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• W1531520263 abstract "Testing for high-risk (HR) human papillomavirus (HPV) is a key component of current recommendations for cervical cancer screening. 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. Using data from a high-volume commercial laboratory, a retrospective analysis of cytologic and Cervista HPV HR test results from 56,501 samples was performed, and an indirect comparison was made with previous experience with 53,008 samples tested using the Hybrid Capture 2 platform. Of samples analyzed using Cervista HPV HR, 1.5% were of insufficient volume for testing and 1.1% yielded an insufficient signal from the internal control to be reported. In samples with a cytological interpretation of atypical squamous cells of undetermined significance, 48.5% (95% confidence interval [CI], 47.5 to 49.5) tested positive using Cervista HPV HR, compared with 59.4% (95% CI, 58.3 to 60.5) of samples using Hybrid Capture 2. Of samples from women aged 30 years or older with a negative cytological interpretation, 5.8% (95% CI, 5.6 to 6.1) tested positive using Cervista HPV HR, compared with 5.5% (95% CI, 5.3 to 5.7) of samples using Hybrid Capture 2. When stratified by five-year age groups between 30 and 65 years, positivity rates for high-risk human papillomavirus were similar in the Cervista HPV HR and Hybrid Capture 2 populations, and were consistent with expectations established by the literature. Testing for high-risk (HR) human papillomavirus (HPV) is a key component of current recommendations for cervical cancer screening. 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. Using data from a high-volume commercial laboratory, a retrospective analysis of cytologic and Cervista HPV HR test results from 56,501 samples was performed, and an indirect comparison was made with previous experience with 53,008 samples tested using the Hybrid Capture 2 platform. Of samples analyzed using Cervista HPV HR, 1.5% were of insufficient volume for testing and 1.1% yielded an insufficient signal from the internal control to be reported. In samples with a cytological interpretation of atypical squamous cells of undetermined significance, 48.5% (95% confidence interval [CI], 47.5 to 49.5) tested positive using Cervista HPV HR, compared with 59.4% (95% CI, 58.3 to 60.5) of samples using Hybrid Capture 2. Of samples from women aged 30 years or older with a negative cytological interpretation, 5.8% (95% CI, 5.6 to 6.1) tested positive using Cervista HPV HR, compared with 5.5% (95% CI, 5.3 to 5.7) of samples using Hybrid Capture 2. When stratified by five-year age groups between 30 and 65 years, positivity rates for high-risk human papillomavirus were similar in the Cervista HPV HR and Hybrid Capture 2 populations, and were consistent with expectations established by the literature. The relationship of cervical cancer and cervical intraepithelial neoplasia grades 2 and 3 to persistent infection with human papillomavirus (HPV) is well established. Since the identification of HPV as the primary etiologic agent of cervical cancer,1Schwarz E. Freese U.K. Gissmann L. Mayer W. Roggenbuck B. Stremlau A. zur Hausen H. Structure and transcription of human papillomavirus sequences in cervical carcinoma cells.Nature. 1985; 314: 111-114Crossref PubMed Scopus (1122) Google Scholar 14 sexually transmitted oncogenic variants have been identified. These variants, referred to as the high-risk subtypes (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), are responsible for most cervical cancers worldwide.2Cogliano V. Baan R. Straif K. Grosse Y. Secretan B. El Ghissassi F. Carcinogenicity of human papillomaviruses.Lancet Oncol. 2005; 6: 204Abstract Full Text Full Text PDF PubMed Scopus (573) Google Scholar, 3Meijer C.J. Snijders P.J. Castle P.E. Clinical utility of HPV genotyping.Gynecol Oncol. 