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CIBA - CORNING 550EXPRESSINSTRUCCIONES DE TRABAJODIRECTIONS FOR USEAUTOMATIZACIÓNAUTOMATIONLABKIT – CLINICAL DIAGNOSTIC REAGENTCHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSACID PHOSPHATASEPREPARATION OF REAGENT:Dissolve one tablet (R2) with one vial of Buffer Solution (R1). This monoreagent is stable 2 daysrefrigerated.CALIBRATION:Through calculation factor.General ParametersTest Name : A.PHOSPH. Test : ACPBar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 1Calculation ParametersWavelength 1 : 405 Wavelength 2 : NONETime : 120 Blank of Sample : NOFactor : 360Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.5Low limit Abs. : 0.1 High limit Abs. : 2.0Normal Low : 0.0 High Normal : 7.0Linearity Limit : 150 Deviation Limit :Dispensation ParameterSample Volume : 3 Sample diluent :Dilution Repetition : 1 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 300LINEARITY:Until 150 U/L. Acid Phosphatase.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSUREA UV/GLDHPREPARATION OF REAGENT:Dissolve one vial of Enzymes (R2) with a little volume of Buffer Solution (R1). Return to the original flask ofbuffer when the enzymes are dissolved. This monoreagent is stable for 1 month refrigerated and keeps itout of light.CALIBRATION:Use serum calibrator.General ParametersTest Name : UREA Test : UREABar Code :Type of Test : END POINT Type of Curve : LINEAR SUPRESSEDUnits : mg/dl. Decimal Position : 0Calculation ParametersWavelength 1 : 340 Wavelength 2 : NONETime : 60 Blank of Sample : NOFactor :Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 2 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.9 High limit in Blank : 1.9Low limit Abs. : 0.5 High limit Abs. : 2.0Normal Low : 15 High Normal : 50Linearity Limit : 300 Deviation Limit : 5.0Dispensation ParameterSample Volume : 3 Sample diluent :Dilution Repetition : 1 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 30LINEARITY:The method is lineal until 300 mg/dl. Urea.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSPHOSPHORUSPREPARATION OF REAGENT:The reagent is ready to use. This reagent is stable until expiration date appointed on the flask. Keep out ofsunlight.CALIBRATION:Use serum calibrator.General ParametersTest Name : PHOSPHORUS Test : PHOSPH.Bar Code :Type of Test : END POINT Type of Curve : LINEAR SUPRESSEDUnits : mg/dl. Decimal Position : 1Calculation ParametersWavelength 1 : 340 Wavelength 2 : 600Time : 10 Blank of Sample : NOFactor :Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 2 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.4Low limit Abs. : 0.0 High limit Abs. : 2.0Normal Low : 1.5 High Normal : 6.8Linearity Limit : 20.0 Deviation Limit : 5.0Dispensation ParameterSample Volume : 3 Sample diluent :Dilution Repetition : 1 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 60LINEARITY:Until 20 mg/dl. Phosphorus.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSPHOSPHOLIPIDESPREPARATION OF REAGENT:Dissolve one tablet (R2) with 10 ml. of Buffer Solution (R1). This monoreagent is stable 2 weeksrefrigerated and keep out of light.CALIBRATION:Use serum calibrator or standard enclosed in the kit.General ParametersTest Name : PHOSPHOLIP. Test : PLIP.Bar Code :Type of Test : END POINT Type of Curve : LINEAR SUPRESSEDUnits : mg/dl. Decimal Position : 0Calculation ParametersWavelength 1 : 510 Wavelength 2 : NONETime : 10 Blank of Sample : NOFactor :Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 2 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.2Low limit Abs. : 0.0 High limit Abs. : 1.7Normal Low : 200 High Normal : 270Linearity Limit : 600 Deviation Limit : 5.0Dispensation ParameterSample Volume : 3 Sample diluent :Dilution Repetition : 1 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 300LINEARITY:Until 600 mg/dl. Phospholipides.