POET REPORT Perspectives on Emerging Technology
|
|
- Dayna Walsh
- 5 years ago
- Views:
Transcription
1 POET REPORT Perspectives on Emerging Technology Testing for High-Risk Human Papillomavirus (hrhpv) DNA in the Management of Cervical Cancer October, 2010 Developed by the CAP s Technology Assessment Committee College of American Pathologists 325 Waukegan Rd. Northfield, IL Tel: Version no. 1
2 Human Papillomavirus DNA Testing CAP Page 2 THE PATHOLOGIST S MESSAGE High-risk human papillomavirus (hrhpv) DNA testing is a mainstay component of cervical cancer screening and a cost-effective management tool for equivocal cervical cytology results. The presence of hrhpv DNA is a necessary agent for the development of cervical cancer. Infection with hrhpv is common and, in the vast majority of cases, is self-limited clearing within 2 years. 1 In a small percentage of cases, the infection becomes persistent and oncogenic portions of the hrhpv genome can interact with host cells in ways that lead to genetic and cell regulatory changes. These events may, in turn, lead to carcinogenesis. Therefore, identification of hrhpv DNA is important in the context of screening and triage. Currently the use of hrhpv testing is FDA-approved in the following three scenarios: (1) Triage of patients having equivocal (ASC-US) Pap tests; (2) Use in conjunction with the Pap test in primary screening for women over the age of 30 years; (3) Use of HPV 16/18 testing for triage in women in the second scenario above who have positive hrhpv and negative Pap tests. Additional consensus management guidelines also include hrhpv testing for post-colposcopy and post-treatment management of patients, including those with histologic cervical intraepithelial neoplasia (CIN) and endocervical adenocarcinoma in situ (AIS), and for the triage of postmenopausal women with low grade squamous intraepithelial lesion (LSIL) on cytology. Because of the high volume of tests performed and the significance of the results for cancer risk and high cost interventions, well-validated tests with known operating characteristics are vital to maintain the robust nature of the tests prediction of risk. The FDA has approved three tests for hrhpv DNA detection. FDAapproval indicates that the performance characteristics of these tests are well validated and, therefore, predictive for the indications of excluding risk of high-grade cervical dysplasia or carcinoma (screening), and the triage of equivocal cervical cytology tests. Qiagen Hybrid Capture 2 assay 2 : approved for use with Hologic ThinPrep Pap Test media (PreservCyt) and with Qiagen Standard Transport Media. It detects 13 of the most prevalent hrhpv types. Hologic/Third Wave Cervista HR assay 3 : approved for use with the Hologic ThinPrep Pap Test (PreservCyt). It detects 14 of the most prevalent HPV types and has a cellular control incorporated in the procedure to insure that the specimen is adequate. Hologic/ThirdWave Cervista HPV 16/18 assay 4 : approved by the FDA and detects only hrhpv types 16 and 18, the two most prevalent HPV types in cervical cancers. Use of these tests with other types of transport media requires self-validation as per the regulations of CLIA 88. Other methods of testing such as polymerase chain or in situ hybridization assays have been developed for the detection of hrhpv, however at the time of this POET; none of these methodologies has been approved by the FDA and as such require self-validation as per CLIA 88. At the present time, there are no clinical indications for the use of kits for low risk HPV DNA detection and testing for this analyte is strongly discouraged. 5 hrhpv testing is not currently recommended for use as a single test in primary screening for cervical cancer, however, studies have suggested that due to its high Copyright College of American Pathologists. All rights reserved.
3 Human Papillomavirus DNA Testing CAP Page 3 sensitivity for cervical cancer and its precursor lesions, hrhpv testing may be an effective first step. 6,7,8 hrhpv s lack of specificity for cancer and high grade lesions is a limiting characteristic; any use of hrhpv alone in a primary screening scenario would require a more specific secondary triage method for hrhpv positive cases (e.g., Pap tests or other markers of high grade disease to be discussed in a future POET) CLINICAL CONTEXT High risk types of human papillomavirus have been shown to be associated with virtually all forms of cervical cancer and their precursor lesions. As such, testing for the presence of high risk HPV DNA has become an important tool in cervical cancer screening. Currently available hrhpv DNA detection systems have been FDA-approved for use in 3 clinical applications: 1. Triage of patients having equivocal (ASC-US) Pap tests reflex hrhpv testing. 9 In this context, patients having ASC-US interpretations can receive a hrhpv test. A positive hrhpv result would triage the patient to colposcopic examination whereas a negative result would triage a patient back to annual Pap screening. Data from the National Cancer Institute s ASC-US/Low Grade Squamous Intraepithelial Lesion Triage Study (ALTS) show that use of this triage method identified as many patients having cervical intraepithelial neoplasia grade 2 and higher (CIN2+) lesions as direct referral to colposcopic examination, with overall referral of about half the number of patients. In this study, when compared to cytologic followup only, use of hrhpv testing identified more CIN2+ lesions with no need for repeat cytology specimens requiring costly followup office visits. 10 HPV testing should not be performed in women less than 21 years of age with ASC-US on the Pap test Use in conjunction with the Pap test in women over the age of 30 years. 9 In this context, a negative Pap in conjunction with a negative hrhpv test has a nearly perfect (100%) negative predictive value for the presence of CIN2+. In women having negative results in both of these tests, the very low risk of the presence of a neoplastic process allows the screening interval to be safely increased to 3 years. In women having a negative Pap test with a positive hrhpv test, the followup recommendation is to rescreen with both tests at 12 months. If the Pap test is negative, but the hrhpv test remains positive at 12 months, the patient should be sent for colposcopic examination at that point.
