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KITS AND REAGENTS FOR EVALUATION HEMOSTASIS SYSTEM

PRODUCED BY TECHNOLOGY-STANDARD

The company produces the most varied range of diagnostic testers and standardized reagents for hemostasis evaluation in Russian Federation. The testers are fit for both manual and automatic tests done with use of different kinds of coagulometers. The list of products includes original reagents and testers (test systems), designed to diagnose thrombophilia including those caused by disorders of protein-C system, Lupus anticoagulant, etc.

COMMON PARAMETERS of HEMOSTASIS SYSTEMS

Prothrombin test

Techplastin-test

Purpose: The kit of reagents is designed to evaluate prothrombin time in blood plasma with  thromboplastin, standardized by International Sensitivity Index (ISI). In different series of Techplastin ISI is 1.1 and 1.2. The kit includes normal control plasma. Is used to test prothrombin complex factors and  to control  treatment with coumarins. Testing is performed on a coagulometer or manually.

Composition:  1. Lyophilized thromboplastin-calcium mixture for 2 or 5 ml of distilled water – 4 bottles. 2. Control plasma (lyophilized) – 1 bottle. Kits are available in sets for 40 and 100 tests.

Normative Values: Normal prothrombin time is: a) in  tests on coagulometer – 11-14 sec, b) manual tests –  12-15 sec.

Techplastin-test (C)

Purpose: The kit of reagents designed to evaluate prothrombin time in capillary blood with the ISI standardized thromboplastin (1.1 or 1.2) The kit includes normal control plasma. Is used to test prothrombin complex factors and to control treatment with coumarins. Testing is performed on coagulometer with mechanical principle of result registration or manually.

Composition:   1. Lyophilized thromboplastin-calcium mixture for 5 ml of distilled water – 2 bottles.  2. Techplastin diluent – 1 bottle. 3. Control plasma (lyophilized) – 1 bottle. 4. Sodium citrate – 1 bottle. The kit is designed for 25 double prothrombin time tests.

Normativ Values:  normal prothrombin time is: a) in tests on coagulometer – 11-14 sec, b) manual tests – 12-15 sec.

Activated Partial Thromboplastin Time (aPTT)

Tech-aPTT-test

Purpose: The kit of reagents is designed for performing of aPTT tests.

100-tests kit: 1. Liquid PTT-reagent – 2 bottle. 2.Calcium chloride ( Solution, 0,277%) – 2 bottle.

Normative Values: normal aPTT is  25-37 sec.

aPTT-500-test

Purpose: The kit of reagents is designed for aPTT tests or caolin clotting time.

500-tests kit composition: 1. Phospholipids (lyophilized) – 2 bottles. 2. Caolin – light fraction (concentrated suspension 200:1) – 1 bottle. 3 Tris-HCl-buffer (concentrated  20:1 solution 1 M) – 1 bottle. 4. Calcium chloride ( concentrated 20:1 solution, 5,54%) – 1 bottle.

Normative Values: normal aPTT is: 28-42 sec.

 aPTT-El-test

Purpose: The kit of reagents is used to evaluate aPTT. The peculiarity is the use of optically more transparent Elag acid in place of caolin, as well as easy preparation of reagents operational solution.

Composition: aPTT-reagent (lyophilized mixture of phospholipids and Elag acid) – 4 bottles. 2. Calcium chloride (concentrated 20:1 solution, 5,54%) – 1 bottle.

The kit is designed for 100 tests.

Normative Values: 32-42 sec.

Caolin (light fraction)

Purpose: Caolin is used for aPTT-test and Caolin clotting time test.

Composition: 1. Caolin – light fraction (concentrated suspension 200:1) – 1 bottle. 2. Caolin diluent (concentrated solution 20:1) – 1 bottle.

Thrombin time

Thrombo-test

Purpose: The kit of reagents is designed for thrombin time evalution in diagnostic of disorders at the final disfibrinogenemic stage.

50 tests kit composition: 1. Human thrombin (6-8 NIH) – 4 bottles. 2. Control plasma (lyophilized) – 1 bottle.

400 tests kit composition: 1. Human thrombin (500 NIH) – 1 bottle. 2. Standard plasma (lyophilized) – 2 bottles. 3. 3 Tris-HCl-buffer (concentrated  20:1 solution 1 M) – 1 bottle.

Normative Values: Normal thrombin time is 14-17 sec.

Thrombin 500

Purpose: Thrombin is used for thrombin time test, antithrombin III activity tests, fibrinogen concentration tests  etc.

Packing: One bottle contains 500 NIH lyophilized human thrombin and necessary stabilizers. Thrombin stock solution (50 units NIH/ml) retains activity at +2…+8 ^оС – 1 month, at  -20 ^оС – up to 2 months.

