Validation study of Axis-Shield carbohydrate-deficient transferrin (CDT) on ARCHITECT chemistry analyzer.

Autor:	Janssen MJ; Laboratory of Clinical Chemistry and Hematology, VieCuri Medical Center, Venlo, The Netherlands. marceljanssen@viecuri.nl, De Gruyter HL, Stappers PM, Velmans MH, van den Ouweland JM, van Daal H, Hampsink RM
Jazyk:	angličtina
Zdroj:	Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2007; Vol. 45 (11), pp. 1555-8.
DOI:	10.1515/CCLM.2007.319
Abstrakt:	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.
Databáze:	MEDLINE
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