2006; 103: 12-17Abstract Full Text Full Text PDF PubMed Scopus (109) Google Scholar, 4Muñoz N. Bosch F.X. de Sanjosé S. Herrero R. Castellsagué X. Shah K.V. Snijders P.J. Meijer C.J. Epidemiologic classification of human papillomavirus types associated with cervical cancer.N Engl J Med. 2003; 348: 518-527Crossref PubMed Scopus (4934) Google Scholar The remarkable success of Papanicolaou test–based cervical cancer screening programs demonstrates that cervical cancer is largely preventable. However, despite its many advantages and historical success, morphologic examination of cervical cytologic material alone has limitations as a screening test. The addition of high-risk HPV (HR-HPV) DNA testing to screening algorithms has enabled better identification of clinically significant precancerous cervical lesions and more accurate evaluation of the risk of developing cervical cancer.5Apgar B.S. Kittendorf A.L. Bettcher C.M. Wong J. Kaufman A.J. Update on ASCCP consensus guidelines for abnormal cervical screening tests and cervical histology.Am Fam Phys. 2009; 80: 147-155PubMed Google Scholar, 6Smith R. Cokkinides V. Brooks D. Saslow D. Brawley O. Cancer screening in the United States, 2010: a review of current American Cancer Society guidelines and issues in cancer screening.CA Cancer J Clin. 2010; 60: 99-119Crossref PubMed Scopus (374) Google Scholar HR-HPV DNA testing is currently recommended by the American Society for Colposcopy and Cervical Pathology screening guidelines in two principal clinical settings. One setting in which HR-HPV DNA testing is beneficial is when cytologic findings are ambiguous or equivocal. HR-HPV DNA testing for triage of patients with atypical squamous cells of undetermined significance (ASC-US) cytological interpretations decreases colposcopic referrals by roughly half without sacrificing screening sensitivity.7ASCUS-LSIL Triage Study GroupResults of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance.Am J Obstet Gynecol. 2003; 188: 1383-1392Crossref PubMed Google Scholar A second setting in which HR-HPV testing is useful is for primary screening (“co-testing,” along with cytology) in patients aged 30 years or older. Women in this group with both normal cytological interpretations (ie, negative for intraepithelial lesion or malignancy [NILM]) and negative HR-HPV test results are at extremely low risk of developing cervical cancer over the next several years.8Sherman M.E. Lorincz A.T. Scott D.R. Wacholder S. Castle P.E. Glass A.G. Mielzynska-Lohnas I. Rush B.B. Schiffman M. Baseline cytology, human papillomavirus testing, and risk for cervical neoplasia: a 10-year cohort analysis.J Natl Cancer Inst. 2003; 95: 46-52Crossref PubMed Scopus (375) Google Scholar Accordingly, the current (2006) American Society for Colposcopy and Cervical Pathology screening guidelines and the 2010 American Cancer Society screening guidelines recommend that the repeat screening interval should be increased to three years in this “double-negative” population.6Smith R. Cokkinides V. Brooks D. Saslow D. Brawley O. Cancer screening in the United States, 2010: a review of current American Cancer Society guidelines and issues in cancer screening.CA Cancer J Clin. 2010; 60: 99-119Crossref PubMed Scopus (374) Google Scholar, 9Wright T.C. Massad L.S. Dunton C.J. Spitzer M. Wilkinson E.J. Solomon D. 2006 Consensus guidelines for the management of women with abnormal cervical screening tests.J Low Genit Tract Dis. 2007; 11: 201-222Crossref PubMed Scopus (311) Google Scholar Until 2009, clinical testing for HR-HPV was limited to a single US Food and Drug Administration (FDA)–approved method, the Hybrid Capture 2 (hc2; Digene Corp./QIAGEN, Gaithersburg, MD) assay. This platform remains the most widely used clinical method for HR-HPV DNA testing. A second testing platform, the Cervista HPV HR Assay (Hologic, Inc., Bedford, MA) was FDA-approved for clinical use in March 2009. Both tests involve hybridization of nucleic acid probes that are complimentary to the viral genome, followed by a signal amplification method for detection. Given its recent approval for clinical use, few data about Cervista clinical test performance are available.10Einstein M.H. Martens M.G. Garcia F.A. Ferris D.G. Mitchell A.L. Day S.P. Olson M.C. Clinical validation of the Cervista HPV HR and 16/18 genotyping tests for use in women with ASC-US cytology.Gynecol Oncol. 2010; 17: 1-7Google Scholar, 11Ginocchio C.C. Barth D. Zhang F. Comparison of the Third Wave Invader human papillomavirus (HPV) assay and the Digene HPV Hybrid Capture 2 assay for detection of high-risk HPV DNA.J Clin Microbiol. 