Re-dimer Latex Test

Set composition:

Code D-1/1:

• Latex reagent (1 ml in a dropper bottle) – 1 pc.
• Positive control (0.6 ml in a dropper bottle) – 1 pc.
• Negative control (1 ml in a dropper bottle) – 1 pc.
• Imidazole buffer concentrated (5 ml in a bottle) – 1 pc.
• Agglutination plates – 5 pcs.
• Stirring sticks – 40 pcs.

Code D-1/2:

• Latex reagent (2 ml in a dropper bottle) – 1 pc.
• Positive control (0.6 ml in a dropper bottle) – 1 pc.
• Negative control (1 ml in a dropper bottle) – 1 pc.
• Imidazole buffer concentrated (5 ml in a bottle) – 1 pc.
• Agglutination plates – 10 pcs.
• Stirring sticks – 80 pcs.

One set is intended for conducting from 30 to 40 determinations (Code D-1/1) or from 60 to 80 determinations (Code D-1/2) with an approximate consumption of 0.025 ml of Latex reagent per one analysis.

Interpretation of results: In the norm, the concentration of D-dimers does not exceed 250 ng/ml. A normal level of D-dimers with high probability allows excluding venous thromboembolic conditions (VTE) – DVT (deep vein thrombosis), PE (pulmonary embolism). The D-dimer level is elevated in almost all patients with acute VTE, and in patients with a normal D-dimer level, the presence of DVT or PE is highly unlikely. An elevated D-dimer level cannot confirm the presence of VTE, as an increase in D-dimer is also observed in many other conditions with activation of the coagulation and fibrinolysis system.

Therefore, the D-dimer test is characterized by HIGH SENSITIVITY to the presence of VTE, which allows excluding it in diagnostically unclear cases, and LOW SPECIFICITY to the presence of VTE, which cannot be used as a confirming VTE test.

Qualitative analysis: In the absence of agglutination in undiluted test plasma, the D-dimer level is less than 200 ng/ml (0.2 mg/l). With a positive agglutination result, the D-dimer level is more than 200 ng/ml.

Semi-quantitative analysis: The approximate level of D-dimers in the examined sample can be determined based on the data presented in the table:

Note: D-dimer levels above 3200 ng/ml (3.2 mg/l) can be determined by further dilution of the examined sample more than 8 times.

For each series of analyzes, it is recommended to use Positive and Negative controls, which should be studied according to the same scheme as patient plasma. Agglutination of the Latex reagent with the Negative control and the absence of agglutination with the Positive control indicates the unsuitability of this Latex reagent for determining D-dimers.