Introduction/Background An analysis of the body of science published recently about the clinical value of triage options after HPV-positive test results.

Methodology MedLine was searched from 2001 through 2019 for relevant studies. Hand-searching of retrieved article reference lists supplemented the search. Eligible studies included prospective studies of women and retrospective studies of residual specimens from women that were tested using HPV genotyping tests. The reference standards were CIN2 or CIN3 or CIN2+ or CIN3+ or invasive cervical cancer. The comparator was cytology as a triage for HPV-positive results.

Results Reporting genotyping provides profound discrimination of both current and future CIN3+ risks, due to the differential risks. Genotyping combined with cytology improves risk discrimination for Bethesda categories NILM, ASC-US, LSIL. Improvements in referral rates may be achieved. Similar management for similar risk-discrimination is benchmarked. Immunohistochemical staining with p16 and Ki67 has good evidence for triage of HPV-positive screening results. Methylation of viral HPV and host markers has fair evidence for triage of HPV-positive screening results, and may be applicable to self-collected samples.

Conclusion Based on quality-evaluated studies that met inclusion criteria, genotyping combined with cytology discriminates risk and supports risk-based clinical action steps by the principle of equal management for equal risk. P16/Ki67 staining could be used as an adjunct to cytology or to replace cytology. Methylation tests could be developed as a screening test, an adjunct triage test with cytology, or to replace cytology as triage. Future research is needed to determine if genotyping could have clinical use without cytology. Inclusion of vaginal swab and/or urine self-collection as initial screening samples will stimulate development of triage tests that do not require direct sampling of the transformation zone. Models for different management paradigms are described.

Disclosure Speaker is a full-time employee of BD, as Worldwide Medical Director of Women´s Health & Cancer.