2008; 46: 1641-1646Crossref PubMed Scopus (48) Google Scholar Cervista HPV–HR package insert. Herein we present our experience using the Cervista HPV HR platform in a commercial laboratory, along with an indirect comparison with previous experience using the hc2 assay. In addition, estimates of the prevalence of HR-HPV infection in women with ASC-US and NILM cytologic interpretations in the present patient population are provided. The present study was a retrospective evaluation of cervical screening data from specimens subjected to both cytologic examination and HR-HPV DNA testing at a physician-owned commercial laboratory (ProPath, Dallas, TX). Identified were 56,501 samples analyzed between August 2009 and April 2010 using the Cervista platform and 53,008 samples analyzed during 2008 using the hc2 platform. The Western Institutional Review board determined this study to be exempt under 45 CFR.101(b) (4). Test samples were received in SurePath (Becton, Dickinson and Co., Franklin Lakes, NJ) liquid-based cytology medium or in ThinPrep vials containing PreservCyt (Hologic, Inc.) medium, and were collected by clinical providers referring specimens for cytologic analysis and HPV testing. For all samples, HR-HPV DNA testing and cytologic examination were performed using material from the same specimen container. Papanicolaou tests for all patients were evaluated using manual cytotechnologist review or the ThinPrep Imaging System (Hologic, Inc.) or the FocalPoint Slide Profiler (Becton, Dickinson and Co.), followed by manual cytotechnologist review. Papanicolaou tests suspicious for reactive, reparative, or dysplastic changes were reviewed by board-certified anatomic pathologists (G.A.H., P.J.W., and E.P.J.). Cytologic findings were classified according to the 2001 Bethesda System terminology for reporting results of cervical cytology.12Solomon D. Davey D. Kurman R. Moriarty A. O'Connor D. Prey M. Raab S. Sherman M. Wilbur D. Wright T. Young N. The 2001 Bethesda System: terminology for reporting results of cervical cytology.JAMA. 2002; 287: 2114-2119Crossref PubMed Scopus (2672) Google Scholar All HR-HPV DNA testing was performed according to the manufacturers' instructions. On the Cervista platform, sequence-specific probe and Invader (Third Wave Technologies, Inc., Madison, WI) oligonucleotides cycle rapidly on and off the 14 HR-HPV target DNA sequences, creating substrate for the proprietary Cleavase enzyme (Hologic, Inc.). The action of the enzyme results in production of cleaved 5′ oligonucleotide flaps. These flaps bind to a universal hairpin fluorescence resonance energy transfer oligonucleotide, creating a second substrate for the Cleavase enzyme. Cleavage of the fluorescence resonance energy transfer oligonucleotide results in production of a fluorescent signal. Oligonucleotides specific for the human histone 2 gene are present in each mixture and act as an internal control (Cervista HPV-HR package insert.). The hc2 platform uses a signal amplification method in which target HPV DNA from any of the 13 high-risk HPV types tested (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) is hybridized with HPV-specific RNA probes. Some cross-reactivity of the probes with other HPV types (including type 66) also occurs.13Poljak M. Marin I.J. Seme K. Vince A. Hybrid Capture II HPV test detects at least 15 human papillomavirus genotypes not included in its current high-risk probe cocktail.J Clin Virol. 2002; 25 (3): S89-S97Abstract Full Text Full Text PDF PubMed Google Scholar The resulting DNA-RNA hybrids are captured on the surface of a microplate well coated with antibodies specific for DNA-RNA hybrids. In the detection step, multiple signaling antibodies conjugated to alkaline phosphatase bind to each hybrid. Cleavage of a chemiluminescent substrate by alkaline phosphatase results in light emission, measured using a luminometer (Digene Hybrid Capture 2 High-Risk HPV DNA Test package insert. Gaithersburg, MD: Digene Corp., 2004, 1–24). Before commencing the present study, 176 liquid-based cytologic specimens were analyzed, 79 in SurePath medium and 97 in PreservCyt medium, using both the Cervista and hc2 assays. Four specimens yielded a low internal