Pharmacogenetics, generally accepted as the study, or clinical testing, of genetic variation that gives rise to differing responses to drugs, is increasingly being applied to the prospective testing of patients for HLA-B*57:01 who are to be treated with the antiretroviral drug abacavir. Thus, a strong association exists between HLA-B*57:01 and the development of drug hypersensitivity reactions to abacavir. Accordingly, this scheme tests participants’ ability to define HLA-B*57:01 using the method(s) they employ for routine clinical service HLA-B*57:01 testing.
To assess participants’ ability to correctly determine HLA-B*57:01 status.
A total of ten blood samples will be sent each year as three distributions. Participants will receive three blood samples in the first shipment, four samples the second shipment and three samples in the final shipment.
Participants are required to report on the HLA-B*57:01 status as positive or negative.
Participants are encouraged to report a B*57 – non-B*57:01 – allele for information purposes.
Participants must only use the reporting forms provided within the UK NEQAS for H&I Participant’s Portal and are required to return results within 10 days.
The consensus HLA-B*57:01 status of each sample is determined by at least 75% of laboratories agreeing on the presence or absence of HLA-B*57:01. A reference result will be used for assessment for samples failing to reach the 75% consensus level.
Each report in agreement with the consensus/reference HLA-B*57:01 status – Acceptable
Each report not in agreement with the consensus/reference HLA-B*57:01 status – Unacceptable
Each sample not reported – with valid reason, or equivocal – Not Assessed
Each sample not reported / late submission of results – Unacceptable
Satisfactory performance is making ten sample reports in agreement with the consensus/reference HLA-B*57:01 status in a year.
Laboratories with unsatisfactory performance will receive written notification of their status and will be expected to reply to UK NEQAS for H&I detailing their corrective actions. For UK laboratories, unsatisfactory performance will be reported to UK NQAAP for Immunology. For UK laboratories, failure to reply or replies deemed unsatisfactory are likely to be further actioned by UK NQAAP for Immunology.
Information/Analysis Provided to Participants
- The HLA-B type of the donor samples (for indication only).
- Anonymised summary table of all participant results, comments and methodology. Including sample assessment result (acceptable/unacceptable classification) for each participant.
- End of year summary of participant performance.