Detection of cervical precancerous lesions with Aptima HPV assays using SurePath preservative fluid specimens

Max Chernesky; Dan Jang; Nick Escott; Jodi Gilchrist; Jenny Li; Laurie Elit; Alice Lytwyn; Marek Smieja; Sam Ratnam; Manuel Arias; Damon Getman; Barbara Weinbaum; Brett Kirkconnell; Janel Dockter

doi:10.1016/j.pvr.2017.04.005

Detection of cervical precancerous lesions with Aptima HPV assays using SurePath preservative fluid specimens

Papillomavirus Res. 2017 Jun:3:155-159. doi: 10.1016/j.pvr.2017.04.005. Epub 2017 Apr 28.

Authors

Max Chernesky¹, Dan Jang², Nick Escott³, Jodi Gilchrist², Jenny Li², Laurie Elit⁴, Alice Lytwyn⁴, Marek Smieja², Sam Ratnam⁵, Manuel Arias², Damon Getman⁶, Barbara Weinbaum⁶, Brett Kirkconnell⁶, Janel Dockter⁶

Affiliations

¹ St. Joseph's Healthcare/McMaster University, Hamilton, Ontario, Canada. Electronic address: chernesk@mcmaster.ca.
² St. Joseph's Healthcare/McMaster University, Hamilton, Ontario, Canada.
³ Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON, Canada.
⁴ Juravinski Hospital Colposcopy Clinic, Hamilton, ON, Canada.
⁵ Newfoundland & Labrador Public Health Laboratory, St. John's, NL, Canada.
⁶ Hologic, Inc., San Diego, CA, United States.

Abstract

SurePath specimens from women referred to colposcopy were treated with Aptima Transfer Solution (ATS) before testing in Aptima HPV (AHPV) and Aptima HPV 16, 18/45 (AHPV-GT) assays. Untreated SurePath specimens were tested with the cobas HPV test. PreservCyt specimens were assessed for cytology and tested with AHPV. High-grade cervical intraepithelial neoplasia lesions served as the reference standard. Excellent agreement (95.5%; k=0.91) was observed for ATS-treated SurePath specimens between Tigris and Panther systems and between the PreservCyt and ATS-treated SurePath specimens (91.1%, k=0.81) with the AHPV assay on Tigris. Agreement between the AHPV and cobas assays with SurePath specimens was substantial (89.9%, k=0.80). AHPV sensitivity for CIN2+(n=147) was 91.2% for SurePath and PreservCyt. Cobas HPV sensitivity was 93.9% for SurePath specimens. AHPV testing of SurePath specimens was more specific (59.4%) than cobas (54.7%) (p<0.001). Detection and genotyping showed similar absolute and relative risks. ATS-treated SurePath specimens tested with AHPV and AHPV-GT assays showed similar performance with greater specificity than cobas HPV on SurePath specimens. Similar overall results were seen using a CIN3 disease endpoint.

Keywords: Aptima transfer solution (ATS); CIN2+,; Cervical intraepithelial neoplasia; Human papillomavirus; PreservCyt; SurePath.