DiaPharma Group, Inc.

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).

ISI ~1.0 Human Recombinant

Summary and principle
The thromboplastin reagent included in the RecombiPlasTin 2G kit, after reconstitution with the RecombiPlasTin 2G Diluent, is a liposomal preparation that contains human RTF relipidated in a synthetic phospholipid blend and combined with calcium chloride, buffer and a preservative. The enhanced manufacturing process used for this reagent ensures an excellent lot to lot uniformity and better performance than thromboplastins derived from natural sources. Due to its very high sensitivity, comparable to the International Reference Preparations, RecombiPlasTin 2G is especially suitable for monitoring Oral Anticoagulant Therapy. Since RTF does not contain any contaminating coagulation factors, this PT reagent shows a high sensitivity to deficiencies of Factors X, VII, V and II, which makes it particularly appropriate for factors assay of the extrinsic pathway.

The RecombiPlasTin 2G reagent is formulated to be insensitive to therapeutic levels of heparin. In the PT test, the addition of the tissue thromboplastin (RecombiPlasTin 2G reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrinogen to fibrin, with formation of a solid gel. For the IL Coagulation Systems only, the Fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during
clotting to a calibrator.

Composition

• RecombiPlasTin 2G (RTF): 5 x 20 mL vials of lyophilized recombinant human tissue factor, synthetic phospholipids with stabilizers, preservative and buffer.
• RecombiPlasTin 2G Diluent (RTF Diluent): 5 x 20 mL vials of an aqueous solution of calcium chloride, polybrene and a preservative.