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Validation study of Axis-Shield carbohydrate-deficient transferrin (CDT) on ARCHITECT® chemistry analyzer
Published/Copyright:
November 1, 2007
Abstract
Background: Carbohydrate-deficient transferrin (CDT) is a biochemical marker used for identifying chronic alcohol intake. We developed and validated an ARCHITECT c8000® (Abbott) instrument application for the Axis-Shield %CDT immunoassay.
Methods: Standard CLSI (Clinical and Laboratory Standards Institute) evaluation protocols were performed.
Results: The Axis-Shield %CDT ARCHITECT® method was standardized against the Axis-Shield %CDT microtiter test by linear regression analysis (n=50 mean of duplicate, R=0.996). Method comparison by Deming regression revealed a slope of 1.01 and an intercept of –0.03 with Axis-Shield %CDT microtiter test (n=50 in duplicate, R=0.995), and a slope of 0.82 and an intercept of 1.09 with HPLC method (n=47 in duplicate, R=0.990) as the candidate IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) reference method. The predicted medical decision points (MDPs) are both 2.6% and equal the MDP that is generally used for the Axis-Shield %CDT tests. Precision derived from pooled patient sera (low level) and commercially available control material (high level) was excellent. Total variation was 3.2% and 1.8%, respectively.
Conclusions: The Axis-Shield %CDT ARCHITECT® method, as one of the first Axis-Shield applications on a large-scale analyzer, is a reliable test for routine %CDT analysis providing precise and well-standardized %CDT results.
Clin Chem Lab Med 2007;45:1555–8.
Received: 2007-5-25
Accepted: 2007-7-23
Published Online: 2007-11-01
Published in Print: 2007-11-01
©2007 by Walter de Gruyter Berlin New York
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Keywords for this article
Abbott;
alcohol abuse;
ARCHITECT®;
Axis-Shield;
carbohydrate-deficient transferrin (CDT)
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