Study to Determine Concordance between High-Risk Human Papilloma Virus DNA Detection in Self Collected First Voided Urine Samples and Health-Care Worker Collected Cervical Samples in a Subset of Women with Proven Histopathological Precancerous and Cancerous Lesions of the Cervix.

Objective: The objective of our study was to assess whether urinary samples for human papilloma virus (HPV) detection are a good predictive marker of cervical cancerous and precancerous lesions, by comparing against results from cervical scrapings as the gold standard test. Materials and Methods: The study is a hospital-based cross-sectional study wherein symptomatic women were screened at the colposcopy clinic. Paired samples-cervical scrapings/washings and urine samples were tested for hr-HPV for women who were found to harbor premalignant and malignant lesions of the cervix in histopathological lesions, by multiplex real-time polymerase chain reaction and HPV genotyping. Diagnostic accuracy was tested by calculating concordance with Cohen's kappa with hr-HPV detection in cervical samples as the gold standard. Results: A total of 295 patients undergoing colposcopy were recruited in the study, out of which 54 had histopathological-proven premalignant and malignant lesions of the cervix. Overall, positivity rate in urinary samples for both HPV 16 and 18 combined is 64.81%, whereas for cervical samples is 68.51%. HPV 16 was seen in 30 (55.5%) and 32 (59.3%) cervical and urinary samples, respectively, whereas HPV 18 was seen in 7 (12.9%) and 6 (11.1%) samples, respectively. There was substantial concordance between the cervical samples and first-void urinary samples results with Cohen's k: 0.6988 (95% confidence interval: From 0.507 to 0.891). There was 85.96% agreement among all the tests that were performed with only 14.04% disagreement. Conclusions: The study showed that HPV DNA detection from the urine and cervical samples showed significant agreeability for the detection of precancerous and cancerous lesions of the cervix among women with abnormal histology results. Thus, urinary sampling can be done as a potential replacement for cervical sampling methods with the added benefit as it can be used in females reluctant to provide cervical samples, if there is no availability of skilled workforce for collecting samples, for mass screening, and for the follow-up of vaccination programs.

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

OBJECTIVES: 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. METHOD: 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). RESULTS: 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%. CONCLUSION: 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.

Burden and Associated Genotype Patterns of High-Risk Human Papilloma Virus Infection and Cervical Cytology Abnormalities among Women in Central India.

Background: The epidemiology of human papilloma virus (HPV) infection and the pattern of HPV genotype distribution are much-needed parameters to assess the risk of cervical cancer among females. However, due to less availability of data on HPV burden and its genotypes from various geographical regions in India makes cervical cancer screening modalities and vaccination strategies difficult to implement. Objective: The present study was conducted to identify the various genotypes particularly high-risk HPV types in premalignant or malignant cervical lesions. Methods: The study was a hospital-based cross-sectional study wherein 295 symptomatic women were screened by Pap smear and multiplex real-time PCR was performed for HPV genotypes identification in women with abnormal cervical cytology. Results: Out of 295 women, 237 (80.3%), 45 (15.3%), and 13 (4.4%) women had normal Pap smear, squamous cell carcinoma and precancerous cytology, respectively. Among these 58 women having abnormal cervical cytology, HPV was detected in 48 (81.0%) participants. Most common HPV genotypes in our study were HPV 16 (n = 29; 60.4%) followed by mixed infections; i.e., more than one type of HPV was detected (n = 10, 20.8%). HPV 18 was detected only in 6.25%, whereas other high-risk HPV genotypes were found to be 12.5%. Conclusion: HPV positivity was >80% in women having abnormal Pap smear. The prevalence of HPV 18 was found to be much less in Central India, compared to other parts of country. HPV 16 was the most common genotype followed by mixed HPV genotype infections. It is evident from our study that symptomatic women even if having normal Pap smear should be screened for HPV and followed up with periodic Pap smears for detecting any change in cervical cytology, thus preventing cervical cancer in women.

Postplacental Intrauterine Contraceptive Device Transmigration - Rare but the Real Concern for Service Providers.

Uterine perforation following postplacental intrauterine contraceptive device (PPIUCD) insertion is a rare event with a potential for serious injuries. In the present case, a young lady with a history of PPIUCD insertion presented with a mass having ill-defined margins and restricted mobility palpable in her right iliac region. Examination reported a conglomerated mass in right adnexa with an IUCD surrounded by a heterogeneous inflammatory collection to which omentum and bowel loops adherent to it. Additional imaging reported involvement of right iliac vessels and right ureter with upstream hydroureteronephrosis. Intraoperatively, ureter was found intact and away from the IUCD which was removed with a gentle pull, and a rent in the right posterolateral surface of uterus was repaired with delayed absorbable sutures. With PPIUCD services being provided on an unprecedented scale, it becomes prudent and ethically crucial to create a national repository to document post insertion outcomes and complications. Case report aims to inform and sensitize stakeholders about possible post insertion complications to help improve expansion of the PPIUCD programs.