The prevalence of hrhpv infection varies geographically, which might reflect the epidemiological characteristics of cervical cancer among different populations. Abstractthe diagnostic performance of the widelyused cervista hpv hr test was compared to the hybrid capture 2 hc2. It is usually spread through vaginal, oral, or anal sex. Evaluation of commercial hpv assays in the context of post. Cervista hpv hr test for cervical cancer screening. Highrisk human papillomavirus hr hpv testing has been shown to be a valuable tool in cervical cancer screening for the detection of cervical precancer and cancer. Worldwide, the most common highrisk hr hpv are 1618, and approximately 70% of cervical cancers cc are due to infection by these genotypes. Started in 1995, this collection now contains 6767 interlinked topic pages divided into a tree of 31 specialty books and 732 chapters. It can also cause cancer in the back of the throat, including the base of the tongue and tonsils called oropharyngeal cancer. Cervista hpv hr is a qualitative, in vitro diagnostic test for the detection of dna from 14 high risk hpv types, namely, types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
Cervista hpv hr test and cervista hpv 1618 test the cervista hpv hr is designed for detection of 14 hpv types i. Cervista hpv test facts a subgroup of the human papillomaviruses hpvs are known to cause cancers of the uterine cervix and other genital areas, the socalled high risk hpvs. Learn about positive test results, hpv and cancer, and hpv testing guidelines. The hpv test is used with other tests to screen for the 2 hpv types most likely to cause cancer, and to identify all highrisk hpv types. Also, keep in mind insurances dont cover the test, as a screening test, unless you are between 3065. Those that persist for 2 years or longer may lead to the development of precancerous lesions and cxca. Full text cervical cancer screening using the cervista. Human papillomavirus hpv is the cause of nearly all cervical cancers and most oropharyngeal, anal, penile, vulvar, and vaginal cancers. Cervista hpv 1618, informing the clinician about the presence of highrisk types of hpv and a womans risk of developing cervical cancer. The hybrid capture 2 highrisk hpv dna test qiagen, gaithersburg, maryland and the cervista hpv highrisk dna test hologics, beford, massachusetts detect presence of 14 oncogenic hpv types, whereas the cervista hpv 1618 dna test only detects oncogenic hpv types 16 and 18.
Agestratified performance of the cervista hpv 1618 genotyping test in women with ascus cytology. Aug 01, 2010 read clinical validation of the cervista hpv hr and 1618 genotyping tests for use in women with ascus cytology, gynecologic oncology on deepdyve, the largest online rental service for scholarly research with thousands of academic publications available at your fingertips. Hpv and the fda audrey p garrett, md, mph june 6, 2014. The hybrid capture 2 hc2 test is currently the most widely used method to screen for hpv. Anogenital hpv is associated with virtually all cancers of the cervix. The cervista tm hpv 1618 test uses the invader chemistry, a signal amplification method for detection of specific nucleic acid sequences.
Interpretation of the hpv results was done in accordance with the cervista hpv hr. Hpv manual for the surveillance of vaccinepreventable diseases human papillomavirus chapter 5 skip directly to site content skip directly to page options skip directly to az link centers for disease control and prevention. Males are at risk for hpv and related diseases, too, so boys and young men are also recommended to be vaccinated. Hpv infections are so common that nearly all men and women will get at least one type of hpv at some time in their lives. Genprobe aptima hpv test cervista hpv hr cobas hpv test hc2 highrisk hpv dna test 1. Surveillance manual hpv vaccine preventable diseases cdc. Hologic massachusetts, usa provides the cervista hpv 1618 with the aim of identifying two of the viral strains of human papillomavirus hpv that are associated with highgrade cervical cancer. The technology would be made available through general practitioners for women aged 30 years or more or for women who returned an. The clinical performance of the cervista hpv hr test was assessed relative to. Cervista hpv hr test hologic, san diego, ca, the cobas hpv test.
