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HUMAN MULTISERA NORMAL - ABNORMAL
PRESENTACION
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
Abrir el tapón del vial, tirar cuidadosamente del obturador sin liofilizado de origen humano y para uso en diagnóstico in vitro.
sacarlo completamente, y dejar que el aire entre por las ranuras Este control es producido a partir de sangre de donantes situadas en la parte inferior del obturador. Evitar pérdidas del voluntarios de diferentes Bancos de Sangre. material liofilizado. Entonces retirar completamente el obturador y Los datos analíticos del LINEAR Human Multisera Control se
adicionar el volumen exacto de agua destilada que viene indicado han elaborado en colaboración entre laboratorios de reconocido prestigio, utilizando métodos de referencia. 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
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, PRECAUCIONES
después de su reconstitución, tiene un aspecto claro (absorbancia Este suero control ha sido analizado frente a anticuerpos anti-HIV, LINEAR Human Multisera Control se presenta con dos niveles
anticuerpos anti-HCV y HBsAg, obteniéndose resultados negativos. de concentración: Normal and Abnormal. Sin embargo, se recomienda tomar precauciones durante su usocomo si fuera material potencialmente infeccioso. La contaminación bacteriana del suero control reconstituido, puede provocar reducciones en la estabilidad de los diferentes ESTABILIDAD DEL PRODUCTO
LINEAR Human Multisera control es estable conservado en la
- En forma liofilizada, al menos 4 años desde la fecha de - 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 - Características diferentes de estabilidad se aplicarán a: - Fosfatasa Acida, Bilirrubina, CK y LDH, 1-2% de pérdida por - 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
HUMAN MULTISERA ABNORMAL
For in vitro diagnostic use only PRINCIPLE
PREPARATION
LINEAR Human Multisera Control is a stable and lyophilized
Open the screw cap and carefully lift the rubber stopper without serum of human origin for in vitro diagnostic use. This control is removing it completely and let the air enter the vial through the produced from blood collected from thoroughly controlled voluntary groove of the lower part of the stopper. Avoid loss of dried material. Then remove the rubber stopper and add exactly the stated volume The analytical data of LINEAR Human Multisera Control are
of pure water, as indicated on the vial label (5 mL). eleborated in collaboration between expert laboratories in part 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.
REAGENT COMPOSITION
This control serum contains no preservatives. Contains traceelements and polypeptides, which ensure that control and test PRECAUTIONS
samples are analyzed under the same conditions. The control is clear after reconstitution (absorbance at 700 nm: <0.278). The control serum is controlled and found non reactive for HBs LINEAR Human Multisera Control offers two different levels of
antigen, HCV antibodies and HIV 1/2 antibodies. Nevertheless, the concentration: Normal and Abnormal. 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. STABILITY
LINEAR Human Multisera control kept in the dark is stable:
- In lyophilized form at least 4 years from date of production at 2-8
- 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 - 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
Colorimetry, Bromocresol Green, succinate REF 1985005
LOT Nº 19073
EXP 2008-11
mmol/L Colorimetry. Chlorophosphonazo III Enzymatic Colorimetric (Uricase/Endpoint) REF 1985005
LOT Nº 19073
EXP 2008-11
DGKC (37ºC) Pyruvate to lactate phosphate ELECTROPHORESIS VALUES
Componente
Valor (g/L)
Rango (g/L)
% de Proteina total
Component
Value (g/L)
Range (g/L)
% of Total protein
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

Source: http://www.cromatest.mx/Insertos/Calibradores%20y%20Controles/CONTROL%20ANORMAL.pdf

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