Annual conventional cytology (cc) is still the standard in the German cervical cancer prevention program. For the external quality control by the association of health insurance physicians (KV) a yearly report of the distribution of the histological results relating to the PAP groups is required. The sensitivity of a single cc for the detection of cervical intraepithelial neoplasia of grade 2 or higher (CIN 2+) is low. However, within the last decade HPV testing, liquid based cytology and new biomarkers (e.g. p16/Ki-67) have made it into routine use mainly in the triage of borderline and low grade cytological findings.
Cytomol is a commercial lab specialized in cervical cancer prevention. Here since the year 2000 HPV testing has been used at a progressive rate in triage and to a much lesser extent as a self-payed service in addition to cc. Since 2007 p16 testing, from 2010 on coupled with Ki-67 staining (all in liquid based cytology), is used in the triage of borderline and abnormal cytology as well as in cases with HPV positivity and normal cytology. Here we report the rate of histologically confirmed CIN 2+ cases correlated with the preceding cytological findings. Cytological diagnoses originally reported in the Munich Nomenclature II (MN; with the use of the inofficial Pap IIW category) until 30.6.2014, from then in the MN III (which is still the reporting standard in Germany) were translated to TBS (The Bethesda System). All the yearly Cytomol reports from 2007 till 2015 to the KV are analyzed
The finding rate for CIN 2+ lesions per year [Pap > ASC-US] in the screened population increased from 2007 until 2015 from 0,059% to 0,44%. The percentage of histological reports related to the different cytological groups remained almost the same over the years. The most significant increase was observed from 2007 until 2011. In parallel, a strong rise in cases of p16/ Ki-67 [2007: 292 p16, 2015: 6130 p16/Ki-67] diagnostics performed in the lab occurred. In parallel a systematic mode of review in cases with a history of abnormal cytological, histological, HPV and chlamydia findings and of actual borderline or abnormal cytology specimens had been established.
The introduction of new diagnostic techniques and /or improved cytological approaches in a routine lab for cytology seems to lead to a significantly increased sensitivity and specificity for CIN 2+.