A Pilot Study of Human Papillomavirus Detection in Urine Using a Novel Nucleic Acid Amplification Test.

INTRODUCTION: Human papillomavirus (HPV) testing is the standard-of-care for cervical cancer screening globally. Urine is a promising alternative to collecting a cervical specimen during a pelvic exam for HPV testing. There are no studies to date of HPV testing of urine using the Xpert HPV test. METHODS: We conducted a pilot study of 40 women; 30 women undergoing colposcopy because of a previous abnormality and 10 undergoing routine screening, to evaluate HPV detection in urine by the Xpert HPV test on the GeneXpert platform. Xpert HPV testing of urine was done according to the manufacturer's instructions for testing cervical specimens. These results were compared to a reference of combined results of 2 research HPV genotyping tests conducted on cervical specimens and to repeat Xpert HPV testing of urine. RESULTS: Analytic sensitivity and specificity of Xpert testing of urine for any high-risk HPV versus the cervical sample, categorized as HPV positive if at least 1 test was positive, were 64.3% (95% confidence interval [95%CI] = 42.1-76.1%) and 100% (97.5%CI = 71.5-100%), respectively. Analytic sensitivity and specificity of Xpert testing of urine for any high-risk HPV versus the cervical sample, categorized as positive if both tests were positive, were 66.7% (95%CI = 44.7-84.4%) and 86.7% (95%CI = 59.5-98.3%), respectively. Kappa values for first vs. second and first vs. third testing of urine by Xpert were 0.89 (95%CI = 0.79-1.00) and 0.90 (95%CI = 0.81-1.00), respectively. DISCUSSION: Given the call for global elimination of cervical cancer and widespread availability of GeneXpert, optimizing Xpert HPV testing of urine may be warranted.

The Effect of Forced Cough to Minimize Pain and Discomfort at the Time of Colposcopy-Guided Cervical Biopsy.

OBJECTIVE: The aim of the study was to determine whether forced cough during colposcopy-guided cervical biopsy affected pain and anxiety levels. MATERIALS AND METHODS: The study was conducted at the University Hospital (Newark, NJ) Ambulatory Care Center from December 2016 to June 2018 and evaluated 110 patients at the time of a colposcopy-guided cervical biopsy. Study patients were randomized to either cough or no cough group during the biopsy procedure. Pain level was assessed using a visual analog pain scale before, during, and immediately after a colposcopy-guided cervical biopsy. Study patients also completed a standardized anxiety survey before and after the procedure. T tests, Pearson χ, or Cochran-Mantel-Haenszel were used to compare baseline characteristics between the cough and no cough groups. Multivariate linear regression analysis was used to identify potential confounders and then compare pain levels across both groups. RESULTS: There was no statistically significant difference in pain scores between the cough and no cough group when analyzed for each demographic variable even when confounders were accounted for. The anxiety scores for both study groups before and after the procedure were similar and not significantly reduced. CONCLUSIONS: We observed a trend that cough reduced pain associated with the colposcopy-guided cervical biopsy but did not reach statistical significance. A similar outcome was observed in anxiety level, where anxiety was reduced in the cough group but was not statistically significant as compared with the no cough group. Further studies are necessary to assess various modalities in reducing pain and anxiety associated with colposcopy-guided cervical biopsy.