COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)
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1 COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) Cat No. CG5023 Lot No. 182CG Size: 12 x 1 ml Expiry: INTENDED USE This product is intended for in vitro diagnostic use, and in the quality control of coagulation systems. The Coagulation Controls are for the control of accuracy and precision. DEVICE DESCRIPTION The Coagulation Controls are supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes listed in the values section. SAFETY PRECAUTIONS AND WARNINGS The controls are intended for in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents and controls. Human source material, which has been added, has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and was found to be NON-REACTIVE. FDA approved methods have been used to conduct these tests. However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly. Health and Safety Data sheets are available on request. STORAGE AND STABILITY OPENED: Store refrigerated (+2 C to +8 C). APTT, TT, PT, Fibrinogen and Antithrombin III in reconstituted serum are stable for 24 hours at +2 C to +8 C if kept capped in original container and free from contamination. Protein C, Protein S, Plasminogen, and Factors II, V, VII, VIII, IX, X, XI, XII are stable for 8 hours at +2 C to +8 C. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial. UNOPENED: Store refrigerated (+2 C to +8 C). Stable to expiration date printed on individual vials. PREPARATION FOR USE The Coagulation Controls are supplied lyophilised. 1. Carefully reconstitute each vial of lyophilised control with exactly 1 ml of distilled water at +15 C to +25 C. Close the bottle and allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid the formation of foam. Do not shake the vial. 2. Refer to the Control section of the individual analyser application. 3. Refrigerate any unused material. Prior to reuse, mix the contents of the vial thoroughly. MATERIALS PROVIDED Coagulation Control - Level 3 12 x 1 ml MATERIALS REQUIRED BUT NOT PROVIDED Volumetric pipette ASSIGNED VALUES Each batch of Coagulation Control is submitted to a number of external laboratories. Values are assigned from a consensus of results obtained by these laboratories and internal testing conducted at Randox Laboratories Ltd. The expected range of the mean is provided to aid laboratory, until it has established its own mean and SD for its test methods. 14 Jan 16 ne PAGE 1 OF 7
2 Activated Partial seconds Tcoag TriniCLOT aptt S Thromboplastin Time (APTT) seconds Siemens/Dade Actin seconds Siemens/Dade Actin FS seconds Siemens/Dade Actin FSL seconds Helena aptt seconds HemosIL APTT-SP Liquid seconds HemosIL Synthasil seconds Pacific Hemostasis APTT-XL seconds Stago aptt seconds Stago Cephascreen seconds Stago CK-Prest seconds Stago PTT Automate seconds Teco TEClot APTT seconds Human Hemostat APTT seconds Bio-Ksel System APTTs seconds Grifols DG-APTT seconds Diagon Dia-PTT seconds Weiner Lab APTT seconds Biolabo Bio-CK APTT seconds Spinreact APTT seconds Gernon Hemos PTT seconds Technology-Standard aptt seconds Tcoag TriniCLOT Automated aptt seconds Biomedica QuikCoag aptt seconds Siemens Dade Actin Cephaloplastin seconds Technoclone