Agreement and comparative performance of the MobiLab rapid oncoprotein E6/E7 antigen test and Cobas 4800 high-risk human papillomavirus deoxyribonucleic acid test for cervical cancer screening in a low-resource setting: a cross-sectional study

Abstract Background: Persistent high-risk human papillomavirus is responsible for 95% of all cases of cervical cancer worldwide. Screening for high-risk genotypes has been acknowledged as the gold standard for the elimination of cervical cancer. However, most low- and middle-income countries have limited access to this screening method because ofa lack of adequate sustainable resources. Objective: This study aimed to compare the diagnostic accuracy of the rapid high-risk human papillomavirus 16/18 oncoprotein E6/E7 antigen test to that of the polymerase chain reaction (PCR) deoxyribonucleic acid test among women who presented to family planning and dysplasia clinics at Moi Teaching and Referral Hospital. Methods: This was a cross-sectional study performed between February and July 2024 to compare the diagnostic accuracy of the rapid high-risk human papillomavirus 16/18 oncoprotein E6/E7 antigen test to that of the polymerase chain reaction deoxyribonucleic acid test among women who underwent cervical cancer screening at Moi Teaching and Referral Hospital. Two hundred and fifty-seven (257) women aged 30 years and older were randomly selected for this study. A cervical swab was obtained from all participants for human papillomavirus polymerase chain reaction deoxyribonucleic acid testing, followed by cervical sample collection using the Delphi vaginal self-sampler for the rapid human papillomavirus oncoprotein E6/E7 antigen test. To achieve the objective of the study, sensitivity, specificity, positive predictive value, and negative predictive value were measured. Data on sociodemographicand clinical characteristics were collected and analysed. The significance of the data was set at a two-tailed p<0.05. The chi-squaretest was used to compare categorical variables. Fisher’s exact test or the Monte Carlo correction was used for the chi-square analysis when more than 20% of the cells had an expected count <5. Results: The sensitivity of the rapid oncoprotein E6 and E7 test was 99.33%, and the specificity was 99.07%. In addition, the positive predictive value and negative predictive value were 99.33% and 99.07%, respectively. Furthermore, the accuracy of the rapid oncoprotein E6/E7 test was 99.22%. These findings were statistically significant (p <0.001, 95% CI=0.98–1.00), and the AUC for the rapid oncoprotein E6/E7 test was 0.992. Conclusion: The accuracy of the rapid high-risk human papillomavirus mRNA oncoprotein E6/E7 antigen test is as good as that of the polymerase chain reaction deoxyribonucleic acid test for cervical cancer screening in low-resource settings.