control signal using the Cervista assay, and tested negative for HR-HPV using the hc2 assay. Of the remaining 172 specimens, 147 (85.5%) demonstrated concordant results (62 positive, 85 negative). One specimen tested HR-HPV positive using the Cervista assay and negative using the hc2 assay, and 24 specimens tested negative using Cervista and positive using hc2. Discordant samples were submitted to SeqWright, Inc. (Houston, TX) for testing using PCR and sequencing. All of the discordant specimens tested negative for HR-HPV by PCR and sequencing. As part of the Cervista validation process, it was determined that a FAM dye fold over zero (FOZ) ratio threshold for positivity for SurePath specimens of 2.0 was optimal. This cutoff was used for all subsequent analyses. The manufacturer-recommended 1.525 FAM FOZ ratio was used as the positivity threshold for PreservCyt specimens. Performance characteristics of the Cervista assay that were evaluated included number and percentage of specimens classified as having a low internal control, number and percentage of specimens with insufficient volume for testing, and number and percentage of total reportable results. Rates of HR-HPV positivity were calculated. Results were stratified according to patient age and were compared by specimen preservative type and cytologic interpretation. When appropriate, results from the Cervista population were compared with data from the hc2 population, and the Fisher's exact test was used to determine statistical significance. No corrections or adjustments for patient demographic characteristics were applied. Confidence intervals were calculated at 95% using the binomial method. Statistical computations were performed using commercially available software (Microsoft Excel 2003 for Windows; Microsoft Corp., Redmond, WA) and the R software package (R Foundation for Statistical Computing, Vienna, Austria). Specimens were referred for analysis primarily from outpatient private practices including gynecology and family practice clinics, from multiple states in all regions of the United States. Aggregated demographic characteristics of the women undergoing testing and information about the specimens according to preservative type used are given in Table 1. The age distribution of patients undergoing testing in the Cervista and hc2 populations was similar (see Supplemental Table S1 at http://jmd.amjpathol.org).Table 1Patient Demographics and Specimen Preservative TypeVariableCervista (n = 56,501)hc2 (n = 53,008)Age, years Mean (SD)40.9 (12.9)40.6 (12.0) Median (range)40 (12–97)39 (11–92)Preservative, % SurePath3326 ThinPrep6774 Open table in a new tab A summary of nonreportable results is given in Table 2. Overall, 97.5% of samples from the Cervista population [55,065 of 56,501; 95% confidence interval (CI), 97.4 to 97.6] could be reported, compared with 96.3% of samples from the hc2 population (51,071 of 53,008; 95% CI, 96.1 to 96.5). For the Cervista population, 1.5% of samples (848 of 56,501; 95% CI, 1.4 to 1.6) were of insufficient volume to perform the HPV HR test, compared with 3.6% of samples (1908 of 53,008; 95% CI, 3.4 to 3.8) for the hc2 population. For the Cervista population, 1.1% of tested specimens (622 of 56,501) provided an insufficient signal from the internal control; the hc2 platform lacks an internal control.Table 2Summary of Nonreportable ResultsVariableCervista (n = 56,501)⁎Data are given as % (95% CI).hc2 (n = 53,008)⁎Data are given as % (95% CI).P valueLow internal control1.1 (1.0–1.2)NANAQuantity not sufficient1.5 (1.4–1.6)3.6 (3.4–3.8)<0.001Borderline positiveNA<0.1NATotal reportable results97.5 (97.3–97.5)96.3 (96.1–96.5)<0.001NA, not applicable. Data are given as % (95% CI). Open table in a new tab NA, not applicable. Overall, the rate of HR-HPV positivity in reportable samples from the entire Cervista population was 15.9% (8778 of 55,065; 95% CI, 15.6 to 16.2). In all reportable samples from the hc2 population, 16.9% (8635 of 51,071; 95% CI, 16.6 to 17.2) were positive for HR-HPV (Figure 1A). For specimens classified as unsatisfactory for cytologic evaluation, 11.7% (24 of 205; 95% CI, 8.0 to 16.8) were of insufficient volume to perform the HR-HPV test in the Cervista population, compared