Development of a United Kingdom National External Quality Assessment Scheme (UK NEQAS) for HIV point of care testing

Abdul-Khaliq, Catherine

No specimens included in the study were positive for HIV p24 antigen. It was anticipated that the use of Determine HIV-1/2 Ag/Ab Combo will increase as at the time of the study it was already employed by 24% of the participants. It was recommended that p24-antigen-positive material is sourced for future investigations. It may prove difficult to source antigen-positive material as blood would need to be donated from recently infected individuals before seroconversion has occurred or from patients who have progressed to late stage AIDS when levels of p24 antigen increase as antibody levels diminish. It may also be possible to spike existing UK NEQAS specimens with p24 antigen as recombinant p24 antigen is commercially available. However, this may also prove to be difficult in practice as antibodies present in the serum sample would form complexes with p24 antigen upon addition rendering it undetectable by the POCTs. Participant performance in this pilot scheme was excellent. Constructive feedback was received from those who participated, although overall there was a lack of awareness of EQA schemes within sexual health clinics and the role the schemes had in this setting. It became apparent that, in most cases, the clinics had never encountered, or even heard of EQA before and were unaware how this type of assessment would benefit them. Upon explaining the purpose and benefits of EQA, more interest was shown and participating clinic numbers rose from 3 to 10. Personally contacting the clinics was a very time-consuming process as it proved difficult to make contact with the appropriate people especially when some clinics were only open once or twice a week. In some cases those contacted were unaware of who would give consent for participation and were unwilling to help any further. Often telephone messages and follow-up emails were left unanswered. It was accepted that a lack of awareness of EQA was the main reason for the low number of participating sexual health clinics however correspondence with those who chose not to participate also highlighted other reasons for not participating. Cost implications were a concern for those clinics operating as charities, even though the pilot was free of charge they had to take into account the costs of kits involved in testing. Some clinics were interested in the scheme but did not participate due to lack of staff and time as certain clinics only operate 1 or 2 days a week they felt EQA was another burden on their heavy workload. In a minority of cases, a general lack of interest in EQA was encountered where the clinics in question felt that their own internal quality assurance measures were sufficient. For future pilot studies, it is recommended that further promotion of the scheme be carried out at the local and management level. It would be important to target higher management levels of primary care trusts, charities and organizations involved in sexual health such as the Terrence Higgins Trust or the British Association for Sexual Health and HIV to further promote the benefits of EQA and make them aware of the recommendations from the Medicines and Healthcare products Regulatory Agency and from the International Organization for Standardization. If needed, an EQA scheme may be developed that also provided quality and technical training.