Digital ANA (dANA) EQA - Image Based
| Accreditation Status: | UKAS Schedule of Accreditation | ||||||||
| Date Scheme started: | 2021 | ||||||||
| Clinical Applicability: | Recognition of HEp-2 patterns seen in autoimmune disease in accordance with International Consensus on Antinuclear Antibody (ANA) Patterns (ICAP). | ||||||||
| Analytes: |
A digital based image programme. Includes identifying the presence and identification of staining patterns in HEp-2 cell lines using the ICAP system (DA/601) Multiple digital users can be registered |
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| Units for Reporting: | N/A | ||||||||
| Samples Distributed: | A set of 3 digital images (magnification 1x100, 1x200, 1x400) from healthy donors or patients with autoimmune connective tissue disease. | ||||||||
| Number of Distributions per year: | 4 | ||||||||
| Number of Samples per Distribution: | 2 digital samples per distribution | ||||||||
| Frequency of Distributions: | Every 12 weeks as outlined in the Distribution Schedule | ||||||||
| Schedule of Analysis: |
Access to the digital images is via the web and includes the submission of interpretations. Data analysis commences 21 days after release of case. Late returns cannot be accepted. |
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| Data Analysis: |
Qualitative responses are assessed in terms of MI scoring for each scoring element in relation to the Designated Response. |
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| Performance Scoring: | MI Scoring | ||||||||
| Criteria of Performance: |
Laboratory performance is classified in terms of OMIS derived from the qualitative responses for:
over a running analytical window of 4 Distributions (12 months) The categories of performance are:
An OMIS of 2 or more for any one analyte will be classed as poor performance. |
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| Persistent Poor Performance: |
Defined as being in the Poor Performance category for two or more successive Distributions |