MULTICALIBRADOR CC/H MULTICALIBRATOR CC/H - Linear
MULTICALIBRADOR CC/H MULTICALIBRATOR CC/H - Linear
MULTICALIBRADOR CC/H MULTICALIBRATOR CC/H - Linear
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<strong>MULTICALIBRATOR</strong> <strong>CC</strong>/HREFPRESENTACION / CONTENTS1975005 Multicalibrator <strong>CC</strong>/H 5 x 5 mL<strong>MULTICALIBRADOR</strong> <strong>CC</strong>/H<strong>MULTICALIBRATOR</strong> <strong>CC</strong>/HSólo para uso diagnóstico in vitroOnly for in vitro diagnostic useAPLICACIONESLINEAR Multicalibrator <strong>CC</strong>/H es un suero de origen humanoliofilizado para la calibración de ensayos en química clínica. Sesuministra como un suero analizado y los valores se asignan apartir de los resultados obtenidos en más de 3000 laboratorios.Las concentraciones y actividades de los componentes hansido seleccionadas para asegurar una óptima calibración entécnicas manuales y analizadores automáticos.COMPOSICIONCAL Preparado a partir de suero de origen humano,conservantes no reactivos y estabilizantes.PRECAUCIONESTodos los componentes de origen humano han resultado sernegativos para el antígeno HBs, HCV y para el anti-HIV (1/2).Sin embargo, deben tratarse como potencialmente infecciosos.ESTABILIDADEl calibrador sin reconstituir es estable hasta la fecha decaducidad indicada en la etiqueta del vial, conservado a 2-8ºC.Después de la reconstitución, es estable 8 horas a 25ºC, 7 díasa 2-8ºC o un mes a –20ºC congelado una sola vez. (Ver Notas).INTENDED USELINEAR Multicalibrator <strong>CC</strong>/H is a lyophilized human serum foruse in clinical chemistry assays. This calibrator is offered in theform of an assayed serum. Given values are assigned onresults from 3000 different laboratories.The concentrations and activities have been selected so as toensure optimum calibration for use in manual and automaticanalyzers.COMPOSITIONRECONSTITUCIONRECONSTITUTION1. Abrir el vial cuidadosamente, evitando la perdida de material. 1. Open the vial carefully, avoiding any loss of material.2. Reconstituir el liofilizado con exactamente con 5 mL de agua 2. Reconstitute by pipetting exactly 5 mL of distilled water at 20-destilada a 20-25ºC25ºC, into the vial.3. Cerrar el vial y esperar 30 minutos, protegido de la luz . 3. Replace the rubber stopper and leave to stand for 30 minutes4. Agitar suavemente varias veces en el tiempo de espera, out of bright light before using.evitando la formación de espuma, hasta que este totalmente 4. Swirl gently several times during the reconstitution period todisuelto.ensure that the contents are completely dissolved.5. Antes de su uso, mezclar el contenido por inversión del vial. 5. Prior to use, mix the contents by inverting the vial. Do notEvitar la formación de espuma.shake the vial as the formation of foam should be avoided.6. El Multicalibrator <strong>CC</strong>/H estará entonces listo para su uso. 6. The Multicalibrator <strong>CC</strong>/H is then ready for use.NOTAS- La bilirrubina presente en el suero es fotosensible. Serecomienda mantener el suero protegido de la luz. Asiconservado es estable al menos 8 horas a 2-8ºC. Noconservar a 15-25ºC. No congelar.Para la determinación de la fosfatasa ácida Total y Prostática,el suero debe estabilizarse añadiendo 1 gota (25-30 µL) desolución de Acido Acético 0,7M a 1 mL de suero. Una vezestabilizado, es estable al menos 2 horas a 25ºC, 2 días a 2-8ºC o por lo menos 1 mes si se congela una vez a –20ºC.Los niveles de fosfatasa alcalina en el suero reconstituidoaumentarán durante el período de estabilidad. Dejar reposarel suero reconstituido durante 1 hora a 25ºC antes de su uso.- La contaminación bacteriana del Multicalibrator <strong>CC</strong>/Hreconstituído, reduce la estabilidad de muchos de suscomponentes.- La reconstitución inexacta, la inadecuada manipulación yconservación pueden causar resultados erróneos en losensayos.