Authors
Osamu Kumano, Masato Matsuda, Mino Sakata, Osamu Maruyama
Published in
International journal of laboratory hematology. Sep 07, 2026. Epub Sep 07, 2026.
Abstract
Pooled normal plasma (PNP) used for lupus anticoagulant (LA) mixing tests may carry platelet-derived phospholipid (PL) activity introduced during freezing/lyophilization, potentially attenuating LA-mediated prolongation of clotting times.
To determine whether thrombin generation assay (TGA) under low-PL conditions functionally captures endogenous, platelet-derived PL activity in commercial PNP and relates to LA mixing outcomes.
Four commercial PNPs (CRYOcheck PNP, Coagtrol N, SHP, Ci-Trol 1) were tested by TGA at PL 4, 1, 0.1, and 0 μM with 1 pM tissue factor and 1.6 μM corn trypsin inhibitor. LA weak-positive and LA positive controls were mixed 1:1 with each PNP and assessed by five APTT reagents to compute the index of circulating anticoagulant (ICA). Platelet factor 4 (PF4) levels were measured by ELISA.
SHP and Ci-Trol 1 showed consistently higher TGA peak heights than CRYOcheck PNP and Coagtrol N across all PL concentrations; thrombin generation persisted at 0 μM PL, consistent with activity in the absence of added PL. The other TGA parameters exhibited the same trend. Mean ICA values were inversely correlated with TGA peak height at 4 and 1 μM PL (r ≤ -0.985), with direction preserved at 0.1 and 0 μM. PF4 levels were markedly higher in SHP and Ci-Trol 1 and paralleled higher TGA peak height and lower ICA.
Endogenous, platelet-derived PL activity in commercial PNP is a key determinant of the LA mixing test performance. TGA under low-PL conditions, complemented by PF4 measurement, offers a practical approach to qualify PNP lots and reduce the under recognition of LA.
PMID:
42706011
Bibliographic data and abstract were imported from PubMed on 08 Sep 2026.
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