Study to determine efficacy of urinary HPV 16 & HPV 18 detection in predicting premalignant and malignant lesions of uterine cervix.

Abstract

To evaluate clinical performance and diagnostic accuracy of urinary HPV for non-invasive screening of high-grade precancerous and cancerous cervical lesions in a visual inspection under acetic acid (VIA) -positive cohort. The study included 180 women aged 35-65 years, who were VIA positive in a colposcopy clinic. All participants had the initial stream of a random urine sample tested for the presence of high-risk HPV (hrHPV) types 16 and 18 and acetowhite lesions were biopsied per protocol. Concordance analysis was conducted to assess agreement between detection of hrHPV in urine and the presence of premalignant and malignant lesions in cervix on histopathology. Measures of diagnostic accuracy were estimated to evaluate the performance of urinary HPV against histopathology (reference standard). Substantial agreement between urinary HPV detection and histopathology was found (Cohen's κ is 0.696, P≤ 0.001), with an agreement in 88.9% of the cases and disagreement in 11.1%. The diagnostic performance of urinary HPV in predicting the presence of a high-grade precancerous or cancerous lesion was as follows: sensitivity 67%, specificity 97%, positive predictive value 89%, and negative predictive value 88.8%. HPV DNA detection from urine has good concordance with the histopathology for detection of precancerous and cancerous lesions of the cervix. Further studies on optimization of urine sampling and processing techniques are warranted.