Digene HPV Genotyping RH Test RUO: Comparative evaluation with INNO-LiPA HPV Genotyping Extra Test for detection of 18 high-risk and probable high-risk human papillomavirus genotypes

Seme, Katja; Lepej, Snježana Židovec; Lunar, Maja M.; Iščić-Beš, Janja; Planinić, Ana; Kocjan, Boštjan J.; Vince, Adriana; Poljak, Mario

doi:10.1016/j.jcv.2009.07.017

Cited by 11 publications

(11 citation statements)

References 21 publications

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“…Specifically, chromogenic in situ hybridization probes (Ventana probes; Ventana Research) were used to test for the presence of 12 oncogenic HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 66) 15. After 2009, when the chromogenic in situ hybridization high‐risk probes were no longer commercially available, polymerase chain reaction amplification of purified DNA using the SPF (short polymerase chain reaction fragment) primer system, which amplified a 65‐bp region of the conserved L1 viral capsid gene, became the primary method of testing for both low‐ and high‐risk HPV (Inno‐LiPA; Innogenetics) 15, 16. In addition, during the same period, reflex testing for the presence of p16 was incorporated for cases of squamous cell origin because p16 protein expression is generally considered a surrogate for HPV infection (Genpoint; Dako) 17.…”

Section: Methodsmentioning

confidence: 99%

Human Papillomavirus Status and the Risk of Cerebrovascular Events Following Radiation Therapy for Head and Neck Cancer

Seidelmann

Janjua

Emami

et al. 2017

JAHA

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BackgroundRadiation therapy (RT) is a standard treatment for head and neck cancer; however, it is associated with inflammation, accelerated atherosclerosis, and cerebrovascular events (CVEs; stroke or transient ischemic attack). Human papillomavirus (HPV) is found in nearly half of head and neck cancers and is associated with inflammation and atherosclerosis. Whether HPV confers an increased risk of CVEs after RT is unknown.Methods and ResultsUsing an institutional database, we identified all consecutive patients treated with RT from 2002 to 2012 for head and neck cancer who were tested for HPV. The outcome of interest was the composite of ischemic stroke and transient ischemic attack, and the association between HPV and CVEs was assessed using Cox proportional hazard models, competing risk analysis, and inverse probability weighting. Overall, 326 participants who underwent RT for head and neck cancer were tested for HPV (age 59±12 years, 75% were male, 9% had diabetes mellitus, 45% had hypertension, and 61% were smokers), of which 191 (59%) were tumor HPV positive. Traditional risk factors for CVEs were similar between HPV‐positive and ‐negative patients. Over a median follow‐up of 3.4 years, there were 18 ischemic strokes and 5 transient ischemic attacks (event rate of 1.8% per year). The annual event rate was higher in the HPV‐positive patients compared with the HPV‐negative patients (2.6% versus 0.9%, P=0.002). In a multivariable model, HPV‐positive status was associated with a >4 times increased risk of CVEs (hazard ratio: 4.4; 95% confidence interval, 1.5–13.2; P=0.008).ConclusionsIn this study, HPV‐positive status is associated with an increased risk of stroke or transient ischemic attack following RT for head and neck cancer.

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Section: Methodsmentioning

confidence: 99%

Human Papillomavirus Status and the Risk of Cerebrovascular Events Following Radiation Therapy for Head and Neck Cancer

Seidelmann

Janjua

Emami

et al. 2017

JAHA

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“…Evaluation on 70 hc2-positive clinical samples showed comparable genotyping results to INNO-LiPA Extra, although INNO-LiPA Extra identified significantly more samples with multiple HPV types [89]. Evaluation on 493 hc2-positive samples demonstrated high concordance between digene RH Test and the in-house GP5+/GP6+ RLB Assay [21] for the overall detection of the 18 targeted HPV types (k value 0.886) and typing of individual types (k value 0.951; values for individual types ranging from 0.77 to 1.00) [102].…”

Section: Digene Hpv Genotyping Rh Test Ruomentioning

confidence: 87%

“…To the best of our knowledge, only two evaluations of this assay have been published in peer-reviewed journals to date [89,102]. Evaluation on 70 hc2-positive clinical samples showed comparable genotyping results to INNO-LiPA Extra, although INNO-LiPA Extra identified significantly more samples with multiple HPV types [89].…”

