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


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.

Keywords: HPV; vaginal self-sampling; urine self-sampling; health professional sampling; cytology, sensitivity and specificity.


El cáncer de cuello uterino (CC) es considerado una amenaza para la vida de las mujeres, por esta razón la OMS lanzó la estrategia 90-70-90, que busca erradicar el CC hasta el 2030. Parte de la estrategia implica el tamizaje con pruebas de biología molecular de alta sensibilidad para el diagnóstico de VPH, que sustituyan a la citología cervical. El objetivo de esta investigación, fue comparar la sensibilidad y especificidad de las pruebas de biología molecular, incluyendo la auto toma para el diagnóstico del VPH con la citología tradicional. Metodología: Se realizó un estudio de pruebas diagnósticas, en una parroquia rural de Cuenca, Ecuador. Un total de 120 mujeres participaron. Cada participante recolectó por sí misma una muestra vaginal y otra de orina y luego un profesional de salud realizó una toma cervical estándar para el diagnóstico molecular de VPH y citología. Esta última prueba fue considerada como el estándar de oro. Las tres muestras fueron procesadas con el mismo protocolo de amplificación e hibridación genómica para de detección del VPH (Hybribio) siguiendo las instrucciones del fabricante. La citología fue procesada siguiendo la técnica estándar. Resultados: La sensibilidad de la auto toma vaginal para el diagnóstico del VPH AR alcanzó el 100 % (IC 75.7, 100.0), y la especificidad 94.4% (IC 88.4, 97,43). El auto muestreo de orina tuvo una sensibilidad de 91,6 % (IC 64.61, 98.51), y una especificidad de 96,435 (IC 91.18, 98.6). La citología cervical alcanzó una sensibilidad 41,67% (IC 19.33, 68.5) y una especificidad de 85,19% (IC 77.28, 90.67) Conclusiones: Este estudio demuestra que los métodos de auto muestreo vaginal y auto muestreo en orina tienen una sensibilidad y especificidad similar a la comparada con la muestra tomada por el profesional de salud para el diagnóstico molecular del VPH. La sensibilidad de la citología (Papanicolaou) es inferior en relación a las pruebas de biología molecular para el tamizaje primario del CC.

Palabras Clave: VPH; auto muestreo vaginal; auto muestreo en orina; muestreo por profesional de salud; citología, sensibilidad y especificidad.

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