Agreement between factor XIII activity and antigen assays in measurement of factor XIII: A French multicenter study of 147 human plasma samples. (20th March 2017)

• Record Type: Journal Article
• Authors: Caron, C.; Meley, R.; Le Cam Duchez, V.; Aillaud, M. F.; Lavenu‐Bombled, C.; Dutrillaux, F.; Flaujac, C.; Ryman, A.; Ternisien, C.; Lasne, D.; Galinat, H.; Pouplard, C.
• Is Part Of: International journal of laboratory hematology. Volume 39:Number 3(2017:Jun.)
• Page Start: 279
• Page End: 285
• Publication Date: 2017-03-20
• Subjects: FXIII deficiency -- FXIII activity -- FXIII antigen; Hematology -- Periodicals; Blood -- Diseases -- Periodicals; Hematology -- Periodicals; 616.15005
• DOI: 10.1111/ijlh.12621
• Languages: English
• ISSNs: 1751-5521

Abstract

Summary: Introduction: Factor XIII (FXIII) deficiency is a rare hemorrhagic disorder whose early diagnosis is crucial for appropriate treatment and prophylactic supplementation in cases of severe deficiency. International guidelines recommend a quantitative FXIII activity assay as first‐line screening test. FXIII antigen measurement may be performed to establish the subtype of FXIII deficiency (FXIIID) when activity is decreased. Methods: The aim of this multicenter study was to evaluate the analytical and diagnostic levels of performance of a new latex immunoassay, K‐Assay ® FXIII reagent from Stago, for first‐line measurement of FXIII antigen. Results were compared to those obtained with the Berichrom ® FXIII chromogenic assay for measurement of FXIII activity. Of the 147 patient plasma samples, 138 were selected for analysis. Results: The accuracy was very good, with intercenter reproducibility close to 7%. Five groups were defined on FXIII activity level (<5% ( n = 5), 5%–30% ( n = 23), 30%–60% ( n = 17), 60%–120% ( n = 69), above 120% ( n = 24)), without statistical differences between activity and antigen levels ( P value >0.05). Correlation of the K‐Assay ® with the Berichrom ® FXIII activity results was excellent (r = 0.919). Good agreement was established by the Bland and Altman method, with a bias of +9.4% on all samples, and of −1.4% for FXIII levels lower than 30%. One patient with afibrinogenemia showed low levels of Berichrom ® FXIII activity but normal antigen level and clot solubility as expected. Conclusions: The measurement of FXIII antigen using the K‐Assay ® is a reliable first‐line tool for detection of FXIII deficiency when an activity assay is not available.