Assessment of the Reliability of a Novel Self-sampling Device for Performing Cervical Sampling in Malaysia

Abstract

<b>Background:</b> The participation of women in cervical cancer screening in Malaysia is low. Self-sampling mightbe able to overcome this problem.The aim of this study was to assess the reliability of self-sampling for cervicalsmear in our country. Materials and <br/><b>Methods</b>: This cross-sectional study was conducted on 258 communitydwelling women from urban and rural settings who participated in health campaigns. In order to reduce thesampling bias, half of the study population performed the self-sampling prior to the physician sampling while theother half performed the self-sampling after the physician sampling, randomly. Acquired samples were assessedfor cytological changes as well as HPV DNA detection. <br/><b>Results</b>: The mean age of the subjects was 40.4±11.3 years.The prevalence of abnormal cervical changes was 2.7%. High risk and low risk HPV genotypes were found in4.0% and 2.7% of the subjects, respectively. A substantial agreement was observed between self-sampling andthe physician obtained sampling in cytological diagnosis (k=0.62, 95%CI=0.50, 0.74), micro-organism detection(k=0.77, 95%CI=0.66, 0.88) and detection of hormonal status (k=0.75, 95%CI=0.65, 0.85) as well as detectionof high risk (k=0.77, 95%CI=0.4, 0.98) and low risk (K=0.77, 95%CI=0.50, 0.92) HPV. Menopausal state wasfound to be related with 8.39 times more adequate cell specimens for cytology but 0.13 times less adequate cellspecimens for virological assessment. <br/><b>Conclusions</b>: This study revealed that self-sampling has a good agreementwith physician sampling in detecting HPV genotypes. Self-sampling can serve as a tool in HPV screening whileit may be useful in detecting cytological abnormalities in Malaysia.