4 Human Papillomavirus DNA Testing CAP Page 4 3. The use of specific testing for hrhpv types 16 and 18 (distinct from the pooled tests for the 13 or 14 of the most prevalent hrhpv types) 11 In this context, testing for hrhpv types 16 and 18 has been FDA-approved for adjunctive use only at the time of this POET. Adjunctive use indicates that the test should only be used in addition to the hrhpv tests approved for the 2 clinical indications noted above. The American Society for Colposcopy and Cervical Pathology (ASCCP) has issued a recommendation for the use of specific type 16/18 testing only in the circumstance of screening using Pap and hrhpv testing in the over 30 years of age population. 7 In this circumstance, women having a positive test for hrhpv in addition to a negative Pap test could be triaged to immediate colposcopy if the 16/18 test were positive and triaged to 12 month repeats of both tests if the 16/18 test were negative. At present, there is no recommendation for triage using the 16/18 test alone in women having ASC-US Pap tests. Approximately 25% of women who are positive for hrhpv in the circumstance of an ASC-US Pap test were found to be positive for hrhpv types 16 and Those ASC-US patients who were found to be HPV types 16/18 positive had a 40% cumulative risk or CIN2+, while those found to be 16/18 negative still had a 20% cumulative risk of CIN2+. Hence, although some risk stratification was possible, the rate in the 16/18 negative group was still substantial, warranting immediate referral to colposcopy. Some studies have suggested that long term follow-up of patients having HPV 16/18 positive tests versus all other hrhpv positive tests might be useful, as these patients appear to be at significantly higher risk for the development of CIN3+ lesions and hence risk stratification may be clinically useful at this level. 13 At the present time, confirmatory studies will need to be performed to determine if this holds true. In addition to FDA-approved indications, recent consensus management guidelines (American Society for Colposcopy and Cervical Pathology (ASCCP)) have indicated that hrhpv testing can also be used as part of the post-colposcopic management of histologic diagnoses of CIN 1/2/3 and endocervical adenocarcinoma in situ. In addition, hrhpv testing can be used to triage postmenopausal women having LSIL cytology results. ASCCP consensus management guidelines stipulate that hrhpv testing should not be performed in women under the age of 21 years and, in general, should not be performed on any patient more than once per calendar year. 9,14 Non-FDA approved off-label methods for hrhpv DNA detection are commonly used in laboratories, and are acceptable under CLIA 88 assuming appropriate self-validation studies are performed. Such off-label use most commonly consists of approved methods (Qiagen or Hologic) used with different non-fda approved transport medias ( e.g., BD SurePath). 15,16 In addition, non-fda approved methods such as polymerase chain reaction (PCR) and in situ hybridization have been used for high risk HPV DNA detection. Because of the high volume of hrhpv testing performed and the implications for clinical management of patients based on the results, guidelines for validations have recently been published and include both analytic and clinical components. 1
5 Human Papillomavirus DNA Testing CAP Page 5 These guidelines include the following: Capable of detecting the 13 most common high risk HPV types Clinical specificity of at least 85% - adequate PPV for CIN 3+ Clinical sensitivity of 92% +/- 3% for CIN 3+ Sensitivity data is available for peer review Interlaboratory reproducibility kappa > 0.7 Determination of specimen adequacy TECHNOLOGY OVERVIEW FDA APPROVED METHODS Qiagen Hybrid Capture 2: This method is FDA approved for use with Qiagen Standard Transport Media (STM) and the ThinPrep Pap Test (Hologic). Published self-validation studies have shown similar utility with BD SurePath media. 15,16 The method uses whole genomic RNA probe cocktail directed toward 13 hr HPV types (16/18/31/33/35/39/45/ 51/52/56/58/59/68). Probes are reacted with denatured sample DNA, which form complementary DNA-RNA hybrids when hrhpv types are present. The hybrids are stabilized on the walls of the testing vial or plate by antibodies directed against hybrids. Once stabilized the hybrids are identified via additional anti-hybrid antibodies which are labeled with alkaline phosphatase. Multiple alkaline phosphatase molecules are present on each antibody and multiple antibodies attach to each hybrid leading to substantial final signal amplification. A positive specimen is detected by a chemiluminescent reaction caused when a substrate molecule is cleaved by the alkaline phosphatase. The intensity of the light emitted is measured as relative light units (RLU) which is compared to known negative and positive controls in each specimen run. A cutoff value is obtained from these control specimens which determines the positive and negative results for clinical samples. The RLU level is proportional to the amount of hybrid (and hence the amount of hrhpv DNA in the tested sample), however the assay is only semiquantitative as there is no control for the number of cells present in the sample. (e.g., high signal may denote large numbers of cells containing low copy numbers of hrhpv DNA or low numbers of cells containing high copy numbers of hrhpv DNA).
6 Human Papillomavirus DNA Testing CAP Page 6 Automation procedures are available for the Hybrid Capture 2 assay (Rapid Capture) that may allow for significant improvement in laboratory productivity. This method is well-validated, both analytically and clinically, based on the results of the ALTS and FDA approval. Limitations of the test include issues of cross reactivity with some non-hrhpv types (types 6 and 13), which may account for small numbers of false-positive results. In addition, the test does not account for low- or non-cellular samples which may yield false-negative results, because no probe recognizing normal cellular components is included with the assay. Hologic/Third Wave Cervista HPV HR and Cervista HPV 16/18: These 2 tests utilize the same method and are FDA approved for use only with the ThinPrep Pap Test PreservCyt Solution (Hologic). There have been a number of studies evaluating the use of Third Wave Cervista in BD SurePath samples and results have shown comparability with FDA-approved methods; however, as per the regulations of CLIA 88, use of non-fda approved methods require in-house validation studies. 18,19 The Third Wave Cervista HPV assay is a qualitative test for the detection of 14 hrhpv types (16/18/31/33/35/39/45/51/52/ 56/58/59/66/68). The test uses the Invader chemistry technology, which is a 2 stage signal amplification method. In the first stage specific probe oligonucleotides directed toward hrhpv DNA sequences and Invader oligonucleotides are reacted with the target mixture. When these oligonucleotides overlap by at least one base pair at the target sequence, an invasive structure forms that acts as a substrate for a proprietary enzyme (Cleavase). This enzyme cleaves the 5 portion (flap) of the probe at the position of the overlap. The oligonucleotide probes are in large excess in the mixture and continually cycle on and off the target sequence such that many cleaved 5 flaps are generated at each target sequence the basis of the amplification. In the second stage, the cleaved flaps bind to a universal hairpin fluorescence resonance energy transfer (FRET) oligonucleotide creating another invasive structure that the Cleavase enzyme recognizes as a substrate. This enzyme cleaves the FRET oligonucleotides between the fluorophore and quencher molecule and produces a fluorescence signal as the cleaved flaps cycle on and off. For each copy of the HPV DNA target, the combined primary and secondary reactions result in fold signal amplification per hour. In addition, an oligonucleotide probe directed toward human histone 2 gene is included in the mix, serving as an internal control. Reaction of this probe with complementary cellular DNA is detected simultaneously using a different flap sequence and different FRET oligonucleotide, each with a different fluorophore. Positive reactions for each of the analytes are determined by levels of fluorescence above an empirically derived cut-off value. The control probe (human histone 2) guards against negative HPV results being caused by inadequate numbers of cells in the sample and as an overall quality control check on the testing procedure. The Cervista HPV 16/18 assay uses identical technology but contains probes only directed at HPV types 16 and 18. Automation
7 Human Papillomavirus DNA Testing CAP Page 7 procedures are available for the Cervista assays that may allow for significant improvement in laboratory productivity. FDA trials of the Cervista assay showed 92.8 and 100% sensitivity for the detection of colposcopically confirmed CIN 2+ and CIN 3+, respectively. When compared to the data derived from ALTS, the results of the trial were comparable. Reproducibility studies showed 99% agreement for positive tests and 100% agreement for negative tests. No cross reactivity for the most common low risk HPV types (6/11) was identified in analytic studies. Post-approval studies have shown high sensitivities for CIN 2+ detection in the ASC-US triage testing application and direct comparisons with Hybrid Capture 2 have shown good concordance and fewer false positive results, with a slight majority of discordant cases being verified by sequencing as correct in the Third Wave method. 20,21,22 Non-FDA Approved Methods Polymerase Chain Reaction (PCR): Identification of HPV DNA by polymerase chain-based assays has been in widespread use for many years. Many assays have been laboratory-developed tests and a number of tests are commercially available. The Roche Amplicor method is one widely used commercial product for PCR detection of HPV. This assay detects the 13 most common high risk HPV types and extension of the procedure with the Roche Linear Array Genotyping kit allows for specific typing of the HPV once it is found to be present. Although not FDA approved at present, PCR detection of HPV has been used as a gold-standard for the presence of HPV in numerous studies and clinical trials, including ALTS. Interestingly when compared directly to Hybrid Capture 2 in ALTS, PCR was found to be slightly less sensitive for detection of clinical disease; 23 however numerous additional studies have shown PCR clinical sensitivity to be comparable for use in screening tasks In addition, specific typing of hrhpv provides utility in the identification of simultaneous infection by multiple HPV types and investigation of persistent hrhpv infections to determine if the same hrhpv types are implicated. In Situ Hybridization (ISH): ISH refers to direct visualization on tissues or cells of a hybridization reaction between nucleotide probes and target DNA. ISH for HPV has been in wide use as a research tool for many years. The only commercial assay developed is the Ventana INFORM HPV. Use of this assay has not been shown to be sensitive enough for routine use in clinical situations of ASC-US triage or primary screening. 20,28 Its potential advantage however, is higher specificity for high grade lesions and the ability to directly identify signal and its association with cells/tissues of interest under the microscope. Some investigators have advocated ISH for HPV in circumstances of equivocal morphology for high grade dysplasia in biopsy specimens.
