TRI-LEVEL CARDIAC CONTROL (CRD CONTROL 1, 2, 3)
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1 TRI-LEVEL CARDIAC CONTROL (CRD CONTROL 1, 2, 3) CAT NO. CQ3259 LOT NOS. 3190CK, 3191CK, 3192CK SIZE: 3 x 2ml EXPIRY: INTENDED USE This product is intended for in vitro diagnostic use in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. DEVICE DESCRIPTION The Cardiac Controls are supplied at 3 levels, 1, 2 and 3. Target values and ranges are supplied for the following analytes at level 1; CK Total, CKMB Mass, Homocysteine, Myoglobin, Troponin I and Troponin T. Target values and ranges are supplied for the following analytes at levels 2 & 3; CK Total, CK-MB (Activity and Mass), Homocysteine, Myoglobin, Troponin I and Troponin T. SAFETY PRECAUTIONS AND WARNINGS For in vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents. Human source material from which this product has been derived, 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 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). Reconstituted serum is stable for 5 days at +2 C to +8 C, and 4 weeks at -20 C if kept capped in original container and free from contamination. Troponin I is stable for 2 weeks at -20 C if kept capped in original container and free from contamination. 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 Tri-Level Cardiac Control is supplied lyophilised. 1. Carefully reconstitute each vial of lyophilised serum with exactly 2ml of redistilled water at +20 C to +25 C. Close bottle and allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of foam. Do not shake. 2. Refer to the Control section of the individual analyser application. 3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly. MATERIALS PROVIDED Tri-Level Cardiac Control Level 1 1 x 2ml Level 2 1 x 2ml Level 3 1 x 2ml MATERIALS REQUIRED BUT NOT PROVIDED Volumetric pipette Redistilled water ASSIGNED VALUES Each batch of Cardiac 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 methods. If a method is unavailable, contact Randox Laboratories - Technical Support, Northern Ireland, tel: +44 (0) or Technical.Support@randox.com Revised 09 Mar '12 ne PAGE 1 OF 7
2 CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1) Cat. No. CQ3259 Lot No. 3190CK Size: 1 x 2ml Expiry: CK Total U/l CK-NAC substrate start (DGKC) 37 C U/I CK-NAC substrate start (DGKC) 30 C U/I CK-NAC substrate start (DGKC) 25 C U/l Vitros 37 C U/l CK-NAC serum start (DGKC) 37 C U/I CK-NAC serum start (DGKC) 30 C U/I CK-NAC serum start (DGKC) 25 C U/l CK-NAC (IFCC) 37 C U/I CK-NAC (IFCC) 30 C U/I CK-NAC (IFCC) 25 C U/l Monothioglycerol 37 C U/I Monothioglycerol 30 C U/I Monothioglycerol 25 C CK-MB Mass ng/ml = µg/l Siemens Dimension ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Roche Elecsys Modular E170 Cobas 6000 ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Ortho Vitros ECi ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Architect ng/ml = µg/l Beckman DxI800 Homocysteine umol/l Abbott AXSYM umol/l Abbott Architect Myoglobin ng/ml = µg/l Roche Elecsys ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Abbott AXSYM ng/ml = µg/l Roche Integra ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Architect ng/ml = µg/l Randox Immunoturbidimetric Troponin I ng/ml = µg/l Abbott AXSYM ng/ml = µg/l Siemens Dimension ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Ortho Vitros ECi ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Axsym ADV ng/ml = µg/l Diasorin Liaison RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 2 OF 7
3 CARDIAC CONTROL - LEVEL 1 (CRD CONTROL 1) Cat. No. CQ3259 Lot No. 3190CK Size: 1 x 2ml Expiry: Troponin I ng/ml = µg/l Abbott Architect ng/ml = µg/l Biomerieux Vidas Ultra ng/ml = µg/l Beckman DXi800 1st gen ng/ml = µg/l Roche Elecsys/E170/c6000/e411 Troponin T ng/ml = µg/l Roche Cobas TroponinT ng/ml = µg/l Roche Cardiac Reader ng/ml = µg/l Roche Cobas Troponin T HS ng/ml = µg/l Roche h232 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 3 OF 7
