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2006 Consensus guidelines for the management of women with abnormal cervical cancer screening tests.
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04/10/2009
SERUM FREE LIGHT CHAINS, A New Test for Patients with Monoclonal Gammopathies
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02/04/2009
Article Answers Questions Re: Testing for GC/Chlamydia in Liquid Based Pap Collection Vials
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08/04/2008
RML, Inc. Receives Accreditation From College of American Pathologists
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05/18/2007
www.mybiopsy.org Informative Website Answers Questions About Cancer
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Human Papilloma Virus (HPV) Testing Update
09/09/04
Human Papilloma Virus (HPV) Tesing Update
HPV DNA testing, used as an adjunct to Pap smears in cervical cancer screening, has drawn a considerable amount of interest within the past few years. It has been demonstrated that 99 percent of cervical cancers have detectable HPV DNA. In 2002, the American Society of Colposcopy and Cervical Pathology issued guidelines for the management of women with cervical abnormalities. Their recommendation, for women with an ASC-US Pap smear diagnosis, is follow up with high risk HPV DNA testing. Women who test positive for high risk HPV DNA should be referred for colposcopic evaluation. In 2003, the American College of Obstetricians and Gynecologists made the recommendation that one screening option, for patients over 30 years of age, is to perform the Pap smear in conjunction with high risk HPV DNA testing. If both the cervical cytology and the high risk HPV DNA test are negative, rescreening should occur no sooner than 3 years.
Currently there are two testing methodologies which are used for routine HPV DNA testing, HC (hybrid capture) and ISH (in-situ hybridization). Both use a cocktail of probes for high-risk types of HPV DNA. Recent correlation studies have been presented giving a comparison of the two methods. In the first study a total of 10,861 women aged 17-67 were screened using a liquid based Pap collection system. 762 cases of ASC-US or LSIL were reflexed to both HC and ISH testing. The accuracy of the testing was evaluated using histologic diagnosis as the gold standard. Sensitivity (proportion of patients identified by the test that are truly positive) and specificity (proportion of patients that are identified as negative that are truly negative) were evaluated. The overall sensitivity for ISH testing was 97%, while the sensitivity for HC testing was 79%. The overall specificity for ISH was 86%, while the specificity for HC was 56%. This particular study documented the increased diagnostic value of ISH HPV over the HC HPV. As a public health concern, the ISH HPV has the potential to eliminate many unnecessary colposcopic examinations. In a second study, conducted by Impath Laboratories, a comparison study of the two methods utilized PCR DNA testing as the gold standard. Both ISH and HC methods showed similar sensitivities of 100%, but ISH testing demonstrated a significantly better specificity when compared with HC (100% vs 71%). The conclusion of the study was because of its high specificity for high risk HPV detection, HPV testing by ISH should be strongly considered the method of choice when selecting patients with the cytologic diagnosis of ASC-US for subsequent therapeutic intervention.
Beginning in September, RML will be performing all high risk HPV testing by the ISH method. Testing will be performed utilizing the SurePath liquid Pap collection vials. Collection
instructions have not changed. For your convenience, the HPV report will now be incorporated into the Pap report.
High risk HPV testing may be ordered with the Pap test on the RML test request in two ways:
1. Test number 4148 Pap, Surepath w/HPV if indicated. The high risk HPV test will be run if the Pap diagnosis is ASC-US.
2. Test number 3148 Pap, Surepath w/HPV. The high risk HPV test will be run regardless of the Pap interpretation.
If you have questions regarding this methodology change, please contact our Pathology Department at 969-6161 ext. 6979.
References:
Qureshi MN, Rudelli RD, et al., Role of HPV DNA Testing in Predicting Cervical Intraepithelial Lesions: Comparison of HC HPV and ISH HPV. Diagnostic Cytopathology. 2003 Sept; 29(3): 149-55.
Horton B, Owens M, et al., Comparison of Evaluation of In Situ Hybridization vs. Hybrid Capture II for High Risk HPV Detection in Liquid
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