There are more than 100 known types of human papillomavirus hpv, of which at least appear to confer highrisk hr for cervical carcinogenesis. The role of oncogenic human papillomavirus hpv as the causative agent of cervical cancer has been well documented. Cervista hr and hpv 1618 assays vs hybrid capture 2 assay. Download the hpv fact sheet to help guide the conversation with your childs doctor about who is at risk for hpv and what parents can do. Hpv was considered as the most important risk factor in the pathogenesis of cacx after the demonstration of integrated hpv 16 and 18 genome in the biopsy specimens and cell lines derived from hivpositive cacx in the early 1980s. Hpvassociated cancers and precancers 2015 std treatment. 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. Comparison of the aptima and cervista tests for detection.
So far, a large number of methods for screening cin or early cc have been developed, such as hpv dna testing 8, papanicolaou pap smear 9, liquidbased cytology lbc 10, joint test, and. To test the performance of the cervista hpv hr test for cervical screening. Analytical performance of cervista hpv 1618 genotyping test. Hpv was considered as the most important risk factor in the pathogenesis of cacx after the demonstration of integrated hpv16 and 18 genome in the biopsy specimens and cell lines derived from hivpositive cacx in the early 1980s. Horizon scanning technology prioritising summary cervista. Comparison of the cervista hpv hr test and luminex xmap. The cervista hpv hr test uses the invader chemistry, a signal amplification method for. Cervical cancer screening using the cervista highrisk. Cervista hpv hr test for cervical cancer screening.
In all reportable samples from the hc2 population, 16. We calculated the data collected from hpv testing by the two hpv detection methods, and the results showed the following distribution of the hpv genotypes. The cervista hpv test human papillomavirus infection test in women is a screening test used with other tests such as pap smear and colposcopy for screening the two hpv types most likely to cause cancer, and to identify all highrisk hpv types. Clinical validation of the cervista hpv hr test according to the. Of the 79 cases, 33 42% were positive for hpv1618 by cervista hpv 1618 and 37. Clinical validation of the cervista hpv hr and 1618. New approaches in the evaluation for highrisk human. These tests are approved for primary screening as a cotest with a pap smear in women over 30 years and for reflex testing after a positive ascus result in women 21 years or more. A recent comparison of the data in the cervista package insert with data from historical hc2 and pcrbased hrhpv assays concluded that the rate of positive results of the cervista assay 18% was 4 times as high as that of the composite hc2 and pcrbased assays 4%, suggesting that the cervista assay was significantly less specific than the. Further analysis of positive cervista hr results showed a 2 to 1 predominance of mix 1 hpv types 51, 56, and 66 and mix 2 hpv types 18, 39, 45, 59, and 68 over mix 3 hpv types 16, 31, 33, 35, 52, and 58 or all mixes when the 2 hr hpv assays were in agreement table 5. Hpvtypen, namelijk type 16, 18, 31, 33, 35, 39, 45. Use of cervista hpv hr assay for detection of human papillomavirus in samples with hybrid capture borderline negative results.
Correlation of cytology and hpv status from 56,501 specimens. Testing for highrisk hr human papillomavirus hpv is a key component of current recommendations for cervical cancer screening. Pdf use of cervista hpv hr assay for detection of human. The cervista hpv hr test is an in vitro diagnostic test for the qualitative detection of dna from 14 highrisk human. Clinical experience with the cervista hpv hr assay.
Additionally, the concordance between seeplex hpv4a ace and the cervista hpv hr test was 87. Analytical performance of cervista hpv 1618 in surepath. Hpv tests are subsequently referred to as cervista, ghpv, rthpv and cobas, respectively. Comparing the cervista hpv hr test and hybrid capture 2 assay.