Thrombin 6

Purpose: Thrombin is used for thrombin time test.

Packing: One bottle contains 6-8 NIH lyophilized human thrombin and necessary stabilizers.

Ancystron

Purpose: Ancystron is purified coagulaze, extracted from the venom of Agkistrodon halys halys. This enzym, as well as reptilaze, is used to evaluate final coagulation stage.

Packing: One bottle contains coagulaze whose activity when dissolved is equivalent to 3-4 NIH thrombin.

Fibrinogen

Fibrinogen-test

Purpose: the kit of reagents is designed for quick fibrinogen concentration quantity test in blood plasma (Clauss’s time test). The test is performed on coagulometer only.

Composition: 1. Human thrombin (activity 500 NIH units) – 1 bottle. 2. Thrombin diluent – 1 bottle. 3. Standard plasma with specified fibrinogen concentration 1 bottle. 3. Tris-HCl-buffer (concentrated  20:1 solution 1 M) – 1 bottle. The kit is designed for 100 tests.

Normative Values: Normal fibrinogen concentration is 2,0 – 4,0 g/l.

Fibrin-monomer marker

SFMC – test  (Soluble fibrin-monomers complexes)

Purpose: The kit of reagents SFMC-test is designed for quantitative determination of soluble fibrin or soluble fibrin-mono-metric complexes  (SFMC) in blood plasma, which is the marker of intra vascular blood coagulation (thrombosis, thromboembolism, DIC-syndrome of different genesis) with the use of phenantroline reagent. As opposed to ethanol test or protamine sulphate test, SFMC-test enables to conduct dynamic control over SFMC abundance in blood plasma in the course of disease and in the process of treatment, due to quantitative result and simplicity of conducting.

Concept of the method is based on determination of time then fibrin particles appear in plasma after phenanthroline is added to it. The higher the concentration of SFMC in plasma, the shorter this time is. Average time for test conducting – 3 min.

Composition: 1. O-phenanthroline hydrochloride – 2 bottles. (plotting board version of packaging: the reagent is distributed among 96 sockets of the plotting board.) 2. Control-minus (lyophilized human plasma, not containing SFMC) – 1 bottle. 3. Control-plus (lyophilized human plasma containing SFMC) – 1 bottle.

The kit is designed for 200 tests.

Note: Different versions of  SFMC-test packing are designed for laboratories with different needs. Plotting board version provides the use of the kit within the entire validity period (24 months). When packed in bottles the useful time is up to 1,5 months.

Normative Values: Normal concentration of SFMC in plasma is 3,0 – 4,0 mg/ml.

PHYSIOLOGICAL ANTICOAGULANTS

ChromoTech-Antithrombin

Purpose: The kit of reagents designed for quantitative determination ( in % ratio to norm) of plasma anti-thrombin (PAT), based on hydrolysis of chromogenic substratum (two point method).

Composition: 1. Human thrombin (activity 500 NIH units) – 1 bottle. 2. Control plasma with specified PAT abundance (lyophilized) – 1 bottle. 3. Chromogenic substratum (lyophilized) – 1 bottle. 4. Thrombin solvent – 1 bottle. 5. Buffer for plasma dilution (tris-HCl, 0,1 M), containing heparin – 1 bottle.

The kit is designed for 30-300 tests (depending on capacity of measuring container), the test is conducted at 405 nm wave.

Normativ Values: Normal AT-III activity for this method is 75-125%.

Parus-test

Purpose: The kit of reagents is designed to screen disorders in protein-C system. The test determines combined or isolated protein-C deficiency, and factor V resistance to protein C.

Concept of the method: APTT is determined before and after introduction of protein-C activator into plasma. The test is conducted on coagulometer or manually.

Composition: 1. Protein-C activator (lyophilized) – 2 bottles. 2. APTT-reagent (lyophilized mixture of phospholipids

and  Elag acid) – 2 bottles. 3. Standard plasma (lyophilized) – 2 bottles. 4. Calcium chloride (concentrated 20:1 solution, 5,54%) – 1 bottle.

The kit is designed for 30-40 tests.

Normativ Values: Addition of protein-C activator to plasma leads to prolongation of APTT minimum 2,1 times. Protein-C system disorders are accompanied by shorter prolongation of APTT. Normal ratio is calculated. Normal ratio is more than 0,7. All results below than 0,7 indicate protein-C system disorders.

 Factor V-PC - test

Purpose: the kit of reagents is designed to determine of factor V resistance to activated protein-C

Concept of the method: Resulted in the introduction of protein-C activator into mixture of normal and factor V-deficient plasma coagulation time is increased in APTT increases. If factor V is resistant to protein-C (in mixture of patient plasma and factor V-deficient plasma) decrease of coagulation time is less evident.

