Digital Electrophoretic Patterns - Pilot

Accreditation Status: currently not accredited to ISO 17043
Date Scheme started: 2025
Clinical Applicability: Investigation of monoclonal antibodies using the interpretation of electrophoresis.
Analytes:

Identification of the presence and location of staining, alongside the reporting of the pattern observed, allowing assessment of competency for electrophoretic strip reading within your laboratory. (DA/602)

Multiple digital users can be registered

Units for Reporting: N/A
Samples Distributed: 2 sets of digital images representing 2 different cases.
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.
Data Analysis: Qualitative responses are assessed in terms of MI scoring for each scoring element in relation to the Designated Response.
Performance Scoring: MI Scoring
Criteria of Performance:

Laboratory performance is classified in terms of OMIS derived from the qualitative responses for:

  • Pattern identification
  • Overall interpretation

over a running analytical window of 4 Distributions (12 months)

The categories of performance are:

  Total MIS
Good Zero
Adequate 1 - 2
Poor >2

An OMIS of 2 or more for any one analyte will be classed as poor performance.

Persistent Poor Performance: Defined as being in the Poor Performance category for two or more successive Distributions