D-Dimer Assay Kit & Bulk Reagents

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US$417.00

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Selling unit: per 100ml

Product Name

  1. Common name: D-Dimer (D-Dimer) assay kit (immunoturbidimetric assay)
  2. English name: D-Dimer Reagent Kit (Immunoturbidimetric method)

Reagent Ratio

3:1, 4:1, 5:1, common ratio 3:1, other ratios need to be customized

Intended Use

This reagent is used to detect D-dimer, a product of fibrin breakdown by fibrinolytic enzymes in plasma or serum, as an aid to diagnosis.

D-dimer is a specific degradation product of cross-linked fibrin hydrolyzed by fibrinolytic enzymes, which is important for the diagnosis and treatment of fibrinolytic system diseases (e.g. DIC, various thrombosis) and fibrinolytic system-related diseases, as well as for the monitoring of thrombolytic therapy. Elevated levels of fibrin degradation product D indicate the presence of frequent fibrin degradation processes in the body.

Therefore, D-dimer is a key indicator of deep vein thrombosis (DVT), pulmonary embolism (PE), and diffuse intravascular coagulation (DIC).

Test Principle

This product is based on the principle of latex agglutination method. The antigen in the sample, can produce an agglutination reaction with the antibody attached to the latex particles, forming an antigen-antibody complex. The change in turbidity can be calculated by measuring the absorbance value at a specific wavelength to determine the amount of D-dimer in the sample.

Main Components

Reagent components included in the product.

D-Dimer Assay Kit & Bulk Reagents

*Components are not interchangeable in kits with different lot numbers.

*Reagent components not included in the product, but necessary for the test: outsourced normal and abnormal QCs and calibrators.

Storage Conditions And Expiration Date

The kit is stored at 2-8°C away from light and is valid for one year.

Reagents that have been opened are careful not to be contaminated, and reagents are stable in the instrument compartment (2-8°C) for one month.

The reagents must not be frozen.

Applicable Instruments

Hitachi 7180/7600; Olympus AU680/2700; Toshiba TBA120; Myriad BS2000M/480; Siemens ADVIA 1800/2400 series automatic biochemical analyzers.

Sample Request

Fresh serum or plasma, care should be taken to avoid hemolysis.

Sample stability: stable at 2-8°C for 7 days, -20°C for 4 weeks (freeze-thaw only once)

Test Method

  1. Reagent preparation: liquid reagents are ready to use out of the bottle.
  2. test conditions: (different parameters on the machine can be requested according to different testing instruments)

D-Dimer Assay Kit & Bulk Reagents

Operation steps.

D-Dimer Assay Kit & Bulk Reagents

Reagents and sample volumes can be increased or decreased in proportion to the requirements of different biochemical analyzers.

  1. Calibration procedure.

Landau calibrators are recommended.

  1. QC control procedures.

It is recommended that each laboratory establish its own quality control system and select appropriate quality control products for quality control. The measured values of QC products should be within the specified range. If outside the specified range, it is necessary to take appropriate measures or contact the manufacturer.

  1. Calculation.

6 points are calibrated and the corresponding values are entered. The standard curve is plotted with △A as the vertical coordinate and the concentration as the horizontal coordinate, and the standard curve is corrected with a suitable mathematical model such as Spline model, and this standard curve is saved for calculating the results.

Positive Judgment Value Or Reference Interval

<1.0 μg/ml

It is recommended that each laboratory establish its own reference range of normal values.

Interpretation Of Test Results

Bilirubin ≤ 40 mg/dL, hemoglobin ≤ 500 mg/dL and celiac ≤ 500 mg/dL did not interfere with the determination.

Limitations Of The Test Method

The measurement of D-Dimer in human serum or plasma is only one of the indicators used by the clinician to make a diagnosis of the patient. The clinician must also make a comprehensive judgment based on the patient’s physical symptoms, medical history, and other diagnostic items and diagnostic tools.

Product Performance Index

Absorbance of reagent blank: wavelength 700 nm, optical diameter 1.0 cm, temperature 37°C, A0  ≤ 1.5.

Analytical sensitivity: The kit tests 1.0 μg/ml of the analyte with an absorbance change of ΔA ≥ 0.015.

Linearity range: The linearity of the reagent should be within the range of 0.2~10.0 μg/ml, and the linear correlation coefficient|r| should not be less than 0.980; within the range of 0.2~3.0 μg/ml, the absolute deviation of linearity should not exceed 0.3 μg/ml; within the range of (3.0~10.0 μg/ml, the relative deviation of linearity should not exceed ±10%.

Precision: repeatability CV ≤ 10%; relative extreme difference between batches ≤ 15%.

Accuracy: Relative deviation ≤ 15%.

Caution

  1. This product is for in vitro diagnosis only.
  2. Avoid contamination when using the reagent, the container used must be clean, and please take necessary precautions, do not swallow, and avoid contact with skin and mucous membrane.
  3. Please dispose of the measured samples and waste liquids in accordance with the relevant national and local laws and regulations.
  4. When changing the reagent lot number, the calibration should be re-calibrated.

Reference

  1. Galivin.J.P. et al.;Clin Lab.Assays 4:73-95(1983)
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