Tumour Markers
| Accreditation Status: | UKAS Schedule of Accreditation | ||||||||||
| Date Scheme started: | 1988 | ||||||||||
| Clinical Applicability: | Diagnosis and management of malignant disease | ||||||||||
| Analytes: |
Ovarian Markers (CA125) (SER/021) Gut Markers (CA199) (SER/022) Breast Markers (CA153) (SER/023) Lung Markers (NSE) (SER/024) Chromogranin A (SER/049) All analytes are available separately |
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| Units for Reporting: | kU/L (CA series markers), ug/L (NSE), ng/mL and nmol/L (Chromogranin A) | ||||||||||
| Samples Distributed: | Liquid format. Normal and pathological human serum | ||||||||||
| Number of Distributions per year: | 6 | ||||||||||
| Number of Samples per Distribution: | 10 (2 x CA125, 2 x CA15-3, 2 x CA19-9, 2 x NSE, 2 x Chromogranin A) | ||||||||||
| 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: |
All Laboratory Trimmed Mean (ALTM) with truncation at 2SD, SD, and CV%. Reports also show method and manufacturer specific statistics. Individual laboratory performance is expressed in terms of MRBIS, SDBIS, and MRVIS. Because of marked differences in antigenic potency of some commercial kits, the Designated Value (DV) for calculation of VI is the Method Laboratory Trimmed Mean (MLTM). Chosen Coefficient of Variation: CA125 and Ovarian markers 7% CA15-3 and Breast markers 10% CA19-9 and GI markers 10% NSE and Lung markers 12.5% Chromogranin A (pilot analyte) 30.0% |
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| Performance Scoring: | MRVIS | ||||||||||
| Criteria of Performance: |
Laboratory performance is classified in terms of the MRVIS over a running analytical window of 6 Distributions (12 months)
In addition, the summation of the four subclasses should equate to within 10%, ideally within 5%, of the total IgG as estimated by an independent method |
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| Persistent Poor Performance: |
Defined as being in the Poor Performance category for two or more successive Distributions |
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| Cancer Treatment Trials: |
Participation in these EQA programmes is often a requirement for laboratories providing analytical services to clinicians wishing to enter patients. Such laboratories will be required to agree to the organiser releasing their performance data to the relevant Trials Office. |