Assessment of the basic performance of a new D-dimer reagent, LPIA-GENESIS D-dimer, and its characteristics

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  • 新規D-dimer試薬LPIAジェネシスDダイマーの基礎性能評価および試薬特性

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<p>We examined the basic performance and characteristics of a new D-dimer reagent, LPIA-GENESIS D-dimer (LG-DD), which recognizes an antigen epitope different from those recognized by conventional reagents. The CV values of precision test were from 0.21% to 2.67% for within run, and from 1.86% to 2.80% for 10 days’ between run. A dilution linearity of ≤ 56.3 μg/mL was confirmed. The minimum detection sensitivity was 0.34 μg/mL. The correlation with LPIA-ACE-D-Dimer II (ACE-DD) was y = 0.964x + 0.092 (r = 0.952). When serially measuring each parameter after fibrinogen fibrinolysis, there was no serial increase in any parameter of LG-DD. When serially measuring each parameter after fibrin fibrinolysis, there was a serial increase in each parameter. The values of all parameters of LG-DD were higher than those of ACE-DD. Fibrinolysis was promoted after coagulation-factor-XIII-deficient plasma coagulation, and there were serial increases in all parameters, but their values were lower than those of ACE-DD. This suggests that there is no influence on values in samples coagulated in blood collection tubes. From the results of this study, LG-DD may show a high performance without being affected by coagulation in blood collection tubes and also a high specificity for the D-dimer produced in vivo.</p>

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