HUMAN MULTISERA NORMAL - ABNORMAL PRESENTACION REF 1985005 HUMAN MULTISERA Abnormal 5 x 5 ml HUMAN MULTISERA ABNORMAL Sólo para uso diagnóstico in vitro FUNDAMENTO PREPARACION LINEAR Human Multisera Control es un suero estabilizado y liofilizado de origen humano y para uso en diagnóstico in vitro. Este control es producido a partir de sangre de donantes voluntarios de diferentes Bancos de Sangre. Los datos analíticos del LINEAR Human Multisera Control se han elaborado en colaboración entre laboratorios de reconocido prestigio, utilizando métodos de referencia. COMPOSICION DE LOS REACTIVOS Este suero control no contiene conservantes. Contiene oligoelementos y polipéptidos, que aseguran que el control y las muestras se analizan bajo las mismas condiciones. El control, después de su reconstitución, tiene un aspecto claro (absorbancia a 700 nm: <0.278). LINEAR Human Multisera Control se presenta con dos niveles de concentración: Normal and Abnormal. ESTABILIDAD DEL PRODUCTO Abrir el tapón del vial, tirar cuidadosamente del obturador sin sacarlo completamente, y dejar que el aire entre por las ranuras situadas en la parte inferior del obturador. Evitar pérdidas del material liofilizado. Entonces retirar completamente el obturador y adicionar el volumen exacto de agua destilada que viene indicado en la etiqueta del vial (5 ml). Cerrar el vial y dejarlo reposar durante 30 minutos en la oscuridad. Disolver el contenido por agitación suave, evitando la formación de espuma. No sacudir. A partir de este momento, el contenido del vial se utilizará como si fuera una muestra de suero. PRECAUCIONES Este suero control ha sido analizado frente a anticuerpos anti-hiv, anticuerpos anti-hcv y HBsAg, obteniéndose resultados negativos. Sin embargo, se recomienda tomar precauciones durante su uso como si fuera material potencialmente infeccioso. La contaminación bacteriana del suero control reconstituido, puede provocar reducciones en la estabilidad de los diferentes componentes del control. LINEAR Human Multisera control es estable conservado en la oscuridad: - En forma liofilizada, al menos 4 años desde la fecha de fabricación a 2-8 ºC. - Después de su reconstitución y salvo que se den otras especificaciones: 1 mes a 20 ºC, 7 días a 2-8 ºC o 8 horas a 15-25 ºC. - Características diferentes de estabilidad se aplicarán a: - Fosfatasa Acida, Bilirrubina, CK y LDH, 1-2% de pérdida por semana a 20 ºC. - Fosfatasa Alcalina, 1-2% pérdida por día a 2-8 ºC. - Fosfatasa Acida y LDH, 1-2% incremento por día a 2-8 ºC. - Fósforo y Triglicéridos, 0.5% incremento por día a 2-8 ºC. - Fosfatasa Acida, 1% incremento por hora a 15-25 ºC. - Fosfatasa Alcalina, 1% incremento por hora a 15-25 ºC. Bilirrubina and CK son sensibles a la luz.
