Clinical application of a new latex photometric immunoassay reagent, LPIA-GENESIS D-dimer, and its performance in patient-derived plasma samples

Abstract

Introduction: We previously reported an antibody MIF-220 that recognizes a specific structure induced on the surface of thrombin-activated E-domain of one fibrin molecule bound with the D-domains of other fibrinogen/fibrin molecules. Utilizing MIF-220, we produced a test kit for cross-linked fibrin degradation products (XDP), LPIA-GENESIS D-dimer (LG-DD), and evaluated basic performance characteristics for clinical application. We then attempted to apply LG-DD to see its eligibility in clinical plasma samples. Method: The characteristic performances requested for clinical use were studied including limit of quantitation, within-run imprecision, day-to-day imprecision, antigen excess, interference study, and method comparison with LPIAACE-Ddimer (ACE-DD) available on the market. Results: The performance characteristics were all satisfactory. Extraordinarily high concentrations of XDP are occasionally obtained by ACE-DD in samples with collection problems, but not by LG-DD, indicating that a certain XDP species present in the former was not measured by LG-DD. Structural studies suggested that the “B-b” set of polymerization sites must be involved as well in the maintenance of cross-linked fibrin in vivo. Conclusion: LG-DD was able to measure a wide range of XDP, that is, 0.20-35.0 μg FEU/mL that covers the levels of XDP in most of the clinical samples. LG-DD was found to almost avoid false-positive results noticed in samples as mentioned above, and this feature seems to be preferable to established kits for the measurement of XDP.