Reporting References and Notes
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High Risk HPV
References
- National Cancer Institute website: www.cancer.gov (2008).
- Meijer CJ,et al. 2006. Clinical utility of HPV genotyping. Gynecol Oncol 103: 12-17.
- Wright TC, et al 2002. Consensus Guidelines for the management of women with cervical cytological abnormalities. JAMA 287: 2120-2129.
- Wright TC, Jr. et al, 2007. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol 197(4): 346-55.
Testing Notes
The Cervista HPV HR test is an in vitro diagnostic test for the qualitative detection of DNA from the 14 high-risk Human Papillomavirus (HPV) types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) in cervical specimens collected in the Cytyc ThinPrep Pap Test PreservCyt Solution. Performance characteristics for specimens collected in TriPath Imaging SurePath Pap Collection Fluid have been validated at EPI. EPI is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.
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HPV 16/18 References
References
- Meijer CJ, et al. 2006. Clinical utility of HPV genotyping.Gynecol Oncol 103: 12-17.
- Khan MJ, et al. 2005. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 andthe possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst 97:1072-1079.
- Castle PE et al 2005. Human Papillomavirus Type 16 Infections and 2-Year Absolute Risk of Cervical Precancer in Women With Equivocal or Mild Cytologic Abnormalities. J
- Natl Cancer Inst 97: 1066-1071.
- Wright TC, Jr. et al, 2007. 2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests. Am J Obstet Gynecol 197(4): 346-55.
Testing Notes
Cervista HPV 16/18 test can be used adjunctively with the Cervista HPV HR test in women 30 years and older and in patients with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV types 16 and 18. This information together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The Cervista HPV 16/18 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 collected in the Cytyc ThinPrep Pap Test PreservCyt Solution. Performance characteristics for specimens collected in TriPath Imaging SurePath Pap Collection Fluid have been validated at EPI. EPI is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.