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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

Editorial Board Member: Gillery, Philippe / Kazmierczak, Steven / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Whitfield, John B.

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Reliability and correlation study of a new homocysteine assay

Silvia Persichilli1 / Jacopo Gervasoni2 / Daniel De Martino3 / Antonia Vitrani4 / Domenico Ettore Capoluongo5 / Bruno Giardina6 / Bruno Zappacosta7

1Istituto di Biochimica e Biochimica Clinica, Università Cattolica del Sacro Cuore, Rome, Italy

2Istituto di Biochimica e Biochimica Clinica, Università Cattolica del Sacro Cuore, Rome, Italy

3Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche “Giovanni Paolo II”, Università Cattolica del Sacro Cuore, Campobasso, Italy

4Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche “Giovanni Paolo II”, Università Cattolica del Sacro Cuore, Campobasso, Italy

5Istituto di Biochimica e Biochimica Clinica, Università Cattolica del Sacro Cuore, Rome, Italy

6Istituto di Biochimica e Biochimica Clinica, Università Cattolica del Sacro Cuore, Rome, Italy

7Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche “Giovanni Paolo II”, Università Cattolica del Sacro Cuore, Campobasso, Italy

Corresponding author: Dr. Silvia Persichilli, Istituto di Biochimica e Biochimica Clinica, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 8, 00168 Rome, Italy Phone: +39-06-3015-4222, Fax: +39-06-3015-6783,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 46, Issue 12, Pages 1786–1788, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2008.334, December 2008

Publication History

Received:
2008-05-08
Accepted:
2008-08-05

Abstract

Background: Hyperhomocysteinemia is a risk factor for cardiovascular, cerebrovascular diseases and is also associated with congenital birth defects, pregnancy complications and cancer. Many homocysteine assays have been developed since the 1960s and most companies have commercially available kits for homocysteine determination. In this paper, we report the performance characteristics of the new Architect homocysteine assay and the correlation with HPLC and other routine analytical methods.

Methods: Recovery, limit of detection (LOD), total imprecision and interferences were evaluated; furthermore, the method was compared with HPLC and with two routine methods.

Results: Recovery was higher than 95%, LOD was lower than 1.0 μmol/L, the range for total imprecision was 1.7%–3.8%. No significant degree of interference was observed up to 5 g/L hemoglobin, 20 mg/dL (342.5 μmol/L) bilirubin and 60 g/L lipids. For the comparison study, this new method shows a lightly positive bias with HPLC (mean±SD: 0.03±1.7 μmol/L) with R2=0.96, a positive bias with the immunonephelometric method (mean±SD: 1.7±1.2 μmol/L) with R2=0.98, and a negative bias with the enzymatic method (mean±SD: –1.8±2.2 μmol/L) with R2=0.94.

Conclusions: This new method from Abbott can be included among the methods suitable for homocysteine routine analysis.

Clin Chem Lab Med 2008;46:1786–8.

Keywords: enzymatic method; HPLC; immunonephelometric method

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