From January 2017 primary screening for cervical cancer in the Netherlands has switched from cytology to HPV based screening. The programme expects to examine well over 500.000 samples per year distributed over five CCKL or ISO15189 accredited laboratories. To achieve uniform performance between the five sites all laboratories are equipped with identical Roche Cobas4800 systems, three per laboratory. Furthermore, the Cobas 4800 HPV test kit production lot, laboratory reagents and assay procedures are all standardized between the laboratories.
To develop a quality control programme to monitor and continuously ensure the quality of HPV based screening results within and between the Dutch screening laboratories and to compare their performance with international peer laboratories outside the Dutch screening network. This integrated quality monitoring system is based on:
A verification and release programme for acceptance testing of equipment upon installation and upon repair or major service. In addition, this programme is used to test and release (new lots of) critical reagents.
2. A run control programme with a manufacturer-independent control sample in each HPV run.
3. External Quality Assessment to monitor inter-laboratory performance by participating in both international inter-laboratory comparisons with proficiency panels and in national comparisons based on inter-laboratory exchange of clinical materials from the screening program.
Dedicated HPV control panels were designed and used for acceptance of systems and kits prior to the start of the programme. These panels have been instrumental to achieve the required level of performance standardization within and between laboratories. Furthermore, the results to be presented demonstrated that the observed inter-run, inter-system as well as inter-laboratory variations in the Ct values of the results were small and well within acceptable ranges.
From the start of the screening programme an independent run control sample was included in each assay run. This control is completely independent from the assay supplier both in design, development, production and result interpretation. The independent run control, called User Defined External Control (UDEC), is examined in every run in each laboratory. UDEC results are used to monitor the (variation in) assay performance within and between the screening laboratories; it is not aimed for acceptance of individual runs
The quality monitoring programs have been implemented to monitor assay performance in the Dutch hrHPV screening network of five laboratories participating in the recently renewed national screening program for cervical cancer.