Here we describe the general and typespecific reproducibility of the linear array hpv genotyping test roche molecular diagnostics, indianapolis, in. The test utilizes amplification of target dna by the polymerase chain reaction pcr and nucleic acid hybridization for the detection of 14 highrisk hpv types in a single analysis. Assessment of the roche linear array hpv genotyping test. Pdf specificity of the linear array hpv genotyping test for. Hpv testing using the cobas hpv test roche molecular systems that provides three hpv positivenegative results. Molecular diagnostics of human papillomavirus laboratory. Crosshybridization between hpv genotypes in the linear array. Evaluation of the spf10inno lipa human papillomavirus.
Reproducibility of linear array for human papillomavirus. Total dna was extracted and purified from each cervical sample using the amplilute liquid media extraction amplicor kit cat. Comparison of dna sequencing and roche linear array in human. Pdf performance evaluation of manual and automated. 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. The evaluation of human papillomavirus genotyping in cervical. Genotyping test kit to identify, and then specifically genotype, hpv in formalinfixed, paraffinembedded tis sues. This is another potential risk to miss cervical precancerous lesions or cancers if the hpv test is used as the primary screening. Amplilute liquid media extraction kit extrn 50 tests pn. The hc2 test qiagen, gaithersburg, md previously digene is the first u.
At present, two widely used hpv genotyping assays are on the market, among them the spf 10lipa hpv genotyping address correspondence to this author at the institute for virology, infectiology and epidemiology e. Crosshybridization between hpv genotypes in the linear. Valgent is an international study framework aimed at comprehensive comparison and validation of hrhpv dna tests in primary. Comparison of dna sequencing and roche linear array in human papillomavirus hpv genotyping article in anticancer research 265b. Hpv testing solutions primary hpv testing cervical. 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. Performance evaluation of manual and automated magna pure nucleic acid isolation in hpv detection and genotyping using roche linear array hpv test. Comparison of the diagcor genoflow human papillomavirus array test and roche linear array hpv genotyping test article pdf available in the open virology journal 41. The most widely used hpv genotyping assay, the roche linear array hpv genotyping test linear array, is unable to identify hpv52 status in samples containing hpv33. The linear array hpv genotyping test roche was used to genotype cobas other high risk positive specimens.
Linear array hpv genotyping test roche diagnostics. Linear array test using l1 gblocks double stranded genomic blocks gblocks were designed by choosing the pgmy1109 amplified l1 sequences from hpv reference genotypes 32 x74475, 44. Evaluation of the spf10inno lipa human papillomavirus hpv genotyping test and the roche linear array hpv genotyping test article pdf available in journal of clinical microbiology 449. Because the presence of only lowrisk hpv genotypes was detected in all 37 specimens after extensive testing using the innolipa hpv genotyping extra test, the linear array hpv genotyping test, hpv6114243. Twenty randomly selected deianegative samples that had previously tested negative by the roche amplicor hpv test 35 were also assessed using both genotyping assays. The linear array hpv lahpv genotyping test roche diagnostics offers a reliable, sensitive, and. Summary of test principle and clinical relevance the general outline of the nhanes project involves isolation of dna from human scope oral rinse samples ors and analysis of dna for 37 types of hpv via roche linear array hpv. Assessment of the roche linear array hpv genotyping test within. The sensitivity in detection of underlying highgrade histological diagnosis by paptype was 90. Pdf comparison of the diagcor genoflow human papillomavirus. In the present study, the genoflow test was evaluated by comparing the genotyping results of 100 samples with roche linear array hpv.
All samples were genotyped by linear array hpv genotyping test cat. Strips are evaluated by two technologists independently within 72 hours. Evaluation of linear array human papillomavirus genotyping using. Comparison of paptype to digene hybrid capture 2, roche. Wrightd a department of pathology and cell biology, columbia university, new york, ny, usa. The linear array test was used for hpv detection and genotyping of the paired cervicovaginal scrapings and cone biopsy specimens. Prevalence of human papilloma virus hpv and its genotypes in cervical specimens of egyptian women by linear array hpv genotyping test article pdf. Validation of an automated detection platform for use with the.
