Agreement between factor XIII activity and antigen assays in measurement of factor XIII: A French multicenter study of 147 human plasma samples.
BACKGROUND
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.
Laboratoire d'Hématologie-Hémostase, CHU Lille, Lille, France.
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Caron
Laboratoire d'Hématologie-Hémostase, CHU Saint-Etienne, Saint-Etienne, France.
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Meley
Laboratoire d'Hématologie-Hémostase, CHU Rouen, Rouen, France.
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Le Cam Duchez
Laboratoire d'Hématologie-Hémostase, CHU Marseille, Marseille, France.
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Aillaud
Laboratoire d'Hématologie-Hémostase, CHU Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France.
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Lavenu-Bombled
Laboratoire d'Hématologie-Hémostase, CHU Dijon, Dijon, France.
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Dutrillaux
Laboratoire d'Hématologie-Hémostase, CHU Paris Cochin, Paris, France.
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Flaujac
Laboratoire d'Hématologie-Hémostase, CHU Bordeaux, Bordeaux, France.
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Ryman
Laboratoire d'Hématologie-Hémostase, CHU Nantes, Nantes, France.
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Ternisien
Laboratoire d'Hématologie-Hémostase, CHU Paris-Necker, Paris, France.
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Lasne
Laboratoire d'Hématologie-Hémostase, CHU Brest, Brest, France.
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Galinat
Laboratoire d'Hématologie-Hémostase, CHU Tours, Tours, France.
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Pouplard
D005176:Factor XIII / Q000032:analysis* / Q000378:metabolism*; D005177:Factor XIII Deficiency / Q000097:blood*; D005260:Female; D005602:France; D006801:Humans; D008297:Male
D005176:Factor XIII
FXIII activity; FXIII antigen; FXIII deficiency