Objectives. Several large population-based trials have demonstrated that tests detecting human papillomavirus (HPV) DNA of oncogenic types (hrHPV) are more effective in reducing cervical cancer than the cytology. The latest cervical cancer screening guidelines recommend hrHPV DNA testing as a primary screening test. The meta-analysis by Arbyn et al demonstrated that validated PCR-based tests detecting hrHPV DNA are as accurate on self-samples as on clinician-collected samples. Offering self-sampling kits for HPV testing is an opportunity to reach women who do not attend in the regular screening program, thereby increasing the effectiveness of the overall program.
Methods. Our aim is to validate the Qvintip (Aprovix) vaginal self-sampling device to the CONFIDENCE™ HPV test (Neumann Dx). CONFIDENCE™ HPV is a multiplex real-time PCR assay for HPV DNA detection. The test has a partial genotyping feature, it detects HPV16, 18, 31, 45 separately and other high risk types (HPV33, 35, 39, 52, 56, 58, 59, 66, 68) in group. The quality of the sample is guaranteed by the amplification of human control (factor V Leiden gene) and internal control. The internal control is an artificial DNA sequence added to the sample during DNA preparation.
In 2015 as a pilot study of a multicentric prospective clinical trial in Hungary, women aged between 18 and 65 years who attended cervical sampling at 4 clinical sites (among them outpatient and colposcopy clinics) were asked to self-collect a vaginal sample by using the Qvintip self-sampling kit, before the clinician obtained their cervical specimen in PreservCyt (Hologic). Currently we have collected 335 vaginal Qvintip and 335 cervical PreservCyt samples from these women.
Results. The Qvintip collects the vaginal fluid by its collection head, which is then placed into a carrier tube provided by the kit and shipped to the laboratory. The preanalytical procedures for sample DNA preparation were adjusted to the vaginal sample type. We measured the cellularity of the Qvintip sample and diluted it with a buffer to a similar cellularity as the PreservCyt sample. We tested for a possible inhibitory effect of the vaginal sample type on the PCR reaction.
The CONFIDENCE™ HPV testing of the clinical samples is ongoing. We plan to specify the agreement of the CONFIDENCE™ HPV test on the Qvintip self-collected vaginal sample versus the clinician-collected cervical sample.