Chronic infection by the human papillomavirus (HPV) is the most important risk factor for developing cervical cancer. With the introduction of cervical cytology and population screening, the incidence and mortality from cervical cancer has been reduced. Isolated cytology has a sensitivity of 50%. Subsequently, techniques for detection of HPV DNA have been developed, and a sensitivity of more than 60-70% has been achieved. In any case, both techniques require a gynecological exam. In addition, they may not be possible in areas with low economic status. Therefore, other techniques have been developed for determining HPV in self-making or in urine collected by woman.
This is a prospective study on a sample of 100 patients from the Program of Screening for Cervical Cancer in our hospital area. As inclusion criteria in our study, the patients must have a positive determination of PCR of HPV DNA in liquid medium cytology using Cobas 4800® method, Roche Diagnostic Spain. This positive test may be accompanied by cytological alteration or not. These patients are informed to collect the samples (all of them first urine of the day and self-sampling) and derived to cervical pathology consultation. The self-sampling was taken using the device Qvintip® of the brand Aprovix.
Finally 92 patients were included on the study (N=92). The average age was 40,2 years. 82,6% have had at least 3 couples in the last 3 years. 22,8% have not followed the correct cytological screening (7.6% had never previously made a cytology). About comfort in taking samples, 68.5% considered it more convenient and accessible than conventional cytology.
The results of the citology were: 66,3% negatives, 23,9% ASC-US, 1,1% ASC-H, 6,5% L-SIL and 2,2% H-SIL. The types of HPV diagnosed were: 23,9% HPV 16, 2,2% HPV 18, 66,3% HPV no 16–18, 7,6% mixture. Biopsy was performed in 33.7% of cases, being positive in 61.3%.
Concordance of HPV in urine with citology is 53,3% (44,4% for HPV 16, 25% for HPV 18 and 59% for other HPV). Concordance of HPV in self-sampling with citology is higher,73,9% (70% for HPV 16, 75% for HPV 18 and 75% for other HPV).
We analysed the 16 cases resulting in high-grade lesion on biopsy. If we compare the results for the urine to detect high-grade lesions sensitivity is 50%, specificity 44,7%, PPV 14,3% and NPV 82,9%. Regarding self-sampling: sensitivity 87,5%, specificity 28,9%, PPV 20,6% and NPV 91,7%.
The study highlights the higher concordance of self-sampling in high-grade lesions (87.5% of cases). It is a test with high sensitivity and NPV for high-grade lesions, which is what is intended, as it will be used in women who do not use conventional screening.
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