Low sensitivity of the careHPV™ Assay for detection of Oncogenic Human Papillomavirus in cervical samples from HIV-infected and HIV-uninfected Kenyan women

Abstract

Background: Human papillomavirus (HPV) infection causes cervical cancer (CC), a common malignancy among Kenyan women. New CC screening methods rely on oncogenic HPV (“high-risk”, or HR-HPV) detection, but most have not been evaluated in swabs from Kenyan women. Methods: HPV typing was performed on 155 cervical swabs from Kenyan women using the Roche Linear Array® (LA) and careHPV™ (careHPV) assays. Detection of 14 oncogenic HPV types in careHPV assay was compared to LA results. Results: Compared to LA, sensitivity and specificity of careHPV assay was 53.0% and 80.9%, respectively. The sensitivity and specificity of careHPV in swabs from women with cervical dysplasia was 74.1% and 65.2%, respectively. The sensitivity and specificity of careHPV in swabs from HIV-infected women was 55.9% and of 96.4%, respectively. Overall agreements of careHPV assay with LA was substantial. Conclusion: The results for careHPV assay are promising for oncogenic HPV detection in Kenyan women. The low sensitivity of careHPV for detection of HR-HPV could limit it’s benefit as a screening tool. Thus, a full clinical validation study is highly desirable before the careHPV assay can be accepted for cervical cancer screening.