HLA-B*57:01 Typing for Drug Hypersensitivity (Scheme 7)
ACCREDITATION STATUS:
UKAS Schedule of Accreditation, Accredited to ISO/IEC 17043:2010 Provider 8351
CLINICAL APPLICATION:
HLA-B*57:01 typing for drug hypersensitivity
PURPOSE OF PROGRAMME:
To assess participants' ability to correctly determine HLA-B*57:01 status
ANALYTES:
| Analyte | Default Unit |
|---|---|
| HLA-B*57:01 | HLA-B*57:01 status as positive or negative |
MATERIAL PROVIDED: Blood
DISTRIBUTIONS PER YEAR: 3
SAMPLES PER DISTRIBUTION: 2 x 3 samples, 1 x 4 samples
FREQUENCY OF DISTRIBUTION: As per Distribution Timetable
PROGRAMME OF ANALYSIS:
Results should be submitted via online data entry. Results are expected to be returned within the specified reporting period (please refer to results deadline for each distribution on the UK NEQAS for H&I website or Participants Manual). The majority of UK NEQAS for H&I schemes are assessed on a consensus basis, therefore samples are distributed with the assigned value not being determined. Where a reference result is used, this testing is performed alongside or after the close of the EQA scheme. For these reasons UK NEQAS for H&I is unable to disclose results early.
DATA ANALYSIS:
Qualitative analysis.
PERFORMANCE SCORING:
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.
PERFORMANCE MONITORING:
Satisfactory performance is making ten sample reports in agreement with the consensus/reference HLA-B*57:01 status in a year.
PERSISTENT POOR PERFORMANCE:
Laboratories not meeting the Satisfactory Performance criteria are deemed to have Unsatisfactory Performance and must complete a root cause, corrective and preventative action form.
Histocompatibility & Immunogenetics
The External Quality Assessment Scheme for Histocompatibility and Immunogenetics was founded in 1975 by Dr Heather Dicks and Dr Colin Entwistle at the National Tissue Typing and Reference Laboratory (NTTRL) based at Southmead Hospital in Bristol. In 1989 the Service became known as the UK National External Quality Assessment Service for Histocompatibility and Immunogenetics with Dr Peter Klouda as the service director and Mr Terry Ray as the service manager. The service relocated to a new host organisation in September 2000. UK NEQAS for Histocompatibility and Immunogenetics is now part of the Welsh Blood Service. For the most up-to-date scheme information (including any pilot schemes) please contact the centre directly.
Contact Details
- Welsh Blood Service
- Ely Valley Road
- Talbot Green
- CF72 9WB
Histocompatibility & Immunogenetics
- Telephone: +44 (0) 144 362 2185
- Email: handi@ukneqas.org.uk
- Web: http://www.ukneqashandi.org.uk