Evaluation of the usefulness of a device for human papilloma virus dna collection and preservation in self-collected cervicovaginal samples stored dry in women with cervical dysplasia, Bogotá, Colombia

Abstract

Objective: To evaluate the usefulness of a device for collecting and preserving human papilloma virus (HPV) DNA in self-collected vaginal samples stored dry during 14 days. Materials and methods: Diagnostic concordance pilot study that included non-pregnant women over 25 years of age with a biopsy-confirmed result of cervical intraepithelial neoplasia (CIN) grade 1 or more, coming to two referral centres in Bogotá, Colombia. Women with a history of total hysterectomy were excluded. Convenience sampling was used. The device uses real-time PCR (polymerase chain reaction) for DNA detection. Sociodemographic and clinical variables were measured, as well as the results of the test when the sample was collected by the patient and when it was collected by the physician, and the amount of DNA in the samples taken and processed on day 1, and in those processed on day 14, using Ct thresholds. Descriptive statistics were applied. Overall concordance was estimated by means of the kappa coefficient and mean differences in DNA amount. Results: A kappa coefficient of 0.84 (95% CI: 0.71- 0.96) was found for concordance in high-risk HPV detection between the self-collected cervicovaginal sample and the sample taken by the clinician. There were no differences in terms of the amount of viral DNA between day 1 and day 14 (DM -0.34 cycles; 95% CI: - 2.29 to 1.61). Conclusion: Self-collected vaginal samples using the storage device are reliable for high-risk HPV detection in patients with cervical dysplasia, and preserve viral DNA for 14 days if stored dry at room temperature. Confirmation studies in the general population are required.