Cytology Versus Molecular Diagnosis of HPV for Cervical Cancer Screening. Comparison of the Diagnostic Properties of Four Tests in a Rural Community of Cuenca Ecuador

Abstract Cervical cancer (CC) is considered a threat to women's lives, which is why the WHO launched the 90-70-90 strategy, seeking to eradicate CC by 2030. Part of the strategy involves screening with highly sensitive molecular biology tests for HPV diagnosis to replace cervical cytology. The objective of this research was to compare the sensitivity and specificity of molecular biology tests, including self-testing for HPV diagnosis with traditional cytology. Methodology: A study of diagnostic tests was conducted in a rural parish of Cuenca, Ecuador. A total of 120 women participated. Each participant self-collected a vaginal and a urine sample and then a health professional performed a standard cervical smear for HPV molecular diagnosis and cytology. The latter test was considered the gold standard. All three samples were processed with the same amplification and genomic hybridization protocol for HPV detection (Hybribio) following the manufacturer's instructions. Cytology was processed following the standard technique. Results: The sensitivity of vaginal self-sampling for the diagnosis of HR HPV reached 100% (CI 75.7, 100.0), and specificity 94.4% (CI 88.4, 97.43). Urine self-sampling had a sensitivity of 91.6% (CI 64.61, 98.51), and a specificity of 96.435 (CI 91.18, 98.6). Cervical cytology achieved a sensitivity of 41.67% (CI 19.33, 68.5) and a specificity of 85.19% (CI 77.28, 90.67) Conclusions: This study demonstrates that vaginal self-sampling and urine self-sampling methods have similar sensitivity and specificity compared to the sample taken by the health professional for molecular diagnosis of HPV. The sensitivity of cytology (Papanicolaou) was lower in relation to molecular biology tests for primary screening of CC.