Development of an analytical quality assessment programme to assure reliable, consistent, high-quality laboratory results in the Dutch national hrHPV-based cervical cancer screening programme.
Five laboratories will be selected to carry out the renewed primary hrHPV based cervical screening programme in the Netherlands. All will use the same clinically validated hrHPV test system. Both clinically (pap-smear) and self-sampled material will be tested within the same workflow. The laboratories will all use the same QC reagents, and will report QC results in (nearly) real-time to a central database, which will allow monitoring of performance of the laboratories in a timely and fully transparent way.
In accordance with ISO 15189: 2012 Medical Laboratories – Requirements for quality and Competence, the programme for quality control of the analytical performance of hrHPV-testing in the laboratory will be based on the following three elements:
1. A programme for verification and acceptance testing of equipment upon installation, repair or major service, and of (new lots of) critical reagents and critical consumables.
2. A run control programme with a manufacturer-independent control sample in each hrHPV run to monitor day-to-day test variation, lot-to-lot performance of test kits, and operator variation, and will assist in identifying increased random or systematic error.
3. Interlaboratory comparisons such as external quality control programme with proficiency panels, some of which will be specific to the Dutch programme and some being part of a larger international programme.
As homogeneity and long term stability are essential requirement for these QC materials, control materials will consist of carefully selected dilutions of cell lines incorporating (parts) of the genome of hrHPV’s
A quality assessment programme that enables to monitor the quality of the analytical performance of the participating laboratories, to identify emerging problems and to take corrective action.
A strong analytical quality assessment programme is an essential part of the Dutch hrHPV screening programme for the prevention of cervical cancer. The implementation of the proposed quality assessment programme will enable to closely monitor the analytical performance of the participating laboratories in a timely and transparent manner.