Chapter 10: HPV testing on cervical cancer specimens: which assay can be used in cervical cancer screening.

HPV-based screening offers more effective prevention against cervical cancer than cytology-based screening. Managers of screening programmes need to know which HPV tests are credible and have evidence-based performance in primary screening. Systematic reviews have assessed which high-risk HPV DNA tests are sufficiently reproducible and have non-inferior clinical accuracy compared to standard comparator tests already evaluated in large randomised trials. Other reviews compared the cross-sectional and longitudinal performance of hrHPV mRNA tests with validated DNA tests. These reviews are updated and summarised in this chapter. The assays that can be considered as clinically validated are listed in Text Box 1:

• Standard comparator tests (validated in population-based randomised trials: Hybrid Capture 2 HPV DNA Test; GP5+/6+ PCR-EIA.
• hrHPV DNA tests validated consistently in multiple studies against standard comparator tests: Alinity m HR HPV Assay; Anyplex II HPV HR Detection; Cobas 4800 HPV Test; HPV-Risk Assay; NeuMoDX; HPV Test Onclarity HPV Assay; PapilloCheck HPV-Screening Test; RealTime High Risk HPV Test; Xpert HPV.
• hrHPV DNA test validated consistently in multiple studies against alternative comparator test: Cobas 6800 HPV Test.
• hrHPV DNA tests evaluated in only one study against standard comparator tests: CLART HPV4S; OncoPredict HPV Screening; REALQUALITY RQ-HPV Screen.
• hrHPV mRNA test: APTIMA HPV Assay.

Published by Günes Publishing 2023