A total of 208 specimens were tested with both tests, and those with discordant results were tested with the cobas hpv test roche diagnostics, indianapolis, in. Hologic is the leader in pap and human papillomavirus hpv testing. To estimate the highrisk human papillomavirus hrhpv prevalence in a hospitalbased population using the cervista and to determine. 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. Use of cervista hpv hr assay for detection of human papillomavirus in samples with hybrid capture borderline negative results article pdf available in apmis 1189. Fiftyseven of 60 hc2 negativecervista positive cases tested hpvnegative with pcrbased hpv assays. Data from over 33,000 specimens tested were compared for differences in overall positivity rate, positivity by cytologic diagnosis, tat, and. The athena study was designed to assess the performance of carcinogenic human papillomavirus hpv testing and hpv16 or hpv18 genotyping compared with liquidbased cytology for cervical cancer screening in a large us population aged 21 years and older. The aptima and cervista tests hologic genprobe, san diego, ca were compared for detection of highrisk human papillomaviruses hpv in cervical cytology specimens. The technology would be made available through general practitioners for women aged 30 years or more or for women who returned an. Comparison of the performance of hpv tests in women with. Human papillomavirus hpv is a circular double stranded dna virus that integrates into the host dna of squamous epithelial cells and can lead to cervical cancer and its precursors.
For specimens classified as unsatisfactory for cytologic evaluation, 11. Populationbased clinical trial comparing endocervical high. 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. 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. By contrast, the ratio was reversed when the hc2 and cervista hr results. A populationbased observational study comparing cervista. Nationwide prevalence of human papillomavirus infection and viral. We examined 875 cervical samples by hc2 and cervista. Comparison of roche cobas to hologic cervista assays in the.
Pdf cervical cancer screening using the cervista high. Hpv 16 and 18 are responsible for over 65% of all cervical cancers in the. Evaluation of the cervista hpv a9 group in screening. The intra and interlaboratory reproducibilities of cervista were 92. The cervista hpv hr test fulfills all the international. Future strategies for cervical cancer screening will be based on hpv detection. Immunology and vaccinepreventable diseases pink book. Clinical validation of the cervista hpv hr test according to. The cervistatm hpv hr test cannot determine the specific hpv type present. In the us and europe four types of hpv tests are approved for primary screening. Pdf evaluation of the cervista hpv a9 group in screening. Of the 79 cases, 33 42% were positive for hpv1618 by cervista hpv 1618 and 37 47% were positive by easychip. This study demonstrates that both the clinical sensitivity and specificity of the cervista hpv hr test for highrisk human papillomavirus hpv detection are not inferior to those of the hybrid capture 2 hc2 test. It was not until 2009 when the second hr hpv device, cervista hpv hr, manufactured by third w ave technologies now hologic, was approved for both the ascus triage and adjunct indications.
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. Download the three tables in one document pdf here. There are 14 oncogenic, highrisk hr hpv types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 that have been recognized as the cause of nearly all cervical cancers. Evaluation of the cervista hpv a9 group in screening patients. In the cervista group, the a9 hpv group was the most prevalent genotype 33. The cervista hpv hr test uses the invader chemistry, a signal amplification method for detection of specific nucleic acid sequences. The hybrid capture 2 hc2 test is currently the most widely used method to screen for hpv.
Oct 29, 2014 hpv 1618 genotypes of the 79 specimens were analyzed by cervista hpv 1618 assay and easychip genotyping assay and compared with the patients follow. This information, together with the physicians assessment of. Food and drug administration in march of 2009 and was the first dna test. Clinical validation of the cervista hpv hr and 1618 genotyping tests. Analytical performance of cervista hpv 1618 in surepath pap.
Performance of carcinogenic human papillomavirus hpv. The cervistahpv 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. Comparison of roche cobas to hologic cervista assays in. Perform dna extraction from cervical specimens collected in preservcyt solution using the genfind dna. Cervical cancer screening using the cervista highrisk human. Hpv typing according to the innolipa assay table 3 and table s1 showed multiple hpv types in the tested samples.