Siron aptt seconds Sclavo APTT-S seconds Cypress Diagnostics aptt seconds Coagpia APTT-N Activated Partial ratio Siemens/Dade Actin FSL Thromboplastin Time (APTT) Ratio ratio Stago Cephascreen ratio Stago PTT Automate ratio Stago aptt ratio HemosIL APTT-SP Liquid ratio HemosIL Synthasil ratio Pacific Hemostasis APTT-XL ratio Stago CK-Prest ratio Human Hemostat APTT ratio Bio-Ksel System APTTs ratio Siemens/Dade Actin FS ratio Diagon Dia-PTT ratio Siemens/Dade Actin Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 2 OF 7
3 Activated Partial ratio Siemens Dade Actin Cephaloplastin Thromboplastin Time (APTT) Ratio ratio Sclavo APTT-S ratio Coagpia APTT-N Antithrombin III activity % Siemens/Dade Berichrom ATIII % Helena Chrom-Z % HemosIL Liquid Antithrombin % Roche Chronogenic Thrombin % Hemosil Lyophilised Antithrombin III % STAChrom ATIII % Siemens/Dade Antithrombin III % Siemens Innovance Antithrombin III % Sclavo ATIII Factor II activity % Dade Innovin % Siemens/Dade Thromborel S % Stago Neoplastine CI Plus % Stago Neoplastine CI % HemosIL PT-Fibrinogen HS Plus % HemosIL PT-Fibrinogen Recombiplastin 2G % Stago Neoplastin R Factor IX activity % Stago PTT Automate % Siemens/Dade Actin FS % Siemens/Dade Pathromtin SL % HemosIL Synthasil % Stago CK-Prest % HemosIL APTT-SP Liquid % Stago aptt % HemosIL Factor IX deficient plasma Factor V activity % Stago Neoplastine CI Plus % Siemens/Dade Thromborel S % Dade Innovin % HemosIL PT-Fibrinogen HS Plus % HemosIL PT-Fibrinogen Recombiplastin 2G % Stago Neoplastin R % HemosIL Factor V deficient plasma Factor VII activity % Stago Neoplastine CI Plus % Siemens/Dade Thromborel S % Dade Innovin % HemosIL PT-Fibrinogen Recombiplastin 2G % Stago Neoplastin R Factor VIII activity % Stago CK-Prest % Siemens/Dade Actin FS % Siemens/Dade Pathromtin SL % Siemens/Dade Actin FSL % HemosIL Synthasil % HemosIL APTT-SP Liquid % Stago aptt Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 3 OF 7
4 Factor X activity % Siemens/Dade Thromborel S % Dade Innovin % HemosIL PT-Fibrinogen HS Plus % Stago Neoplastine CI Plus % HemosIL PT-Fibrinogen Recombiplastin 2G % Stago Neoplastin R Factor XI activity % Siemens/Dade Actin FSL % Stago aptt Factor XII activity % Siemens/Dade Actin FS % Siemens/Dade Pathromtin SL % HemosIL Synthasil % Siemens/Dade Actin FSL % HemosIL APTT-SP Liquid % Stago CK-Prest Fibrinogen g/l HemosIL PT-Fibrinogen HS Plus mg/dl g/l Stago Fibrinogen mg/dl g/l Tcoag TriniCLOT Thrombin Time mg/dl g/l Dade Multifibrin mg/dl g/l HemosIL Fibrinogen C mg/dl g/l Dade Thrombin mg/dl g/l Technoclone Fibrinogen mg/dl g/l Tcoag TriniCLOT Fibrinogen mg/dl g/l Biolabo Bio-Fibri g/l Teco Teclot Fibrinogen g/l HemosIL QFA (bovine thrombin) mg/dl g/l Pacific Hemostasis Fibrinogen mg/dl g/l Human Fibrinogen mg/dl g/l Stago STA Fibri-Prest Automate mg/dl g/l Bio-Ksel System PT mg/dl g/l Bio-Ksel Fibrinogen Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 4 OF 7