4 CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) Cat. No. CQ3259 Lot No. 3191CK Size: 1 x 2ml Expiry: CK Total U/l CK-NAC substrate start (DGKC) 37 C U/I CK-NAC substrate start (DGKC) 30 C U/I CK-NAC substrate start (DGKC) 25 C U/l Vitros 37 C U/l CK-NAC serum start (DGKC) 37 C U/I CK-NAC serum start (DGKC) 30 C U/I CK-NAC serum start (DGKC) 25 C U/l CK-NAC (IFCC) 37 C U/I CK-NAC (IFCC) 30 C U/I CK-NAC (IFCC) 25 C U/l Monothioglycerol 37 C U/I Monothioglycerol 30 C U/I Monothioglycerol 25 C CK-MB Activity U/l Vitros 37 C U/l Immunoinhibition substrate start 37 C U/l Immunoinhibition substrate start 30 C U/l Immunoinhibition substrate start 25 C U/l Immunoinhibition serum start 37 C U/l Immunoinhibition serum start 30 C U/l Immunoinhibition serum start 25 C U/l Immunoinhibition (IFCC) 37 C U/l Immunoinhibition (IFCC) 30 C U/l Immunoinhibition (IFCC) 25 C U/l Randox Immunoinhibition serum start 37 C U/l Randox Immunoinhibition serum start 30 C U/l Randox Immunoinhibition serum start 25 C U/l Randox Immunoinhibition substrate start 37 C U/l Randox Immunoinhibition substrate start 30 C U/l Randox Immunoinhibition substrate start 25 C CK-MB Mass ng/ml = µg/l Siemens Dimension ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Roche Elecsys Modular E170 Cobas 6000 ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Ortho Vitros ECi ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Architect ng/ml = µg/l Beckman DxI800 Homocysteine umol/l Siemens Immulite 2000/2500 umol/l Abbott AXSYM umol/l Abbott Architect Myoglobin ng/ml = µg/l Roche Elecsys RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 4 OF 7
5 CARDIAC CONTROL - LEVEL 2 (CRD CONTROL 2) Cat. No. CQ3259 Lot No. 3191CK Size: 1 x 2ml Expiry: Myoglobin ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Roche Integra ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Architect ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Randox Immunoturbidimetric Troponin I ng/ml = µg/l Vitros ng/ml = µg/l Abbott AXSYM ng/ml = µg/l Siemens Dimension ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Ortho Vitros ECi ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Axsym ADV ng/ml = µg/l Abbott Architect ng/ml = µg/l Biomerieux Vidas Ultra ng/ml = µg/l Roche Elecsys/E170/c6000/e411 Troponin T ng/ml = µg/l Roche Cobas TroponinT ng/ml = µg/l Roche Cardiac Reader ng/ml = µg/l Roche Cobas Troponin T HS ng/ml = µg/l Roche h232 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 5 OF 7
6 CARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3) Cat. No. CQ3259 Lot No. 3192CK Size: 1 x 2ml Expiry: CK Total U/l CK-NAC substrate start (DGKC) 37 C U/I CK-NAC substrate start (DGKC) 30 C U/I CK-NAC substrate start (DGKC) 25 C U/l Vitros 37 C U/l CK-NAC serum start (DGKC) 37 C U/I CK-NAC serum start (DGKC) 30 C U/I CK-NAC serum start (DGKC) 25 C U/l CK-NAC (IFCC) 37 C U/I CK-NAC (IFCC) 30 C U/I CK-NAC (IFCC) 25 C U/l Monothioglycerol 37 C U/I Monothioglycerol 30 C U/I Monothioglycerol 25 C CK-MB Activity U/l Vitros 37 C U/l Immunoinhibition substrate start 37 C U/l Immunoinhibition substrate start 30 C U/l Immunoinhibition substrate start 25 C U/l Immunoinhibition serum start 37 C U/l Immunoinhibition serum start 30 C U/l Immunoinhibition serum start 25 C U/l Immunoinhibition (IFCC) 37 C U/l Immunoinhibition (IFCC) 30 C U/l Immunoinhibition (IFCC) 25 C U/l Randox Immunoinhibition serum start 37 C U/l Randox Immunoinhibition serum start 30 C U/l Randox Immunoinhibition serum start 25 C U/l Randox Immunoinhibition substrate start 37 C U/l Randox Immunoinhibition substrate start 30 C U/l Randox Immunoinhibition substrate start 25 C CK-MB Mass ng/ml = µg/l Siemens Dimension ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Roche Elecsys Modular E170 Cobas 6000 ng/ml = µg/l Abbott AXSYM ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Ortho Vitros ECi ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Architect ng/ml = µg/l Beckman DxI800 Homocysteine umol/l Siemens Immulite 2000/2500 umol/l Abbott AXSYM umol/l Abbott Architect RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 6 OF 7
7 CARDIAC CONTROL - LEVEL 3 (CRD CONTROL 3) Cat. No. CQ3259 Lot No. 3192CK Size: 1 x 2ml Expiry: Myoglobin ng/ml = µg/l Roche Elecsys ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Roche Integra ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Architect ng/ml = µg/l Beckman DxI800 ng/ml = µg/l Randox Immunoturbidimetric Troponin I ng/ml = µg/l Abbott AXSYM ng/ml = µg/l Siemens Dimension ng/ml = µg/l Siemens Stratus ng/ml = µg/l Beckman Coulter Access ng/ml = µg/l Siemens Advia Centaur ng/ml = µg/l Ortho Vitros ECi ng/ml = µg/l biomerieux Vidas ng/ml = µg/l Tosoh ng/ml = µg/l Abbott Axsym ADV ng/ml = µg/l Abbott Architect ng/ml = µg/l Biomerieux Vidas Ultra ng/ml = µg/l Beckman DXi800 1st gen Troponin T ng/ml = µg/l Roche Cobas TroponinT ng/ml = µg/l Roche Cardiac Reader ng/ml = µg/l Roche Cobas Troponin T HS ng/ml = µg/l Roche h232 RANDOX Laboratories Ltd., 55 Diamond Road, Crumlin, Co. Antrim, United Kingdom, BT29 4QY PAGE 7 OF 7
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