The test is conducted on coagulometer or manually.

Composition: 1. Protein-C activator (lyophilized) – 2 bottles. 2. APTT-reagent (lyophilized mixture of phospholipids and Elagic acid) – 2 bottles. 3. Standard plasma (lyophilized) – 2 bottles. 4.  Factor V-deficient plasma (lyophilized) – 4 bottles. 5. Calcium chloride (concentrated 20:1 solution, 5,54%) – 1 bottle.

The kit is designed for 30-40 tests.

Normativ Values:  Normal ratio of control APTT results and patient results is calculated. Normal ratio is more than 0,8. All results below 0,8 indicate factor V-resistance to activated protein-C.

LUPUS ANTICOAGULANT

Express Lupus test

Purpose: The kit of reagents is designed to screen Lupus anticoagulant (LA).

Concept of the method:The test is based on comparative analysis of APTT in patient plasma: highly sensitive to LA (APTT_LА+) and non-sensitive to LA (APTT_LА-). Presence of LA in plasma leads to comparatively longer coagulation time in APTT_LА+ than in APTT_LА- reagent. This difference is not evident in other coagulation time increase factors in APTT test. The test is conducted on coagulometer or manually.

Composition: 1. APTT reagent highly sensitive to LA – 1 bottle. 2. APTT reagent non-sensitive to LA – 2 bottles. 3. Control plasma, positive to LA (lyophilized) – 1 bottle. 4. Calcium chloride (concentrated 20:1 solution, 5,54%) – 1 bottle.

The kit is designed for 50 tests on blood plasma.

Lupus test

Purpose: The kit of reagents is designed to determine Lupus anticoagulant (LA) by caolin time of thrombocyte-deficient plasma, pro-thrombin time with dissolved thromboplastin and Lebetox-test.

Composition:  1. Caolin (light caolin suspension, 0,25 mg/ml) – 1 bottle. 2. Thromboplastin (lyophilized), 1 g – 1 bottle. 3. Lebetox (lyophilized fraction of venom of vipera lebetina ) – 1 bottle. 4. Thrombocytin (lyophilized preparation of washed and destroyed human thrombocytes (concentrated 20:1 solution) – 1 bottle. 5. Thromboplastin and thrombocytin solvent (concentrated 20:1 solution) – 1 bottle. 6. Calcium chloride (concentrated 20:1 solution, 5,54%) – 1 bottle.

The kit is designed to test 100 plasma samples

FIBRINOLYSIS

Chromo-Tech-Plasminogen

Purpose: The kit of reagents is designed for quantitative determination (%ratio to norm) of the main component of fibrinolytic system – plasminogen, based on hydrolysis of chromogen substrate (two point method). Plasminogen evaluation is used for DIC-syndrome diagnosis, thrombophilia, fibrinolysis disorders, and to monitor  treatment with  thrombolitic medications.

Composition: 1. Chromogen substrate (lyophilized) – 2 bottles. 2. Streptokinaze (lyophilized) 5000 ME – 2 bottles.  3. Tris-HCl-buffer (concentrated 20:1 solution, 1M) – 1 bottle. 4. Control plasma with determined plasminogen concentration (lyophilized) – 1 bottle.

The kit is designed for 30-300 tests (depending on capacity of measuring container), the test is conducted at 405 nm wave.

Normativ Values: Normal AT-III activity with use of this method is 75-140%.

Streptokinaze

Purpose: For plasminogene activation in methods of fibrinolytic activity evaluation. The kit is designed for approximately 150-200 tests.

Composition: 1. Streptokinaze (5000 ME) – 1 bottle. 2. Streptokinaze solvent – 1 bottle.

FUNCTIONS of PLATELETS

ADP

Purpose: For use as platelet aggregation inductor for aggregometers. Applied in diagnostics of inborn and acquired platelets disorders and to monitor treatment with anti-aggregators.

Composition: 1. ADP (lyophilized) – 2 bottles. 2. ADP solvent – 2 bottles.

Adrenaline

Purpose: Thrombocytopathia diagnosis, monitoring of treatment with disaggregators.

Composition: 1. Adrenaline (epihephrine) – 1 bottle of dark glass. 2. Solvent for adrenaline - 1 bottle.

Collagen

Purpose: Thrombocytopathia diagnostics

Composition: collagen (lyophilized) – 1 bottle. 2. Solvent for collagen – 1 bottle.

Human thrombocytes

Purpose:  For diagnosis of Willebrand disease.

