Scheme Description
Scheme 1A is aimed at laboratories undertaking HLA-A, B, C, DR, DQ typing or any combination of these, using serological techniques.
The Steering Committee acknowledges that few laboratories use serological HLA typing in isolation, and many use DNA-based supplementary techniques to aid in the definition and refinement of the HLA specificities detected by serology. Therefore, in line with previous years’ results, there will ordinarily be an expectation that Scheme 1A results are reported by participants at the split specificity level – based on a combination of serological and molecular typing results.
Participants are requested to report Scheme 1A results using the correct HLA specificity nomenclature https://hla.alleles.org/.
Purpose
To assess participants’ ability to use serological and supplementary methods to correctly identify HLA specificities.
Samples
A total of ten blood samples will be sent each year as five distributions of two blood samples.
Reporting
Depending on their typing strategies participants may register for HLA- A, B, C, DR, DQ assessment.
Participants must only register to be assessed on those loci tested using serological methods. Participants must make a report for each HLA locus for which they have registered.
It is acknowledged that many laboratories use supplementary techniques to confirm serological HLA specificity assignment. The report should detail the HLA phenotype using official WHO HLA specificity nomenclature.
Reports should be made at the split specificity level, where appropriate, using the results of the serological typing and any typing performed using supplementary techniques.
Participants must only use the reporting forms provided within the UK NEQAS for H&I Participant’s Portal and are required to make their report within 10 days.
Assessment
Participants will be assessed on the HLA loci for which they are registered.
The consensus complete HLA phenotype for assessment is determined by at least 75% of laboratories agreeing each specificity. Specificities failing to reach the 75% consensus level will not be assessed. In the event that a consensus is not reached, a reference HLA type will be obtained and used instead.
A “blank” forms part of the assessment if at least 75% of laboratories report a single specificity at a locus.
Assessment Procedure
Each complete HLA phenotype in agreement with the consensus phenotype – Acceptable
Each complete HLA phenotype not in agreement with the consensus phenotype – Unacceptable
Each sample/registered loci not reported- with valid reason – Not Assessed
Each sample/registered loci not reported / late submission of results – Unacceptable
Satisfactory Performance
Satisfactory performance is obtaining nine or more complete HLA phenotypes in agreement with the consensus phenotypes 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
- 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.