Hpv screening and linear array hpv genotyping test. A total of 175 cervical lbc samples were tested using the roche linear array hpv genotyping test. Study design extracts of 276 cervical samples from two ongoing epidemiologic hpv studies were retested while blinded to prior results. Hpv genotyping is achieved with the linear array hpv genotyping test that is based on. Evaluation of the spf inno lipa human papillomavirus. Assessment of the roche linear array hpv genotyping test within the valgent framework. The roche linear array hpv genotyping test is an easytouse method for determining hpv genotype in the routine analysis of formalinfixed, paraffinembedded tumors. Linear array human papillomavirus genotyping test amenable.
Polymerase chain reaction human papillomavirus hpv. The linear array hpv genotyping test roche molecular system, inc. Typespecific reproducibility of the roche linear array hpv genotyping test. Evaluation of the spf inno lipa human papillomavirus hpv. Roche diagnostics spa, milan, italy is also a suitable method for hpv genotyping from a variety of ffpe specimens. Cervical cancer screening programs are switching from cytologybased screening to highrisk hr hpv testing. Performance of the linear array hpv genotyping test on. Comparison of different studies that use various hpv genotyping tests is possible only after a performance assessment of the different assays. In the present study, the spf10 lipa version 1 and the recently launched roche linear array hpv genotyping assays are compared. Tilsigtet brug linear array hpv human papilloma virus genotypingtesten er en kvalitativ in vitro. For each new hpv detection test, it is important to validate the clinical performance by using established tests as benchmarks.
Crosshybridization between hpv genotypes in linear array genotyping test. The use of hpv linear array assay for multiple hpv typing. Comparison of the diagcor genoflow human papillomavirus array. Genotyping profiles showed 100% concordance between the methods, suggesting that automation could complement the roche linear array for enhanced speed and. 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. The full spectrum of hpv genotypes amplified by the pgmy primer system used in the roche linear array hpv genotyping test has not been assessed. Linear array hpv genotyping test is a qualitative test that detects 37 high and lowrisk human papillomavirus genotypes, including those considered a. Only clinically validated tests should be used in clinical practice. The results suggest that typespecific performance should be included in the evaluation of hpv typing.
Laboratory procedure manual centers for disease control. Hpv genotypes were matched to the cervical cytology results, which included negative, borderline nuclear abnormalities, mild, moderate and severe dyskaryosis. Performance of the linear array hpv genotyping test on paired. 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. Typespecific reproducibility of the roche linear array hpv. Realtime pcr test for qualitative detection of mycobacterium tuberculosis mtb complex dna. 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, andor hpv 58. Screening with hpv dna can identify women at risk for cervical bas. However, in 2009 the fda approved the first highrisk hpv dna test in more than a decade. Pdf prevalence of human papilloma virus hpv and its. The valgent framework is designed for comprehensive comparison and clinical validation of hpv tests that have limited to extended genotyping capacity. The utility of this kit for multiple hpv typing of archival frozen tissue and cervical cells not collected in preservcyt are described.
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. Hpv 16, hpv 18, and 12 other hpv genotypes 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 66, pooled. Comparison of the diagcor genoflow human papillomavirus. An isothermal, multiplex amplification assay for detection. The present study is the first to demonstrate the utility of paraffinembedded tissue for hpv subtyping by the linear array hpv genotyping test. Comparison of the genoflow human papillomavirus hpv test. Various genotyping assays have been developed to meet this demand. Genotyping of human papillomavirus viruses using linear array.
In this study, we assessed the performance of the linear array hpv genotyping test linear array. Our broad assay menu is held to the rigorous performance standards you expect from roche, and our realtime pcr technology delivers reliable results every time. The cobas pcr cell collection media is a methanolbased reagent that serves as a transport preservative and antibacterial medium for gynecologic samples. Emerging biomarkers and clinical significance of hpv. Assessment of the roche linear array hpv genotyping test within the. The roche linear array is licensed in canada and in europe, but not in the united states. The use of hpv linear array assay for multiple hpv typing on. The linear array hpv genotyping test is currently the only available pcrbased kit that can qualitatively test for 37 hpv types in single detection reaction.
