The pilot project WOLPHSCREEN (Wolfsburg primary HPV screening for better cervical cancer prevention) comprises 24,000 women aged 30+ years who attended for routine screening between 2006 and 2016. In July 2015 we tested samples from an HPV screening pilot project with Anyplex II HPV HR (Seegene Inc) for HPV genotypes to compare Anyplex performance with HC2 results as gold standard
The selected samples were originally collected and tested in 2007 with Hybrid Capture 2 (HC2). The original STM samples were stored at -22° Celsius. A first set of stored and fresh samples was tested in Wolfsburg earlier and showed that the 2007 samples were still of good quality.
On the 15th of July 2015 the central lab of Klinikum Wolfsburg received 292 samples for HPV testing with Anyplex. 282 samples were finally tested; eleven samples were excluded because of difficulties with the identification numbers. Out of this group another ten samples gave invalid results with HR-Anyplex, leaving 271 valid results.
Diagnoses are based on the maximum findings within long-term follow-up and are therefore more reliable than in cross-sectional trials.
Overall 109 out of 116 HC2 positive CIN1+ tested positive for HPV high risk types with Anyplex (94%). More important, all of two invasive cancers, all three Adenocarcinoma in situ (AIS) and all 30 CIN3 cases tested positive for HPV-HR with Anyplex (35/35 = 100%). 4 out of 25 CIN2 and 3 out of 56 CIN1 were Anyplex negative but as CIN2 diagnoses are based on primary histology only, the overall sensitivity of the test for HSIL can be considered as excellent. Sensitivity and NPV for CIN3+ reached 100% in this cohort. 11 out of 150 HC2 negative samples tested positive for HR-HPV-types and 9 samples gave invalid results. If HC2 would be considered as benchmark, the specificity of Anyplex is 130/141 (92,2%).
The type distribution of the 14 individual HPV types resembled very much the distribution pattern found with LiPA genotyping in WOLPHSCREEN. HPV is the most frequent type in CIN3+ lesions but with less than 50% not as frequent as observed among young women at age 20-25 years in Wolfsburg (78-88%).
Anyplex II HPV HR showed an excellent sensitivity for CIN3+ and a plausible pattern of genotype distribution. The data is not sufficient for a reliable conclusion of the observed low specificity in HC2 negative samples.