Follow-up Outcomes in a Large Cohort of Patients With Human Papillomavirus-Negative ASC-H Cervical Screening Test Results
Dept of Pathology, Magee-Womens Hospital of University of Pittsburgh Medical Center, 300 Halket St, Pittsburgh, PA 15213American Journal of Clinical Pathology (Impact Factor: 2.51). 10/2012; 138(4):517-23. DOI: 10.1309/AJCPYK60BZRNNAHQ
Limited follow-up data are available on patients with cervical cytology results of atypical squamous cells, cannot exclude a high-grade intraepithelial lesion (ASC-H), who test negative for high-risk human papillomavirus (hrHPV). Between June 2005 and December 2010, 885 patients were identified with ThinPrep results of Hybrid Capture 2 (HC2) hrHPV-negative cervical ASC-H liquid-based cytology and follow-up histopathology or cytology results extending to September 2011. Of the 885 patients with available follow-up results, 549 (62.0%) had at least 1 histopathologic result during the entire follow-up period, whereas 336 (38.0%) had only cytologic follow-up documented. In an average follow-up period of 29 months, 14 (1.6%) of 885 patients with HPV-negative ASC-H results showed evidence of high-grade cervical intraepithelial neoplasia (CIN2/3). No cases of invasive cervical cancer were diagnosed. Four of 14 patients with HPV-negative ASC-H results with follow-up diagnoses of CIN2/3 had a history of earlier CIN2/3 diagnoses before HPV-negative ASC-H results. Follow-up of patients with HPV-negative ASC-H results using methods specified in this study yielded low rates of detectible CIN2/3 and no diagnoses of cervical cancer. Triage of study patients with HPV-negative ASC-H results to routine HPV and cytology cotesting at 1 year was a safe follow-up option.
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ABSTRACT: Cervical cancer is the second most common cancer in women worldwide and nearly all cases are human papillomavirus (HPV) related. Pap cytology screening has been very successful in lowering cervical cancer incidence and mortality in the US. With the increasing use of HPV DNA tests as a reflex test for ASC-US and co-testing of women over 30 for primary screening, there have been many reports of the HPV positive rates and clinical follow-up findings for women with various abnormal Pap diagnoses. This review describes the reported HPV detection rates for HSIL, LSIL, ASC-US, ASC-H, AGC, and negative Pap cytology and highlights the effect of HPV positivity on the follow-up detection of cervical lesions.Diagnostic Histopathology 08/2012; 18(8):341–347. DOI:10.1016/j.mpdhp.2012.06.007
- Zhonghua bing li xue za zhi Chinese journal of pathology 11/2012; 41(11):774-8. DOI:10.3760/cma.j.issn.0529-5807.2012.11.017
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ABSTRACT: Objective: To increase awareness of the limitations of high-risk human papillomavirus (hrHPV) laboratory-developed testing (LDT) widely used in US cervical cancer screening. Methods and results: A young woman in her 30s was diagnosed and treated for stage 1B1 cervical squamous cell carcinoma in which HPV 16 DNA was detected using polymerase chain reaction testing. Both 1 month before and 42 months before cervical cancer diagnosis, the patient had highly abnormal cytology findings; however, residual SurePath™ (Becton, Dickson and Company, Franklin Lakes, NJ) vial fluid yielded negative Hybrid Capture 2 (HC2; Qiagen NV, Hilden, Germany) hrHPV LDT results from each of the two specimens. This prompted questions to be asked concerning the performance characteristics of hrHPV LDT. A review of the available data indicates that (1) purification of DNA from SurePath specimens requires complex sample preparation due to formaldehyde crosslinking of proteins and nucleic acids, (2) HC2–SurePath hrHPV testing had not been Food and Drug Administration-approved after multiple premarket approval submissions, (3) detectible hrHPV DNA in the SurePath vial decreases over time, and (4) US laboratories performing HC2–SurePath hrHPV LDT testing are not using a standardized manufacturer-endorsed procedure. Conclusion: Recently updated cervical screening guidelines in the US recommend against the use of hrHPV LDT in cervical screening, including widely used HC2 testing from the SurePath vial. The manufacturer recently issued a technical bulletin specifically warning that use of SurePath samples with the HC2 hrHPV test may provide false negative results and potentially compromise patient safety. Co-collection using a Food and Drug Administration-approved hrHPV test medium is recommended for HPV testing of patients undergoing cervical screening using SurePath samples.Drug, Healthcare and Patient Safety 11/2012; 4(1):167-172. DOI:10.2147/DHPS.S37273
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