Urine-Based HPV DNA Detection in Histopathologically Confirmed Cervical Cancer Patients: A Pilot Feasibility Study from a Tertiary Cancer Care Centre in Eastern India
摘要
WHO has recommended primary Human Papillomavirus (HPV) DNA testing if feasible, for cervical cancer screening in lower-middle income countries.The number of women undergoing screening is very low as a result of limited information, inadequate infrastructure and invasive nature of sampling.
Aim and ObjectiveTo know about feasibility of urinary HPV testing as screening method and to assess its sensitivity, specificity, positive predictive value, negative predictive value in comparison to cervical HPV testing.
MethodsA cross sectional analytical study was carried out to compare the detection rate of HPV DNA (16,18) in urine and cervical sample in histo pathologically proven sixtyeight carcinoma cervix patients attending the Gynae Oncology OPD before definitive management by surgery or CCRT (concurrent chemo radiation). Informed written consent was taken from all study population.
ResultsAmongst the samples collected from 68 cervical cancer cases, HPV DNA was tested positive in cervical samples of 53 (77.9%) and urine samples of 33 (48.52%) patients. The agreement between the two sampling methods was 64.71% and the kappa value was 0.3(95% confidence interval 0.122–0.488) indicating a fair agreement. The sensitivity of HPV detection using urine samples was 58.49% (95% confidence interval 44.13–71.86%) and the specificity was 86.67% (95% confidence interval 59.54%–98.34%). PPV was 93.94% (95% confidence interval 80.70–98.29%); NPV was 37.14% (95% confidence interval 28.86%–46.256%).
ConclusionEven though not acceptable as an HPV DNA screening tool due to low sensitivity and specificity, the urine sampling method is inexpensive and more socially acceptable for large epidemiological surveys in developing countries like INDIA.