Our Haemostasis reagent portfolio has been carefully selected to ensure our customers receive the highest quality performance from our market leading analysers.

Our Reagents Portfolio

Reagents Products

PT

Dade Innovin - Registered Under Act 737 (IVDC429406316)

Dade Innovin Reagent is prepared from purified recombinant human tissue factor produced in E. coli, combined with synthetic phospholipids, calcium, buffers, and stabilisers. It is highly sensitive to extrinsic factor deficiencies and oral anticoagulant-treated patient plasma samples. The sensitivity of Dade Innovin Reagent is very similar to that of the WHO human brain reference thromboplastin. It is insensitive to therapeutic levels of heparin, which, in combination with high sensitivity to coagulation factors, makes Dade Innovin Reagent ideal for monitoring oral anticoagulant therapy and differentiating abnormal plasmas, even in the mildly pathological range.

Thromborel S - Registered Under Act 737 (IVDC877786216)

Thromborel S Reagent is prepared from human placental tissue factor combined with calcium chloride and stabilisers. The reagent contains minimal residual clotting factors, such as prothrombin or factors VII or X, for clear definition of factor deficiencies and steep factor assay curves. Because of its high sensitivity to these coagulation factors, the reagent is suitable for monitoring oral anticoagulant therapy. Thromborel S Reagent exhibits good correlation with the WHO international reference thromboplastin preparation. With the Thromborel S Reagent and the appropriate deficient plasma, it is possible to determine activity of coagulation factors II, V, VII, and X. The reagent differentiates abnormal plasmas, even in the mildly pathological range.

APTT

Dade Actin FS - Registered Under Act 737 (IVDC695822916)

Dade Actin FS Reagent is a highly sensitive reagent for the detection of factor deficiencies (VIII, IX, XI and XII) of the intrinsic system. With moderate sensitivity to lupus anticoagulants and high sensitivity to heparin, it fulfills all requirements of routine coagulation testing.

Dade Actin FSL - Registered Under Act 737 (IVDC169236416)

Dade Actin FSL Reagent exhibits increased sensitivity to lupus anticoagulants and moderate heparin sensitivity. The reagent shows good factor sensitivity to detect clinically significant deficiencies of the intrinsic system.

Fibrinogen

Dade Thrombin - Registered Under Act 737 (IVDC2248823-148596)

Dade Thrombin Reagent is an effective reagent for use in the determination (Clauss method) of fibrinogen in the detection of hereditary or acquired hypo- and hyperfibrinogenemia, dysfibrinogenemia, and afibrinogenemia. The reagent offers long stability after reconstitution.

Dade Fibrinogen Determination Reagents - Registered Under Act 737 (IVDC2887423-151509)

The Dade Fibrinogen Determination Reagent consists of Dade Thrombin Reagent, Fibrinogen Standard, and Dade Owren’s Veronal Buffer for use in the determination of fibrinogen (Clauss method) in the detection of hereditary or acquired hypo- and hyperfibrinogenemia, dysfibrinogenemia, and afibrinogenemia. The reagent offers long stability after reconstitution.

Thrombin Time

Test Thrombin - Registered Under Act 737 (IVDC16629312818)

Test Thrombin Reagent is intended for the determination of thrombin time in citrated human plasma. The reagent is suitable for monitoring of fibrinolytic therapy, screening for disorders of fibrin formation, in suspected cases of severe fibrinogen deficiency states, and for differentiation between heparin-induced prolongation of thrombin time and disorders of fibrinogen formation. Thrombin time is found to be prolonged not only due to disorders in fibrin polymerisation, but also due to the presence of heparin. Differentiation can be achieved using Batroxobin Reagent.

Thromboclotin - Registered Under Act 737 (IVDC99053334018)

Thromboclotin Reagent is intended for the determination of thrombin time in citrated human plasma. The reagent is suitable for monitoring of fibrinolytic therapy, screening for disorders of fibrin formation, in suspected cases of severe fibrinogen deficiency states, and for differentiation between heparin-induced prolongation of the thrombin time and disorders of fibrinogen formation. Thrombin time is found to be prolonged not only due to disorders in fibrin polymerization, but also due to the presence of heparin. Differentiation can be achieved using Batroxobin Reagent.

Deficient Factor

Coagulation Factor II Deficient Plasma - Registered Under Act 737 (IVDB4803624-165909)

Coagulation Factor II Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired deficiencies of factor II (prothrombin). It is manufactured by immunoabsorption and contains a residual factor concentration of 1% prothrombin activity and normal levels of fibrinogen and other extrinsic clotting factors. Coagulation Factor II Deficient Plasma was designed to be used in combination with Dade Innovin or Thromborel S Reagents.

