicor and linear array hpv genotyping test roche molecular systems which are research tests with high analytic sensitivities. Carestart hpv genotyping kit is a bead array based hpv genotyping that combines polymerase chain reaction amplification followed hybridization to fluorescence labeled polystyrene bead microarrays. Crosshybridization between hpv genotypes in the linear.
Cervical samples, hpv, l1 mutations, linear array hpv genotyping test, nextgeneration sequencing, crosshybridization background human papillomaviruses hpv belong to a diverse group of small nonencapsulated dsdna viruses that. Prevalence of human papilloma virus hpv and its genotypes in cervical specimens of egyptian women by linear array hpv genotyping test article pdf available in infectious agents and cancer 111. This technique is based on pcr amplification of target dna using l1 consensus hpv primer pgmy0911, hybridization of the amplified product to oligonucleotide probes and their. Its value, however, is hampered by the underlying labourintensive manual line blot technology. Pdf prevalence of different hpv types and estimation of. Pdf prevalence of human papilloma virus hpv and its. Genital seborrheic keratoses are human papillomavirus. Evaluation of linear array human papillomavirus genotyping using.
This is another potential risk to miss cervical precancerous lesions or cancers if the hpv test is used as the primary screening. To evaluate the roche linear array hpv genotyping test kit to identify, and then specifically genotype, hpv in formalinfixed, paraffinembedded tissues. Reproducibility of linear array for human papillomavirus. Valgent is an international study framework aimed at comprehensive comparison and validation of hrhpv dna tests in primary. L1 consensus polymerase chain reaction pcr amplification of. Performance of the linear array hpv genotyping test on paired. The linear array test was used for hpv detection and genotyping of the paired cervicovaginal scrapings and cone biopsy specimens. Hpv testing solutions primary hpv testing cervical. Specificity of the linear array hpv genotyping test for. Molecular diagnostics of human papillomavirus laboratory. Odds ratios ors with their 95% confidence intervals 95% ci were estimated by logistic regression, adjusting for age and immigrant status. Of the cytologic samples, 25 were positive for a single hpv genotype, whereas the remaining 14 samples harbored a multiple infection, with.
In april 2011, the fda approved the roches cobas 4800 hpv test, which is a quantitative test that can detect highrisk strains of hpv using dna amplification and genotype hpv 16. Prevalence of highrisk hpv genotypes, categorised by. However, the assay is limited to a restricted number of hpv, and sequence variations in the detection region of the hpv probes could give false negatives results. Enhanced detection and typing of human papillomavirus hpv dna in anogenital samples with pgmy primers and the linear array hpv genotyping test. L of the dna extracts using the linear array hpv genotyping test following manufacturer instructions roche diagnostics. In this study, we assessed the performance of the linear array hpv genotyping test linear array. Human papillomavirus genotyping by linear array and next. Hpv genotypes, and with these data, estimate the potential benefit of administrating hpv vaccine in this population. Genotyping profiles showed 100% concordance between the methods, suggesting that automation could complement the roche linear array for. The roche linear array is licensed in canada and in europe, but not in the united states. Typespecific reproducibility of the roche linear array hpv genotyping test. Kocjan, mario poljak r 1institute of microbiology and immunology, faculty of medicine, university of ljubljana, ljubljana, slovenia.
The objective of the present study was to investigate the performance of the linear array hpv genotyping test linear array on ffpe cervical cone biopsy specimens using paired cytologic samples obtained. Assessment of the roche linear array hpv genotyping test. Linear array hpv genotyping test roche na ruo l1 consensus pcr with lineblot assay 37 hpv genotypes. Human papillomavirus hpv dna detection with genotyping. Resultsnine of the 16 tumors analyzed were hpv positive. Evaluation of the spf10inno lipa human papillomavirus. Expand hpv testing with simultaneous detection of 14 highrisk hpv types and specific genotyping information for hpv 16 and 18. Pdf detection and genotyping of human papillomavirus hpv from formalinfixed, paraffinembedded ffpe samples may be difficult when. Specimens were tested for the presence of hpv by amplifying 50. Validation of an automated detection platform for use with. Use of a linear array for the detection of human papillomavirus. Conclusionsthe roche linear array hpv genotyping test is an easytouse method for determining hpv genotype in the routine analysis of formalinfixed, paraffinembedded tumors. Linear array hpv genotyping test roche diagnostics. Primary cervical cancer screening with human papillomavirus.
376 134 1419 1338 906 277 1391 484 1215 1292 1194 248 451 716 602 24 78 1497 747 1511 651 910 535 790 516 1365 267 581 1492 1118 391 187 698 860 154 57 1289 492 410 329 364 948 721