COVID-19 / SARS CoV-2 Antibodies EQA

Accreditation Status: UKAS Schedule of Accreditation
Date Scheme started: 2020
Clinical Applicability: Detection of antibodies to SARS-CoV-2 / COVID-19 confirming previous infection
Analytes: Antibodies to SARS-CoV-2 as IgG, Total Ig (SER/059)
Units for Reporting:

Qualitative and quantitative responses, method dependent

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 21 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 antibodies to SARS-CoV-2 as IgG and as Total Ig and assessed in relation to the designated response. Reports show method or kit related statistics in terms of Group Laboratory Trimmed Mean (GLTM) with truncation at 2SD, SD, and CV%. Reports also show method and manufacturer specific statistics.

Chosen Coefficient of Variation for quantitative results is 20%

Performance Scoring: MI Scoring
Criteria of Performance:

Laboratory performance for the qualitative element of the Scheme is assessed over a running analytical window of 12 Distributions (12 months)

The categories of performance are:

Good OMIS = 0
Adequate OMIS = 1 - 2
Poor OMIS = >2

 

Persistent Poor Performance:

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