The cobas 4800 human papillomavirus hpv test is a qualitative in vitro test for the detection of human papillomavirus in patient specimens. Evaluation of the spf10inno lipa human papillomavirus hpv genotyping test and the roche linear array hpv genotyping test article pdf available in. Learn how hpv dna testing can detect a womans cervical cancer risk. Hpv penile swab linear array laboratory procedure manual. Hpv genotyping in cervical cancer in northern thailand. The cobas hcv gt is an in vitro nucleic acid amplification test for the qualitative identification of hepatitis c virus hcv genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum from individuals with chronic hcv infection, using the cobas 4800 system, the cobas x 480 instrument for automated specimen processing and the cobas z 480 analyzer for automated. This test is a qualitative in vitro test for the detection of human papilloma virus in clinical specimens. Array hpv genotyping test hereafter referred to as linear array test. End of study results from the athena study using hpv as the. Open access linear array human papillomavirus genotyping test. Study design the valgent framework is designed for comprehensive comparison and clinical validation of hpv tests that have limited to extended genotyping capacity.
Cervical cancer screening with hpv tests should use only clinically validated assays. 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 re. Roche molecular diagnostics, branchburg, nj, usa through the validation of hpv genotyping tests valgent framework. The linear array hpv genotyping test uses consensus pcr in combination with typespecific hybridization to detect 37 individual types. Storage at 20c hpv16 plasmid dna containing 50 copies10ul of hpv 16 dna and 105 copies of human placental dna 6. Ability to detect hpv dna of 37 anogenital hpv types. Typespecific reproducibility of the linear array hpv genotyping test is good but not perfect. Apr 22, 2019 crosshybridization between hpv genotypes in linear array genotyping test.
Validation of an automated detection platform for use with. 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 detection by colorimetric reaction. Hpv genotyping extra test innogenetics, gent, belgium, and the linear array hpv genotyping test roche diagnostics. To assess the clinical performance of the roche linear array hpv genotyping test linear array within the valgent3 framework. Offering highly efficient workflows from sample processing to result interpretation, the cobas 6800 system puts the future of molecular testing in your hands. The presence of a blue line indicates specific binding of dna to an analogous probe sequence. Hpv genotyping test and the roche linear array hpv genotyping test. Pdf specificity of the linear array hpv genotyping test. Summary of test principle and clinical relevance the general outline of the nhanes project involves isolation of dna from human scope oral rinse samples ors and analysis of dna for 37 types of hpv via roche linear array hpv genotyping test and roche linear array detection kit. 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. The suitability of the assay use in routine cytopathology laboratory was considered. Genotyping profiles showed 100% 5 concordance between methods, suggesting automation could complement the linear.
This valgent study is the first to demonstrate that linear array hpv. Human papillomavirus genotyping by linear array and next. 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. Some commercially available pcr kits include amplicor, duopap, linear array hpv test, innolipa hpv genotyping v2 and dna microarray chips. The linear array hpv genotyping test is a pcrbased hpv detection kit which can detect qualitatively multiple hpv infection in cervical cells collected in preservcyt solution. 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. Comparison of the performance of carcinogenic hpv typing of the. A hpv1618 genotype was assigned if the specimen was cobas positive for one or both of hpv16 or hpv18, regardless of the detection of any other hpv types. Linear array hpv genotyping assay roche diagnostics. No hpv genotyping test is available in the quebec public healthcare system. Use of a linear array for the detection of human papillomavirus. Primary cervical cancer screening with human papillomavirus. The linear array hpv genotyping strip is read visually by comparing the pattern of blue lines to the linear array hpv genotyping test reference guide. Pdf evaluation of the spf10inno lipa human papillomavirus.
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