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Clinical Chemistry and Laboratory Medicine (CCLM)

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

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An enzyme linked immunosorbent assay (ELISA) for the determination of the human haptoglobin phenotype

Nina S. Levy1 / Moshe Vardi1 / Shany Blum1 / Rachel Miller-Lotan1 / Yefim Afinbinder1, a / Patricia A. Cleary2 / Andrew D. Paterson3, 4 / Bhupinder Bharaj3 / Janet K. Snell-Bergeon5 / Marian J. Rewers5 / Orit Lache1 / 6

1Technion-Institute of Technology, The Ruth and Bruce Rappaport Faculty of Medicine, Haifa, Israel

2The Biostatistics Center, The George Washington University, Rockville, MD, USA

3Program in Genetics and Genome Biology, The Hospital for Sick Children, Toronto Ontario, Canada

4Dalla Lana School of Public Health, University of Toronto, Ontario, Canada

5Barbara Davis Center for Childhood Diabetes, University of Colorado, Aurora, CO, USA

6Technion-Israel Institute of Technology, 1 Efron Street, Bat Galim, POB 9649, Haifa 31096 Israel

aYefim Afinbinder is deceased.

Corresponding author: Andrew P. Levy, Technion-Israel Institute of Technology, 1 Efron Street, Bat Galim, POB 9649, Haifa 31096, Israel, Phone: +972-4-8295202, Fax: +972-4-8514103

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 51, Issue 8, Pages 1615–1622, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2013-0018, March 2013

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This article offers supplementary material which is provided at the end of the article.


Background: Haptoglobin (Hp) is an abundant serum protein which binds extracorpuscular hemoglobin (Hb). Two alleles exist in humans for the Hp gene, denoted 1 and 2. Diabetic individuals with the Hp 2-2 genotype are at increased risk of developing vascular complications including heart attack, stroke, and kidney disease. Recent evidence shows that treatment with vitamin E can reduce the risk of diabetic vascular complications by as much as 50% in Hp 2-2 individuals. We sought to develop a rapid and accurate test for Hp phenotype (which is 100% concordant with the three major Hp genotypes) to facilitate widespread diagnostic testing as well as prospective clinical trials.

Methods: A monoclonal antibody raised against human Hp was shown to distinguish between the three Hp phenotypes in an enzyme linked immunosorbent assay (ELISA). Hp phenotypes obtained in over 8000 patient samples using this ELISA method were compared with those obtained by polyacrylamide gel electrophoresis or the TaqMan PCR method.

Results: Our analysis showed that the sensitivity and specificity of the ELISA test for Hp 2-2 phenotype is 99.0% and 98.1%, respectively. The positive predictive value and the negative predictive value for Hp 2-2 phenotype is 97.5% and 99.3%, respectively. Similar results were obtained for Hp 2-1 and Hp 1-1 phenotypes. In addition, the ELISA was determined to be more sensitive and specific than the TaqMan method.

Conclusions: The Hp ELISA represents a user-friendly, rapid and highly accurate diagnostic tool for determining Hp phenotypes. This test will greatly facilitate the typing of thousands of samples in ongoing clinical studies.

Keywords: diabetes; ELISA; haptoglobin phenotype; pharmacogenomics; vitamin E

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T. J. Orchard, W. Sun, P. A. Cleary, S. M. Genuth, J. M. Lachin, P. McGee, A. D. Paterson, P. Raskin, Y. Anbinder, and A. P. Levy
Diabetes, 2013, Volume 62, Number 9, Page 3218

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