RESUMO
OBJECTIVE: The objective of this study was to evaluate the effectiveness of human papillomavirus HPV test with HPV16/18 genotyping and liquid-based cytology (LBC) triage as a primary screening method for cervical cancer compared to conventional Pap test in women undergoing routine cervical cancer screening in Tbilisi. METHODS: Cross-sectional, prospective study was conducted, where 1,000 enrolled women aged 30-60 years during one visit underwent conventional Pap smear and Hr-HPV testing (Roche Cobas system). Women with any positive screening results were referred for further evaluation and remaining cells from the Cell Collection Medium vial were used for LBC. The study calculated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for each screening method and receiver-operating characteristic (ROC) curve to evaluate the accuracy of each diagnostic method in identifying people with CIN2+ diseases. RESULTS: The HPV test with HPV16/18 genotyping and LBC triage demonstrated higher sensitivity (76.9%), specificity (71.6%), and PPV (34.5%) compared to conventional Pap tests (p < 0.05). NPV was also high with the HPV test (94.1%). The HPV test alone had the highest sensitivity (92.3%) and NPV (96.7%), but lower specificity (41.4%) and PPV (22.6%) than the HPV test with HPV16/18 genotyping and LBC triage (p < 0.05). Comparing the areas under the curve (AUCs), only the HPV with HPV16/18 genotyping and LBC triage showed a statistically significant difference when compared to conventional Pap (0.71 vs. 0.55, p = 0.03) and high figures of AUC 0.71 (95% CI: 0.58-0.85) suggesting that HPV test with HPV16/18 genotyping and LBC triage is a more reliable screening method for detecting CIN2+ disease and preventing cervical cancer, than other screening modality. CONCLUSION: The results suggest that the HPV test with HPV16/18 genotyping and LBC triage is a more effective primary screening method compared to conventional Pap tests. This information should be the basis for transition from cytological screening to HPV testing in Georgia.