8 Human Papillomavirus DNA Testing CAP Page 8 IMPACT ON CURRENT PATHOLOGY PRACTICE The use of hrhpv testing has become routine in most cervical cancer screening programs at present. Its use in triage of ASC-US cases to colposcopic examination or followup is the primary application, and its use as an adjunct to the Pap test in screening the over 30 years of age population is growing. Use of HPV 16/18 typing has not become a mainstream procedure at present, although its use may increase over time as refinements to clinical triage algorithms mature. ACCELERATION/DECELERATION TRIGGERS TO ADOPTION Although hrhpv testing is not currently approved for use as the primary cervical cancer screening test, there have been a number of studies that suggest that hrhpv testing may be more sensitive than the Pap test for the detection of high grade cervical disease and hence might be a more attractive first screen, followed by the Pap (or other more specific) test in positive cases. 30 If ultimately found to be a cost-effective method of cervical cancer screening, HPV testing would balloon in use, to the detriment of Pap testing. In addition, other markers (cell cycle related, gene amplifications) have the potential to provide sensitive and specific information about the potential for the presence or risk of development of a high grade dysplasia or carcinoma. Such markers have the potential to serve as either primary screening probes or as downstream triage mechanisms following either positive hrhpv or Pap tests. (These new markers will be the topic of a future POET analysis.) ACKNOWLEDGEMENTS The TAC would like to thank Teresa Darragh, MD, FCAP for critical review and suggestions for the paper. FOR MORE INFORMATION/REFERENCES 1. Schiffman M, Castle PE, Jeronimo J, Rodriguez AC, Wacholder S. Human Papillomavirus and cervical cancer. Lancet 2007;370: Hybrid Capture 2, REF , US Food and Drug Administration Package Insert. L01002 Rev.0, Cervista HPV HR, REF , US Food and Drug Administration Package Insert. PIN , Revision A, Cervista HPV 16/18, REF , US Food and Drug Administration Package Insert. PIN , Revision A, Solomon D, Papillo JL, Davey DD; Cytopathology Education and Technology Consortium. Statement on human papillomavirus DNA test utilization. Arch Pathol Lab Med. 2009;133:
9 Human Papillomavirus DNA Testing CAP Page 9 6. Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy A, Ratnam S, Coutlée F, Franco EL; Canadian Cervical Cancer Screening Trial Study Group. Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer. N Engl J Med. 2007;357: Naucler P, Ryd W, Törnberg S, Strand A, Wadell G, Elfgren K, Rådberg T, Strander B, Johansson B, Forslund O, Hansson BG, Rylander E, Dillner J. Human papillomavirus and Papanicolaou tests to screen for cervical cancer. N Engl J Med. 2007;357: Kitchener HC, Almonte M, Thomson C, Wheeler P, Sargent A, Stoykova B, Gilham C, Baysson H, Roberts C, Dowie R, Desai M, Mather J, Bailey A, Turner A, Moss S, Peto J. HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial. Lancet Oncol. 2009;10: Epub 2009 Jun Wright Jr TC, Massad LS, Dunton CJ, Spitzer M, Wilkinson EJ, Solomon D Consensus Guidelines for the Management of Women with Abnormal Cervical Cancer Screening Tests. Am J Obstet Gynecol 2007;197: Solomon D, Schiffman M, Tarone R. Comparison of three management strategies for patients with atypical squamous cells of undetermined significance: baseline results from a randomized trial. J Natl Cancer Inst 2001;93: Wheeler CM, Hunt WC, Schiffman M, Castle PE; Atypical Squamous Cells of Undetermined Significance/Low-Grade Squamous Intraepithelial Lesions Triage Study Group. Human papillomavirus genotypes and the cumulative 2-year risk of cervical precancer. J Infect Dis. 2006;194: Epub 2006 Sep Khan MJ, Casle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst 2005;97: Wright Jr TM, Massad LS, Dunton CJ, Spitzer M, Wilkinson EJ, Solomon D consensus guidelines for the management of women with cervical intraepithelial neoplasia or adenocarcinoma in situ. Am J Ob Gynecol 2007;197: Ko V, Tambouret RH, Kuebler DL, Black-Schaffer WS, Wilbur DC. Human Papillomavirus Testing using Hybrid Capture II with SurePath Collection: Initial Evaluation and Longitudinal Data Provides Clinical Validation for this Method. Cancer (Cancer Cytopath) 2006;108: Siddiqi A, Spataro M, McIntire H, Akhtar I, Baliga M, Flowers R, Lin E, Guo M. Hybrid capture 2 human papillomavirus DNA testing for women with atypical squamous cells of undetermined significance papanicolaou results in SurePath and ThinPrep specimens. Cancer Cytopathol. 2009;117: [Epub ahead of print]
10 Human Papillomavirus DNA Testing CAP Page Stoler MH, Castle PE, Solomon D, Schiffman M; American Society for Colposcopy and Cervical Pathology. The expanded use of HPV testing in gynecologic practice per ASCCP-guided management requires the use of well-validated assays. Am J Clin Pathol. 2007;127: Wong AK, Chan RC-K, Nichols WS, Bose S. Human Papillomavirus (HPV) in Atypical Squamous Cervical Cytology: the Invader HPV Test as a New Screening Assay. J Clin Microbiol 2008;46: Harvey M, Stout S, Starkey CR, Hendren R, Holt S, Miller GC. The clinical performance of Invader technology and Surepath when detecting the presence of high-risk HPV cervical infection. J Clin Virol 2009;45:S Kurtycz DFI, Smith M, He R, Miyazaki K, Shalkham J. Comparison of Methods Trial for High-Risk HPV. Diagn Cytopathol 2009 Aug 17 (Epub ahead of print). 21. Johnson LR, Starkey CR, Palmer J, Taylor J, Stout S, Holt S, Hendren R, Bock B, Waibel E, Tyree G, Miller GC. A Comparison of Two Methods to Determine the Presence of High-Risk HPV Cervical Infections. Am J Clin Pathol 2008;130: Ginocchio CC, 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: Epub 2008 Mar Schiffman M, Wheeler CM, Dasgupta A, Solomon D, Castle PE; ALTS Group. A comparison of a prototype PCR assay and hybrid capture 2 for detection of carcinogenic human papillomavirus DNA in women with equivocal or mildly abnormal Papanicolaou smears.am J Clin Pathol. 2005;124: Wahlström C, Iftner T, Dillner J, Dillner L; Swedescreen study group. Population-based study of screening test performance indices of three human papillomavirus DNA tests. J Med Virol. 2007;79: Stevens MP, Garland SM, Rudland E, Tan J, Quinn MA, Tabrizi SN. Comparison of the Digene Hybrid Capture 2 assay and Roche AMPLICOR and LINEAR ARRAY human papillomavirus (HPV) tests in detecting high-risk HPV genotypes in specimens from women with previous abnormal Pap smear results. J Clin Microbiol. 2007;45: Epub 2007 May Carozzi F, Bisanzi S, Sani C, Zappa M, Cecchini S, Ciatto S, Confortini M. Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 assay in detection of high-risk human papillomavirus and diagnosis of biopsy-confirmed high-grade cervical disease. J Clin Microbiol. 2007;45: Epub 2006 Nov 22.
