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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter

IMPACT FACTOR 2017: 3.556

CiteScore 2017: 2.34

SCImago Journal Rank (SJR) 2017: 1.114
Source Normalized Impact per Paper (SNIP) 2017: 1.188

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Volume 39, Issue 3


Analytical Performance of a Direct Assay for LDL-Cholesterol

Eva M.L. Smets / Nathalie C.V. Péquériaux / Victor Blaton / Henk M.J. Goldschmidt
Published Online: 2005-06-01 | DOI: https://doi.org/10.1515/CCLM.2001.042


We evaluated a direct assay for the determination of LDL-cholesterol (LDL-C) L-Type assay, Wako Pure Chemicals in two laboratories. This assay is applicable to most random access clinical chemistry analyzers, allowing full automation.

Between-run coefficient of variation (NCCLS EP5) varied between 1.29 % and 3.13 % and thus met the National Cholesterol Education Program (NCEP) goal. The assay was considered linear over a physiologically relevant range of LDL-C, 2.22 to 7.04 mmol/l (NCCLS EP6).

Method comparison yielded identical results at both evaluation sites for LDL-C when assayed with the direct method. LDL-C results obtained with the homogeneous method under investigation (y) differed significantly from values from density-gradient ultracentrifugation (x) according to Chung (y = 0.87x + 0.43 mmol/l, syx = 0.38 mmol/l, r = 0.91). With the latter method as a reference method, mean bias was 3.16 % meeting the NCEP criteria. Diagnostic performance was excellent at a clinically relevant cut-off level of 3.37 mmol/l. Results of the direct method (y) and the commonly used Friedewald formula (x) were highly correlated (syx = 0.22 mmol/l, r = 0.97), but both slope and intercept differed significantly from one and zero respectively (y = 0.90x + 0.37 mmol/l).

Bilirubin, hemolysis and ascorbate did not interfere; triglycerides did not cause clinically relevant interference below 11.3 mmol/l.

The direct method we investigated is user-friendly and provides an improvement in the determination of LDL-C in routine laboratories.

About the article

Published Online: 2005-06-01

Published in Print: 2001-04-09

Citation Information: Clinical Chemistry and Laboratory Medicine, Volume 39, Issue 3, Pages 270–280, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/CCLM.2001.042.

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