Comparative study of a novel application of automated HR HPV assay and stability in a previously untested Preservative media

- Performance comparison of storage media for use with automated HR HPV assays.
- Cell stability demonstrated for up to 120 days at room temperature in Novaprep vials.
- Analytical performance assessment of HPV detection in Novacyt vials when used with an automated HR HPV assay.

BackgroundThe suitability and stability of cervical cells in Novaprep media (NHQ) for certain HPV assays is unknown.MethodsWe evaluated the accuracy of an automated HPV assay (Abbott RealTime HR HPV) for cervical cells prepared in NHQ and NHQ with a pre-treatment to mimic a worst case clinical use, compared to the assay manufacturers media; repeatability and reproducibility of HPV results and the stability of detectable HPV in NHQ over time compared to CE marked liquid based cytology preservatives. Cell lines were used to simulate patient samples.ResultsCells stored in NHQ produced accurate, repeatable and reproducible results. Stability in NHQ was comparable to the best performing LBC, with at least 7 months' stability at 18-25 °C, 2-8 °C, −20 °C and −80 °C; and at least 3 months' stability at 40 °C. Similar results were obtained for pre-treated NHQ except only 3.5 months' stability at 18-25 °C. Cell line samples in all media and concentrations tested were detected appropriately by the assay.ConclusionsBased on this first stage validation analytical study, cervical cells stored in NHQ are suitable for the Realtime HPV assay. There should be no reservations for inclusion of NHQ in any further validation and clinical performance evaluation of this assay.