D-Dimer Microlisa

Intended Use

D-Dimer Microlisa is designed for in-vitro quantitative determination of D-Dimer in human plasma.

Salient Features

Microwell ELISA Immunoassay for the Quantitative Detection of D-Dimer in Human Plasma

• Based on Sandwich ELISA principle.
• Ready to use Enzyme conjugate.
• Measuring Range: 25 ng/ml to 10000 ng/ml.
• Analytical Sensitivity 25 ng/ml
• Total Test Time :55 minutes.
• Shelf life :15 month at 2-8°C
• Breakaway Microwells provided in 24 test pack.
• Colour coded reagents to monitor procedural steps.
• Convenient pack size: 96 Test.

Principle

D-Dimer Microlisa test is an enzyme immunoassay based on sandwich ELISA. Anti-D-Dimer antibodies has been coated onto the wells of the microwell plate provided. Plasma sample including standards are pipetted into these wells.

During the first incubation, human D-Dimer antigen from samples and coated antibody is react and after washing the enzyme conjugate (anti-D-Dimer antibody HRPO) is added after incubation and washing to remove all the unbounded enzyme conjugate. A substrate solution which acts on the bound enzyme is added to induce a coloured reaction product. The intensity of this coloured product is directly proportional to the concentration of D-Dimer present in the samples.

Ordering Information

Performance Characteristics (Internal Evaluation) Of D-Dimer Microlisa Test

1. Accuracy : The kit has been tested using 25 clinical samples in comparison with commercially available reference immunoassay test kits and the Accuracy co-efficient is 0.995.
2. Precision
   A) The test results are repeatable in within run precision testing with CV <10%.
   B) The test results are reproducible in between run precision testing with CV <15%.