1. No category

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.
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.
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
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.
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.
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.
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.
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
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.
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.
MULTISERA CONTROL ABNORMAL
REF 1985005
COMPONENTE
COMPONENT
LOT Nº 19073
EXP 2008-11
VALOR
VALUE
RANGO
RANGE
UNIDAD
UNIT
METODO
METHOD
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
g/L
g/L
g/L
g/L
µmol/L
µmol/L
µmol/L
µmol/L
µmol/L
µmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mg/dL
Colorimetry, Bromocresol Green, citrate
Colorimetry, Bromocresol Green, succinate
Colorimetry, Bromocresol Purple
Dry Chemistry
Jendrassik & Grof
Dry Chemistry
Colorimetric (DPD)
Colorimetric Diazo/caffeine benzoat
Ferricyanide oxidation
Dry Chemistry
Flame Atomic Absorption
Colorimetric, (OCC)
Colorimetric , Arsenazo III
Indirect determination with ISE
Dry Chemistry
Flame Atomic Absorption
+
Colorimetric titration with Ag
ISE Direct
Dry Chemistry
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
HDL-Colesterol
HDL-Cholesterol
1.6
62
1.2-2.0
47-77
mmol/L
mg/dL
Direct enzymatic colorimetric
LDL-Colesterol
LDL-Cholesterol
5.1
197
4.1-6.1
158-236
mmol/L
mg/dL
Direct enzymatic colorimetric
Cobre
Copper
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
Albúmina
Albumin
Bilirrubina Directa
Direct Bilirubin
Bilirrubina Total
Total Bilirubin
Calcio
Calcium
Cloruros
Chloride
Creatinina
Creatinin
Glucosa
Glucose
Hierro
Iron
Lactato
Lactate
Litio
Lithium
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
µmol/L
µg/dL
µmol/L
mg/dL
µmol/L
mg/dL
mmol/L
mg/dL
mmol/L
mg/dL
µmol/L
µg/dL
µmol/L
µg/dL
mmol/L
mg/dL
mmol/L
mmol/L
mmol/L
CHOD-PAP, enzymatic colorimetric
Atomic Absorption Spectrophotometry
Jaffe´s reaction
Ferricyanide oxidation (O´Leary)
Hexokinase/ G6PD
Glucose Oxidase/ Dehydrogenase
Ferrozine/TPTZ
Dry Chemistry, Ortho Vitros
LOD/POD Enzymatic Colorimetric
Flame Photometry
Indirect determination with ISE
Direct ISE
REF 1985005
COMPONENTE
COMPONENT
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
LOT Nº 19073
VALOR
VALUE
RANGO
RANGE
UNIDAD
UNIT
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
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
mg/dL
mmol/L
mg/dL
mmol/L
mmol/L
mmol/L
mmol/L
mmol/L
g/L
g/L
g/L
g/L
mmol/L
mg/dL
mmol/L
mg/dL
mmol/L
mg/dL
mmol/L
mg/dL
µmol/L
mg/dL
µmol/L
mg/dL
µmol/L
µg/dL
U/L
U/L
U/L
U/L
U/L
U/L
U/L
U/L
U/L
U/L
U/L
U/L
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
EXP 2008-11
METODO
METHOD
Colorimetry. Xylidyl Blue
Colorimetry. Arsenazo III
Colorimetry. Calmagite
Colorimetry. Chlorophosphonazo III
Phosphomolybdate
Dry Chemistry, Ortho Vitros
Indirect determination with ISE
Direct determination with ISE
Indirect determination with ISE
Direct determination with ISE
Dry Chemistry, Ortho Vitros
Colorimetry, blanked Biuret
Colorimetry, unblanked Biuret
Colorimetry, polycromatic Biuret
Dry Chemistry, Ortho Vitros
Enzymatic endpoint
Kinetic (Urease-GLDH)
Kinetic conductimetry
Dry chemistry, Ortho Vitros
Enzymatic Colorimetric (Uricase/POD)
Enzymatic Colorimetric (Uricase/Endpoint)
Atomic Absorption Spectrophotometric
p-NPP/AMP, 37ºC (IFCC/AACC)
DEA, 37ºC (DGKC/SCE)
Dry chemistry, Ortho Vitros
IFCC/SEQC/SFBC (37ºC)
SCE, 37ºC
Dry chemistry
Enzymatic colorimetric, EPS IFCC 37ºC
Enzymatic colorimetric, CNPG3 37ºC
Enzymatic colorimetric, UV 37ºC
IFCC/SEQC/SFBC, 37ºC
SCE, 37ºC
Dry chemistry
REF 1985005
LOT Nº 19073
EXP 2008-11
COMPONENTE
COMPONENT
VALOR
VALUE
RANGO
RANGE
UNIDAD
UNIT
METODO
METHOD
Colinesterasa
Cholinesterase
10600
8700-12500
U/L
Colorimetric Butyrylthiocholine 37ºC
CK
CK
295
334
236-354
267-401
U/L
U/L
NAC optimised SCE/DGKC/IFCC 37ºC
Dry chemistry, Ortho Vitros
CK-MB
CK-MB
66
38-94
U/L
Immunological UV 37ºC
GGT
GGT
153
129
119-187
101-157
U/L
U/L
Carboxynitroanilide IFCC, 37ºC
Nitroanilide, 37ºC
GLDH
GLDH
10.8
4.2-17.4
U/L
DGKC, 37ºC
LDH
LDH
417
757
846
746
1173
342-492
621-893
694-998
612-880
962-1384
U/L
U/L
U/L
U/L
U/L
IFCC (37ºC) Lactate to pyruvate
DGKC (37ºC) Pyruvate to lactate phosphate
SCE (37º) Pyruvate to lactate Tris
SFBC (37º) Pyruvate to lactate
Dry chemistry
Lipasa
Lipase
122
84-160
U/L
Enzymatic colorimetric 37ºC
ELECTROPHORESIS VALUES
Componente
Component
Albumin
Alpha 1
Alpha 2
Beta 1
Beta 2
Gamma
Valor (g/L)
Value (g/L)
64
2
10
8
4
11
Rango (g/L)
Range (g/L)
40-52
1-3
4-9
4-7
1-4
6-13
% de Proteina total
% of Total protein
65.1
2.3
9.7
8.4
3.6
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