Factor XIII Assays and Associated Problems for Laboratory Diagnosis of Factor XIII Deficiency: An Analysis of International Proficiency Testing Results

Peihong Hsu; Nicole D. Zantek; Piet Meijer; Catherine P. M. Hayward; Judith Brody; Xinmin Zhang; Kristi J. Smock; Elizabeth M. Van Cott

doi:10.1055/s-0034-1365841

Seminars in Thrombosis and Hemostasis, Table of Contents

Semin Thromb Hemost 2014; 40(02): 232-238
DOI: 10.1055/s-0034-1365841

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Factor XIII Assays and Associated Problems for Laboratory Diagnosis of Factor XIII Deficiency: An Analysis of International Proficiency Testing Results

Peihong Hsu

¹Department of Pathology/Laboratory Medicine, Hofstra North Shore-LIJ School of Medicine, Lake Success, New York

,

Nicole D. Zantek

²Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota

,

Piet Meijer

³ECAT Foundation, Leiden, The Netherlands

,

Catherine P. M. Hayward

⁴Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada

,

Judith Brody

¹Department of Pathology/Laboratory Medicine, Hofstra North Shore-LIJ School of Medicine, Lake Success, New York

,

Xinmin Zhang

¹Department of Pathology/Laboratory Medicine, Hofstra North Shore-LIJ School of Medicine, Lake Success, New York

,

Kristi J. Smock

⁵Department of Pathology and ARUP Institute for Clinical and Experimental Pathology, ARUP Laboratories, University of Utah, Salt Lake City, Utah

,

Elizabeth M. Van Cott

⁶Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts

› Author Affiliations

Abstract

We analyzed results from the External quality Control of diagnostic Assays and Tests program to assess current clinical laboratory practice and performance of different methods for factor XIII (FXIII) testing internationally. FXIII proficiency testing data from all eight surveys conducted in 2010 and 2011 were analyzed (1,283 results), comparing the three available methods for detecting FXIII deficiency, thus including clot-solubility qualitative activity, quantitative activity, and antigen. Clot-solubility qualitative assays detected a deficiency in only 16% (11/69) of samples with less than 2% FXIII. Assays using added thrombin detected more deficiencies (33%) than did assays without added thrombin (11%). The most commonly used quantitative activity method tended to produce higher results for low FXIII samples than other quantitative activity methods. Antigen results generally showed good accuracy compared with expected levels. The mean interlaboratory coefficients of variation showed wide variability, especially for samples with less than 10% FXIII activity. Laboratory self-classification of results (as normal vs. abnormal) was good, and was slightly better for specimens with ≤ 25% FXIII than for specimens with 26 to 70% or those with >70% FXIII. We conclude that quantitative activity assays perform better for detecting FXIII deficiency than clot solubility assays, although some quantitative activity assays overestimate low FXIII levels.

Keywords

factor XIII - clot-solubility assay - quantitative activity - antigen - ECAT - NASCOLA

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References

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