Diabetic Markers EQA
| Accreditation Status: | UKAS Schedule of Accreditation | ||||||||
| Date Scheme started: | 2011 | ||||||||
| Clinical Applicability: | Aiding the clinical diagnosis of type I diabetes | ||||||||
| Analytes: |
Islet cell (ICA), Glutamic Acid Decarboxylase (GAD), Protein Tyrosine Phosphatase (IA2), Insulin antibody (IA), Zinc Transporter 8 Antibody (ZnT8) and Diabetic Marker Autoantibody Screen (SER/047) The sample analytes included will depend on their prevalence in the general population, therefore not all analytes may be covered during the year |
||||||||
| Units for Reporting: |
Islet cell: qualitative (titre) or U/mL GAD: U/mL IA2: U/mL IA: U/mL, Index or % Binding ZnT8: U/mL Diabetic Marker Autoantibody Screen: U/mL or Ratio |
||||||||
| Samples Distributed: | Liquid format. Normal and pathological human serum | ||||||||
| Number of Distributions per year: | 6 | ||||||||
| Number of Samples per Distribution: | 2 | ||||||||
| Frequency of Distributions: | Every two months as outlined in the Distribution Schedule | ||||||||
| Schedule of Analysis: | Data entry is via the web for the submission of results. Data analysis commences 28 days after sample dispatch. Late returns are accepted and will contribute to the laboratory's cumulative performance statistics. | ||||||||
| Data Analysis: | Qualitative responses are recorded for each analyte and assessed in relation to the designated response. Reports show method or kit related statistics in terms of Method Laboratory Trimmed Mean (MLTM) and range of results reported | ||||||||
| Performance Scoring: | MI Scoring | ||||||||
| Criteria of Performance: |
Laboratory performance is classified in terms of OMIS over a running analytical window of 6 Distributions (12 months). Cumulative performance scores are based on qualitative response The categories of performance are:
|
||||||||
| Persistent Poor Performance: |
Defined as being in the Poor Performance category for two or more successive Distributions |