Abstract:
ackground: 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 careHPVTM (careHPV) assays. Detection of 14 oncogenic HPV types
in careHPV assay was compared to LA results.
Results: Compared to LA, sensitivity and specifi city of careHPV assay was 53.0% and 80.9%,
respectively. The sensitivity and specifi city of careHPV in swabs from women with cervical
dysplasia was 74.1% and 65.2%, respectively. The sensitivity and specifi city 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 benefi t as
a screening tool. Thus, a full clinical validation study is highly desirable before the careHPV assay
can be accepted for cervical cancer screening.