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Serum alpha1-proteinase inhibitor concentrations in healthy dogs – method validation and determination of reference interval and intra-individual variation

Authors

  • Romy M. Heilmann,

    Corresponding author
    • Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Gastrointestinal Laboratory, Texas A&M University, College Station, TX, USA
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  • Craig G. Ruaux,

    1. Department of Veterinary Clinical Sciences, College of Veterinary Medicine, Oregon State University, Corvallis, OR, USA
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  • Iwan A. Burgener,

    1. Department of Small Animal Medicine, University of Leipzig, Leipzig, Germany
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  • Jennifer D. Hern,

    1. Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Gastrointestinal Laboratory, Texas A&M University, College Station, TX, USA
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  • Jan S. Suchodolski,

    1. Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Gastrointestinal Laboratory, Texas A&M University, College Station, TX, USA
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  • Jörg M. Steiner

    1. Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Gastrointestinal Laboratory, Texas A&M University, College Station, TX, USA
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Correspondence

Dr. Romy M. Heilmann, Gastrointestinal Laboratory, Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, 4474 TAMU, College Station, TX 77843-4474, USA

E-mail: rheilmann@cvm.tamu.edu

Abstract

Background

A chronic loss of canine α1-proteinase inhibitor (cα1-PI) into the gastrointestinal (GI) tract could change the systemic proteinase-proteinase inhibitor balance. Serum cα1-PI concentrations have not been studied in dogs with well-defined GI diseases.

Objectives

To further evaluate serum cα1-PI concentrations in dogs with GI diseases, the objectives of this study were to (1) analytically validate a previously developed fecal cα1-PI immunoassay to determine serum concentrations, (2) determine a population-based reference interval (RI) and assess the clinical utility, (3) determine stability of serum cα1-PI, (4) determine the intra-individual variation in healthy dogs, and (5) determine the clinically relevant magnitude of change of serum cα1-PI.

Methods

Prestudy validation of the 125I-cα1-PI immunoassay included linearity, spiking recovery, and intra- and inter-assay precision. A RI was calculated with samples of healthy dogs. Stability at −20°C was tested on 36 samples. Intra-individual variation was assessed using samples collected from 11 healthy dogs over a 12-week period.

Results

The cα1-PI radioimmunoassay (RIA) was linear, accurate, precise, and reproducible. Serum cα1-PI decreased by 11% after one year at −20°C. Analytical, intra-individual, inter-individual, and total variation were 6.4, 9.9, 9.0, and 25.3%, respectively. The RI for serum cα1-PI was 732–1802 mg/L (n = 87); there were no differences between sex and age groups. The index of individuality was 1.31. As analytical variation was > ½ inter-individual variation, the minimum critical difference was not determined.

Conclusions

The results of this study provide the basis for further evaluating serum cα1-PI in dogs with GI disease. Using a population-based RI for serum cα1-PI appears to be appropriate.

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