Section: Digene Hpv Genotyping Rh Test Ruomentioning

confidence: 99%

“…Similarly, INNO-LiPA 25 demonstrated high concordance with Amplicor for the overall detection of the 13 assay-common hr-HPVs, with a k value of 0.9327 [50]. The INNO-LiPA HPV Genotyping v2 and INNO-LiPA HPV Genotyping CE assays (Innogenetics), which followed the prototype test, allowed the identification of 24 and 17 individual HPV types, respectively [87,88] [89]. The performance of INNO-LiPA Extra requires standard laboratory equipment.…”

Section: Inno-lipa Hpv Genotypingmentioning

confidence: 99%

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Commercially available assays for multiplex detection of alpha human papillomaviruses

Poljak

Kocjan

2010

Expert Review of Anti-infective Therapy

Self Cite

115

129

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“…Typically, these were restricted to DNA extracts from patient-collected anogenital specimens, which cannot be validated independently and limit the analysis to relative comparisons and assessments of type prevalence found by the individual assays (5,7,10). The use of plasmid standards offers clear advantages for more objective evaluations beyond that level.…”

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confidence: 99%

Performance of Commercial Reverse Line Blot Assays for Human Papillomavirus Genotyping

et al. 2012

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The performance of three line blot assays (LBAs), the Linear Array HPV genotyping assay (LA) (Roche Diagnostics), INNO-LiPA HPV Genotyping Extra (LiPA) (Innogenetics), and the reverse hybridization assay (RH) (Qiagen), was evaluated using quantitated whole genomic human papillomavirus (HPV) plasmids ( T he introduction of human papillomavirus (HPV) vaccines has highlighted the need for standardized accurate HPV genotyping assays to ensure comparability of results in laboratories worldwide, both before and after vaccine introduction. A large variety of assays, using both in-house methods and commercial kits, are available for HPV detection and typing (6), and more can be anticipated. International proficiency testing organized by the WHO HPV LabNet has documented significant differences in sensitivity, specificity, and reproducibility between different laboratories using a variety of testing platforms (2). Variation in performance for laboratories using the same assay implicates laboratory practice; however, the results also indicated differences between assays. The WHO HPV LabNet has further recognized the need for HPV typing assays that can easily be standardized, require minimal equipment for assay performance and interpretation, and can be used in a variety of laboratory settings. Following its meeting on the standardization of HPV assays and the role of the WHO HPV LabNet in supporting vaccine introduction (WHO, Geneva, Switzerland, 23 to 25 January 2008 [http://www.who.int/biologicals /publications/meetings/areas/vaccines/human_papillomavirus /HPV%20Jan%20meeting%20report_20080909%20_Clean _.pdf]), it was agreed that commercial assay kits should be evaluated in collaborative studies for proficiency.Reverse line blot assays (LBAs), based on consensus amplification of conserved regions of HPV followed by hybridization to type-specific probes on line blot strips, have been widely used. Available LBAs differ in the primer set (1, 3, 4) used in the amplification phase and in the number and sequences of the detection probes. Beyond thermocyclers for target amplifications, only temperature control water baths and visual inspection are required to carry out these assays. Therefore, the LBA platforms have the potential to meet the needs of the WHO for high-performance genotyping that does not involve expensive equipment.Studies have been conducted previously to compare and evaluate the performance of these HPV typing assays. Typically, these were restricted to DNA extracts from patient-collected anogenital specimens, which cannot be validated independently and limit the analysis to relative comparisons and assessments of type prevalence found by the individual assays (5,7,10). The use of plasmid standards offers clear advantages for more objective evaluations beyond that level. Cloned, full-length HPV genomic DNA (gDNA) provides complete control over genotype identity as well as copy number input and eliminates the need for a gold standard test.We selected three commercial LBAs using different primer sets and subjec...

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Digene HPV Genotyping RH Test RUO: Comparative evaluation with INNO-LiPA HPV Genotyping Extra Test for detection of 18 high-risk and probable high-risk human papillomavirus genotypes

Cited by 11 publications

References 21 publications

Human Papillomavirus Status and the Risk of Cerebrovascular Events Following Radiation Therapy for Head and Neck Cancer

Human Papillomavirus Status and the Risk of Cerebrovascular Events Following Radiation Therapy for Head and Neck Cancer

Commercially available assays for multiplex detection of alpha human papillomaviruses

Performance of Commercial Reverse Line Blot Assays for Human Papillomavirus Genotyping

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