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hemostasis product catalogue

hemostasis product catalogue
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hemostasis product catalogue

Product catalog summary
Hemostasis Product Catalogue Overview
This document provides a comprehensive overview of hemostasis products offered by Diagnostic Grifols, S.A., including reagents, instrumentation, and software for diagnostic applications in hemostasis.
1. Screening / Stats
  • DG-PT: A high sensitivity reagent for determining Prothrombin Time and measuring Derived Fibrinogen, suitable for screening laboratories and Oral Anticoagulant Therapy.
  • DG-APTT: Used for determining Activated Partial Thromboplastin Time, sensitive to intrinsic pathway factor deficiencies.
  • DG-CaCl2 0.025M: Provides calcium for APTT determination and intrinsic pathway factor analysis.
  • DG-Ref: Calibration plasma for establishing calibration curves with normal range analytes.
  • DG-C1 and DG-C2: Control plasmas for quality control of hemostasis parameters, with DG-C2 providing prolonged results in coagulation tests.
  • DG-FIB and DG-FIB L Human: Used for quantitative determination of Fibrinogen, with human thrombin as a reagent.
  • DG-DDimer kit: Latex test for quantitative determination of D-dimer, indicating active fibrinolysis.
  • DG-Fibrinlis: Latex manual assay for qualitative or semi-quantitative determination of D-dimer in plasma.
  • DG-TT and DG-Fibroclotin: Used for determining Thrombin Time and Reptilase Time, respectively.
2. Thrombophilia
  • DG-APC: Functional assay for resistance to activated protein C, targeting the prothrombinase complex level.
  • DG-DRVVT and Controls: Used for lupus anticoagulant testing, with confirmatory and control reagents available.
  • DG-Chrom and DG-EIA series: Chromogenic and enzyme immunoassays for various factors and proteins involved in thrombophilia.
  • DG-ADAMTS-13 Activity: Assay for measuring ADAMTS-13 activity, relevant in thrombotic thrombocytopenic purpura.
3. Hemophilia
  • Reagents for determining various clotting factors such as FVIII, FIX, essential for diagnosing and managing hemophilia.
4. Instrumentation and Software
  • Details on hemostasis analyzers, reagents, and software solutions like Sintromac® Plus v3 for managing and analyzing hemostasis data.
Conclusion
This catalogue provides detailed specifications and intended uses for a wide range of hemostasis products, supporting diagnostic and therapeutic applications in clinical settings.
Diagnostic Kits Overview
This section provides detailed information on diagnostic kits and reagents used for coagulation and thrombophilia testing in human plasma, utilizing methodologies such as chromogenic assays and ELISA.
1. DG-DRVVT and DG-DRVVT Confirm: Reagents for detecting Lupus Anticoagulants (LA) in human plasma, with DG-DRVVT Confirm used to confirm LA presence by reducing coagulation time in positive samples.
2. DG-Chrom AT and DG-Chrom AT L: Chromogenic kits for determining functional Antithrombin (AT) levels in plasma.
3. DG-Chrom PC: Measures protein C functionality using a chromogenic substrate.
4. DG-EIA PC and DG-EIA PS: ELISA assays for quantifying Protein C and Protein S in plasma.
5. DG-Chrom Hep: Quantifies unfractionated and low molecular weight heparins in plasma.
6. DG-ADAMTS-13 Activity: Chromogenic ELISA for measuring ADAMTS-13 activity.
Key Procedures: Each kit includes specific procedures involving sample preparation, reagent addition, incubation, and measurement steps.
Conclusion: The document outlines the intended use, components, and detailed procedures for each diagnostic kit, emphasizing their role in coagulation testing.
Instrumentation and Software Overview
This section provides detailed information on diagnostic kits and instruments used in hemostasis and hemophilia testing, including specifications, procedures, and components for different assays and analyzers.
1. Diagnostic Kits:
  • DG-Chrom FVIII: Chromogenic kit for determining Factor VIII activity in human plasma.
  • DG-Latex VWF:Ag: One-step assay for quantifying von Willebrand Factor antigen in plasma.
  • DG-EIA vWF Activity: ELISA assay for determining VWF activity.
  • Deficient Plasma Kits: Kits providing lyophilized plasma deficient in specific coagulation factors for testing purposes.
2. Instrumentation:
  • Hemostasis Analyzer: Modular design optimizing testing efficiency with features like a touch screen interface and advanced detection systems.
  • Efficiency Enhancements: Concentric layout minimizes space and movement, improving analysis time and reducing waste.
3. Key Components:
  • Reagents and Buffers: Various reagents and buffers provided for specific assays.
  • Sample Handling: Flexible sample handling with minimal interference and efficient processing.
Conclusion: The document outlines comprehensive solutions for hemostasis testing, emphasizing efficiency, innovation, and accuracy in diagnostic procedures.
Specifications and Features:
The document outlines the specifications and features of a fully automated hemostasis analyzer designed for clotting, chromogenic, and immunoturbidimetric tests.
Sample and Reagent Management:
The analyzer features a cap piercing system, sample buffer system, and reagent barcode reader for precise reagent handling.
Software and Data Management:
Advanced software for sample and result management, supporting open system programming for new tests.
Reagents and Assays:
Lists various assays validated in Q software v2.0, highlighting compatibility with Grifols’ reagents.
Formats and Accessories:
Details various formats and accessories, including magnetic stirrers and sample holders.
Sintromac® Web Software:
Sintromac® Web aids Oral Anticoagulant Therapy (OAT) with an Expert System for dosage adjustments and integration with hospital IT systems.
See more