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSLDHPREPARATION OF REAGENT:Dissolve one tablet (R2) with 15 ml. of Buffer Solution (R1) into the vial enclosed in the kit. Thismonoreagent is stable 7 days refrigerated.CALIBRATION:Through calibration factor.General ParametersTest Name : LDH-P Test : LDHBar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 0Calculation ParametersWavelength 1 : 340 Wavelength 2 : NONETime : 60 Blank of Sample : NOFactor : -9690Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.9 High limit in Blank : 2.0Low limit Abs. : 0.6 High limit Abs. : 2.0Normal Low : 5 High Normal :Linearity Limit : 1500 Deviation Limit : 460Dispensation ParameterSample Volume : 5 Sample diluent :Dilution Repetition : 2 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 60LINEARITY:Until 1500 U/L. LDH.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSGPT/ALTPREPARATION OF REAGENT:Dissolve one tablet (R2) with one vial of Buffer Solution (R1) or 15 ml. depending of presentation. Thismonoreagent is stable 21 days refrigerated.CALIBRATION:Through calibration factor.General ParametersTest Name : AST/GOT Test : GOTBar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 0Calculation ParametersWavelength 1 : 340 Wavelength 2 : NONETime : 90 Blank of Sample : NOFactor : -1750Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.9 High limit in Blank : 2Low limit Abs. : 0.6 High limit Abs. : 2.1Normal Low : 5 High Normal : 40Linearity Limit : 350 Deviation Limit :Dispensation ParameterSample Volume : 25 Sample diluent :Dilution Repetition : 2 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 250 Code :Vol. Diluent : Incubation Time : 60LINEARITY:Until 275 U/L. ALT/GPT.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSGOT/ASTPREPARATION OF REAGENT:Dissolve one tablet (R2) with one vial of Buffer Solution (R1) or 15 ml. depending of presentation. Thismonoreagent is stable 21 days refrigerated.CALIBRATION:Through calibration factorGeneral ParametersTest Name : AST/GOT Test : GOTBar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 0Calculation ParametersWavelength 1 : 340 Wavelength 2 : NONETime : 90 Blank of Sample : NOFactor : -1750Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.9 High limit in Blank : 2Low limit Abs. : 0.6 High limit Abs. : 2.1Normal Low : 5 High Normal : 38Linearity Limit : 350 Deviation Limit :Dispensation ParameterSample Volume : 25 Sample diluent :Dilution Repetition : 2 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 250 Code :Vol. Diluent : Incubation Time : 60LINEARITY:Until 275 U/L. AST/GOT.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSGLUCOSEPREPARATION OF REAGENT:Dissolve one vial of Enzymes (R2) with a little volume of Buffer Solution (R1). Return to the original flask ofbuffer when the enzymes are dissolved. This monoreagent is stable for 1 month refrigerated and keeps itout of light.CALIBRATION:Use serum calibrator.General ParametersTest Name : GLUCOSE Test : GLUBar Code :Type of Test : KINETIC Type of Curve : LINEAR SUPRESSEDUnits : mg/dl. Decimal Position : 0Calculation ParametersWavelength 1 : 510 Wavelength 2 : 600Time : 60 Blank of Sample : NOFactor :Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 2 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.2Low limit Abs. : 0.0 High limit Abs. : 1.0Normal Low : 60 High Normal : 110Linearity Limit : 450 Deviation Limit : 5.0Dispensation ParameterSample Volume : 3 Sample diluent :Dilution Repetition : 1 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 60LINEARITY:Until 450 mg/dl. Glucose.