Abstract
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.
Highlights
The suitability and stability of cervical cells in Novaprep media (NHQ) for certain Human papilloma virus (HPV) assays is unknown
There was some variation in the Cycle Number (CN) values between different media samples with the same HPV16 copy number, which was most pronounced for samples containing an estimated 4.8−20 × 105 HPV16 copies per assay
The CN values and shape of the curve were closer to samples prepared in Abbott Transport Buffer (ATB) than those prepared in Novaprep® HQ+ orange (NHQ)
Summary
The suitability and stability of cervical cells in Novaprep media (NHQ) for certain HPV assays is unknown. Methods: We 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. Conclusions: Based on this first stage validation analytical study, cervical cells stored in NHQ are suitable for the Realtime HPV assay. Various clinically validated molecular diagnostic tests to detect HR HPV exist, one of which is the Abbott RealTime High Risk HPV (RT HR HPV) test [4,5,6], a qualitative test utilizing Polymerase Chain Reaction (PCR) and probe hybridization to detect 14 HPV types in one assay. The test identifies HPV16 and HPV18 whilst detecting other HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
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