Catalog excerpts

hemostasis product catalogue-3

hemostasis product catalogue Hemostasis Product Catalogue Screening / Stats Thrombophilia Hemophilia Instrumentation Software Diagnostic Grifols, S.A. Passeig Fluvial, 24 08150 Parets del Vallès Barcelona - SPAIN Tel. [34] 935 710 400 Fax [34] 935 731 373 www.grifols.com

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Screening / Stats DG-DDimer Control DG-Fibrinlis DG-TT Thrombophilia DG-APC DG-DRVVT Confirm DG-EIA Control

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Hemophilia DG-Chrom FVIII DG-Latex vWF: Ag DG-EIA vWF Activity DG-EIA vWF DG-CBA Hemostasis Analyzer Sample Holder Sample Holder Red Stirrers Waste Tray Vials

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DG-PT DG-APTT DG-CaCI2 0,025M DG-Ref DG-C1 DG-C2 DG-FIB DG-FIB L Human DG-Owren DG-DDimer kit DG-DDimer Control DG-Fibrinlis DG-TT DG-Fibroclotin

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Screening / Stats DG-PT DG-PT is intended for use in the determination of the Prothrombin Time (PT, Quick) and for measuring Derived Fibrinogen in optical systems. DG-PT is a thromboplastin extracted from rabbit brain dehydrated with acetone (40-50%), buffer, calcium ions and preservatives. The DG-PT Thromboplastin is a high sensitivity reagent with an ISI between 1.0 and 1.29, and is suitable for use in screening laboratories and Oral Anticoagulant Therapy. DG-PT is sensitive to factor deficiencies in the extrinsic pathway (deficiencies in factors II, V, VII and X). DG-PT is not sensitive to...

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DG-CaCI 2 0,025M DG-CaCl2 0.025M is used as a source of calcium in the determination of the Activated Partial Thromboplastin Time (APTT), and in the determination of factors of the intrinsic pathway (VIII, IX, XI and XII). 213904 6 x 20 ml DG-CaCl2 0.025M, calcium chloride 0.025 M. 2400 in automatic micro systems (1200 in manual or macro systems). DG-Ref DG-Ref is intended for use as the calibration plasma for establishing calibration curves using the assigned value for each analyte. DG-Ref is prepared from a pool of normal human plasma, collected in sodium citrate, and is rapidly processed,...

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Screening / Stats DG-C2 DG-C2 is intended for use as the assayed control plasma (Level 2) for quality control of the hemostasis parameters. DG-C2 is prepared from a pool of human plasma, collected in sodium citrate, freeze-dried and is further processed and adjusted to provide prolonged results in Coagulation Tests. Assayed ranges for: - Prothrombin Time (clotting) - Activated Partial Thromboplastin Time (clotting) - Fibrinogen (clotting) - Thrombin Time (clotting) - Reptilase Time (clotting) - Antithrombin (chromogenic) - Factors II, V, VII, VIII, IX, X, XI and XII (clotting) - Plasminogen (chromogenic)...