with 15.6% (32 of 205; 95% CI, 11.3 to 21.2) in the hc2 population. In the Cervista population, 31.7% (65 of 205) of these cytologically unsatisfactory samples provided an insufficient signal from the internal control; hc2 lacks an internal control. The HR-HPV positivity rate for cytologically unsatisfactory specimens that yielded a reportable HR-HPV result was 8.6% (10 of 116; 95% CI, 4.7 to 15.1) in the Cervista population and 9.8% (17 of 173; 95% CI, 6.2 to 15.1) in the hc2 population. For specimens with an ASC-US cytologic interpretation, the HR-HPV positivity rate in the Cervista population was 48.5% (4438 of 9151; 95% CI, 47.5 to 49.5), compared with 59.4% (4495 of 7568; 95% CI, 58.3 to 60.5) in the hc2 population (Table 3 and Figure 1B). Relative to the total number of reportable results in each test population, the percentage of specimens with both an ASC-US cytologic interpretation and a positive HR-HPV test result was 8.1% (4483 of 55,065; 95% CI, 7.9 to 8.3) in the Cervista population and 8.8% (4495 of 51,071; 95% CI, 8.6 to 9.0) in the hc2 population (Table 3).Table 3HR-HPV Results for All Samples with ASC-US Cytologic InterpretationsVariableCervista (n = 9151)hc2 (n = 7568)Age, years Mean (SD)32.5 (12.4)31.4 (11.9) Median (range)29 (13–86)28 (12–89)HR-HPV positive, No. (%; 95% CI)⁎P < 0.001.4438 (48.5; 47.5–49.5)4495 (59.4; 58.3–60.5)Reportable results with both ASC-US cytologic interpretation and positive HR-HPV test, % (95% CI)⁎P < 0.001.8.1 (7.9–8.3)8.8 (8.6–9.0) P < 0.001. Open table in a new tab For specimens from patients younger than 30 years with a NILM cytologic interpretation, the HR-HPV positivity rates were 18.2% (847 of 4648; 95% CI, 17.1 to 19.3) and 21.9% (769 of 3507; 95% CI, 20.6 to 23.3), respectively, in the Cervista and hc2 populations. For specimens from patients aged 30 years or older with a NILM cytologic interpretation, the HR-HPV positivity rates were 5.8% (2289 of 39,619; 95% CI, 5.6 to 6.1) and 5.5% (2117 of 38,448; 95% CI, 5.3 to 5.7), respectively, in the Cervista and hc2 populations (Table 4 and Figure 1C). Relative to the total number of reportable results in each test population, the percentage of specimens from women aged 30 years or older with both a NILM cytologic interpretation and a positive HR-HPV test result was 4.16% (2289 of 55,065; 95% CI, 4.00 to 4.33) and 4.15% (2117 of 51,071; 95% CI, 3.98 to 4.33), respectively, in the Cervista and hc2 populations. Age-specific rates of HR-HPV positivity in the Cervista and hc2 populations in samples from women aged 30 years or older with a NILM cytologic interpretation are shown in Figure 2.Table 4HR-HPV Results for All Samples, Women Aged 30 Years or Older with NILM Cytologic InterpretationsVariableCervista (n = 39,619)hc2 (n = 38,448)Age, years Mean (SD)44.8 (10.7)43.8 (9.9) Median (range)43 (30–88)42 (30–90)HR-HPV positive, No. (%; 95% CI)⁎P = 0.072.2289 (5.8; 5.6–6.1)2117 (5.5; 5.3–5.7)Reportable results†Women aged 30 years or older. with both NILM cytologic interpretation and positive HR-HPV test, % (95% CI)‡P = 0.926.4.16 (4.00–4.33)4.15 (3.98–4.33) P = 0.072.† Women aged 30 years or older.‡ P = 0.926. Open table in a new tab For specimens from patients aged 30 years or older with a NILM cytologic interpretation, the HR-HPV positivity rates were compared according to specimen preservative type. In the Cervista population, the HR-HPV positivity rates were 4.7% (666 of 14,133; 95% CI, 4.4 to 5.1) and 6.4% (1624 of 25,486; 95% CI, 6.1 to 6.7), respectively, for SurePath and PreservCyt. In the hc2 population, the HR-HPV positivity rates were 6.3% (631 of 9957; 95% CI, 5.8 to 6.8) and 5.2% (1486 of 28,491; 95% CI, 6.1 to 6.7), respectively, for SurePath and PreservCyt (Table 5).Table 5HR-HPV Results According to Preservative Type, Women Aged 30 Years or Older with NILM Cytologic InterpretationsVariablePreservativeSurePathPreservCytCervista group No. of samples (%)14,133 (35.7)25,486 (64.3) Patient age, mean, y45.244.6 Positive for HR-HPV No. (%; 95% CI)⁎P < 0.001.666 4.7 (4.4–5.1)1624 6.4 (6.1–6.7)hc2 group No. of samples (%)9957 (25.9)28,491 (74.1) Patient age, mean, y44.643.6 Positive for HR-HPV No. (%; 95% CI)†P < 0.001.631 (6.3; 5.8–6.8)1486 (5.2; 4.9–5.5) P < 0.001.