Composition: 1. Human thrombocytes (lyophilized) 1 bottle.

CONTROL PLASMAS

RNP-plasma. Reference normal plasma

Mix of PPP (about 40 healthy people).

Purpose: To standardize  biological reagent used in different tests for hemostasis evaluation, to get control results, and to test result quality evaluation. RNP-plasma is used for control purpose in the following tests: pro-thrombin time, APTT-test, thrombin time, fibrinogen concentration (by kinetic and gravimetric methods).

Packing: One bottle contains 1,0 ml of lyophilized RNP-plasma.

Pathoplasma. Pathologic plasma (abnormal plasma)

Purpose: To test result quality evaluation when conducting hemostasis tests. For control purpose use in the following tests: pro-thrombin time, APTT-test, fibrinogen concentration (by kinetic and gravimetric methods).

Packing: One bottle contains 2,0 ml of lyophilized plasma.

Protein C-resistant plasma

Factor Va-resistancy to activated protein C plasma.

Purpose: As control for determining protein C system disorders.

Packing: One bottle contains 1,0 ml of lyophilized plasma.

ADDITIONAL REAGENTS

Factor VIII deficient plasma

Plasma with VIII-factor level not more than 1 %.

Purpose: To determine of clotting factor VIII in patients with hemophilia A, for diagnostics of Willebrandt disease and to monitor treatment by concentrates of VIII-factor.

Packing: One bottle contains 1,0 ml of lyophilized plasma.

Factor IX deficient plasma

Plasma with IX-factor level not more than 1 %.

Purpose: To determine of clotting factor IX in patients with hemophilia B and to monitor treatment by concentrates of IX-factor.

Packing: One bottle contains 1,0 ml of lyophilized plasma.

Calcium chloride

Purpose: Calcium chloride solution (0,277%) is used to evaluate coagulation time in blood plasma, stabilized by citrate (for prothrombin test, caolin time, APTT, etc)

Packing: One bottle contains 10 ml of concentrated (20:1, 5,54%) calcium chloride solution. When dissolved it is equivalent to 200 ml 0,277% (0,025% M) solution.

Tris-buffer

Purpose: For different methods of hemostasis evaluation.

Packing: One bottle contains tris-HCl-bufer (concentrated 20:1 solution, 1M), 10ml.

When dissolved to 200 ml the working solution (0,05M) has pH-factor of 7,3-7,4 at +37^оС.

Human fibrinogen

Purpose: Fibrinogen is thrombin substrate. This reagent is used in different methods of hemostasis evaluation.

Packing: One bottle contains lyophilized fibrinogen, the concentration when dissolved is 2,5-3,0 g/l. Concentration of coagulating protein is not less than 97%.

Lebetox

Purpose: Factor X – activator. For use differential diagnostics of  factor X,V,II deficiency, and Lupus anticoagulant diagnostics.

Packing: The reagent contains coagulaze of  vipera lebetine venom. The kit is designed for 100 lebetox tests.

Echitox

Purpose: Factor II – activator.  Used for differential diagnosis of factor X,V,II and fibrinogen deficit,  for “ulterior” hyper coagulation diagnosis, including heparin therapy and on III stage of   DIC-syndrome.

Packing: The reagent contains coagulaze of echis multisquamatus venom. The kit is designed for 100 echitox tests.

Hepasorb

Purpose: The set of reagents Hepasorb is designed for heparin sorbtion in vitro from blood plasma of patients receiving  this anticoagulant.  Further tests include APTT time in exhausted plasma, pro-thrombin and thrombin coagulation time, progressive anti-thrombin III (AT III) activity and fibrinogen concentration.

Concept of the method: Based on capacity of sorbents to bind heparin in blood plasma by formation of insoluble “sorbent-heparin” complex which is eliminated by further centrifugation.

Sorbent Hepasorb-1 is used for plasma purification from heparin in thrombin time test, fibrinogen concentration test, and activity AT III. Sorbent Hepasorb-2 is used for plasma purification from heparin only for pro-thrombin time test and APTT, and also for fibrinogen concentration tests. Time, necessary for heparin sorbtion is approximately 10 minutes.

Composition: 1. Sorbent Hepasorb-1, 1,0 g – 1 bottle. 2. Sorbent Hepasorb-2, 2,0g – 1 bottle.

The kit is designed for heparin sorbtion by each one of sorbents in 100 ml of plasma.  Sorbent consumption for 1 ml of plasma: 10 mg of Hepasorb-1 or 2 mg of Hepasorb-2.

Sodium citrate

Purpose: Used for blood stabilization for hemostasis evaluation tests.

Packing: One bottle contains citric acid sodium 3-substituted for 50 ml of 3,8% solution.