Digene hc2 high-risk hpv dna test pdf

Comparison with retrospective digene hc2 highrisk hpv dna test data. The highrisk hpv probe in the digene hc2 hpv test detects hrhpv types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68, while the lowrisk hpv probe in the digene test detects lrhpv types 6, 11, 42. Highrisk types of hpv can lead to cervical cancer or anal cancer. Comparison of the third wave invader human papillomavirus. The digene hc2 highrisk hpv test is marketed in the european union including. The digenehpv hc2 dna test and digenehighrisk hpv hc2 dna test are intended for in. Specimens containing the target dna hybridize with the high risk hpv rna probe cocktail whole genomic probes for highrisk. Apr 16, 2014 all women were assessed by digene hc2 high risk hpv dna test hc2, carehpv test and hpv pcr. Qiagens offerings include one of the broadest panels of molecular diagnostic tests available worldwide, including the digene hpv test to detect the high risk types of human papillomavirus hpv that cause cervical cancer. High genotyping concordance between the digene hpv. This quickstart guide is only intended as an overview of the digene hpv hc2 dna test procedure. An in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of human papillomavirus hpv.

Human papillomavirus hpv highrisk dna detection labcorp. The digene hybrid capture 2 hc2 highrisk human papillomavirus hpv dna test digene, gaithersburg, md is widely used for triage of women with atypical squamous cells of undetermined significance. Methods for detection of hpv infection and its clinical. Characteristics of apparently false negative digene hybrid. This test does not detect dna of hpv low risk types eg, 6, 11, 42, 43, 44 since these are not associated with cervical cancer and its precursor lesions. Articles a new hpvdna test for cervicalcancer screening in. Sandri, 1, paola lentati, 1 elvira benini, 2 patrizia dellorto, 2 laura zorzino, 1 francesca m. Sep 22, 2008 much of the evidence on the clinical usefulness of primary screening by testing for the presence of carcinogenic types of hpv dna in cervical and vaginal samples is based on research with the digene high risk hpv hc2 dna test hc2, qiagen inc, gaithersburg, md, usa. Much of the evidence on the clinical usefulness of primary screening by testing for the presence of carcinogenic types of hpvdna in cervical and vaginal samples is based on research with. Specimens containing the target dna hybridize with the high risk hpv rna probe cocktail whole genomic probes for high risk hpv. The vaginal health test described here detects all these types plus hrhpv type 66. Comparison of the digene hc2 assay and the roche amplicor human papillomavirus hpv test for detection of highrisk hpv genotypes in cervical samples maria t. Certain low risk types may also be identified by the test. The digene hc2 high risk hpv test is marketed in the european union including.

Mar 27, 2007 residual preservcyt liquid was tested by hybrid capture 2 hc2 digene, gaithersberg, md for high. Persistent infection with human papillomavirus hpv is the principal cause of cervical cancer and its precursor cervical intraepithelial neoplasia cin. Jan 17, 2017 learn more about simple, sensitive hybrid capture 2 technology in this animated video. Qiagen, which said partnering with kingmed will allow the diagnostic to reach lesspopulated areas, already markets the hpvbased. One approved molecular test is the hybrid capture 2 hc2 highrisk hpv dna test, developed by digene and currently marketed by qiagen. Human papilloma virus hpv test fdas approval digene hybrid capture 2 highrisk hpv dna. Carozzi,3 patrick maisonneuve,4 rita passerini,1 michela salvatici,1. Digene ltd and to cobas 4800 roche an unexpected and s. The digene hc2 hpv dna test using hybrid capture 2 hc2 technology is a nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of 18 lowrisk and highrisk types of hpv dna in cervical specimens. For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, bciq provides accurate information and context to support profitable and strategic decision making.

This article discusses the advantages and disadvantages of the different methods of hpv dna detection. Methods for detection of hpv infection and its clinical utility. Pdf clinical laboratory experience with cervista hpv hr. The digene hybrid capture 2 hc2 high risk human papillomavirus hpv dna test digene, gaithersburg, md is widely used for triage of women with atypical squamous cells of undetermined significance.

Highrisk hpv nucleic acid detection kitthe care hpv test a new. Comparison of the roche cobas 4800 and digene hybrid capture. For example, a widely marketed digene hc2 highrisk hpv assay. Hybrid capture 2 hc2 hpv dna test qiagen, a nucleic acid hybridization microplate assay with signal amplification that utilizes chemiluminescent detection. Watch qiagens digene hc2 highrisk hpv dna test youtube. We compared the digene hybrid capture 2 highrisk hpv dna test hc2 and the roche cobas 4800 hpv test cobas for primary screening. Presence of highrisk hpv in the extracted dna is determined with the digene hc2 hpv dna test qiagen, a nucleic acid hybridization microplate assay with signal amplification that utilizes chemiluminescent detection. Plasmid dna purification using the qiaprep spin miniprep kit and a. This is a brief overview of information related to fdas approval to market this product. The high risk hpv probe in the digene hc2 hpv test detects hrhpv types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68, while the low risk hpv probe in the digene test detects lrhpv types 6, 11, 42, 43, and 44. Name and intended use the hc2 highrisk hpv dna test using hybrid capture2 hc2 technology is a nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of thirteen highrisk types of human papillomavirus hpv dna in cervical specimens. Highrisk hpv nucleic acid detection kitthe care hpv test. Another digene kit, the digene hc2 hpv dna test catalog number.

