Objective: To evaluate the feasibility and reliability of cobas 4800 HPV test for cervical cancer screening and cytology referral.
Methods: cobas 4800 HPV test and hybrid capture 2 (HC-2) were used to detect high risk HPV DNA in 670 specimens of liquid-based cytology collected from three hospitals. The agreement between cobas and HC-2 tests was assessed. HPV PCR detection (HybriBio) and gene sequencing were used for genotyping, and the agreement of HPV16 and 18 genotyped by cobas and HybriBio was evaluated. Histological diagnosis was considered as a gold standard to estimate the sensitivity and specificity of cobas vs. HC-2 in detecting CIN2(+) in cervical lesions.
Results: The crude agreement between cobas and HC-2 tests was 89.40%, the Kappa value was 0.778, the positive concordance rate was 86.42%, and the negative concordance rate was 91.36%. The crude agreement rates between cobas and HybriBio on HPV16 and 18 were 88.89% and 94.94%, the Kappa values were 0.777 and 0.753, the positive concordance rates were 98.91% and 100.00%, and the negative concordance rates were 78.41% and 94.44%, respectively. HPV PCR detection (HybriBio) and gene sequencing were considered as adjusted standard: the high risk HPV positive concordance rate was 100%, negative coincidence rate was 94.42%, HPV16 and 18 positive concordance rates were both 100%, and negative concordance rates were 82.35% and 94.44%, respectively. Regarding the detection of CIN2(+), the sensitivity and specificity were 91.07% and 70.97% for cobas, and 93.75% and 71.33% for HC-2, with a non-significant difference between the results of the two tests (P > 0.05).
Conclusions: cobas4800 HPV test has good screening sensitivity and specificity in correct detection of HPV16 and 18 and other high-risk HPV virus types.