Between 2013 and 2015 a total of 1186 liquid based samples were collected from 750 women with conspicuous clinical data with or without primary abnormal PAP test. The aim of this study was to compare the PAP test and the HPV detection test for timely discovery of cervical cancer and its precursors.
Samples for the PAP test and for the detection of high-risk HPV were taken from the same liquid based material. The PAP test was based on liquid based cytology (LBC). The LBC samples were prepared according to the BD working protocol (Becton, Dickinson and Company). The molecular biological detection of high-risk HPV was determined by PCR (cobas® HPV Test; F.Hoffmann-La Roche AG), that provides specific genotyping information for HPV Types 16 and 18. At the same time 12 other high-risk HPV types were detected in a pooled result. For this study we called the negative result for intraepithelial lesions or malignancy (PAPI and PAPII) a negative PAP test. The results PAPIII; PAPIIIG; PAPIIID and higher: positive PAP test. The results were evaluated as statistically significant at p <0,05 (NCSS Statistical Software).
The average age of the 750 tested women was 44,8 (between 15 and 89). There was a high statistically significant difference (p=0,00000 chi-square test) between positive/negative results (65/685) of the PAP test and positive/negative results (137/613) of high-risk HPV detection. 102 of 750 tested women (13,6%) had a positive result concerning high-risk HPV detection but a negative PAP test. The women with negative cytology results were positive for HPV 16 in 2,0% of all cases (15/750) and for at least one of the 12 other high-risk HPV subtypes in 9,1% of all cases (68/750). 1,9% of the women with a negative PAP test had a mix of different subtypes of the tested high-risk HPV (14/750). All women (n=5) infected with only HPV 18 had a negative PAP test result (0,7%).
The gynecological examination represents an important contribution to women's health and allows diagnostics, therapy but also counselling and prevention. Nowadays the HPV test is conducted to clarify the primary abnormal PAP test in routine check-ups. Our study shows that it would be better to establish the molecular biological test as primer test, because the test can better provide information about the patient’s risk for developing cervical cancer in the future. Cytology should be used to diagnose cervical cancer and its precursors.