Qiagen employs more than 3,200 people in over 30 locations worldwide. Designed for use with the digene hc2 high risk hpv dna test. Approval letter for digene hybrid capture 2 hc2 high risk hpv dna test premarket approval application p890064s009 rockville, md office of in vitro diagnostic device evaluation and safety, center for devices and radiological health, food and drug administration. The first specimen was used for cervical cytology and digene hc2 high risk hpv dna test hc2. Hpv prevalence in the dutch cervical cancer screening. Approval letter for digene hybrid capture 2 hc2 highrisk hpv dna test premarket approval application p890064s009 rockville, md office of in vitro diagnostic device evaluation and. The digene hc2 highrisk hpv dna test is a laboratory test used to show the presence or absence of the genetic dna material from the human papilloma. Dec 16, 2015 hpv focal is a randomized trial isrctn79347302, registered 20 apr 2007 comparing highrisk hr hpv testing vs. Articles a new hpvdna test for cervicalcancer screening.

Qiagens offerings include one of the broadest panels of molecular diagnostic tests available worldwide, including the digene hpv test to detect the highrisk types of human papillomavirus hpv that cause. A novel sequencingbased vaginal health assay combining self. Specimens containing the target dna hybridize with the high risk hpv rna probe cocktail whole genomic probes for high. The digene hc2 highrisk hpv dna test shows sensitivity of approximately 93% and a negative predictive value of nearly 95% in women who have had pap test results of lsil lowgrade squamous intrapethelial lesion, hsil highgrade squamous intraepithelial lesion, or equivalent see table. Comparison study of bd onclarity hpv with digene hc2 high. Carozzi, 3 patrick maisonneuve, 4 rita passerini, 1 michela salvatici, 1. Qiagen and kingmed will comarket qiagens digene hpv test in china. The digene hc2 highrisk hpv dna test uses advanced hybrid capture 2 technology to directly detect hpv. Clinical laboratory experience with cervista hpv hr as a function of cytological classification. The digene hc2 highrisk hpv test is a nucleic acid hybridization assay with signal amplification that utilizes microplate chemiluminescent. The hpvdna test is done to determine if you are infected with one of these highrisk types. The advantage of pcrbased methods of hpv dna detection is that they allow for the identification of different types of hpv. Hybrid capture assay, version hc2 digene, gaithersburg, md, usa which is able to detect high risk types of hpv.

Designed for use with the digene hc2 hpv dna test designed for use with the digene hc2 highrisk hpv dna test open product page in new tabwindow. The digene hc2 hpv dna test based on hybrid capture 2 technology is the only hpv test procedure enabling physicians to estimate the clinical relevance of highrisk hpv infection using a validated threshold cutoff value specifying the number of dna copies above which a test is regarded as positive. The cobas hpv test is not recommended for evaluation of suspected sexual abuse. Two cervical specimens from 144 women were obtained and placed in bd surepath collection vials. The first specimen was used for cervical cytology and digene hc2 highrisk hpv. A novel sequencingbased vaginal health assay combining. High risk types of hpv can lead to cervical cancer or anal cancer. The test, the hc2 high risk hpv dna test, manufactured by digene corp. The digene hc2 highrisk hpv dna test is a laboratory test used to show the presence or absence of the genetic dna material from the human papilloma virus hpv, in cells from a womans cervix. Unlike other intelligence solutions, bciq exclusively supports the unique needs of the biopharma industry and.

Studybased evaluation of the abbott realtime high risk. Watch qiagens digene hc2 highrisk hpv dna test duration. The hc2 highrisk hpv dna test using hybrid capture2 hc2 technology is a. The hpv dna test is done to determine if you are infected with one of these high risk types. The digenehpv hc2 dna test and digenehighrisk hpv hc2 dna test are intended for invitro diagnostic use. Lbc samples were tested by abbott realtime high risk hpv test rt hrhpv in compliance with the manufacturers instructions. Women with persistent hr hpv positivity have a clearly enhanced risk of. Comparison of the digene hc2 assay and the roche amplicor. Objective when the sheffield screening laboratory changed the high. The digene hpv test uses full genome detection to achieve higher sensitivity. The digene hc2 hpv dna test detects the presence of 18 types of hpv using full genome rna probes complementary to the hpv dna, specific antibodies, and chemiluminescent detection. This is an isothermal signalamplification method that uses crude cell lysis with denaturation of the resulting dna before probe hybridization. This is an isothermal signalamplification method that.