5 Fibrinogen g/l Grifols DG-FIB mg/dl g/l Diagon Dia-FIB mg/dl g/l Dade Innovin Derived Fibrinogen mg/dl g/l Siemens/Dade Thromboplastin Derived Fibrinogen mg/dl g/l Liofilchem Fibrinogen mg/dl g/l Biodevice PT mg/dl g/l HemosIL PT-Fibrinogen Recombiplastin 2G mg/dl g/l Sclavo Fibrinogen mg/dl g/l Beijing Steelex Fibrinogen g/l Cypress Diagnostics Fibrinogen mg/dl g/l Helena Clauss Fibrinogen 100 mg/dl g/l Coagpia Fibrinogen mg/dl Plasminogen activity % Stago Stachrom Plasminogen % HemosIL Plasminogen % Siemens/Dade Berichrom Plasminogen Protein C activity % Siemens/Dade Berichrom Protein C % Biomerieux VIDAS Protein C % IL HemosIL Protein C % STAChrom Protein C Protein S activity % STA Liatest % IL HemosIL ProS % IL HemosIL Free Protein S % Stago Asserachrom Free Protein S % Siemens Innovance Free PS Ag Prothrombin Time (PT) Seconds Tcoag TriniCLOT PT Excel Seconds Tcoag TriniCLOT PT HTF Seconds Dade Innovin Seconds Siemens/Dade Thromborel S Seconds HemosIL PT-Fibrinogen HS Plus Seconds STA Hepato Quick Seconds Stago Neoplastine CI Seconds Stago Neoplastine CI Plus Seconds Biolabo Bio-TP Seconds Stago SPA Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 5 OF 7
6 Prothrombin Time (PT) Seconds Stago Neoplastin R Seconds Bio-Ksel System PT Seconds Human Thromboplastin Seconds Grifols DG-PT Seconds Diagon, Dia-PT Seconds Weiner Lab Soluplastin Seconds Spinreact PT Seconds TCoag TriniCLOT PT Excel S Seconds Biodevice PT Seconds Biomedica QuikCoag PT-HS Seconds HemosIL PT-Fibrinogen Recombiplastin 2G Seconds Helena Thromboplastin LI Seconds Helena Thromboplastin Seconds Labitec PT Seconds Cypress Diagnostics PT Seconds Technoclone Technoclot PT Plus Seconds Coagpia PT-N Seconds Bio-Ksel PT Plus Seconds Beijing Succeeder PT Prothrombin Time (PT) % Tcoag TriniCLOT PT Excel activity % Tcoag TriniCLOT PT HTF % Dade Innovin % Siemens/Dade Thromborel S % Stago Neoplastine CI % Stago Neoplastine CI Plus % HemosIL PT-Fibrinogen % HemosIL PT-Fibrinogen HS Plus % Biolabo Bio-TP % Stago SPA % Stago Neoplastin R % Bio-Ksel System PT % Human Thromboplastin % Biomedica QuikCoag PT-HS % HemosIL PT-Fibrinogen Recombiplastin 2G % Technoclone Technoclot PT Plus % Coagpia PT-N % Bio-Ksel PT Plus Prothrombin Time (PT) INR Tcoag TriniCLOT PT Excel INR INR Tcoag TriniCLOT PT HTF INR Dade Innovin INR Siemens/Dade Thromborel IS INR Siemens/Dade Thromborel S INR HemosIL PT-Fibrinogen INR HemosIL PT-Fibrinogen HS Plus INR STA Hepato Quick INR Stago Neoplastine CI Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 6 OF 7
7 Prothrombin Time (PT) INR Stago Neoplastine CI Plus INR INR Human Thromboplastin INR Teco TEClot PT-S INR Biolabo Bio-TP INR Stago SPA INR Stago Neoplastin R INR Bio-Ksel System PT INR Grifols DG-PT INR Diagon, Dia-PT INR Futura System Thromboplastin S INR SGM Italia Thromboplastin INR TCoag TriniCLOT PT Excel S INR Biomedica QuikCoag PT-HS INR HemosIL PT-Fibrinogen Recombiplastin 2G INR Helena Thromboplastin LI INR Technoclone Technoclot PT Plus INR Coagpia PT-N INR Bio-Ksel PT Plus INR Beijing Succeeder PT Prothrombin Time (PT) ratio Dade Innovin ratio ratio Siemens/Dade Thromborel S ratio Stago Neoplastine CI Plus ratio Stago Neoplastin R ratio Diagon, Dia-PT ratio HemosIL PT-Fibrinogen HS Plus ratio HemosIL PT-Fibrinogen Recombiplastin 2G ratio Biodevice PT Thrombin Time (TT) Seconds Siemens/Dade Thromboclotin Seconds Technology-Standard Thrombin Seconds Technoclone Thrombin Reagent Seconds HemosIL Thrombin Time 8ml Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom PAGE 7 OF 7
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