The development of a strategy for providing an HPV testing service for cervical cytology laboratories in South Wales
Cardiff Metropolitan University
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Introduction: Infection with high-risk strains of the Human Papillomavirus (hrHPV) is the essential underlying cause of cervical cancer. The molecular detection of hrHPV DNA has a higher negative predictive value than the smear test in detecting cervical intraepithelial neoplasia (ClN). hrHPV detection in low grade cytology samples can triage women at risk of CIN for referral to colposcopy. The absence of hrHPV following treatment for CIN reduces follow up in these women. Method: A trial HPV detection service was setup in a hub/spoke arrangement for cytology laboratories in South Wales using samples from two sites. This study tested 302 residual cervical samples for the triage of cytological Borderline/Mild Dyskaryosis abnormalities, and as test of cure (TOC) in cytology negative samples following treatment, from women invited through the Welsh Cervical Screening Program. The digene Hybrid Capture® 2 (HC2) system was used to detect 13 strains of HR-HPV. Cytology/colposcopy reporting statistics from 2008-09 were retrieved to estimate the impact of triage/TOC introduction to laboratories in South Wales. Results: For 25-64 yr old women, HR-HPV positivity in Borderline smears was 55.3% (95% CI 46.0%- 63.5%), which decreased with age, and 67.6% (95% Cl 50.2%-82.0%) in Mild Dyskaryosis. hrHPV positivity for TOC in 25-64yr olds was 7.3% (95% Cl 3.0%-14.4%), and highest following treatment for CtNl (1S.2%;95% Cl 2.3%-5L.8%). Variation in positivity between laboratories was not significant (Borderline: P=0.280; Mild: P=0.488; TOC P=1.000). Sample numbers in Cytology laboratories are expected to decrease in the second year after triage/TOC (by 33% Borderline; 48% Mild; 92.7% ClN1- 3 follow up).Colposcopy referrals will increase by 61% in year 1, and 23% in year 2, over 2008-09 when testing 25-64yr olds. The introduction of triage and test of cure in 25-64yr olds will require an investment of £1,439,592.00 in year 1, and £502,938.50 in year 2, primarily due to increased colposcopy referrals. Discussion: A hub and spoke HPV testing service for triage and test of cure can be offered to laboratories in South Wales with minimal further notice. Sample batching through hub and spoke is necessary to minimise turn-around time. The impact of HPV testing 20-24yr olds is uncertain. In view of the 12.5% (95% Cl 0.3%-52.7%) control failure rate which required the re-testing of samples, HC2 is not recommended and alternative HPV testing technologies should be explored.
MSc Biomedical Science (Cellular Pathology)
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