Persistent infection by hr hpv is a necessary but not sufficient cause of this cancer, which develops over a long period through precursor lesions, which can be detected by. Cervista hpv hr is a diagnostic test for the detection of 14 highrisk human papillomavirus hpv types. Association between human papillomavirus dna and temporal. Hpv is spread through intimate skintoskin or sexual contact. Department of pathology specimen submission procedure for gynecologic cytology and hpv testing thinprep pap test, cervista high risk hpv test and hpv 1618 genotyping test purpose to establish collection methods for pap testhpv specimens from the female genital tract. The study group consisted of 22 cases of histologically positivebiopsy confirmed gca. Amplification and genotyping of hpv16 and hpv18 cervista hpv 1618. In conclusion, the specificity of the cervista hpv hr test could be improved.
Pdf false positive cervical hpv screening test results. Cervista hpv 1618 test hologic, madison, wi digene hpv genotyping ps test, ruo. Cervista hpv 1618 is a qualitative, in vitro diagnostic test for the detection of dna from two highrisk hpv types. Hpv 16 54% and hpv 18 21% account for the majority of cervical cancers worldwide5 nononcogenic types include. The persistent infection of highrisk hpv hrhpv is associated with cervical cancer. Cervical specimens that may be tested with the cervista hpv 1618 test include the.
Although many cancers are cured with initial treatment, recurrent cancer is frequently incurable and associated with relatively short survival. Hpv vaccination was introduced as part of the childhood vaccination programme in 2008 and will probably save 400 lives per year. Human papillomavirus hpv vaccines, who should and should not get hpv vaccine, benefits, possible reactions after vaccination, what hpv is and who can get it, and what happens after infection. Hpv testing for cervical cancer screening robert schlaberg, md, mph understand the role of hr hpv in cervical cancer development know the use of hr hpv testing in current cervical cancer screening guidelines be able to compare testing principles used in. In addition, the cervista hpv 1618 test has been approved for two uses. We examined 875 cervical samples by hc2 and cervista. The study, shenccast ii, is a major cervical cancer screening trial conducted in china to evaluate the performance of hpv assays, among other endpoints. The final analysis of this arm of the study, which included 8,435 patients, showed. Available tests hpv types detected identifies hpv type hybrid capture 2 high and low risk panels request high risk only no cervista hpv hr high risk no add on test for 16 and 18 cobas hpv test high risk yes for 16 and 18 aptima hpv mrna assay high risk. To exploit the prevalence of hpv genotypes 5258 in a chinese population, we evaluated algorithms that the use the cervista. Most hpv infections go away by themselves within 2 years.
To estimate the highrisk human papillomavirus hrhpv prevalence in a hospitalbased population using the cervista and to determine the clinical value and significance of cervista for. Cervista hpv assays for fineneedle aspiration specimens. Add 10 l of each control and sample dna to three wells of a 96well plate as indicated in. Pdf cervical cancer screening using the cervista highrisk.
The history of the cervical cancer goes back to eighteenth century as the hpv infection is reported since 1800s. Disclosure speaker for merck gardasil speaker for hologic thin prep and cervista. Full text cervical cancer screening using the cervista highrisk. Inadequate specimen volume can interfere with our ability to provide hpv dna testing. Hpv vaccines dont protect against all types of hpv, though, so women need to continue having pap tests and, as appropriate, hpv tests even after being vaccinated for hpv. In women 30 years and older the test may be used adjunctively with the cervista hpv hr test in combination with cervical cytology to assess the presence or absence of specific highrisk hpv.
While a variety of human papillomavirus hpv tests and surrogate markers are available, currently there is no consensus on the best detection methods that should be used to identify hpv. The cervista test is used to diagnose the presence of dna from the highrisk hpvs in cervical samples. The cervistatm hpv hr test is an in vitro diagnostic test for the qualitative detection of dna from 14 highrisk human papillomavirus hpv types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in cervical specimens. Testing for highrisk hr human papillomavirus hpv is a key component of current recommendations for cervical cancer screening. About 80 percent of women will get at least one type of hpv at some point in their lifetime. Cytology and cytology gynecologic laboratory services.
