*1,2Sineque, A., 1Condo, T., 3Sebastião, J., 3Nhambe, C., 4Manuel, M., 1Mabasso, A., 3Sidumo, Z., 5Ceffa, S., and 5,6Ciccacci, F.
1Department of Biological Sciences, Faculty of Science, Eduardo Mondlane University, Maputo, Mozambique
2Centre for Functional Ecology–One Health, Department of Life Sciences, University of Coimbra, Coimbra, Portugal
3DREAM Program, Community of Saint’Egidio, Maputo, Mozambique
4Laboratory of Mavalane General Hospital, Maputo, Mozambique
5DREAM Program, Community of Saint’Egidio, Roma, Italy
6University of Rome Tor Vergata, Department of Biomedicine and Prevention, Rome, Italy
*Correspondence to: sineque.alberto@uem.ac.mz; Tel: +258 826 459 243; ORCiD: https://orcid.org/0000–0003–2468–9925
Abstract:
Background: High-risk (hr) human papillomaviruses (HPV) testing is immensely important in elucidating molecular epidemiology of HPV infections and has become an essential part of current clinical practice in the management of the precancerous lesions and cervical cancer risks. Evaluation of HPV testing systems suitable for large-scale organized cervical screening programs is required. Very little is known about the diagnostic performance of the Cobas assays in resource-limited settings, particularly in Mozambique. We evaluated the concordance of the Cobas 4800 and Cobas 5800 assays with the Cobas 6800 assay for detecting high-risk HPV genotypes in clinician-collected cervical samples.
Methodology: In Mozambique, HPV-based cervical cancer screening is being regionally implemented and is currently well established in Maputo using the Cobas 4800, Cobas 5800 and Cobas 6800 assays. A random subset of 124 samples from women older than 18 years attending organized cervical cancer screening and previously tested for hrHPV-DNA using Cobas 4800 and Cobas 5800, were used for a subsequent analysis on Cobas 6800. Results: Our results showed a good-to-high overall concordance of the Cobas 4800 and Cobas 5800 tests with Cobas 6800 test, showing strong Cohen’s kappa values (95%, κ=0.89, 95% CI: 0.80–0.98, for Cobas 4800 versus Cobas 6800; and 100%, κ=1.00, 95% CI: 1.00–1.00 for Cobas 5800 versus Cobas 6800). Similar performance to detect HPV-16, HPV-18, and the 12 other hrHPV genotypes was observed.
Conclusion: The global performance to detect the 14 hrHPV genotypes was not significantly different between the three Cobas assays, which supports their suitability for use in large centralized laboratories included within population-based cervical cancer screening programs in resource-limited settings.
Keywords. Cervical cancer screening, HPV testing, Cobas assays, Performance, Interlaboratory comparison
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