In:
International Journal of Laboratory Hematology, Wiley, Vol. 39, No. 3 ( 2017-06), p. 279-285
Abstract:
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.
Type of Medium:
Online Resource
ISSN:
1751-5521
,
1751-553X
DOI:
10.1111/ijlh.2017.39.issue-3
Language:
English
Publisher:
Wiley
Publication Date:
2017
detail.hit.zdb_id:
2268600-9
Permalink