The diagnostic performance of the widelyused cervista hpv hr test was. Cervista hpv 1618 test results should be interpreted alongside, or as a followup to, a cervista hpv hr test result, adjunctively with cytology. Herein is described our clinical experience using cervista hpv hr, a testing platform recently approved by the us food and drug administration for clinical use. Clinical validation of the cervista hpv hr test according to the. Hta and mta lab automation technology serves high, mid and low volume lab segments recent approvals in u. Indeed, together they account for 7080% of cervical cancers, 4050% of vulval and oropharyngeal cancers and 7080% of anal cancers. Pooled detection by hybrid capture ii hpv dna test, cervista hpv dna test, and aptima hpv mrna test specific detection by cobas hpv dna test other. This is the summary and evaluation of the new york state proficiency test for human papilloma virus hpv from april 2014. Clinical experience with the cervista hpv hr assay ncbi. Headneck cytopathology miscellaneous lesions topics. Cervista hpv hr test for cervical cancer screening prbb.
Human papillomavirus hpv infection and genital warts. Emerging biomarkers and clinical significance of hpv. Headtohead comparison of the rnabased aptima human papillomavirus hpv assay and the dnabased hybrid capture 2 hpv test in a routine screening population of women aged 30 to 60 years in germany. Human papillomavirus hpv is the most common viral infection of female reproductive tracts. The cervista tm hpv 1618 test is an in vitro diagnostic test for the qualitative detection of dna from human papillomavirus hpv type 16 and type 18 in cervical specimens. Analytical performance of cervista hpv 1618 genotyping test. To validate the efficacy of seeplex hpv4a ace for the detection of highrisk hr human papillomavirus hpv and hpv 16 andor hpv 18 genotypes as compared to the pcr method and the cervista hpv assays in cervical swab samples. Hpvassociated cancers and precancers 2015 std treatment. The main causative agent for the disease is human papilloma virus hpv. Detection of hpv using the cervista hpv hr test does not differentiate hpv types and cannot evaluate. The final interpretation was based on the cervista hpv 1618 retest value, and equivocal results were considered negative according to the manufacturers guidelines. Human papillomavirus testing in men the journal of the.
The control groups consisted of 21 histologically negative temporal artery biopsies and fifteen cases of vascular margins of nephrectomies. Hpv test cervista human papillomavirus infection test in. A report with your laboratorys score and grade will be sent separately to you. Horizon scanning technology prioritising summary cervista. This method uses two types of isothermal reactions.
Of these, 64 were highgrade cervical intraepithelial. Food and drug administration approved molecular methods for. Cervical cancer is a growing and serious problem worldwide in women, but more acute in developing countries especially in indian subcontinent. Find local cervista hpv test resources for the top u. The cervista hpv 1618 test is not intended for use as a screening device for pap normal women under age 30 and is not intended to substitute for regular pap screening. Human papillomavirus hpv vaccines healthlinkbc file 101b. Future strategies for cervical cancer screening will be based on hpv detection. Comparison of the seeplex hpv4a ace and the cervista hpv. We report a purely observational study evaluating hr hpv prevalences in residual liquidbased cytology lbc samples using both the cervista hpv hr test and the digene hybrid capture 2 highrisk hpv dna test hc2 in a sample. Evaluation of the new york state human papilloma virus hpv proficiency test april 20141 dear laboratory director. In addition to the hc2 which was performed using the manual procedure, the other assays assessed were the realtime hr hpv assay abbott, the aptima hpv test hologic, the cervista hpv test hologic and the cobas 4800 hpv test roche, all used according to the manufacturers instructions. Comparing the cervista hpv hr test and hybrid capture 2 assay. The cervistatm hpv hr test cannot determine the specific hpv type present. Evaluation of the new york state human papilloma virus.
The dna was extracted from residual liquid cytology. Cervical cancer screening american family physician. University of groningen clinical validation of the. Combining immune checkpoint blockade and tumorspecific. This testing is performed inhouse using the remaining fluid in the thinprep pap test vial. In addition, when hpv consensus primers targeted against hpv l1 are used for pcr, integrated forms of the virus may not be detected due to loss of portions of l1. Pdf clinical validation of the cervista highrisk human. Evaluation of the new york state human papilloma virus hpv proficiency test event 311 march 20111 dear laboratory director. Typespecific highrisk hpv hrhpv infection is related to cervical carcinogenesis. Approximately 20 million americans are currently infected. Molecular diagnostics of human papillomavirus laboratory. Use of cervista hpv hr assay for detection of human. Therefore, the cervista hpv hr test met the criterion of noninferiority set forth by the international guidelines, i. The cervista hpv 1618 test uses the invader chemistry, a signal amplification method for detection of specific nucleic acid sequences.