Human papillomavirus hpv is the most common sexually transmitted infection in the united states, affecting men and women. Use of cervista hpv hr assay for detection of human. Hpv 1618 genotypes of the 79 specimens were analyzed by cervista hpv 1618 assay and easychip genotyping assay and compared with the patients follow. 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. Further analysis of positive cervista hr results showed a 2 to 1 predominance of mix 1 hpv types 51, 56, and 66 and mix 2 hpv types 18, 39, 45, 59, and 68 over mix 3 hpv types 16, 31, 33, 35, 52, and 58 or all mixes when the 2 hrhpv assays were in agreement table 5.
Comparing the cervista hpv hr test and hybrid capture 2. The thinprep pap test helps healthcare providers detect the presence of abnormal cervical cells, and the aptima hpv assays identify highrisk hpv mrna that is indicative of the hpv infections most likely to lead to cervical disease. Human papillomavirus 175 11 human papillomavirus hpv is the most common sexually transmitted infection in the united states. 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. Pdf to validate the efficacy of seeplex hpv4a ace for the detection of high risk hr human papillomavirus hpv and hpv 16 andor hpv 18 genotypes as. The cervistahpv 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.
Comparison of the aptima and cervista tests for detection of. Clinical validation of the cervista hpv hr test according. Pdf clinical validation of the cervista highrisk human. Analytical performance of cervista hpv 1618 genotyping test for cervical cytology. Hpv testing as a screen for cervical cancer the bmj. Food and drug administration in march of 2009 and was the first dna test approved by the fda for detection of hpv in women.
Cervista hpv hr, hologic genprobe, fda approved, signal amplification detects 14 highrisk types. Hr hpv testing was performed to 922 cases with normal cytology. Add 10 l of each control and sample dna to three wells of a 96well plate as indicated in. Cervista hpv test is not recommended for routine screening or for women under the age of 30.
The relationship of cervical cancer and sexual behavior was suspected for more than 100 years and was established by epidemiologic studies in the 1960s. The decision to screen for high risk hr hpv subtypes including types 16 and 18 in gynecologic specimens varies for women based on age and concurrent cytology diagnosis according. In the other hpv genotyping tests, seeplex hpv4a ace, and cervista hpv assays, methods to target hpv 16 andor 18 had a higher predictive value than that of hr hpv 66. Nationwide prevalence of human papillomavirus infection. Populationbased clinical trial comparing endocervical. Pdf comparison of the seeplex hpv4a ace and the cervista. Cervical cancer screening using the cervista highrisk human papillomavirus test. Full text cervical cancer screening using the cervista highrisk. For the detection of hpv 16 andor 18, seeplex hpv4a ace and the cervista hpv 1618 test showed substantial agreement 89. The cervista hpv test, manufactured by hologic, is a test that is used to identify the presence of human papillomavirus hpv genetic material, or dna, in cervical samples, such as samples taken during pap screening or colposcopy. This study demonstrates that both the clinical sensitivity and specificity of the cervista hpv hr test for highrisk human papillomavirus hpv detection are not.
The latter two hpv tests could be specified as hpv type 16,18 separate from other high risk hpv type5,7,8. Molecular diagnostics of human papillomavirus laboratory. Herein is described our clinical experience using cervista hpv hr, a testing platform recently. 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. Our center adopted lbc plus a high risk hpv test as the standard cervical cancer screening method in recent years. Pdf false positive cervical hpv screening test results. Molecular hr hpv testing data and corresponding cytology results were analyzed for all thinprep gynecologic specimens tested for hr hpv from 2014 to present with either the cervista or cobas. Pcr and genotyping for hpv in cervical cancer patients. It is well accepted that testing women for the presence of highrisk types of the human papillomavirus hpv is the most sensitive primary screening method for the detection and prevention of cervical cancer. The cervista tm hpv 1618 test uses the invader chemistry, a signal amplification method for detection of specific nucleic acid sequences.
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