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DG-DDimer kit The DG-DDimer kit is a latex test intended for use in the quantitative DG-DDimer Latex 4 x 2 ml. determination D-dimer assay in the Qs hemostasis analyzer. DG-DDimer Buffer 4 x 2 ml. DG-DDimer kit uses a specific anti D-dimer monoclonal antibody attached to DG-DDimer Dil 1 x 4 ml. the latex particles to determine active fibrinolysis in plasma. DG-DDimer Ref 1 x 1 ml. DG-DDimer Control 1 DG-DDimer Control 1 is intended for use as the assayed normal control plasmas for the 4 x 1 ml normal control quality control of DG-DDimer kit. DG-DDimer Control 2 DG-DDimer Control...

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Screening / Stats DG- Fibrinlis DG-Fibrinlis is a latex manual assay intended for use in the qualitative or semiquantitative determination of the D-dimer in plasma. Qualitative Method: To the test card: Add one drop DG-Fibrinlis Latex + 0.020 ml undiluted plasma Mix the card 3 minutes check for agglutination Semi-quantitative method: Prepare dilutions of the test plasmas with DG-Fibrinlis Buffer and run the test as described in the qualitative method for each dilution. Results interpretation: Qualitative method - Agglutination = Positive - No agglutination = Negative Semi-quantitative method...

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DG-APC DG-DRVVT DG-DRVVT Confirm DG-DRVVT Control NEG DG-DRVVT Control POS DG-Chrom AT DG-Chrom AT L DG-Chrom PC DG-Chrom Hep DG-EIA PC DG-EIA PS DG-EIA PS Free DG-Chrom Plg DG-EIA Control DG-ADAMTS-13 Activity

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DG-APC Kit is a plasma based functional assay for the determination of resistance to activated protein C caused by the factor V Leiden mutation (FV: Q506). DG-APC kit is a clotting assay and differs from other functional APC resistance tests by acting specifically on the prothrombinase complex level. It is based on a FV-dependent prothrombin activator isolated from snake venom. Robustness and specificity of the assay is enhanced by elimination of possible disturbing influences by factors upstream the coagulation cascade and independency from calcium. Sample plasma is pre-diluted with DG-Dil (dilution...

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DG-DRVVT Confirm DG-DRVVT Confirm is a DRVV reagent rich in phospholipids in the purpose to confirm the presence of LAs in human plasmas that resulted positive after DG-DRVVT test. In a sample with LAs, the coagulation time with DG-DRVVT Confirm should be significantly lower than with DG-DRVVT because the extra phospholipid content of DG-DRVVT Confirm counteracts the LA antibodies. However, a normal sample will have the same coagulation time with both reagents. DG-DRVVT Control NEG DG-DRVVT Control NEG is intended for use as the assayed normal control for Lupus Anticoagulant (LA) testing. It...

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DG-Chrom AT L DG-Chrom AT L is a liquid chromogenic kit intended for use in the determination of the functional Antithrombin (AT) in human plasma. In the DG-Chrom AT L, the principle for determining AT is based on incubating the sample of diluted plasma with an excess of FXa and in the presence of heparin (heparin accelerates the reaction between AT and FXa). Residual FXa will attach to the chromogenic substrate, causing hydrolysis and later release of paranitroaniline (pNA). The amount of pNA is measured by absorbance at 405 nm and the result is inversely proportional to the level of AT present...

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DG-Chrom Hep is a chromogenic kit used to determine quantitatively functional unfractioned (UFH) and low molecular weight (LMWH) Heparins in human plasma. The principle of heparin determination is based on the addition of Antithrombin to a sample containing heparin, followed by incubation in the presence of an excess of FXa (heparin accelerates the reaction between AT and FXa). Residual FXa will bind to the chromogenic substrate, causing its hydrolysis and later release of para-nitroaniline (pNA). The amount of pNA is monitored measuring the absorbance at 405 nm and the result is inversely proportional...

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