Triaging Women with Prior ASCUS Liquid Based Cytology (LBC) Results with Hr-HPV DNA Testing in Harare, Zimbabwe

Abstract

Background: ASCUS is a borderline cytopathological diagnostic category that leaves clinicians with a dilemma regarding how to manage the patient. Triaging women with prior ASCUS results with Hr-HPV testing helps to distinguish those with true neoplastic lesions from those with reactive epithelial lesions. This distinction helps to inform the best clinical management strategy. Objectives: (1) To determine the proportion of LBC samples with prior ASCUS results that were positive for Hr-HPV. (2) To determine the Hr-HPV genotypes commonly detected in ASCUS LBC samples. (3) To determine an association between the detection of Hr-HPV and the presence of histology dysplasia in the follow up cervical biopsies. Materials and Methods: This was a cross section descriptive study done at Cimas Medical Laboratories and KAVI molecular laboratory from June 2020 to March 2021. The study subjects were women with prior ASCUS cytology results. Hr-HPV testing was done using the HPV Genotypes 14 Real-TM Quant test kit. Follow up cervical biopsies were processed in a Citadel 2000 tissue processor and stained using the manual H&E staining protocol. The histology slides were reported by two independent pathologists. Discrepant findings were referred to a third pathologist who acted as a tie breaker.  A Chi-square test was used to determine an association between the detection of Hr-HPV and the presence of histology dysplasia. A p-value <0.05 was regarded as statistically significant. Results: The mean (SD) age of the study participants was 36.3 (8.5) years. Of the 109 tested LBC samples, 65.1% [71/109] were Hr-HPV positive and 34.9 [38/109] were Hr-HPV negative. The mean ages’ of the HR-HPV+ and HR-HPV- patients were comparable (37.1 years vs. 35.9 years, respectively; p=0.526). Of the 71 Hr-HPV positive samples, 8.5% [6/71] had multiple HPV genotypes detected. Therefore, a total of 78 Hr-HPV genotypes were detected from the 71 samples. HPV 52 was the most frequent; contributed 24.4% [19/78] of all the detected genotypes. Ten of the 17 (58.9%) cervical biopsies analyzed had a ≥LSIL diagnosis. The association between the detection of Hr-HPV and dysplasia on the cervical biopsy was statistically significant p=0.03. Conclusions: The majority (65.1%) of women with prior ASCUS results were positive for Hr-HPV. HPV 52 is the most frequently detected Hr-HPV genotype. A strong association  between the detection of Hr-HPV and dysplasia on the cervical biopsy was noted in this study. Recommendation: Triaging patients with prior ASCUS results with Hr-HPV DNA testing is useful in stratifying patients according to the risk of harboring more serious cervical lesions.