HUMAN MULTISERA NORMAL - ABNORMAL PRESENTATION REF 1980005 HUMAN MULTISERA Abnormal 5 x 5 ml HUMAN MULTISERA ABNORMAL For in vitro diagnostic use only PRINCIPLE PREPARATION LINEAR Human Multisera Control is a stable and lyophilized serum of human origin for in vitro diagnostic use. This control is produced from blood collected from thoroughly controlled voluntary blood donors of Blood Banks. The analytical data of LINEAR Human Multisera Control are eleborated in collaboration between expert laboratories in part using accepted reference methods. REAGENT COMPOSITION This control serum contains no preservatives. Contains trace elements and polypeptides, which ensure that control and test samples are analyzed under the same conditions. The control is clear after reconstitution (absorbance at 700 nm: <0.278). LINEAR Human Multisera Control offers two different levels of concentration: Normal and Abnormal. STABILITY Open the screw cap and carefully lift the rubber stopper without removing it completely and let the air enter the vial through the groove of the lower part of the stopper. Avoid loss of dried material. Then remove the rubber stopper and add exactly the stated volume of pure water, as indicated on the vial label (5 ml). Close the vial carefully and let it stand for 30 minutes in the dark. Dissolve the content completely by swirling gently, avoiding formation of foam. Do not shake. From now on the vial contents should be handled as an ordinary serum. PRECAUTIONS The control serum is controlled and found non reactive for HBs antigen, HCV antibodies and HIV 1/2 antibodies. Nevertheless, the control should be handled with the same precautions as patient samples. The bacterial contamination of the reconstituted control serum, will cause reductions in the stability of many components. LINEAR Human Multisera control kept in the dark is stable: - In lyophilized form at least 4 years from date of production at 2-8 ºC. - After reconstitution, unless otherwise specified:1 month at 20 ºC, 7 days at 2-8 ºC or 8 hours at 15-25 ºC. - Shorter stability characteristics apply to: - Acid Phospatase, Bilirubin, CK and LDH, 1-2% decrease per week at 20 ºC. - Phosphatase Alkaline, 1-2% increase per day at 2-8ºC. - Acid Phosphatase and LDH, 1-2% increase per day at 2-8 ºC. - Phosphate and Triglycerides, 0.5% increase per day at 2-8 ºC. - Acid Phosphatase, 1% decrease per hour at 15-25 ºC. - Phosphatase Alkaline, 1% increase per hour at 15-25 ºC. Bilirubin and CK are sensitive to light.
MULTISERA CONTROL ABNORMAL REF 1985005 LOT Nº 19073 EXP 2008-11 E Albúmina Albumin Bilirrubina Directa Direct Bilirubin Bilirrubina Total Total Bilirubin Calcio Calcium Cloruros Chloride Colesterol total Total Cholesterol 61.1 59.8 60.2 60.6 23.0 8 75.9 80.0 77.4 78.1 3.04 3.00 2.92 2.88 3.02 130 132 132 135 7.26 281 47.0-75.2 46.0-73.6 46.4-74.0 46.7-74.5 18.2-27.8 4-12 56.2-95.6 59.2-100.8 57.3-97.5 57.8-98.4 -- 2.67-3.3 2.60-3.24 2.56-3.20 2.69-3.35 118-142 120-144 120-144 123-147 6.24-8.28 242-320 Colorimetry, Bromocresol Green, citrate Colorimetry, Bromocresol Green, succinate Colorimetry, Bromocresol Purple Jendrassik & Grof Colorimetric (DPD) Colorimetric Diazo/caffeine benzoat Ferricyanide oxidation Flame Atomic Absorption Colorimetric, (OCC) Colorimetric, Arsenazo III Flame Atomic Absorption Colorimetric titration with Ag + ISE Direct CHOD-PAP, enzymatic colorimetric HDL-Colesterol HDL-Cholesterol 1.6 62 1.2-2.0 47-77 Direct enzymatic