The development of a quality assurance programme for HPV testing within the UK NHS cervical screening LBC/HPV studies.

ABSTRACT

BACKGROUND: Cervical screening by cytology is effective but lacks sensitivity. The addition of human papillomavirus (HPV) testing can improve the effectiveness of screening for early identification of cervical disease. As HPV testing represents a new technology, a quality assurance (QA) programme is necessary to confirm the accuracy of results. OBJECTIVE: Our main objective was to design a QA programme for use in the English NHS liquid-based cytology (LBC) and HPV Cervical Screening Pilot Study. Our second objective was to use the knowledge gained to design a QA scheme for future general use within cervical screening and HPV testing programmes. STUDY DESIGN: Four elements were included in the programme provision of clinical samples of known HPV status for internal quality control (IQC), distribution of panels of unknown samples for external quality assessment (EQA), resubmission of aliquots of samples to the reference laboratory for repeat testing and resubmission to reference laboratory to check for transport problems. Three sites took part in the QA programme using PreservCyt medium and ThinPrep for LBC preparation. The assay used at test sites was HPV hybrid capture (hc2) while the quality assurance laboratory used a combination of hc2, in-house HPV polymerase chain reaction (PCR) tests and HPV linear array (LA). RESULTS: Four negative, three low positive and 11 positive pools were used in 22 distributions of IQC samples. Seven distributions each of five 'unknown' EQA samples were sent out. Over 400 samples underwent repeat testing. Discrepant samples were further assessed to provide an explanation. Inter- and intra-laboratory consistency was high as measured by Kappa statistics and 96% agreement for EQA samples was obtained. CONCLUSIONS: The validity of the QA programme was established and reproducibility in different lab settings was reassuring. These results support the use of hc2 as a potential screening test in diagnostic laboratories. The need for robust quality assurance of HPV testing in cervical screening programmes was confirmed and lessons learnt from this pilot study will be incorporated in future schemes.