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RFMK-test

ПГ-12, ПГ-12/1

Registration Certificate

A set of reagents for the determination of soluble fibrin-monomer complexes (RFMC) in human blood plasma using the o-phenanthroline method (RFMC test) according to TU 21.20.23-067-05595541-2020.

Designed for qualitative and quantitative assessment of RFMC content in blood plasma using their precipitation under the influence of o-phenanthroline.

The method has significant diagnostic value as a marker of thrombinemia, one of the key indicators of disseminated intravascular coagulation (DIC) syndrome, as well as thromboses and embolisms. It enables dynamic monitoring of RFMC content in plasma, including during anticoagulant therapy.

Method Principle: The test is based on evaluating the time it takes for fibrin clots to appear in the examined plasma after adding o-phenanthroline. The rate of their formation depends on the concentration of RFMC.

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Composition of the PG-12 kit:

  • O-phenanthroline, dry (100 mg/vial) – 4 vials;
  • Positive control, lyophilized (volume after reconstitution 1.0 ml/vial) – 1 vial;
  • Negative control, lyophilized (volume after reconstitution 1.0 ml/vial) – 1 vial.

One kit is designed for conducting 400 determinations of RFMC with a consumption of 0.1 ml of o-phenanthroline solution per analysis.

Composition of the PG-12/1 kit:

  • O-phenanthroline, lyophilized (volume after reconstitution 5.0 ml/vial) – 4 vials;
  • Positive control, lyophilized (volume after reconstitution 1.0 ml/vial) – 1 vial;
  • Negative control, lyophilized (volume after reconstitution 1.0 ml/vial) – 1 vial.

One kit is designed for conducting 200 determinations of RFMC with a consumption of 0.1 ml of o-phenanthroline solution per analysis.

In the norm, the concentration of fibrin-monomer complexes is 3-4*10-2 g/l. An increase in the concentration of RFMC is characteristic of blood clotting activation. The higher the concentration of RFMC, the higher the risk of intravascular thrombosis.

Qualitative assessment: In the positive control, the appearance of a "snowstorm" is recorded within the first 10 seconds after adding o-phenanthroline. In the negative control, no appearance of flakes should be observed within the first 120 seconds after adding o-phenanthroline. The appearance of visible flakes in the examined plasma within the first 120 seconds indicates the presence of RFMC.

Quantitative assessment: When analyzing the examined plasma, record the time from the moment of adding o-phenanthroline to the onset of the first appearance of fibrin flakes. The amount of RFMC can be estimated using the table converting results of the time of appearance of flakes (s) into the concentration of RFMC (g/l∙10-2) (see the instructions).