Validation of Novaprep® HQ+ liquid-based cytology medium for high-risk human papillomavirus detection by hc2

Abstract

Background: Preanalytical conditions determine the reliability and validity of bioassays. Therefore, the analytic performances of biological tests need to be determined when preanalytical steps differ from those recommended by the manufacturer. The objective of the study was to assess the analytic performance of the hc2 test for the detection of high-risk HPV DNA from cells stored in the new Novaprep® HQ+ medium. Methods: Repeatability, reproducibility, method comparison and stability (-20 °C, +4 °C, +20 °C and +40 °C up to six months) were evaluated from HPV16 and HPV18 positive cell lines diluted in the Novaprep® HQ+ medium and the reference Specimen Transport Medium (STM). A series of cervical samples with atypical squamous cells of undetermined significance (ASC-US) cytology and stored in the Novaprep® HQ+ medium was also tested. Results: Coefficients of variation for repeatability and reproducibility were less than 8 %. Method comparison showed perfect agreement in hc2 results when the HPV-positive cells were diluted in HQ+ and reference media. Stability experiments demonstrated that the storage conditions did not alter the hc2 test results. Furthermore, clinical samples were adequately preserved for hc2 testing. Conclusions: Overall, our data show that the new Novaprep HQ+ medium is suitable for high-risk HPV testing by hc2.