† P < 0.001. Open table in a new tab The present study describes our overall experience with the Cervista HPV HR testing platform in a high-volume commercial laboratory with more than 50,000 specimens over nine months. The comparison of performance of the Cervista and hc2 platforms provides some insight into the overall comparability of the two tests in a high-volume clinical laboratory setting. Given the indirect nature of the comparison, the conclusions derived about the relative performance of the two platforms should be interpreted with caution. For example, the usefulness of comparing HR-HPV positivity rates in the Cervista and hc2 populations depends on the assumption that the prevalence of HR-HPV infection was the same in each patient group compared. Although it is likely that the characteristics of the populations tested were similar, some differences are to be expected. The populations studied were not random samplings, but represent an analysis of specimens from women for whom clinicians believed that HR-HPV testing was needed for clinical management. This likely introduces bias, in particular because testing may have been requested more frequently in patients with other risk factors for sexually transmitted diseases or cervical cancer. In most of the groups analyzed (including samples from patients with ASC-US and unsatisfactory cytologic interpretations, as well as patients younger than 30 years with NILM cytologic interpretations), the HR-HPV positivity rate was higher in the hc2-tested population compared with the Cervista population. One potential explanation for this finding would be if the hc2 assay had greater sensitivity compared with Cervista, possibly because of the larger starting volume used for hc2. Another possible explanation would be if the hc2 assay were less specific than the Cervista assay. Cross-reactivity of the hc2 assay with multiple low-risk HPVs is well documented and could account for an increased rate of false-positive results.13Poljak M. Marin I.J. Seme K. Vince A. Hybrid Capture II HPV test detects at least 15 human papillomavirus genotypes not included in its current high-risk probe cocktail.J Clin Virol. 2002; 25 (3): S89-S97Abstract Full Text Full Text PDF PubMed Google Scholar Several studies that directly compared hc2 with an Invader-based HR-HPV assay (pre-FDA-approval, analyte-specific reagent-based versions) demonstrated a higher false-positive rate with hc2 compared with Invader.11Ginocchio C.C. Barth D. Zhang F. Comparison of the Third Wave Invader human papillomavirus (HPV) assay and the Digene HPV Hybrid Capture 2 assay for detection of high-risk HPV DNA.J Clin Microbiol. 2008; 46: 1641-1646Crossref PubMed Scopus (48) Google Scholar, 14Johnson L.R. Starkey C.R. Palmer J. Taylor J. Stout S. Holt S. Hendren R. Bock B. Waibel E. Tyree G. Miller G.C. A comparison of two methods to determine the presence of high-risk HPV cervical infections.Am J Clin Pathol. 2008; 130: 401-408Crossref PubMed Scopus (35) Google Scholar, 15Schutzbank T.E. Jarvis C. Kahmann N. Lopez K. Weimer M. Yount A. Detection of high-risk papillomavirus DNA with commercial Invadertechnology–based analyte-specific reagents following automated extraction of DNA from cervical brushings in ThinPrep media.J Clin Microbiol. 2007; 45: 4067-4069Crossref PubMed Scopus (29) Google Scholar, 16Wong A.K. Chan R.C. Nichols W.S. Bose S. Human papillomavirus (HPV) in atypical squamous cervical cytology: the Invader HPV test as a new screening assay.J Clin Microbiol. 2008; 46: 869-875Crossref PubMed Scopus (29) Google Scholar In all tested groups, an inverse relationship was observed between HR-HPV positivity rate and increasing age, a pattern consistent with findings in numerous studies of HPV prevalence in developed countries.17Castle P.E. Fetterman B. Poitras N. Lorey T. Shaber R. Kinney W. Five-year experience of human papillomavirus DNA and Papanicolaou test cotesting.Obstet Gynecol. 