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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 / 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 56, Issue 6


A new ELISA for autoantibodies to steroid 21-hydroxylase

Maria del Pilar Larosa / Shu Chen / Nora Steinmaus / Hannah Macrae / Liang Guo / Stefano Masiero
  • Unit of Endocrinology, Department of Medical and Surgical Sciences, University of Padua, Padua, Italy
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/ Silvia Garelli
  • Unit of Endocrinology, Department of Medical and Surgical Sciences, University of Padua, Padua, Italy
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  • De Gruyter OnlineGoogle Scholar
/ Miriam Dalla Costa
  • Unit of Endocrinology, Department of Medical and Surgical Sciences, University of Padua, Padua, Italy
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/ Artur Bossowski
  • Department of Pediatrics, Endocrinology and Diabetes with a Cardiology Unit, Medical University in Bialystok, Bialystok, Poland
  • Other articles by this author:
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/ Jadwiga Furmaniak / Corrado Betterle
  • Unit of Endocrinology, Department of Medical and Surgical Sciences, University of Padua, Padua, Italy
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Bernard Rees Smith
Published Online: 2017-12-21 | DOI: https://doi.org/10.1515/cclm-2017-0456



A new ELISA for autoantibodies to steroid 21-hydroxylase (21-OH Ab) is described.


In the assay test sample autoantibodies form a bridge between 21-OH coated onto the plate well and liquid phase 21-OH-biotin. Bound 21-OH-biotin is detected by the addition of streptavidin peroxidase and colorogenic peroxidase substrate.


Of 100 samples from patients with autoimmune Addison’s disease, 86 (86%) were positive for 21-OH Ab ELISA whereas 84 (84%) were positive in an immunoprecipitation assay based on 125I-labeled 21-OH. Six (0.6%) of 928 healthy adult blood donors and 1 (2.0%) of 49 adult patients with type 1 diabetes mellitus (T1DM) were positive by ELISA. No samples from adult patients with Graves’ disease (GD; n=50), celiac disease (n=29), systemic lupus erythematosis (n=9) or rheumatoid arthritis (n=20) were positive by ELISA. However, 2/51 (3.9%) children with GD, 3/69 (4.3%) children with Hashimoto’s thyroiditis (HT) and 3/119 (2.5%) children with T1DM alone or associated with autoimmune thyroid disorders were ELISA positive.


The new assay should be useful for screening patients known to be at increased risk of developing clinical autoimmune Addison’s disease, in particular children with HT, GD and/or T1DM.

Keywords: autoantibodies; autoimmune Addison’s disease; autoimmune adrenalitis; disease prediction; ELISA; population screening; steroid 21-hydroxylase


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About the article

Corresponding author: Dr. Bernard Rees Smith, FIRS Laboratories, RSR Ltd., Parc Ty Glas, Llanishen, Cardiff, CF14 5DU, UK

Received: 2017-05-24

Accepted: 2017-11-06

Published Online: 2017-12-21

Published in Print: 2018-05-24

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: The work was funded by RSR Limited, Cardiff, UK.

Employment or leadership: MdPL, SC, NS, HM, LG, JF and BRS are employees of RSR Limited. RSR Ltd. is a developer of medical diagnostics, including kits for measuring 21-OH antibodies.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 56, Issue 6, Pages 933–938, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2017-0456.

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