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Clinical Chemistry and Laboratory Medicine (CCLM)

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Determination of serum holotranscobalamin concentrations with the AxSYM active B12 assay: cut-off point evaluation in the clinical laboratory

Fabrizia Bamonti1 / Giovanna Antonella Moscato2 / Cristina Novembrino3 / Dario Gregori4 / Claudia Novi2 / Rachele De Giuseppe1 / Claudio Galli5 / Valentina Uva1 / Silvia Lonati1 / Rita Maiavacca6

1Dipartimento Scienze Mediche, Università degli Studi di Milano, Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Fondazione IRCCS, Milan, Italy

2U.O. Laboratorio di Analisi Chimico-Cliniche Ospedale di Cisanello, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy

3Dipartimento Scienze Neurologiche, Centro “Dino Ferrari”, Università degli Studi di Milano, Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Fondazione IRCCS, Milan, Italy

4Department of Environmental Medicine and Public Health, Labs of Biostatistics and Epidemiological Methods, University of Padova, Padua, Italy

5Abbott Diagnostics, Rome, Italy

6Dipartimento Area Servizi Diagnostici, Laboratorio di Patologia Clinica, Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Fondazione IRCCS, Milan, Italy

Corresponding author: Fabrizia Bamonti, Dipartimento Scienze Mediche, Università degli Studi di Milano, Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Fondazione IRCCS, Via F. Sforza, 35, 20122 Milan, Italy Phone: +390255033473, Fax: +390250320403,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 48, Issue 2, Pages 249–253, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2010.032, December 2009

Publication History

Published Online:


Background: A reliable early marker is required for diagnosis of cobalamin deficiency. We calculated an appropriate holotranscobalamin (HoloTC) cut-off point for identifying cobalamin deficiency using an immunoenzymatic assay.

Methods: Determination of the cut-off threshold and correlation between HoloTC and the other diagnostic parameters routinely used for vitamin B12 deficiency [total vitamin B12 (tB12), folate, homocysteine] were measured in 250 routine blood specimens from 107 men (mean age 59.0±18.8 years) and 143 women (mean age 54.2±23.1 years). The inclusion criterion was serum tB12 concentration ≤221 pmol/L.

Results: Analytical performance results agreed with those reported by others. A weak correlation (R=0.42) was found between HoloTC and tB12. A 40 pmol/L cut-off threshold was chosen for HoloTC and the associated sensitivity and specificity was 0.86 and 0.66, respectively. Out of 250 tested samples, 126 showed tB12 concentrations 139–221 pmol/L (gray zone, GZ) and 124 had tB12 concentrations <139 pmol/L (low, L). Values less than the cut-off for HoloTC were present in 68.2% and 37.9% of cases in the GZ and L group, respectively (p<0.01), and in 53.2% of subjects.

Conclusions: Our results confirmed the analytical reliability of the AxSYM HoloTC assay. The method is adequate for routine use and a cut-off threshold of 40 pmol/L is appropriate for assessing cobalamin deficiency in populations with reduced tB12 values.

Clin Chem Lab Med 2010;48:249–53.

Keywords: analytical performance; holotranscobalamin; immunoenzymatic assay; vitamin B12

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