Coagulation Factor V Deficient Plasma - Registered Under Act 737 (IVDC6791823-151507)

Coagulation Factor V Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired deficiencies of factor V. It is manufactured by immunoabsorption and contains a residual factor concentration of 1% factor V activity and normal levels of fibrinogen and other extrinsic clotting factors. Coagulation Factor V Deficient Plasma was designed to be used in combination with Dade Innovin or Thromborel S Reagents.

Coagulation Factor VII Deficient Plasma - Registered Under Act 737 (IVDC3763724-166628)

Coagulation Factor VII Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired deficiencies of factor VII. It is manufactured by immunoabsorption and contains a residual factor concentration of 1% factor VII activity and normal levels of fibrinogen and other extrinsic clotting factors. Coagulation Factor VII Deficient Plasma was designed to be used in combination with Dade Innovin or Thromborel S Reagents.

Coagulation Factor VIII Deficient Plasma - Registered Under Act 737 (IVDC3763724-166628)

Coagulation Factor VIII Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired deficiencies of factor VIII (haemophilia A). With a residual factor activity of less than 1%, the reagent is ideal for the monitoring of substitution therapy. Coagulation Factor VIII Deficient Plasma was designed to be used in combination with Dade Actin, Dade Actin FS, Dade Actin FSL, or Pathromtin SL Reagents.

Coagulation Factor IX Deficient Plasma - Registered Under Act 737 (IVDC2340624-168298)

Coagulation Factor IX Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired deficiencies of factor IX (haemophilia B). With a residual factor activity of less than 1%, the reagent is ideal for the monitoring of substitution therapy. Coagulation Factor IX Deficient Plasma was designed to be used in combination with Dade Actin, Dade Actin FS, Dade Actin FSL, or Pathromtin SL Reagents.

Coagulation Factor X Deficient Plasma - Registered Under Act 737 (IVDC2437724-174428)

Coagulation Factor X Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired deficiencies of factor X. It is manufactured by immunoabsorption and contains a residual factor concentration of less than 1% factor X activity and normal levels of fibrinogen and other extrinsic clotting factors. Coagulation Factor X Deficient Plasma was designed to be used in combination with Dade Innovin or Thromborel S Reagents.

Coagulation Factor XI Deficient Plasma - Registered Under Act 737 (IVDB4803624-165909)

Coagulation Factor XI Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired deficiencies of factor XI. The reagent has a residual factor concentration of less than 1% factor XI activity and was designed to be used in combination with Dade Actin, Dade Actin FS, Dade Actin FSL, or Pathromtin SL Reagents.

Coagulation Factor XII Deficient Plasma - Registered Under Act 737 (IVDB4803624-165909)

Coagulation Factor XII Deficient Plasma is a human plasma-based reagent for the detection of hereditary or acquired deficiencies of factor XII. The reagent has a residual factor concentration of less than 1% factor XII activity and was designed to be used in combination with Dade Actin, Dade Actin FS, Dade Actin FSL, or Pathromtin SL Reagents.

Platelet Function

Revohem ADP - Registered Under Act 737 (IVDB7488623-148598)

160 µmol/L of ADP. Investigation of platelet aggregation induced by ADP.

Revohem Epinephrine - Registered Under Act 737 (IVDB5712223-151509)

0.8 mmol/L of Epinephrine. Investigation of platelet aggregation induced by Epinephrine.

Revohem Arachidonic Acid - Registered Under Act 737 (IVDB2856023-145616)

12 mmol/L of Arachidonic Acid. Investigation of platelet aggregation induced by Arachidonic Acid.

Revohem Ristocetin - Registered Under Act 737 (IVDB2875523-147174)

12 mg/mL of Ristocetin. Measurement of the von Willebrand Factor Ristocetin cofactor by platelet aggregation.

Revohem Collagen - Registered Under Act 737 (IVDB7463023-150550)

0.8 mg/mL of Collagen. Investigation of platelet aggregation induced by Collagen.

Lupus Anticoagulant

LA1 screening - Registered Under Act 737 (IVDB7578124-159431)

LA 1 Screening Reagent contains dilute Russell’s viper venom and low phospholipids for use in the simplified DRVVT as a screening test for lupus anticoagulants. The LA 1 Screening Reagent was designed to be used in conjunction with the LA 2 Confirmation Reagent.

