Download HPV DNA Testing Guideline

Guideline
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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.
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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
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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
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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
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