2009; 13: 595-600Crossref Scopus (102) Google Scholar, 18Datta S.D. Koutsky L.A. Ratelle S. Unger E.R. Shlay J. McClain T. Weaver B. Kerndt P. Zenilman J. Hagensee M. Suhr C.J. Weinstock H. Human papillomavirus infection and cervical cytology in women screened for cervical cancer in the United States, 2003–2005.Ann Intern Med. 2008; 148: 493-500Crossref PubMed Scopus (117) Google Scholar, 19Franceschi S. Herrero R. Clifford G.M. Snijders P.J. Arslan A. Anh P.T. Bosch F.X. Ferreccio C. Hieu N.T. Lazcano-Ponce E. Matos E. Molano M. Qiao Y.L. Rajkumar R. Ronco G. de SanjoséE S. Shin H.R. Sukvirach S. Thomas J.O. Meijer C.J. Muñoz N. Variations in the age-specific curves of human papillomavirus prevalence in women worldwide.Int J Cancer. 2006; 119: 2677-2684Crossref PubMed Scopus (319) Google Scholar, 20Dunne E.F. Unger E.R. Sternberg M. McQuillan G. Swan D.C. Patel S.S. Markowitz L.E. Prevalence of HPV infection among females in the United States.JAMA. 2007; 297: 813-819Crossref PubMed Scopus (1161) Google Scholar Samples with ASC-US cytological interpretations demonstrated a higher HR-HPV positivity rate in the hc2 population (59.4%) than in the Cervista population (48.5%). Previously reported rates of HR-HPV positivity in samples with ASC-US cytological interpretations vary widely, primarily because of differing HR-HPV prevalence in tested populations; however, in the present study, results in both populations were comparable to the benchmark of 50.7% established by the ASCUS/LSIL Triage Study for Cervical Cancer.7ASCUS-LSIL Triage Study GroupResults of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance.Am J Obstet Gynecol. 2003; 188: 1383-1392Crossref PubMed Google Scholar, 21Allen G.L. Klobocista M.M. Sugarman S. Gravel K. Feldman D. Schnatz P.F. Prevalence of high-risk human papillomavirus in an inner-city population with atypical squamous cells of undetermined significance.J Low Genit Tract Dis. 2009; 13: 63-65Crossref PubMed Scopus (4) Google Scholar The different HR-HPV positivity rates observed in samples with ASC-US cytological interpretations from the Cervista and hc2 populations may be due, in part, to small differences in the patient populations tested. The hc2-tested population was slightly younger (median age, 28 years) than the Cervista-tested population (median age, 29 years). Although this age difference is small, it could have significantly affected HR-HPV prevalence in these populations. Numerous studies have reported higher HR-HPV prevalence in women younger than 30 years compared with women aged 30 years or older.23Evans M.F. Adamson C.S. Papillo J.L. St John T.L. Leiman G. Cooper K. Distribution of human papillomavirus types in ThinPrep Papanicolaou tests classified according to the Bethesda 2001 terminology and correlations with patient age and biopsy outcomes.Cancer. 2006; 106: 1054-1064Crossref PubMed Scopus (106) Google Scholar, 24Jacobs M.V. Walboomers J.M. Snijders P.J. Voorhorst F.J. Verheijen R.H. Fransen-Daalmeijer N. Meijer C.J. Distribution of 37 mucosotropic HPV types in women with cytologically normal cervical smears: the age-related patterns for high-risk and low-risk types.Int J Cancer. 2000; 87: 221-227Crossref PubMed Scopus (246) Google Scholar, 25Sargent A. Bailey A. Almonte M. Turner A. Thomson C. Peto J. Desai M. Mather J. Moss S. Roberts C. Kitchener H.C. Prevalence of type-specific HPV infection by age and grade of cervical cytology: data from the ARTISTIC trial.Br J Cancer. 2008; 98: 1704-1709Crossref PubMed Scopus (86) Google Scholar In the present test populations, the HR-HPV positivity rate in women with NILM cytologic interpretations was threefold to fourfold higher in women younger than 30 years compared with women aged 30 years or older. In the present study, the median ages of the two ASC-US populations were near this age threshold of 30 years, which may have contributed to the higher prevalence of HR-HPV observed in the younger hc2-tested population. Another contributing factor could have been differences in cytologic diagnostic evaluation in the two test populations. Despite standardized morphologic criteria, the ASC-US category exhibits substantial variability in practice.26Stoler M.H." @default.
• W1531520263 created "2016-06-24" @default.
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• W1531520263 date "2011-03-01" @default.
• W1531520263 modified "2023-10-12" @default.
• W1531520263 title "Clinical Experience with the Cervista HPV HR Assay" @default.
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