Key result
The new domestic diagnostic kit Tech-D-dimer-auto demonstrated high correlation with imported analogues (Spearman R 0.88-0.89, p<0.001) for quantitative determination of D-dimer levels.
Why the study?
The study was conducted to perform a comparative analysis of a new home-produced D-dimer reagent based on original monoclonal antibodies against widespread diagnostic analogues.
Does the new Tech-D-dimer-auto kit provide comparable D-dimer measurements to established diagnostic analogues in patients with and without thrombosis?
Observational (n=110)
No
Does the new Tech-D-dimer-auto kit provide comparable D-dimer measurements to established diagnostic analogues in patients with and without thrombosis?
Effect estimate: Spearman R 0.88 to 0.89
p-value: p=<0.001
The new domestic Tech-D-dimer-auto kit shows high comparability with established imported analogues for quantitative D-dimer measurement, making it suitable for thrombosis detection.
Supports domestic D-dimer kit as potential alternative; leaves open prospective validation for thrombosis diagnosis.
The object of this paper is the comparative analysis of the results of determination of the D-dimer level with the new home-produced reagent on the basis of original monoclonal antibodies with the results of the widespread diagnostic analogues. The research study included blood samples of 80 patients. 22 of these patients (27.5 %) were diagnosed venous thrombosises of the lower limbs, 28 patients (35.0 %) did not have any thrombotic complications (control group). Besides, the research included 30 pregnant women (37.5 %) with different duration of gestation. Despite some distinctions when determining the D-dimer level, contemporary quantitative methods of the D-dimer level study demonstrate comparability of the research results which is documented by the high rates of correlation. The new diagnostic kit Tech-D-dimer-auto, based on the use of original monoclonal antibodies, demonstrates good comparability with analogues and is suitable for detection of thrombosis.
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An et al. (2019) conducted an observational in Venous thrombosis (n=110). Tech-D-dimer-auto diagnostic kit vs. Auto Red D-Dimer and INNOVANCE D-dimer kits was evaluated on Correlation of D-dimer levels between different diagnostic kits (Spearman R 0.88 to 0.89, p=<0.001). The new domestic diagnostic kit Tech-D-dimer-auto demonstrated high correlation with imported analogues (Spearman R 0.88-0.89, p<0.001) for quantitative determination of D-dimer levels.
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