Development of Rapid Immunochromatographic Assay for D-dimer Detection

Abstract

An assay was developed for the rapid detection of a marker of coagulation and fibrinolysis, D‑dimer, based on the principle of immunochromatography in the “sandwich” format. The assay allows the quantification of D-dimer in blood plasma in concentrations ranging from 0.1 to 4.0 µg/mL, covering normal, borderline, and pathological levels of D-dimer. For plasma sample testing, the accuracy of detection was 2–8%. The diagnostic sensitivity and specificity of detection relative to the clinical threshold of the difference between the normal and pathological level of D-dimer (0.5 μg/mL) was 95 and 97%, respectively. The assay duration was 10 min. Testing of plasma samples did not require their dilution or other preliminary preparations. The developed immunochromatographic assay may represent a promising analytical tool for the rapid detection of D-dimer.