Two immunological determination methods, a semi-quantitative latex agglutination test (D-Dimer Test) and a quantitative enzyme-immunoassay (ELISA D-Dimer), are presented and investigated with regard to specificity, sensitivity, precision and accuracy in a method-comparison. Both tests are based on monoclonal antibodies to the D-Dimer fibrin fragment No cross-reactions with fibrinogen and the fibrin(ogen) degradation products , and E are detectable. The very slight crossreaction with fragment D can be neglected. The Iower detection limit in the (latex agglutination) DDimer Test is 0.5 g/ml fibrinogen-equivalents (normal ränge: < 0.5 g/ml). As is shown by the results of investigations using several reagent batches in differing D-Dimer concentration ranges, the sensitivity and reproducibility are notsubject to batch-dependent variations.
A method-comparison between the D-Dimer Test and the Dimertest Latex sho'wed good agreement, but the D-Dimer Test permits a more differentiated Statement in the normal/pathological decision ränge. The DDimer Test can be carried out rapidly (3 min) and is characterized in particular by the simple and clear reading of latex agglutination, hence permitting reliable and unequivocal findings to be obtained even when used for the first time or by changing personnel in the night-shift or emergency laboratory.Concentrations of fibrinogen-equivalents above 0.5 ng/ml are reliably detected with ELISA D-Dimer. Method-comparison showed good agreement with the D-Dimer Test and the Dimertest EIA in all concentration ranges. The high reliability of the ELISA D-Dimer method can be concluded from the within-run and day-to-day coefficients of Variation of 1.6-2.1 % and 2.6-4.1%respectively. As it is possible to use different Supports, the method can be applied to differing instrumental Systems, thereby permitting flexible use in practice.
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