colorimetric LDL-Colesterol LDL-Cholesterol 5.1 197 4.1-6.1 158-236 Direct enzymatic colorimetric Cobre Copper Creatinina Creatinin Glucosa Glucose Hierro Iron Lactato Lactate Litio Lithium 35.4 225 251 2.84 251 2.84 10.5 189 10.7 193 31.8 178 30.7 172 6.36 57.3 2.06 2.06 2.07 1) 196-306 2.22-3.46 196-306 2.22-3.46 8.8-12.2 158-220 9.0-12.4 162-224 27.3-36.3 153-203 26.4-35.0 148-196 5.02-7.70 45.2-69.4 1.77-2.35 1.77-2.35 1.78-2.36 Atomic Absorption Spectrophotometry Jaffe s reaction Ferricyanide oxidation (O Leary) Hexokinase/ G6PD Glucose Oxidase/ Dehydrogenase Ferrozine/TPTZ, Ortho Vitros LOD/POD Enzymatic Colorimetric Flame Photometry Direct ISE
REF 1985005 LOT Nº 19073 EXP 2008-11 E Magnesio Magnesium Fósforo inorgánico Inorganic Phosphorus Potasio Potassium Sodio Sodium Proteínas Totales Total Protein Triglicéridos Triglycerides Urea Urea Acido urico Uric acid Zinc Zinc FAL ALP ALT/GPT Amilasa Amylase AST/GOT 1.76 1.96 1.86 1.77 2.95 9.13 3.25 10.1 5.80 5.97 164 172 174 99.3 98.9 96.7 106.1 4.48 396 13.4 80.7 12.9 77.7 10.8 65.1 700 11.8 686 11.5 20.4 133 297 573 236 137 130 134 384 394 221 201 173 183 1.48-2.04 1.65-2.27 1.56-2.16 1.49-2.05 2.42-3.48 7.49-10.8 2.66-3.84 8.27-11.9 5.28-6.32 5.43-6.51 154-174 162-182 163-185 88.4-110 88.0-110 86.1-107 94.4-118 3.67-5.29 324-468 10.5-16.3 63.2-98.2 10.1-15.7 60.8-94.6 8.4-13.2 50.6-79.6 602-798 10.2-13.4 590-782 9.9-13.1 1) 223-371 430-716 177-295 105-169 100-160 103-165 328-440 266-522 179-263 155-247 133-213 141-225 Colorimetry. Xylidyl Blue Colorimetry. Arsenazo III Colorimetry. Calmagite Colorimetry. Chlorophosphonazo III Phosphomolybdate, Ortho Vitros Direct determination with ISE Direct determination with ISE, Ortho Vitros Colorimetry, blanked Biuret Colorimetry, unblanked Biuret Colorimetry, polycromatic Biuret, Ortho Vitros Enzymatic endpoint Kinetic (Urease-GLDH) Kinetic conductimetry, Ortho Vitros Enzymatic Colorimetric (Uricase/POD) Enzymatic Colorimetric (Uricase/Endpoint) Atomic Absorption Spectrophotometric p-npp/amp, 37ºC (IFCC/AACC) DEA, 37ºC (DGKC/SCE), Ortho Vitros IFCC/SEQC/SFBC (37ºC) SCE, 37ºC Enzymatic colorimetric, EPS IFCC 37ºC Enzymatic colorimetric, CNPG3 37ºC Enzymatic colorimetric, UV 37ºC IFCC/SEQC/SFBC, 37ºC SCE, 37ºC
REF 1985005 LOT Nº 19073 EXP 2008-11 E Colinesterasa Cholinesterase CK CK CK-MB CK-MB GGT GGT GLDH GLDH LDH LDH Lipasa Lipase 10600 8700-12500 Colorimetric Butyrylthiocholine 37ºC 295 334 236-354 267-401 NAC optimised SCE/DGKC/IFCC 37ºC, Ortho Vitros 66 38-94 Immunological UV 37ºC 153 129 119-187 101-157 10.8 4.2-17.4 DGKC, 37ºC 417 757 846 746 1173 342-492 621-893 694-998 612-880 962-1384 Carboxynitroanilide IFCC, 37ºC Nitroanilide, 37ºC IFCC (37ºC) Lactate to pyruvate DGKC (37ºC) Pyruvate to lactate phosphate SCE (37º) Pyruvate to lactate Tris SFBC (37º) Pyruvate to lactate 122 84-160 Enzymatic colorimetric 37ºC ELECTROPHORESIS S Componente Component Valor () Value () Rango () Range () % de Proteina total % of Total protein Albumin 64 40-52 65.1 Alpha 1 2 1-3 2.3 Alpha 2 10 4-9 9.7 Beta 1 8 4-7 8.4 Beta 2 4 1-4 3.6 Gamma 11 6-13 10.9 The value table is applicable to this lot and sequential sublots, alphabetical letter following the lot number, indicate in the label. La tabla de valores es aplicable a este lote y sublotes, letras alfabéticas que siguen al nº de lote, indicado en las etiquetas. 1) Linear no recomienda ningun rango acceptable. 1) Linear will not recommended any aceptable range. B1985-1/0406 R1