11 Human Papillomavirus DNA Testing CAP Page Sandri MT, Lentati P, Benini E, Dell'Orto P, Zorzino L, Carozzi FM, Maisonneuve P, Passerini R, Salvatici M, Casadio C, Boveri S, Sideri M. Comparison of the Digene HC2 assay and the Roche AMPLICOR human papillomavirus (HPV) test for detection of high-risk HPV genotypes in cervical samples. J Clin Microbiol. 2006;44: Hesselink AT, van den Brule AJ, Brink AA, Berkhof J, van Kemenade FJ, Verheijen RH, Snijders PJ. Comparison of hybrid capture 2 with in situ hybridization for the detection of high-risk human papillomavirus in liquid-based cervical samples. Cancer. 2004;102: Kong CS, Balzer BL, Troxell ML, Patterson BK, Longacre TA. p16ink4a immunohistochemistry is superior to HPV in situ hybridization for the detection of high-risk HPV in atypical squamous metaplasia. Am J Surg Pathol. 2007;31: Naucler P, Ryd W, Tornberg S, et al. Efficacy of HPV DNA testing with cytology triage and/or repeat HPV DNA testing in primary cervical cancer screening. J Nathl Cancer Inst 2009;101: TECHNOLOGY ASSESSMENT COMMITTEE (TAC) MEMBERS AT THE TIME OF ORIGINAL PUBLICATION: John W. Turner, MD, FCAP, Chair Frederick L. Baehner, MD, FCAP Kenneth J. Bloom, MD, FCAP Samuel K. Caughron, MD, FCAP Thomas J. Cooper, MD, FCAP Richard C. Friedberg, MD, PhD, FCAP Jonhan Ho, MD, FCAP Federico A. Monzon, MD, FCAP David C. Wilbur, MD, FCAP Crystal Palmatier Jenkins, MD, Junior Member This POET was developed by the Technology Assessment Committee (TAC) with input from the Council on Scientific Affairs. Opinions expressed herein are solely those of the authors and do not represent those of the College of American Pathologists (CAP). No endorsement of any proprietary technology or product referenced is implied by the TAC or CAP. This report is provided for educational purposes only. None of the contents of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission of the publisher.
A Cytologic/Histologic Review of 367 Cases. Original Article. Cancer Cytopathology August 25,
Correlation Between Hybrid Capture II High-Risk Human Papillomavirus DNA Test Chemiluminescence Intensity From Cervical Samples With Follow-Up Histologic Results A Cytologic/Histologic Review of 367 Cases
More informationHPV Genotyping: A New Dimension in Cervical Cancer Screening Tests
HPV Genotyping: A New Dimension in Cervical Cancer Screening Tests Lee P. Shulman MD The Anna Ross Lapham Professor in Obstetrics and Gynecology and Chief, Division of Clinical Genetics Feinberg School
More informationHPV TESTING AND UNDERSTANDING VALIDITY: A tough row to hoe. Mark H. Stoler, MD ASC Companion Meeting USCAP 2008
OBJECTIVES: HPV TESTING AND UNDERSTANDING VALIDITY: A tough row to hoe Mark H. Stoler, MD ASC Companion Meeting USCAP 2008 1. Describe the concept of marker validation in the context of HPV tests. 2. Present
More informationThe clearest path to the most meaningful results. The cobas HPV Test delivers clinical value with workflow efficiencies every step of the way
The clearest path to the most meaningful results The cobas HPV Test delivers clinical value with workflow efficiencies every step of the way The cobas HPV Test KNOW THE RISK Help guide clinical decision
More informationNews. Laboratory NEW GUIDELINES DEMONSTRATE GREATER ROLE FOR HPV TESTING IN CERVICAL CANCER SCREENING TIMOTHY UPHOFF, PHD, DABMG, MLS (ASCP) CM
Laboratory News Inside This Issue NEW GUIDELINES DEMONSTRATE GREATER ROLE FOR HPV TESTING IN CERVICAL CANCER SCREENING...1 NEW HPV TEST METHODOLOGY PROVIDES BETTER SPECIFICITY FOR CERVICAL CANCER...4 BEYOND
More informationAbnormal Cervicovaginal Cytology With Negative Human Papillomavirus Testing
280 Abnormal Cervicovaginal Cytology With Negative Human Papillomavirus Testing Giovanni Negri, MD Bettina Rigo, BS Fabio Vittadello, ScD Christine Mian, ScD Eduard Egarter-Vigl, MD Department of Pathology,
More informationHuman Papillomavirus Testing Using Hybrid Capture II With SurePath Collection
468 Human Papillomavirus Testing Using Hybrid Capture II With SurePath Collection Initial Evaluation and Longitudinal Data Provide Clinical Validation for This Method Vincent Ko, MD Rosemary H. Tambouret,
More informationCervical cancer prevention: Advances in primary screening and triage system
Cervical cancer prevention: Advances in primary screening and triage system Dr Farid Hadi Regional Medical and Scientific Affairs Roche Diagnostics Asia-Pacific, Singapore Cervical cancer is highly preventable
More informationClinical Performance of Roche COBAS 4800 HPV Test
JCM Accepts, published online ahead of print on 9 April 2014 J. Clin. Microbiol. doi:10.1128/jcm.00883-14 Copyright 2014, American Society for Microbiology. All Rights Reserved. 1 1 2 3 4 5 6 Clinical
More informationMolecular Analysis in the Diagnosis and Management of Lesions of Uterine Cervix: The 95% solution. Mark H. Stoler, MD PSC Symposium USCAP 2008
Molecular Analysis in the Diagnosis and Management of Lesions of Uterine Cervix: The 95% solution Mark H. Stoler, MD PSC Symposium USCAP 2008 Objectives: This presentation will briefly review the currently
More informationPerformance of the Aptima High-Risk Human Papillomavirus mrna Assay in a Referral Population in Comparison with Hybrid Capture 2 and Cytology
JOURNAL OF CLINICAL MICROBIOLOGY, Mar. 2011, p. 1071 1076 Vol. 49, No. 3 0095-1137/11/$12.00 doi:10.1128/jcm.01674-10 Copyright 2011, American Society for Microbiology. All Rights Reserved. Performance
More informationPushing the Boundaries of the Lab Diagnosis in Asia
Pushing the Boundaries of the Lab Diagnosis in Asia Diana Lim MBBS, FRCPA, FRCPath (UK) Senior Consultant National University Health System and National University of Singapore Department of Pathology
More informationCan HPV-16 Genotyping Provide a Benchmark for Cervical Biopsy Specimen Interpretation?