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSγ-GTPREPARATION OF REAGENT:Dissolve one tablet (R2) with one vial of Buffer Solution (R1) or 15 ml. depending of presentation. Thismonoreagent is stable 21 days refrigerated.CALIBRATION:Through calibration factor.General ParametersTest Name : GGT Test : GGTBar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 0Calculation ParametersWavelength 1 : 405 Wavelength 2 : NONETime : 60 Blank of Sample : NOFactor : 1460Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.6Low limit Abs. : 0.05 High limit Abs. : 2.0Normal Low : 7 High Normal : 509Linearity Limit : 750 Deviation Limit :Dispensation ParameterSample Volume : 20 Sample diluent :Dilution Repetition : 2 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 250 Code :Vol. Diluent : Incubation Time : 60LINEARITY:Until 350 U/L. GGT.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSCKPREPARATION OF REAGENT:Dissolve one tablet (R2) with one vial of Buffer Solution (R1). This monoreagent is stable for 5 daysrefrigerated.CALIBRATION:Through calculation factor.General ParametersTest Name : CK TOTAL Test : CKBar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 0Calculation ParametersWavelength 1 : 340 Wavelength 2 : NONETime : 60 Blank of Sample : NOFactor : 4045Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.5Low limit Abs. : 0.01 High limit Abs. : 2.0Normal Low : 24 High Normal : 195Linearity Limit : 2000 Deviation Limit :Dispensation ParameterSample Volume : 10 Sample diluent :Dilution Repetition : 2 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 250 Code :Vol. Diluent : Incubation Time : 140LINEARITY:Until 2000 U/L. CK.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSCHOLINESTERASEPREPARATION OF REAGENT:Dissolve one tablet (R2) with one vial of Buffer Solution (R1). This monoreagent is stable for 2 hoursrefrigerated.CALIBRATION:Through calculation factor.General ParametersTest Name : CHOLINEST. Test : CHOL.Bar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 0Calculation ParametersWavelength 1 : 405 Wavelength 2 : NONETime : 30 Blank of Sample : NOFactor : 22710Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.6Low limit Abs. : 0.2 High limit Abs. : 2.1Normal Low : 4659 High Normal : 14443Linearity Limit : 15000 Deviation Limit :Dispensation ParameterSample Volume : 3 Sample diluent :Dilution Repetition : 1 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 10LINEARITY:Until 15000 U/L. Cholinesterase.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSCHOLESTEROLPREPARATION OF REAGENT:Dissolve one vial of Enzymes (R2) with a little volume of Buffer Solution (R1). Return to the original flask ofbuffer when the enzymes are dissolved. This monoreagent is stable for 4 months refrigerated and keep itout of light, or 15 days to room temperature.CALIBRATION:Use serum calibrator.General ParametersTest Name : CHOLEST. Test : CHOL.Bar Code :Type of Test : END POINT Type of Curve : LINEAR SUPRESSEDUnits : mg/dl. Decimal Position : 1Calculation ParametersWavelength 1 : 540 Wavelength 2 : NONETime : 10 Blank of Sample : NOFactor :Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 2 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.2Low limit Abs. : 0.0 High limit Abs. : 1.5Normal Low : 120 High Normal : 160Linearity Limit : 800 Deviation Limit : 10Dispensation ParameterSample Volume : 3 Sample diluent :Dilution Repetition : 1 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 240LINEARITY:The method is lineal until 600 mg/dl. Cholesterol.