Analysis on the Performance Concordance of Cobas 4800 and Cobas 5800 Tests with Cobas 6800 Test for High-Risk HPV Detection/Genotyping in Cervical Samples: An Interlaboratory Evaluation in Maputo, Mozambique

Background: High-risk (hr) human papillomaviruses (HPV) testing is immensely important in elucidating the 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 organised 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 implementation of HPV cervical screening is underway on a regional basis; currently in Maputo, and using the Cobas 4800, Cobas 5800, and Cobas 6800 tests. A random subset of 124 samples from women older than 18 years attending organised cervical cancer screening and previously tested for hrHPV-DNA using the 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 centralised laboratories included within population-based cervical cancer screening programs in resource-limited settings.