Anatomic Pathology / Monitoring HPV-16 Fractions in CIN Can HPV-16 Genotyping Provide a Benchmark for Cervical Biopsy Specimen Interpretation? Mary T. Galgano, MD, 1 Philip E. Castle, PhD, MPH, 2 Mark
More informationThe devil is in the details
The cobas KNOW THE RISK For cervical cancer prevention The devil is in the details Leading with the cobas as your primary screening method uncovers disease missed by cytology, and can protect women from
More informationChapter 5. M.G. Dijkstra L. Rozendaal M. van Zummeren F.J. van Kemenade P.J.F. Snijders C.J.L.M. Meijer J. Berkhof. Submitted for publication
Chapter 5 CIN3 and cancer risks after primary HPV DNA testing and cytology triage in cervical cancer screening: fifteen years follow-up of a randomized controlled trial M.G. Dijkstra L. Rozendaal M. van
More informationOver-diagnoses in Cytopathology: Is histology the gold standard?
Over-diagnoses in Cytopathology: Is histology the gold standard? Teresa M. Darragh, MD UCSF Departments of Pathology and Obstetrics, Gynecology & Reproductive Sciences Faculty Disclosures: Teresa M. Darragh,
More informationBiomed Environ Sci, 2015; 28(1): 80-84
80 Biomed Environ Sci, 2015; 28(1): 80-84 Letter to the Editor Assessing the Effectiveness of a Cervical Cancer Screening Program in a Hospital-based Study* YANG Yi1, LANG Jing He1, WANG You Fang1, CHENG
More informationNatural History of HPV Infections 15/06/2015. Squamous cell carcinoma Adenocarcinoma
14,670 5796 United States/ Canada 17,165 8124 Central America 48,328 21,402 South America 59,929 29,814 Europe 78,896 61,670 Africa 157,759 86,708 Southcentral Asia 61,132 31,314 Eastern Asia 42,538 22,594
More informationNo HPV High Risk Screening with Genotyping. CPT Code: If Result is NOT DETECTED (x3) If Results is DETECTED (Genotype reported)
CPAL Central Pennsylvania Alliance Laboratory Technical Bulletin No. 117 August 6, 2013 HPV High Risk Screening with Genotyping Contact: Dr. Jeffrey Wisotzkey, 717-851-1422 Director, Molecular Pathology
More informationCAP Laboratory Improvement Programs
CAP Laboratory Improvement Programs Practices of Participants in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology, 2006 Galen M. Eversole, MD; Ann T. Moriarty,
More informationModernization of your cytology laboratory and Co-Testing Approach for Cervical Screening
Modernization of your cytology laboratory and Co-Testing Approach for Cervical Screening 2 nd ESPC & 27 th IAP-AD annual meeting Dubai - UAE Mousa Al-Abbadi, MD, FIAC, FCAP, CPHQ, CPE Professor of Pathology
More informationA Comparison of Two Methods to Determine the Presence of High-Risk HPV Cervical Infections
Anatomic Pathology / Clinical Validation of Invader HPV Test A Comparison of Two Methods to Determine the Presence of High-Risk HPV Cervical Infections Lawrence R. Johnson, MD, 1,2 Cindi R. Starkey, MD,
More informationHPV Testing & Cervical Cancer Screening:
HPV Testing & Cervical Cancer Screening: Are they linked? By William Chapman, MD, FRCPC Screening for precursor lesions of cervical cancer by the Papanicolaou (Pap) smear has been one of the greatest success
More information(Pap) results, ie, abnormal squamous cells of undetermined significance (ASCUS). According to
The Role of Human Papillomavirus Type 16/18 Genotyping in Predicting High-Grade Cervical/Vaginal Intraepithelial Neoplasm in Women With Mildly Abnormal Papanicolaou Results Ming Guo, MD 1 ; Yun Gong, MD
More informationWelcome. THE ROLE OF oncofish cervical ASSESSMENT OF CERVICAL DYSPLASIA. March 26, 2013
THE ROLE OF oncofish cervical IN THE ASSESSMENT OF CERVICAL DYSPLASIA The phone lines will open, 15 minutes prior to the start of the webinar. Toll Free: 1-800-867-0864. Entry Code: 83956484. You may download
More informationScreening for Cervical Cancer. Grand Rounds 1/16/13 Meggan Linck
Screening for Cervical Cancer Grand Rounds 1/16/13 Meggan Linck Cervical Cancer Worldwide 2 nd most common and 5 th deadliest U.S. 8 th most common 80% occur in developing world Median age at diagnosis
More informationCME/SAM. Follow-up Outcomes in a Large Cohort of Patients With Human Papillomavirus Negative ASC-H Cervical Screening Test Results
Anatomic Pathology / HPV-Negative ASC-H Follow-up Outcomes in a Large Cohort of Patients With Human Papillomavirus Negative ASC-H Cervical Screening Test Results David Cohen, MD, R. Marshall Austin, MD,
More informationHUMAN PAPILLOMAVIRUS TESTING
CLINICAL GUIDELINES For use with the UnitedHealthcare Laboratory Benefit Management Program, administered by BeaconLBS HUMAN PAPILLOMAVIRUS TESTING Policy Number: PDS - 016 Effective Date: October 1, 2018
More informationEvidence-based treatment of a positive HPV DNA test. Th. Agorastos Prof. of Obstetrics & Gynaecology Aristotle University Thessaloniki/GR
Evidence-based treatment of a positive HPV DNA test Th. Agorastos Prof. of Obstetrics & Gynaecology Aristotle University Thessaloniki/GR HPV DNA testing Indications 1. Triage after cytology with ASCUS/LSIL
More informationThe Predictors Studies (1, 2 & 3) A comparison of tests for high grade CIN in women with abnormal smears and in a screening population
The Predictors Studies (1, 2 & 3) A comparison of tests for high grade CIN in women with abnormal smears and in a screening population Jack Cuzick L Cadman, J Austin, D Mesher, A Ahmad, L Ambroisine, L
More information32 OBG Management May 2015 Vol. 27 No. 5 obgmanagement.com
The Advisory Committee on Immunization Practices recommends routine vaccination against HPV in 11- and 12-year-olds, although the age can range from 9 to 26 years (for those who have not been vaccinated
More informationBiomarkers and HPV testing: The future of cervical screening
THE FUTURE OF CERVICAL SCREENING Earn 3 CPD Points online Biomarkers and HPV testing: The future of cervical screening Professor John O Leary Associate Professor and Director of Pathology Coombe Women
More informationCME/SAM. High-Risk HPV Testing in Women 30 Years or Older With Negative Papanicolaou Tests Initial Clinical Experience With 18-Month Follow-up
Anatomic Pathology / HPV Testing in Negative Papanicolaou Tests High-Risk HPV Testing in Women 30 Years or Older With Negative Papanicolaou Tests Initial Clinical Experience With 18-Month Follow-up Michael
More informationOriginal Policy Date
MP 2.04.03 Cervicography Medical Policy Section Medicine Issue 12:2013 Original Policy Date 12:2013 Last Review Status/Date Reviewed with literature search/12:2013 Return to Medical Policy Index Disclaimer
More informationP16 et Ki67 Biomarkers: new tool for risk management and low grade intraepithelial lesions (LGSIL): be ready for the future.