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSTOTAL BILIRUBINPREPARATION OF REAGENT:Mix R1 with R2, 50 R1 / 1 R2 proportion. Homogenise by rotation. This reagent is stable for 3 weeks at 2-8ºC.CALIBRATION:Use serum calibrator.General ParametersTest Name : TOTAL BIL. Test : T.B.Bar Code :Type of Test : END POINT Type of Curve : LINEAR SUPRESSEDUnits : mg/dl. Decimal Position : 1Calculation ParametersWavelength 1 : 540 Wavelength 2 : 600Time : 10 Blank of Sample : NOFactor :Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 2 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.2Low limit Abs. : 0.0 High limit Abs. : 1.5Normal Low : 0.1 High Normal : 1.1Linearity Limit : 20.0 Deviation Limit : 10Dispensation ParameterSample Volume : 30 Sample diluent :Dilution Repetition : 2 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 300 Code :Vol. Diluent : Incubation Time : 240LINEARITY:The method is lineal until 20.0 mg/dl. Bilirubin.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSα-AMYLASEPREPARATION OF REAGENT:Dissolve one tablet (R2) with 15 ml. of Buffer Solution (R1). This monoreagent is stable for 7 daysrefrigerated or 2 to room temperature.CALIBRATION:Through calculation factor.General ParametersTest Name : AMYLASE Test : AMYL.Bar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 0Calculation ParametersWavelength 1 : 405 Wavelength 2 : NONETime : 60 Blank of Sample : NOFactor : 6150Calibration ParametersCalibration Interval : HoursNormalisation Interval : HoursNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.5Low limit Abs. : 0.01 High limit Abs. : 2.0Normal Low : 5 High Normal : 90Linearity Limit : 1000 Deviation Limit :Dispensation ParameterSample Volume : 5 Sample diluent :Dilution Repetition : 2 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 250 Code :Vol. Diluent : Incubation Time : 60LINEARITY:Until 1500 U/L. α-Amylase.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSALKALINE PHOSPHATASEPREPARATION OF REAGENT:Dissolve one tablet (R2) with one vial of Buffer Solution (R1) or 15 ml. depending of presentation. Thismonoreagent is stable 6 days refrigerated.CALIBRATION:Through calculation factor.General ParametersTest Name : AL.PHOSPH Test : ALPBar Code :Type of Test : KINETIC Type of Curve : LINEAR ENZYMEUnits : U/L. Decimal Position : 0Calculation ParametersWavelength 1 : 405 Wavelength 2 : NONETime : 60 Blank of Sample : NOFactor : 2750Calibration ParametersCalibration Interval : HourNormalisation Interval : HourNumber Calibrations : 1 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.5Low limit Abs. : 0.1 High limit Abs. : 2.0Normal Low : 98 High Normal : 279Linearity Limit : 1000 Deviation Limit :Dispensation ParameterSample Volume : 5 Sample diluent :Dilution Repetition : 2 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 250 Code :Vol. Diluent : Incubation Time : 60LINEARITY:Until 800 U/L. ALP.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002

LABKIT CIBA-CORNING 550-EXPRESSURIC ACIDPREPARATION OF REAGENT:Dissolve one vial of Enzymes (R2) with a little volume of Buffer Solution (R1). Return to the original flask ofbuffer when the enzymes are dissolved. This monoreagent is stable for 21 days refrigerated and keep itout of light, or 10 days to room temperature.CALIBRATION:Use serum calibrator.General ParametersTest Name : URIC ACID Test : URICBar Code :Type of Test : END POINT Type of Curve : LINEAR SUPRESSEDUnits : mg/dl. Decimal Position : 1Calculation ParametersWavelength 1 : 510 Wavelength 2 : NONETime : 10 Blank of Sample : NOFactor :Calibration ParametersCalibration Interval : HourNormalisation Interval : HourNumber Calibrations : 2 Repetition Number : 2Parameter LimitsLow limit in Blank : 0.0 High limit in Blank : 0.2Low limit Abs. : 0.0 High limit Abs. : 1.2Normal Low : 2.5 High Normal : 7.0Linearity Limit : 25.0 Deviation Limit : 5.0Dispensation ParameterSample Volume : 10 Sample diluent :Dilution Repetition : 1 Predilution : 1Reagent Diluent :Vol. Reagent 1 : 400 Code :Vol. Diluent : Incubation Time :LINEARITY:The method is lineal until 25.0 mg/dl. Uric Acid.CHEMELEX, S.A. Polígono Industrial Can Castells. C/ Industria, 113 nave J 08420 Canovelles Tel/ +34 93 849 17 35Fax/ +34 93 846 78 75 e-mail: chemelex@terra.esEd. 10.2002