The hc2 test was performed as per manufacturers instructions at quest diagnostics san juan capistrano, ca. Sandri, 1 paola lentati, elvira benini,2 patrizia dellorto,2 laura zorzino, francesca m. Various hpv dna tests have been introduced to meet the need for. Specimen must be submitted using the digene dna collection kit supplied by labcorp or liquidbased cytology fixative. Evaluation of a new p16ink4a elisa test and a high.

Labcorp test details for human papillomavirus hpv highrisk dna detection. Qiagen, germantown, md, and the second specimen was used for onclarity and roche cobas 4800 hpv cobas. The test, the hc2 highrisk hpv dna test, manufactured by. Hpv focal is a randomized trial isrctn79347302, registered 20 apr 2007 comparing highrisk hr hpv testing vs. Comparison of the digene hc2 assay and the roche amplicor human. The advantage of pcrbased methods of hpv dna detection is that they allow for the. Comparison of the digene hc2 assay and the roche amplicor human papillomavirus hpv test for detection of high risk hpv genotypes in cervical samples maria t. All specimens included in this study were initially. The digene hc2 highrisk hpv test has not been withdrawn from marketing for. The digene hc2 high risk hpv dna test is a laboratory test used to show the presence or absence of the genetic dna material from the human papilloma virus hpv, in cells from a womans cervix. An in vitro nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of human papillomavirus hpv types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 in cervical specimens. All women were assessed by digene hc2 highrisk hpv dna test hc2, carehpv test and hpvpcr. Open product page in new tabwindow qiasymphony dsp hpv media kit.

Hybrid capture assay, version hc2 digene, gaithersburg, md, usa which is able to detect highrisk types of hpv. Comparison of the cepheid xpert hpv test and the hc2 high. Highthroughput genotyping of highrisk hpv by the digene hpv. A negative digene hc2 highrisk hpv dna test result with a concurrent normal pap result implies low risk at a single point in time for the development of cervical. Highrisk hpv nucleic acid detection kitthe care hpv test a. The digenehpv test taking samples with the digenehc2 dna collection device the digene hc2 dna collection device the digenehc2 dna collection device from qiagen is a dedicated dna collection device for use with the digene hpv test. Mar 26, 2018 one approved molecular test is the hybrid capture 2 hc2 high risk hpv dna test, developed by digene and currently marketed by qiagen. Highthroughput genotyping of highrisk hpv by the digene. Certain low risk types may also be identified by the. Efficiency of the hybrid capture 2 hpv dna test in cervical cancer. Pdf clinical laboratory experience with cervista hpv hr as.

Includes probe diluent, highrisk probes, quality controls, calibrator, capture microplate, reagents, and buffers. Finally, because no cervical cancer screening test is 100% sensitive, comparisons of 2 highly sensitive tests in a single study, such as 2 high risk hpv dna tests or 1 high risk hpv dna test. Hpv dna test utilization american journal of clinical. Hybrid capture 2 highrisk hpv dna test digene hc2 hpv. The digene hc2 high risk hpv test has not been withdrawn from marketing for any. Using the digenehc2 dna collection device to collect a cervical sample after employing a separate brush to. Hpv types 16 and 18 cause approximately 70 percent of all cervical cancers worldwide and nearly a positive hpv test result, or abnormal cervical. This study compared the clinical performance of the digene hybrid capture 2 hc2 assay to that of a prototype third wave invader human papillomavirus hpv ihpv analytespeci. Prevent cervical cancer by screening with reliable human. Hybrid capture 2 highrisk hpv dna test digene hc2 hpv dna.

The digene hpv genotyping lq test, detection kit was performed in the luminex 100 is system luminex corporation according to the manufactureras instructions. The amplicor hpv test scored positive in a significantly higher percentage of. Learn more about simple, sensitive hybrid capture 2 technology in this animated video. The hc2 highrisk hpv dna test using hybrid capture2 hc2 technology is a nucleic acid hybridization assay with signal amplification using microplate chemiluminescence for the qualitative detection of thirteen highrisk types of human papillomavirus hpv dna in cervical specimens. In brief, 3b buffer was added to the highrisk hpv beads to minimize background in the final luminex readout. The cervix is the lower part of the uterus or womb.

The cobas hpv test detects dna of the high risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Human papillomavirus pan american health organization. If you have a certain type of abnormal pap test result. The concordance rate between care hpv and hc2 was 93. The five fdaapproved hpv assays medical laboratory observer. Samples were placed in the m1 decapper system where barcode identification, homogenization, decappingrecapping and.