P16 et Ki67 Biomarkers: new tool for risk management and low grade intraepithelial lesions (LGSIL): be ready for the future. Mark H Stoler, MD University of Virginia Health System, Charlottesville, VA,
More informationNegative Colposcopic Biopsy After Positive Human Papilloma Virus (HPV) DNA Testing False-Positive HPV Results or False-Negative Histologic Findings?
Anatomic Pathology / FALSE-NEGATIVE HISTOLOGIC FINDINGS Negative Colposcopic Biopsy After Positive Human Papilloma Virus (HPV) DNA Testing False-Positive HPV Results or False-Negative Histologic Findings?
More informationNILM Pap Slides From Women 30 Years of Age and Older With Positive High-Risk HPV DNA
NILM Pap Slides From Women 30 Years of Age and Older With Positive High-Risk HPV DNA Focused Rescreening Prior to Report Issuance, An Enhanced Quality Control Measure Karen Cormier, CT(ASCP), 1 Michael
More informationCervical Cancer Screening
Todd R. Jenkins, MD, MSHA Senior Vice Chair Director, Division of Women s Reproductive Healthcare Learning Objectives Describe the etiology, natural history, and usage of the human papillomavirus (HPV)
More informationHuman Papillomavirus (HPV) in Atypical Squamous Cervical Cytology: the Invader HPV Test as a New Screening Assay
JOURNAL OF CLINICAL MICROBIOLOGY, Mar. 2008, p. 869 875 Vol. 46, No. 3 0095-1137/08/$08.00 0 doi:10.1128/jcm.01424-07 Copyright 2008, American Society for Microbiology. All Rights Reserved. Human Papillomavirus
More informationVasile Goldiş Western University of Arad, Faculty of Medicine, Obstetrics- Gynecology Department, Romania b
Mædica - a Journal of Clinical Medicine ORIGINAL PAPERS Cervical Intraepithelial Neoplasia in the Dr. Salvator Vuia Clinical Obstetrics and Gynecology Hospital - Arad During the 2000-2009 Period Voicu
More informationAtypical Glandular Cells of Undetermined Significance Outcome Predictions Based on Human Papillomavirus Testing
Anatomic Pathology / ATYPICAL GLANDULAR CELLS AND HUMAN PAPILLOMAVIRUS Atypical Glandular Cells of Undetermined Significance Outcome Predictions Based on Human Papillomavirus Testing Jeffrey F. Krane,
More informationHPV test results and histological follow-up results of patients with LSIL Cervical Cytology from the Largest CAP-certified laboratory in China
2436 Ivyspring International Publisher Research Paper Journal of Cancer 2017; 8(13): 2436-2441. doi: 10.7150/jca.19421 HPV test results and histological follow-up results of patients with LSIL Cervical
More informationQuarterly laboratory and pathology update from Legacy Laboratory Services in collaboration with Cascade Pathology
Legacy LabAdvisor Quarterly laboratory and pathology update from Legacy Laboratory Services in collaboration with Cascade Pathology Edition 3 Inside this issue New Testing Developments.... 2 Test Algorithm...
More informationAtypical squamous cells. The case for HPV testing
OBG MANAGEMENT FOCUS ON CERVICAL DISEASE BY J. THOMAS COX, MD ASC-US is most often due to transient changes or HPV. HPV-positive ASC-US is 12.5 to 23 times more likely to be associated with CIN 2,3 on
More informationHe Said, She Said: HPV and the FDA. Audrey P Garrett, MD, MPH June 6, 2014
He Said, She Said: HPV and the FDA Audrey P Garrett, MD, MPH June 6, 2014 Disclosure Speaker for Merck Gardasil Speaker for Hologic Thin Prep and Cervista Cervical Cancer Screening: 21 st century Dr. Papanicolaou
More informationComparison of the DiagCor GenoFlow Human Papillomavirus Array Test and Roche Linear Array HPV Genotyping Test
The Open Virology Journal, 2010, 4, 169-174 169 Open Access Comparison of the DiagCor GenoFlow Human Papillomavirus Array Test and Roche Linear Array HPV Genotyping Test Fiona K.Y. Wong, Johannes C.Y.
More informationPrior High-Risk HPV Testing and Pap Test Results for 427 Invasive Cervical Cancers in China s Largest CAP-Certified Laboratory
Prior High-Risk HPV Testing and Pap Test Results for 427 Invasive Cervical Cancers in China s Largest CAP-Certified Laboratory Baowen Zheng, MD 1 ; Zaibo Li, MD, PhD 2 ; Christopher C. Griffith, MD, PhD
More informationHuman Papillomavirus (HPV) DNA Triage of Women with Atypical Squamous Cells of
JCM Accepts, published online ahead of print on 1 February 2012 J. Clin. Microbiol. doi:10.1128/jcm.06656-11 Copyright 2012, American Society for Microbiology. All Rights Reserved. 1 2 3 Human Papillomavirus
More informationCervical Cancer Screening for the Primary Care Physician for Average Risk Individuals Clinical Practice Guidelines. June 2013
Cervical Cancer Screening for the Primary Care Physician for Average Risk Individuals Clinical Practice Guidelines General Principles: Since its introduction in 1943, Papanicolaou (Pap) smear is widely
More informationPAP SMEAR WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE
Arch Iranian Med 2005; 8 (3): 192 196 Original Article PAP SMEAR WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE Fatemeh Ghaemmaghami MD *, Fereshteh Ensani MD**, Nadereh Behtash MD* Ebrahim
More informationHPV-Negative Results in Women Developing Cervical Cancer: Implications for Cervical Screening Options
HPV-Negative Results in Women Developing Cervical Cancer: Implications for Cervical Screening Options R. Marshall Austin MD,PhD Magee-Womens Hospital of University of Pittsburgh Medical Center (UPMC) (raustin@magee.edu)
More informationLessons From Cases of Screened Women Who Developed Cervical Carcinoma
Lessons From Cases of Screened Women Who Developed Cervical Carcinoma R. Marshall Austin MD,PhD Magee-Womens Hospital of University of Pittsburgh Medical Center raustin@magee.edu Why Focus Study On Cases
More informationComparative study of human papilloma virus DNA detection and results of histopathological examination of cervical colposcopic biopsy
Iranian Journal of Reproductive Medicine Vol.5. No.3. pp:121-126, Summer 2007 Comparative study of human papilloma virus DNA detection and results of histopathological examination of cervical colposcopic
More informationASCCP 2013 Guidelines for Managing Abnormal Cervical Cancer Screening Tests
ASCCP 2013 Guidelines for Managing Abnormal Cervical Cancer Screening Tests www.treatmentok.com Barbara S. Apgar, MD, MS Professor of Family Medicine University of Michigan Ann Arbor, Michigan Disclosures
More informationSESSION J4. What's Next? Managing Abnormal PAPs in 2014
37th Annual Advanced Practice in Primary and Acute Care Conference: October 9-11, 2014 2:45 SESSION J4 What's Next? Managing Abnormal PAPs in 2014 Session Description: Linda Eckert, MD Review current guidelines
More informationCervical-Cancer Screening with Human Papillomavirus and Cytologic Cotesting
The new england journal of medicine clinical practice Caren G. Solomon, M.D., M.P.H., Editor Cervical-Cancer Screening with Human Papillomavirus and Cytologic Cotesting Mark Schiffman, M.D., M.P.H., and
More informationClinical Policy Title: Fluorescence in situ hybridization for cervical cancer screening
Clinical Policy Title: Fluorescence in situ hybridization for cervical cancer screening Clinical Policy Number: 01.01.02 Effective Date: April 1, 2015 Initial Review Date: January 21, 2015 Most Recent
More informationAbstract. Human papillomavirus (HPV) DNA testing is cost-effective 1-3 (S. Kulasingam, PhD, et al, unpublished Atypical
Anatomic Pathology / HPV DNA DETECTION IN ALTS A Comparison of a Prototype PCR Assay and Hybrid Capture 2 for Detection of Carcinogenic Human Papillomavirus DNA in Women With Equivocal or Mildly Abnormal
More informationMaking Sense of Cervical Cancer Screening
Making Sense of Cervical Cancer Screening New Guidelines published November 2012 Tammie Koehler DO, FACOG The incidence of cervical cancer in the US has decreased more than 50% in the past 30 years because
More informationSignificance of High-Risk Human Papillomavirus DNA Detection in Women 50 Years and Older With Squamous Cell Papanicolaou Test Abnormalities
Significance of High-Risk Human Papillomavirus DNA Detection in Women 50 Years and Older With Squamous Cell Papanicolaou Test Abnormalities Chengquan Zhao, MD; Shuping Zhao, MD, PhD; Amer Heider, MD; R.