- Los valores asignados son específicos de cada lote. Los valoresde cada parámetro están incluidos en la Hoja de Valores.CALPrepared from human serum, no reactive conservativesand stabilizers.PRECAUTIONSComponents from human origin have been tested and foundnegative for the presence of HBsAg, HCV and antibody to HIV1/2. However handle cautiously as potentially infectious.STABILITYUnreconstituted serum is stable up to the expiry date shown onthe label when stored at 2-8ºC.Once reconstituted, are stable for at least 8 hours at 25ºC, 7 daysat 2-8ºC or 1 month at –20ºC when frozen once (see Notes).NOTES- The bilirubin present in the serum is light sensitive and it isrecommended that the serum be stored in the dark. Stored inthe dark it is stable for at least 8 hours at 2-8ºC. Do not store at15-25ºC. Do not freeze.For Total and Prostatic acid phosphatase the material shouldbe stabilized by adding 1 drop (25-30 µL) of 0.7M acetic acidsolution to 1mL of serum. After stabilization Total and Prostaticacid phosphatase are stable for at least 2 hours at 25ºC, atleast 2 days at 2-8ºC and 1month when frozen once at –20ºC.Alkaline phosphatase levels in the reconstituted serum will riseover the stability period. It is recommended that thereconstituted serum be allowed to stand for 1 hour at 25ºCbefore measurement.- Bacterial contamination of the Multicalibrator <strong>CC</strong>/H will causereductions in the stability of many components.- Improper handling and/or storage can affect results. Inaccuratereconstitution and errors in assay technique can causeerroneous results.- The assigned values are lot-specific. The exact values aregiven in the value sheet.QUALITY SYSTEM CERTIFIEDISO 9001 ISO 13485LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAINTelf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es
<strong>MULTICALIBRATOR</strong> <strong>CC</strong>/HREF 1975005 LOT Nº 19219 EXP 2011-01COMPONENTECOMPONENTVALORVALUEUNIDADUNITMETODOMETHODAcid Phosphatase(non-prostatic)Acid Phosphatase(prostatic)Acid Phosphatase(total)AlbuminaAlbuminAlkaline PhosphataseFosfatasa AlcalinaALT (GPT)AmylaseAmilasaAST (GOT)Bilirubin DirectBilirrubina DirectaBilirubin TotalBilirrubina TotalCalciumCalcioCalciumCalcioChlorideCloruroCholesterolColesterolCholinesteraseColinesterasaCK TotalCreatinineCreatinina9.30 U/L40.8 U/L50.1 U/L28.52.854363402791198867g/Lg/dLU/LU/L1-Naphthyl Phosphate, Kinetic with Pentane diolActivation 37°C1-Naphthyl Phosphate, Kinetic with Pentane diolActivation 37°C1-Naphthyl Phosphate, Kinetic with Pentane diolActivation 37°<strong>CC</strong>olorimetry, Bromocresol Green (BCG)Diethanolamine buffer DEA 37°CDiethanolamine buffer DEA 37°CDiethanolamine buffer DEA 37°CTris buffer no P5P IF<strong>CC</strong>/SFBC 37°CTris buffer no P5P IF<strong>CC</strong>/SFBC 30°CTris buffer no P5P IF<strong>CC</strong>/SFBC 25°C272 U/L 2-chloro-pNPG3 37°C139946630.21.7778.24.582.8711.52.8811.5U/Lµmol/Lmg/dLµmol/Lmg/dLmmol/Lmg/dLmmol/Lmg/dLTris buffer no P5P IF<strong>CC</strong>/SFBC 37°CTris buffer no P5P IF<strong>CC</strong>/SFBC 30°CTris buffer no P5P IF<strong>CC</strong>/SFBC 25°CDiazo with Sulphanilic AcidDiazo with Sulphanilic AcidArsenazo III114 mmol/L Colorimetric7.16276mmol/Lmg/dLCresolphthalein complexoneCholesterol Oxidase4628 U/L Colorimetric Butyrylthiocholine 37°C4472801903423.86U/Lµmol/Lmg/dLCK-NAC serum start (DGKC) 37°<strong>CC</strong>K-NAC serum start (DGKC) 30°<strong>CC</strong>K-NAC serum start (DGKC) 25°CAlkaline picrate with deproteinizationQUALITY SYSTEM CERTIFIEDISO 9001 ISO 13485LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAINTelf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es
<strong>MULTICALIBRATOR</strong> <strong>CC</strong>/HREF 1975005 LOT Nº 19219 EXP 2011-01COMPONENTECOMPONENTVALORVALUEUNIDADUNITMETODOMETHODγ-GT15412195U/LGamma glutamyl.-3-carboxy-4-nitroanilide 37°CGamma glutamyl.-3-carboxy-4-nitroanilide 30°CGamma glutamyl.-3-carboxy-4-nitroanilide 25°CGlucoseGlucosa14.8267mmol/Lmg/dLGlucose oxidaseIronHierroLD (LDH)MagnesiumMagnesioPhosphorusFósforoProtein TotalProteínas totalesTIBCTriglyceridesTriglicéridosUreaUreaUric AcidÁcido Úrico32.41816834933461.764.282.176.7345.34.5342.32362.8625318.010818.41110.4868.16μmol/Lμg/dLU/Lmmol/Lmg/dLmmol/Lmg/dLg/Lg/dLµmol/Lµg/dLmmol/Lmg/dLmmol/Lmg/dLmmol/Lmg/dLmmol/Lmg/dLColorimetric without ppt.P->L SFBC 37°CP->L SFBC 30°CP->L SFBC 25°<strong>CC</strong>almagitePhosphomolybdate UVBiuret reaction end pointFE+UIBC (saturation with iron)Lipase/Glycerol DehydrogenaseUrease end pointUrease kineticUricase peroxidase no ascorbate oxidaseB1975-2/0509R1QUALITY SYSTEM CERTIFIEDISO 9001 ISO 13485LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAINTelf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es
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