MobiLab rapid E6/E7 antigen test matched Cobas 4800 HPV DNA assay in 257 women, 99.22% agreement
In a cross-sectional study at Moi Teaching and Referral Hospital, a point-of-care antigen test agreed with PCR DNA testing for high-risk HPV; clinical validity is not yet established.
Researchers compared the MobiLab rapid oncoprotein E6/E7 antigen test with the Cobas 4800 HR-HPV DNA assay in a cross-sectional study reported in BMC Infectious Diseases. The work ran from February to July 2024 at Moi Teaching and Referral Hospital and included 257 randomly selected women aged 30 years and older who underwent cervical cancer screening. The two methods showed near-perfect agreement, with an overall agreement of 99.22% biomedcentral.com
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Study design and reference assay
Persistent infection with high-risk human papillomavirus (HR-HPV) accounts for approximately 97–99% of cervical cancer cases worldwide. DNA assays are considered the gold standard for screening and early detection, but in many low-resource settings they remain inaccessible because of cost and technical requirements. The MobiLab test is a point-of-care option that detects active expression of E6/E7 oncoproteins associated with malignant transformation.
Healthcare providers took a cervical swab from every participant for HR-HPV PCR DNA testing. A second cervical sample was then collected with the Delphi vaginal sampler for the MobiLab test. The reference standard, Cobas 4800, is a qualitative real-time PCR assay that amplifies target sequences in the L1 region of the HR-HPV genome. It detects 14 types: 16, 18 and 12 other oncogenic types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).
Agreement and limits
The MobiLab test was positive in 58.0% of women (149 of 257). Both assays classified 148 of 149 positive results and 107 of 108 negative results the same way. Positive agreement was 99.33%, negative agreement 99.07%, and Cohen's kappa 0.992 (95% CI 0.96–1.00; p < 0.001) biomedcentral.com
BMC Infectious Diseasesbiomedcentral.comOpen source ↗.
Against the Cobas 4800 reference, sensitivity was 99.33% (95% CI 96.32–99.98%) and specificity 99.07% (95% CI 94.95–99.98%). The positive predictive value was 99.33% (95% CI 95.46–99.90%), the negative predictive value 99.07% (95% CI 93.82–99.87%), and the area under the ROC curve 0.992 (95% CI 0.979–1.000).
The authors report that the MobiLab results agreed with those of the DNA assay. They state that further studies with cytological, colposcopic and histopathological endpoints are needed to establish clinical validity and to determine the role of the test in HPV screening programs in resource-limited settings.
