Triage of ASC Cytology Using Biomarkers: A Comparative Study of SurePath and ThinPrep Platforms.
Reza Alaghehbandan, Daniel Fontaine, Samuel Ratnam. Faculty of Medicine, Memorial University of Newfoundland, St. John's, Canada
Background: The objective of this study was to assess and compare the predictability of novel biomarkers, MCM/Top2A (ProEx C, BD), HPV E6E7 mRNA (Proofer, NorChip) and HPV DNA (HC II, Qiagen) in women with ASC (atypical squamous cell) cytology with biopsy confirmed high grade dysplasia or worse (CIN [cervical intraepithelial neoplasia] 2 +) in ThinPrep (Hologic) and SurePath (BD) liquid based cytology (LBC) platforms.
Design: Study population consisted of patients referred for colposcopy in 5 of the 10 Canadian provinces as part of the TPAPT (Transient Persistent And Persistent Transforming) study. Two separate cytology samples from each patient were collected (n=1821); the first sample was collected in ThinPrep PreservCyt medium with the second collected in SurePath medium. PreservCyt specimens were tested for HPV DNA and E6/E7 mRNA while those collected in SurePath tested for MCM/Top2A. Histology confirmed CIN2+ served as the disease end point. Binary logistic regression models were performed to examine the usefulness of biomarker profiles for each of the LBC platforms.
Results: Of 1821 patients, 392 (21.5%) and 251 (13.8%) patients were identified having ASC cytology by ThinPrep and SurePath platforms, respectively. The frequency of CIN 2+ in ThinPrep and SurePath cohorts were 20.9% (82/392) and 22.3% (56/251). Table 1 presents findings of logistic regression analysis for the two groups. No statistically significant difference was found between the odds ratio in each model between the two platforms.
|ThinPrep (n=392)||SurePath (n=251)|
|Odds Ratio||95% CI||Odds Ratio||95% CI|
|HC II DNA and E6E7 mRNA||7.3||4.3-12.4||4.6||2.5-8.7|
|HC II DNA and MCM/Top2A||6.6||3.9-11.3||2.5||1.3-4.6|
|E6E7 mRNA and MCM/Top2A||7.0||4.0-12.5||4.6||2.1-9.7|
|HC II DNA, E6E7 mRNA and MCM/Top2A||7.6||4.2-13.5||4.5||2.1-9.7|