More informationCervical FISH Testing for Triage and Support of Challenging Diagnoses: A Case Study of 2 Patients
Cervical FISH Testing for Triage and Support of Challenging Diagnoses: A Case Study of 2 Patients Richard Hopley, MD, Alexandra Gillespie, MD* Laboratory Medicine 47:1:52-56 CLINICAL HISTORY Patients:
More informationCINtec PLUS and the Pap smear: a co-testing alternative
CINtec PLUS and the Pap smear: a co-testing alternative Rosemary Tambouret MD p16/ki67 (CINtec PLUS) and the Pap smear Rosemary Tambouret MD CINtec PLUS dual stain: p16 and Ki67 p16 is anti-proliferative
More informationFocus. International #52. HPV infection in High-risk HPV and cervical cancer. HPV: Clinical aspects. Natural history of HPV infection
HPV infection in 2014 Papillomaviruses (HPV) are non-cultivable viruses with circular DNA. They can establish productive infections in the skin (warts) and in mucous membranes (genitals, larynx, etc.).
More informationCervical Cancer Screening. David Quinlan December 2013
Cervical Cancer Screening David Quinlan December 2013 Cervix Cervical Cancer Screening Modest variation provincially WHO and UK begin at 25 stop at 60 Finland begin at 30 stop at 60 Rationale for
More informationFOR EXPORT ONLY. Not for sale in the United States of America.
Cervista HPV 16/18 92-0200 FOR EXPORT ONLY. Not for sale in the United States of America. An in vitro diagnostic test for the detection of DNA from Human Papillomavirus (HPV) Type 16 and Type 18 in Cervical
More informationUniversity of Groningen. New insights in methodology of screening for cervical cancer Wang, Rong
University of Groningen New insights in methodology of screening for cervical cancer Wang, Rong IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite
More informationEmerging Laboratory Diagnostic Options for Sexually-transmitted Infections
Emerging Laboratory Diagnostic Options for Sexually-transmitted Infections Erik Munson Wheaton Franciscan Laboratory Marquette University Milwaukee, Wisconsin 1 OBJECTIVES I. Appreciate the changing epidemiology
More informationOriginal Articles. Do Infection Patterns of Human Papillomavirus Affect the Cytologic Detection of High-Grade Cervical Lesions on Papanicolaou Tests?
Original Articles Do Infection Patterns of Human Papillomavirus Affect the Cytologic Detection of High-Grade Cervical Lesions on Papanicolaou Tests? Siavash Azadmanesh Samimi, MD; Roxanne R. Mody, MD;
More information!"#$%&'(#)*$+&,$-&.#,$/#0()1-$ ),1')$2(%&,2#,%$%(0'#$34567$
!"#$%&'(#)*$+&,$-&.#,$/#0()1-$ ),1')$2(%&,2#,%$%(0'#$34567$ Updated Consensus Guidelines for Managing Abnormal Cervical Cancer Screening Tests and Cancer Precursors American Society for and Cervical Pathology
More informationHuman Papillomavirus and Papanicolaou Tests to Screen for Cervical Cancer
original article Human Papillomavirus and Papanicolaou Tests to Screen for Cervical Cancer Pontus Naucler, M.D., Ph.D., Walter Ryd, M.D., Sven Törnberg, M.D., Ph.D., Anders Strand, M.D., Ph.D., Göran Wadell,
More informationDetecting High-Grade Cervical Disease on ASC-H Cytology. Role of BD ProEx C and Digene Hybrid Capture II HPV DNA Testing
Anatomic Pathology / BD ProEx C Use in ASC-H Cy t o l o g y Detecting High-Grade Cervical Disease on ASC-H Cytology Role of BD ProEx C and Digene Hybrid Capture II HPV DNA Testing Momin T. Siddiqui, MD,
More informationMEDICAL POLICY. SUBJECT: CERVICAL CANCER SCREENING and HUMAN PAPILLOMA VIRUS (HPV) TESTING
MEDICAL POLICY SUBJECT: CERVICAL CANCER SCREENING PAGE: 1 OF: 12 If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply. If a commercial product, including
More informationUpdate on HPV Testing. Robert Schlaberg, M.D., Dr. med., M.P.H. Assistant Professor, University of Utah Medical Director, ARUP Laboratories
Update on HPV Testing Robert Schlaberg, M.D., Dr. med., M.P.H. Assistant Professor, University of Utah Medical Director, ARUP Laboratories Disclosures In accordance with ACCME guidelines, any individual
More informationThe Korean Journal of Cytopathology 15 (1) : 17-27, 2004
5 The Korean Journal of Cytopathology 5 () : 7-7, / 5 / / (human papillomavirus, HPV), 6%, 5% HPV. HPV HPV. HPV HPV,,5 HPV HPV. HPV, 6 HPV. HPV HPV International Agency for Research on Cancer (IARC) HPV
More informationAppropriate Use of Cytology and HPV Testing in the New Cervical Cancer Screening Guidelines
Appropriate Use of Cytology and HPV Testing in the New Cervical Cancer Screening Guidelines Tim Kremer, MD Ralph Anderson, MD 1 Objectives Describe the natural history of HPV particularly as it relates
More informationOBJECTIVES. Emerging Laboratory Diagnostic Options for Sexually-transmitted Infections
Emerging Laboratory Diagnostic Options for Sexually-transmitted Infections OBJECTIVES I. Appreciate the changing epidemiology of trichomoniasis and clinician ordering patterns on the basis of improved
More informationSafe, Confident, QIAsure
Safe, Confident, QIAsure A new cervical cancer screening test Sample to Insight QIAsure: A breakthrough solution in Women s Health We are at a turning point in the battle against cervical cancer. The global
More informationUsefulness of p16/ki67 Immunostaining in the Triage of Women Referred to Colposcopy
Usefulness of p16/ki67 Immunostaining in the Triage of Women Referred to Colposcopy Jaume Ordi, MD, PhD 1 ; Amaia Sagasta, MD 1 ; Meritxell Munmany, MD 2 ; Leonardo Rodrıguez-Carunchio, MD 1 ; Aureli Torne,
More informationCytology/Biopsy/Leep Gynecologic Correlation: Practical Considerations and Approaches.
