Aptima HPV messenger RNA testing and histopathologic follow-up in women with HSIL cytology: A study emphasizing additional review of HPV-negative cases.

Abstract

BACKGROUND:

High-risk human papillomavirus (hrHPV) messenger RNA (mRNA) testing, the Food and Drug Administration-approved testing platform since 2013, has been increasing as a cervical screening alternative to hrHPV DNA testing methods. This study reports the largest routine clinical follow-up study reported to date of hrHPV mRNA cotesting and histopathologic follow-up results for women with high-grade squamous intraepithelial lesion (HSIL) cytology results.

METHODS:

HSIL Papanicolaou test results for women cotested with Aptima hrHPV mRNA testing between June 2015 and November 2020 were analyzed along with recorded histopathologic follow-up results within 6 months of screening.

RESULTS:

Aptima hrHPV mRNA-positive results were reported for 95.2% of the cotested HSIL cytology cases (905 of 951). Histopathologic cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was diagnosed on follow-up in 538 of 701 hrHPV mRNA-positive cases (76.8%) and in 15 of 36 hrHPV mRNA-negative cases (41.7%). Additional reviews of the hrHPV mRNA-negative HSIL cases showed variable interpretations, and confirmatory blinded-review interpretations of HSIL or atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion were more likely in cases with histopathologic CIN2+ (77.5% [93 of 120]) than those with cervical intraepithelial neoplasia grade 1 or negative findings (63.1% [101 of 160]; P < .01).

CONCLUSIONS:

This large routine-clinical-practice study confirms the previously reported high sensitivity of hrHPV mRNA testing for the detection of high-grade cervical dysplasia and cervical cancers. The blinded-review findings indicate that additional cytology review may be helpful for confirming an interpretation of HSIL in daily practice, especially for hrHPV-negative HSIL cases.

• Authors: Aofei Li, Juan Li, R Marshall Austin, Tiannan Wang, Dayne Ashman, Huina Zhang, Jonee Matsko, Chengquan Zhao
• Journal: Cancer cytopathology (Cancer Cytopathol) Vol. 129 Issue 8 Pg. 622-631 (08 2021) ISSN: 1934-6638 [Electronic] United States
• PMID: 33764649 (Publication Type: Journal Article, Review)
• Copyright: © 2021 American Cancer Society.

Chemical References

• DNA, Viral
• RNA, Messenger

Topics

• Alphapapillomavirus (chemistry)
• Carcinoma, Squamous Cell
• DNA, Viral (genetics)
• Early Detection of Cancer
• Female
• Follow-Up Studies
• Humans
• Papillomaviridae (genetics)
• Papillomavirus Infections (diagnosis)
• RNA, Messenger (genetics)
• Squamous Intraepithelial Lesions
• Uterine Cervical Dysplasia (diagnosis)
• Uterine Cervical Neoplasms (diagnosis)