Comparison of automated cytological analysis of anal cytology in two different moments and evaluation of the results' concordance

Abstract

Anal HPV is a very common infection in men who have sex with men, with incidence rates between 60-70%, and 90-95% in those living with HIV. The infection by multiple types of HPV is frequent and some types of HPV are related to a higher risk of high grade intraepithelial lesions and progression to anal cancer. Types 6 and 11 are more usually found in benign anal lesions as condyloma acuminatum, but types 16 and 18 are more related to anal cancer, as well as to cervical cancer. Other types of HPV (33, 38 and others) are also frenquently found in viral DNA analysis in anal canal samples in men who have sex with men. HPV is the main risk factor associated to anal cancer. The infection persistence, specially by type 16, is responsible for 75% of anal cancer cases. Anal cytology is one of the available tests for screening of anal intraepithelial lesions, with sensibility from 70 up to 90% for high grade lesions and 50 to 77% for low grade lesions, with specificity, respectively, of 32-59% and 53-85%. Liquid base cytology has the benefit of having more material available to be analysed, and the automated analysis can be done to accelerate the results, however it is necessary to know if this system has proper reproducibility. AIMS: Evaluating the results obtained by automated analysis through FocalPoint GS Imaging System (FPGS) (BD, Burlington, NC) in two different moments. MATERIALS AND METHODS: The samples (liquid base) will be collected in participating patients of a previously approved clinical study and will be analysed by the FocalPoint GS Imaging System (FPGS) (BD, Burlington, NC), which selects fifteen probable areas and classify them according to dysplasia risk. The same slides will be reevaluated three months after the first analysis. At the two moments, a cytopathologist will also examine the slides after the initial analysis done by the automated system. EXPECTED RESULTS AND APPLICATIONS: Evaluating, in two different moments, the concordance rate of th FocalPoint GS Imaging System (FPGS) (BD, Burlington, NC) in order to detect probable dysplasia areas in anal cytology samples. (AU)