Fdaapproved for adjunctive use with the cervistatm hpv hr test in patients with ascus cervical cytology results, to assess the presence or absence of highrisk types 16 andor 18. The cervista hpv hr test uses the invader chemistry, a signal amplification method for detection of. Human papillomavirus hpv is the most common viral infection of the reproductive tract. Objectives the cervista highrisk human papillomavirus hrhpv test was evaluated as a primary screening method for cervical cancer in women aged. Highrisk hr human papillomavirus hpv testing is important in cervical cancer screening for triage to colposcopy. The cervista hpv hr test uses the invader chemistry, a signal amplification method for detection of specific nucleic acid sequences. University of groningen innovative molecular markers for. Cervical cancer is thus far the most common human papillomavirus hpvrelated cancer. To test the performance of the cervista hpv hr test for cervical screening. Cervista hpv hr testing of head and neck fna specimens is a valid option for determining hpv1618 status in patients with oropharyngeal carcinoma. Nationwide prevalence of human papillomavirus infection and. A text file is automatically generated and saved for each tape. To examine the relationship between human papillomavirus hpv and giant cell arteritis gca of the temporal artery. Histopathologic followup results a total of 2119 of 3637 cases 58.
Cervical cancer is thus far the most common human papillomavirus hpv related cancer. The cervista hpv hr test was the second hr hpv assay approved by the fda in 2009 and is a qualitative test that uses three separate oligonucleotide mixtures a5a6 pool hpv 51, 56, and 66, a7 pool 18, 39, 45, 59, and 68, and a9 pool hpv 16, 31, 33, 35, 52, and 58 depending on the correlation among 14 types of hr hpv dna gene sequences. Available tests hpv types detected identifies hpv type hybrid capture 2 high and low risk panels request high risk only no cervista hpv hr high risk no add on test for 16 and 18 cobas hpv test high risk yes for 16 and 18 aptima hpv mrna assay high risk no add on test for 16, 18, and 45 asccp. It usually takes more than 10 years for precancerous lesions caused by hpv. Hpv vaccine prevents infection from the hpv types that cause over 90% of these cancers. Cervista hpv 1618 is a qualitative, in vitro diagnostic test for the detection of dna from two highrisk hpv. There is a hpv test that has been on the market for years and is showing that it may be just as, if not more effective in detecting hpv. Human papillomavirus hpv is the most common sexually transmitted virus. Hpv can cause cervical and other cancers including cancer of the vulva, vagina, penis, or anus. Why do you feel you need, specifically,the cervista hpv test. Pdf use of cervista hpv hr assay for detection of human. Pdf agestratified performance of the cervista hpv 1618. The five fdaapproved hpv assays medical laboratory observer.
This is the summary and evaluation of the graded new york state proficiency test for human papilloma virus hpv determination from march 2011. After a 10year lull in fda approval of hpv tests, in march 2009 the cervista hpv hr test third wave technologies, now hologic, bedford, ma was approved by the fda to detect 14 highrisk hpv types. Human papillomavirus hpv is the most common sexually transmitted disease worldwide, with more than 100 types of hpv identified. Cervista high risk hpv typing and cervista hpv 1618 genotyping. To establish a foundation for hpv based screening and vaccination programs in china, we investigated the most recent hpv prevalence and genotypic. Use of cervista hpv hr assay for detection of human papillomavirus in samples with hybrid capture borderline negative results. Pdf evaluation of the cervista hpv a9 group in screening. A populationbased observational study comparing cervista and. Headtohead comparison of the rnabased aptima human. The results of this test are not intended to prevent women from proceeding to colposcopy. Human papillomavirus hpv human papillomavirus, or hpv, is the most common sexually transmitted infection sti in the united states. We have evaluated cervista hpv hr for papillomavirus detection in 65 samples previously borderline negative by the hybrid capture method digene, using innolipa and sequencing as confirmatory.
1273 1403 134 901 154 1064 1408 1112 527 1129 865 689 704 1260 1143 806 1382 282 1191 948 279 215 548 220 1519 334 157 767 182 1493 1164 45 106 287 875 777 29 735 349 560 998