Cytology/Biopsy/Leep Gynecologic Correlation: Practical Considerations and Approaches. Fadi W. Abdul-Karim MD MEd. Professor of Pathology. Vice chair for education. Robert Tomsich Pathology and Lab Med
More informationSTOCS-H Scottish TOC Study HPV test comparison
STOCS-H Scottish TOC Study HPV test comparison What is entailed? Trial of new HPV tests on residual sample after HC2 result obtained, reported and acted on Complements English Sentinel Sites HPV Multi-test
More informationDisclosures Teresa M Darragh, MD
Below the Belt: Screening for HPV-associated Cancers Teresa M. Darragh, MD UCSF Departments of Pathology and Obstetrics, Gynecology & Reproductive Sciences Disclosures Teresa M Darragh, MD Hologic: Research
More informationEradicating Mortality from Cervical Cancer
Eradicating Mortality from Cervical Cancer Michelle Berlin, MD, MPH Vice Chair, Obstetrics & Gynecology Associate Director, Center for Women s Health June 2, 2009 Overview Prevention Human Papilloma Virus
More informationPhilip E. Castle, Diane Solomon, Mark Schiffman, Cosette M. Wheeler for the ALTS Group
ARTICLEARTICLESHuman Papillomavirus Type 16 Infections and 2-Year Absolute Risk of Cervical Precancer in Women With Equivocal or Mild Cytologic Abnormalities Philip E. Castle, Diane Solomon, Mark Schiffman,
More informationClinical Relevance of HPV Genotyping. A New Dimension In Human Papillomavirus Testing. w w w. a u t o g e n o m i c s. c o m
Clinical Relevance of HPV Genotyping A New Dimension In Human Papillomavirus Testing Human Papillomavirus: Incidence HPV prevalence was 26.8% for women in US aged 14 59 yrs 1 20 million Americans are currently
More informationSupplements to the European Guidelines on Prevention of Cervical Cancer
Asturias, 23 October, 2011 Asturias, 23 October Supplements to the European Guidelines on Prevention of Cervical Cancer M. Arbyn Unit Cancer Epidemiology, IPH, Brussels, Belgium Rue Juliette Wytsmanstraat
More informationCervical Cancer Prevention in the 21 st Century Changing Paradigms
Cervical Cancer Prevention in the 21 st Century Changing Paradigms Teresa M. Darragh, MD UCSF Departments of Pathology and Obstetrics, Gynecology & Reproductive Sciences Faculty Disclosures: Teresa M.
More informationRESEARCH ARTICLE. Abstract. Introduction
DOI:http://dx.doi.org/10.7314/APJCP.2015.16.16.6857 Cost-Effectiveness of Strategies for Detection CIN2+ in Women with ASC-US Pap Smears in Thailand RESEARCH ARTICLE Cost-Effectiveness Analysis of Different
More informationVery Low Human Papillomavirus DNA Prevalence in Mature Women With Negative Computer-Imaged Liquid-Based Pap Tests
292 Very Low Human Papillomavirus DNA Prevalence in Mature Women With Negative Computer-Imaged Liquid-Based Pap Tests Chengquan Zhao, MD 1 Esther Elishaev, MD 1 Ke-Hai Yuan, PhD 2 Jing Yu, MD 1 R. Marshall
More information1/12/2016. I do not engage in any lucrative deals that require disclosure.
I do not engage in any lucrative deals that require disclosure. Sabrina Hofmeister, DO Assistant Professor Columbia St. Mary s Family Medicine Residency Program MCW Department of Family and Community Medicine
More informationComparison of HPV test versus conventional and automation-assisted Pap screening as potential screening tools for preventing cervical cancer
BJOG: an International Journal of Obstetrics and Gynaecology August 2004, Vol. 111, pp. 842 848 DOI: 1 0. 1111/j.1471-0528.2004.00210.x Comparison of HPV test versus conventional and automation-assisted
More informationLong-Term Outcome and Relative Risk in Women With Atypical Squamous Cells of Undetermined Significance
Anatomic Pathology / LONG-TERM OUTCOME WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE Long-Term Outcome and Relative Risk in Women With Atypical Squamous Cells of Undetermined Significance Stephen
More informationAjmal Akbari 1, Davy Vanden Broeck 1,2,3,4*, Ina Benoy 1,2,4, Elizaveta Padalko 2,5, Johannes Bogers 1,2,3,4 and Marc Arbyn 6
Akbari et al. Virology Journal (2018) 15:166 https://doi.org/10.1186/s12985-018-1076-6 RESEARCH Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international
More informationThe data from the ATHENA study and others bring this expectation and the appropriateness of the guidelines for women aged into question.
New data support HPV testing beginning at age 25 By Hope Cottrill, M.D. Recent findings from the ATHENA (Addressing the Need for Advanced HPV Diagnostics) study of cervical cancer screening revealed surprising
More informationThe society for lower genital tract disorders since 1964.
The society for lower genital tract disorders since 1964. Updated Consensus Guidelines for Managing Abnormal Cervical Cancer Screening Tests and Cancer Precursors American Society for and Cervical Pathology
More informationEvaluation of Low-Grade Squamous Intraepithelial Lesions, Cannot Exclude High-Grade Squamous Intraepithelial Lesions on Cervical Smear
The Korean Journal of Pathology 2010; 44: 528-35 DOI: 10.4132/KoreanJPathol.2010.44.5.528 Evaluation of Low-Grade Squamous Intraepithelial Lesions, Cannot Exclude High-Grade Squamous Intraepithelial Lesions
More informationThe Bethesda System: Updates for th Cytopathology Congress Bursa, Turkey October 14, 2015
HARVARD MEDICAL SCHOOL The Bethesda System: Updates for 2015 6th Cytopathology Congress Bursa, Turkey October 14, 2015 David C. Wilbur, M.D. Dept. of Pathology Massachusetts General Hospital DISCLOSURES
More informationComparison of the Third Wave Invader Human Papillomavirus (HPV) Assay and the Digene HPV Hybrid Capture 2 Assay for Detection of High-Risk HPV DNA
JOURNAL OF CLINICAL MICROBIOLOGY, May 2008, p. 1641 1646 Vol. 46, No. 5 0095-1137/08/$08.00 0 doi:10.1128/jcm.01824-07 Copyright 2008, American Society for Microbiology. All Rights Reserved. Comparison
More informationJean-Christophe Noël and Philippe Simon. 1. Introduction
Analytical Cellular Pathology Volume 2015, Article ID 746502, 4 pages http://dx.doi.org/10.1155/2015/746502 Research Article Limitations on the Detection Rate of High-Risk HPV by Hybrid Capture 2 Methodology
More informationHPV: cytology and molecular testing
HPV: cytology and molecular testing Human Papillomavirus and how we test for it at Medlab Central Palmerston North for Cervical Cancer prevention and management. Developed by Reem Mustafa Cytology and
More informationMolecular Triage: Partial and Extended Genotyping and More!
Molecular Triage: Partial and Extended Genotyping and More! Thomas C. Wright, Jr. MD Professor Emeritus Columbia University, New York Pathologist, Enzo Clinical Laboratories, Farmingdale, NY Disclosures
More information