LA2 confirmation - Registered Under Act 737 (IVDB7578124-159431)

LA 2 Confirmation Reagent is a simplified dilute Russell’s viper venom test rich in phospholipids, making it ideal for the confirmation of lupus anticoagulants. The LA 2 Confirmation Reagent was designed to be used in conjunction with the LA 1 Screening Reagent.

D-Dimer

Innovance D-Dimer - Registered Under Act 737 (IVDC7840823-144712)

The INNOVANCE D-Dimer Kit is a rapid, highly precise, and sensitive test system for the determination of D-dimer. It offers high diagnostic sensitivity of >98% for exclusion of VTE (venous thromboembolism). With its extended assay range, D-dimer levels can be used for the diagnosis and monitoring of patients with disseminated intravascular coagulopathy (DIC), as well as for the monitoring of anticoagulation treatment and pregnancy-related coagulopathies (e.g., preeclampsia and HELLP syndrome).

Protein C Pathway

Protein C Reagent - Registered Under Act 737 (IVDC5756324-169608)

Protein C Reagent is a coagulometric reagent used for the quantitative determination of protein C activity. The reagent is suitable for the detection of hereditary or acquired protein C deficiencies.

Berichrom Protein C - Registered Under Act 737 (IVDC4372024-163835)

The Berichrom Protein C Kit, a chromogenic activity assay, is used for the detection of hereditary or acquired protein C deficiency types. The assay is also used for the monitoring of substitution therapy with protein C concentrates in congenital protein C deficiency. The Berichrom Protein C Kit is less susceptible to interfering substances than a clotting assay.

ProC Global - Registered Under Act 737 (IVDC6791823-151507)

ProC Global Kit is a coagulometric screening reagent for the protein C pathway. It provides a determination of the anticoagulatory capacity of the protein C system. The heparin-insensitive reagent is useful in screening individuals affected by thrombophilia. ProC Global Kit is sensitive to deficiencies of factor V Leiden and proteins C and S, certain lupus anticoagulants, and high factor VIII levels. When use in combination with FV deficient plasma, it screen for the detection of factor V Leiden.

Protein S Ac - Registered Under Act 737 (IVDC4691624-166628)

Protein S Ac Reagent, a coagulometric activity reagent, is used for the detection of hereditary or acquired protein S deficiencies.

INNOVANCE Free PS Ag - Registered Under Act 737 (IVDB4803624-165909)

The INNOVANCE Free PS Ag Kit is an easy-to-use, highly specific, and stable test for the quantitative detection of free protein S in human plasma. It is based on monoclonal antibodies and employs polystyrene particles covalently coated with two monoclonal antibodies (mAb A and mAb B) that have high specificity for free protein S and do not bind to protein S/C4b-binding protein complexes; the high specificity also shows no major interferences, including interferences commonly incurred from rheumatoid factors and heterophilic antibodies. The ready-to-use liquid reagent provides excellent stability performance as well as precision.

Antithrombin

INNOVANCE Antithrombin - Registered Under Act 737 (IVDC4616620-41035)

The INNOVANCE Antithrombin Kit is an automated chromogenic assay for the quantitative determination of functional antithrombin. The human factor Xa-based reagent has minimal interference with heparin cofactor II and thrombin inhibitors such as hirudin. The ready-to-use liquid reagents provide excellent precision and reliability.

Von Willebrand factor

vWF Ag - Registered Under Act 737 (IVDB4803624-165909)

vWF Ag Kit contains is a quantitative, automated immunoassay used to determine the differentiation of quantitative versus qualitative von Willebrand factor deficiencies. It is sensitive to type 1 and 3 VWF deficiencies and offers a wide measuring range of 2–600%.

INNOVANCE VWF Ac - Registered Under Act 737 (IVDC4353824-168298)

The INNOVANCE VWF Ac Kit is a sensitive, reliable, and convenient test system for direct determination of VWF activity. It employs an advanced new technology that allows the assay to mimic the way in which VWF binds to glycoprotein Ib (GPIb), the major VWF receptor protein on platelets. Latex particles are coated with an antibody against GPIb, to which recombinant GPIb is added. The addition of patient plasma induces a VWF-dependent agglutination, which is detected turbidimetrically. Because the recombinant receptor protein includes two gain-of-function mutations, the assay does not require ristocetin.

BC von Willebrand Reagent - Registered Under Act 737 (IVDC3565024-174424)

BC von Willebrand Reagent provides a simple, rapid, and automated procedure for the determination of the ristocetin cofactor activity of von Willebrand factor. The reagent, which provides a rapid measurement time, is sensitive to types 1, 2, and 3 of von Willebrand disease (except VWD 2N) and is the recommended screening method for von Willebrand disease.