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Guideline [Optional heading here. Change font size to suit] Document Number # QH-GDL-313:2012 HPV DNA Testing 1. Purpose This Guideline provides recommendations regarding best practice for human papillomavirus (HPV) DNA testing undertaken on behalf of the Department of Health. HPV DNA testing is recommended under the National Health and Medical Research Council (NHMRC) Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities for women who have had treatment for a high grade squamous intraepithelial lesion (HSIL) to identify those who are at risk of further high-grade disease. The frequency of positive HPV tests following treatment for high-grade lesions is high in the first twelve months after treatment but diminishes significantly after that. The reliable negative predictive value provides a useful clinical tool for predicting women at greatest risk of recurrence. It also emphasises the importance of not testing for HPV DNA too soon after treatment. 2. Scope This Guideline provides information for all Hospital and Health Service employees providing cervical screening (permanent, temporary and casual) and all organisations and individuals acting as its agents (including Visiting Medical Officers and other partners, contractors, consultants and volunteers). 3. Related documents Authorising Policy and Standard/s: NHMRC Guidelines for the Management of Asymptomatic Women with Screen Detected Abnormalities (2005) Procedures, Guidelines and Protocols: Department of Health Guidelines for the Use of Liquid-based Cytology 4. Guideline for the Process for women after treatment for a high grade squamous intraepithelial lesion (HSIL) In accordance with the NHMRC Guidelines, it is recommended that a woman who has had treatment for a HSIL shall be managed as follows (see Figure 1): colposcopy and cervical cytology at 4-6 months after treatment cervical cytology and HPV DNA ‘test for cure’ at 12 months after treatment and then annually until she has tested negative by both tests on two consecutive occasions then return to the usual two yearly screening interval. Version No.: <no> Version No.: <no> ; Effective From: <date> ; Effective From: <date> Effective From: 10 March 2014 Page 1 of 4 Page 1 of 4 Page 1 of 4 Department of Health: Guideline for HPV DNA Testing Please note: the current guidelines do not indicate the use of HPV DNA test of cure for women with previous glandular lesions. 5. Process for HPV DNA Testing Pathology Queensland (PQ) provides the Digene Hybrid Capture 2® technique for HPV DNA testing. There are two alternative specimen collection methods using this system: Collection method 1 (PQ preferred) If a conventional Pap smear is also required (as will usually be the case), collect this first using the desired collection device/s. Then collect a second specimen for HPV DNA using the cervical sampler included in the Hybrid Capture 2® collection kit. Collection method 2 (Alternative) Collect and prepare a conventional Pap smear using a plastic Ayers spatula and cytobrush or Cervex® broom. Thoroughly rinse the collection devices in a ThinPrep® (PreservCyt) vial. The same ThinPrep® vial can be used for both cytology and HPV DNA testing if required. Please note: the HPV DNA extraction requires additional processing by the laboratory, therefore liquid samples of insufficient volume may not be suitable for HPV DNA testing. The Pap smear and vial for HPV DNA testing should be forwarded as soon as practical to the laboratory. No refrigeration is required. The conventional Pap smear specimen (+/ThinPrep® vial) is processed by Cytopathology at PQ – Central, Royal Brisbane and Women’s Hospital (RBWH). The HPV DNA ‘Test of Cure’ specimen is processed by the Microbiology Division of PQ – Central, RBWH. If both a ThinPrep® test and HPV DNA test are requested on a single vial please remember this must be clearly indicated on the vial AND on the request form, as it will be necessary to split the sample received in the ThinPrep® vial. Thin Prep® vials will be processed in accordance with the Department of Health Guidelines for the Use of Liquid-based Cytology. Effective From: 10 March 2014 Page 2 of 4 Department of Health: Guideline for HPV DNA Testing 6. Results: Reporting of HPV DNA results will take approximately 2-4 weeks. The results of the HPV DNA ‘test of cure’ are reported as: High risk HPV DNA Not Detected High risk HPV DNA Detected When HPV DNA is detected, the following comment will be added to the report: The detection of HPV DNA indicates the presence of a target corresponding to one of thirteen high risk HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68). All HPV DNA ‘test of cure’ results will be automatically forwarded to the Pap Screen Register (PSR) in accordance with the Public Health Act 2005, unless the request form is marked ‘not for PSR’, at the client’s choice. Figure 1: HPV DNA ‘Test of Cure’ pathway 7. Review This Guideline is due for review on: 10/12/2017 Date of Last Review: 10/12/2013 Supersedes: HPV DNA Testing Effective From: 10 March 2014 Page 3 of 4 Department of Health: Guideline for HPV DNA Testing 6. Business Area Contact Preventive Health Unit 7. Definitions of terms used in the policy and supporting documents Term Definition / Explanation / Details HPV Human papillomavirus DNA Deoxyribonucleic acid HSIL High grade squamous intraepithelial lesions CIN Cervical intraepithelial neoplasia RBWH Royal Brisbane and Women’s Hospital PQ Pathology Queensland PSR Pap Smear Registry 8. Source Approval and Implementation Policy Custodian: Senior Director, Preventive Health Unit Responsible Executive Team Member: Chief Health Officer Approving Officer: Dr Jeannette Young, Chief Health Officer Approval date: 10 March 2014 Effective from: 10 March 2014 Version Control Insert details of any changes made to this document Version Date Prepared by Effective From: 10 March 2014 Comments Page 4 of 4