HDL Ultra Cholesterol Calibrator - Sekisui Diagnostics

HDL Ultra CholesterolCalibratorINTENDED USEFor the calibration of the HDL Ultra Cholesterol assay.SUMMARYRefer to the HDL Ultra Cholesterol Reagent package insert.REAGENTSThe HDL Ultra Cholesterol Calibrator is a preparation oflyophilized human serum containing lipoproteins from thevarious lipoprotein classes including high-density lipoproteins.Note: The value of the HDL Ultra Cholesterol Calibrator wasassigned by procedures traceable to the CDC HDL cholesterolreference method. 1, 2Precautions and Warnings1. For In Vitro Diagnostic Use.2. Do not pipette by mouth.3. Do not use the calibrator after the expiration date printed on thebox.4. Warning: Human source material. Treat as potentiallyinfectious. Each plasma donor unit used in the preparationof this product has been tested by an FDA-approved methodand found nonreactive for HBsAg, HCV, HIV 1 & 2 andHIV-1 Antigen. Because no known test method can offercomplete assurance that hepatitis B virus, HumanImmunodeficiency Virus (HIV) or other infectious agentsare absent, all human-based products should be handledin accordance with good laboratory practices usingappropriate precautions.5. Caution: Contains sodium azide, which may react withlead and copper plumbing to form potentially explosive metalazides. On disposal, flush drain with a large volume ofwater to prevent buildup.6. HDL Ultra Cholesterol Reagent must be used with HDLUltra Cholesterol Calibrator.PreparationAllow the vial of calibrator to equilibrate to room temperaturebefore reconstitution. Lyophilized serum calibrator should bereconstituted by adding 1.0 mL of distilled or deionized water.Close the vial and let stand for 20 minutes. Dissolve the contentsof the vial by swirling gently to avoid the formation of foam.DO NOT SHAKEStorage and StabilityUnopened calibrator is stable at 2-8°C until the expiration dateprinted on the vial.After reconstitution, calibrator is stable for 14 days at 2-8°C.Reconstitution stability of the calibrator may be extended byaliquotting and freezing the reconstituted calibrator preparationat less than -70°C for up to 4 weeks.PROCEDUREMaterials ProvidedDescription Configuration Catalog NumberHDL UltraCholesterolCalibrator3 x 1 mL 6272-3Materials Required but not ProvidedDescription Configuration Catalog NumberHDL UltraCholesterolReagentR1 1 x 60 mLR2 1 x 20 mL6121HDL UltraCholesterolReagentHDL UltraCholesterolReagent R1HDL UltraCholesterolReagent R2R1 1 x 250 mLR2 1 x 80 mLR1 1 x 750 mLR2 1 x 250 mL61226123R16123R21. Class A volumetric pipettes.2. Distilled, deionized, Type II water or equivalent.CalibrationThe calibrator should be used to analyze patient samples inaccordance with the instructions outlined in Genzyme’s HDLUltra Cholesterol Reagent package insert. The value of theHDL Ultra Cholesterol Calibrator, which can be found on thecalibrator vial label, is assigned by procedures traceable to theCDC HDL cholesterol reference method. 1,2 Refer to theinstrument manufacturer’s recommendation for calibrationfrequency. If assistance is required please call GenzymeTechnical Marketing at 800-332-1042. Quality Control valuesshould be within the expected range.REFERENCES1. National Reference System for Cholesterol. CRMLN HDLCholesterol Protocol, November 2002.2. Kimberly MM, Leary ET, Cole TG, Waymack PW.Selection, validation, standardization, and performance ofa designated comparison method for HDLcholesterol foruse in the Cholesterol Reference Method LaboratoryNetwork. Clinical Chemistry 1999; 45: 1803-12.Refer to the HDL Ultra Cholesterol Reagent package insert foradditional references.Indications of DeteriorationPresence of turbidity.1

Definitions for SymbolsREF Catalog numberFor in vitro diagnostic useTemperature limitationManufactured byUse by Batch codeConsult instructions for use Caution, consult accompanying documentManufactured by:The Americas31 New York AvenueFramingham, MA 01701-9322USAPhone: 800-999-6578Fax: 610-594-8585Email: usdiagcustomerservice@genzyme.comwww.genzymediagnostics.com80-7291-00-00 6/092