The objective of this study is to evaluate and compare different strategies for the triage of women with a HPV-positive primary screening test. Clinical performance in terms of sensitivity, specificity, PPV, NPV will be calculated both cross-sectionally and longitudinally for of each triage strategy. The overall aim of the study is to define optimal algorithms for triage of HPV DNA positive women from primary HPV screening.
In partnership with CervicalCheck, The National Cervical Screening programme, CERVIVA are undertaking a longitudinal observational HPV primary screening study which will evaluate different triage strategies for management of a HPV-positive primary screening test. Cervical cytology samples from approximately 13,000 women undergoing routine cervical screening will be tested for HPV DNA (cobas 4800 HPV test) and mRNA (Aptima HPV assay). All HPV-positive women will be further assessed with cytology and a panel of molecular tests including HPV16/18 genotyping, p16INK4a/Ki-67, and specific methylation markers. The performance of different triage strategies will be examined both cross-sectionally and longitudinally over two screening rounds for detection of CIN3+.
To date 8500 woman have been recruited into the study. The median age of the population is 39 years. HPV DNA testing, performed on 7301 samples, shows a 14.7% positivity rate. HPV mRNA, performed on 7394 samples, gave a 12.7% positive rate. HPV mRNA had a significantly lower positivity rate in women under the age 40 years and women with a negative cytology (p=0.001 and p=0.0015). Second round testing identified 32% of HPV positive women were positive for HPV 16/18 and 30% had an abnormality on cytology. In a smaller subset 38% were positive for p16/Ki-67.
Overall prevalence of HPV mRNA is lower than HPV DNA in the study population. Here we present the preliminary cross-sectional data in relation in to each of the putative triage tests.