HPV detection and typing by INNO-LiPA assay on liquid cytology media Easyfix Labonord after extraction QIAamp DNA Blood Mini Kit Qiagen and Nuclisens easyMAG Biomérieux

The objective of this study is to validate the use of test INNO-LIPA HPV Genotyping Extra (Innogenetics) on liquid cytology media EasyFix Labonord by comparing the extraction kit QIAamp DNA Blood Mini Kit (Qiagen) and an automated method, Nuclisens easyMAG (Biomérieux). Thirty-two samples were typed by the technique Hybrid Capture 2 (HC2) Digene (Qiagen). DNA was extracted through manual or automated extraction and quality controlled PCR "HLA". Typing was performed with the INNO-LIPA test. A nested PCR followed by sequencing was used to compare different results. Similar results were found for the two types of extraction, with an increase of sensitivity after automated extraction. Among the nine patients with a negative result with the HC2 test, seven had a negative result in INNO-LIPA and two a positive result (one untypable and one HPV66). On the 23 patients with a positive result with the HC2 test, 17 are consistent results. The six discordant results include one negative, one HPV54, two untypable HPV and two HPV53. The overall concordance between the HC2 and INNO-LIPA tests is 81% with a kappa test of 0.79. Coupled with an automated extraction, the test INNO-LIPA confirmed its high sensitivity for detecting and typing HPV in the EasyFix media Labonord, especially in the presence of multiple genotypes. This typing systematic approach is becoming increasingly relevant in the context of HPV vaccination.