human multisera normal

HUMAN MULTISERA NORMAL- ABNORMAL
PRESENTACION
REF 1980005 HUMAN MULTISERA Normal
5 x 5 mL
HUMAN MULTISERA NORMAL
Sólo para uso diagnóstico in vitro
APLICACIONES
LINEAR Human Multisera Normal es un suero estabilizado y
liofilizado de origen humano, para uso en diagnóstico in vitro.
Este control esta elaborado a partir de sangre de donantes
voluntarios de diferentes Bancos de Sangre.
Los datos analíticos del Human Multisera Normal se han
elaborado en colaboración entre laboratorios de reconocido
prestigio, utilizando métodos de referencia.
COMPOSICION
Human Multisera Normal 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).
Human Multisera se presenta con dos niveles de
concentración: Normal and Abnormal.
ESTABILIDAD
Human Multisera Normal 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 : 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 2-8ºC.
− Fósforo y Triglicéridos, 0.5% incremento por día a 2-8ºC.
− Fosfatasa Acida, 1% incremento por hora a 15-25 ºC.
− Fosfatasa Alcalina, 1% incremento por hora a 15-25ºC.
− Bilirrubina y CK son sensibles a la luz.
INTENDED USE
LINEAR Human Multisera Normal 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 Human Multisera Normal are
eleborated in collaboration between expert laboratories in part
using accepted reference methods.
COMPOSITION
Human Multisera Normal 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).
Human Multisera offers two different levels of concentration:
Normal and Abnormal.
STABILITY
Human Multisera Normal 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 Phosphatase, 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.
− Phosphatase 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.
RECONSTITUCION
1. 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).
2. Cerrar el vial y dejarlo reposar durante 30 minutos en la
oscuridad. Disolver el contenido por mezcla suave, evitando
la formación de espuma. No agitar.
A partir de este momento, el contenido del vial se utilizará
como si fuera una muestra de suero.
RECONSTITUTION
1. 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).
2. 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.
PRECAUCIONES
Todos los componentes de origen humano han resultado ser
negativos para el antígeno HBs, HCV y para el anti-HIV (1/2).
Sin embargo, deben tratarse con precaución como
potencialmente infecciosos.
La contaminación bacteriana del control reconstituido puede
causar disminución de la estabilidad de sus componentes.
QUALITY SYSTEM CERTIFIED
ISO 9001 ISO 13485
PRECAUTIONS
Components from human origin have been tested and found
negative for the presence of HBsAg, HCV and antibody to HIV
(1/2). However handle cautiously as potentially infectious.
The bacterial contamination of the reconstituted control will
cause reductions in the stability of its components.
LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAIN
Telf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es
HUMAN MULTISERA NORMAL
REF 1980005
LOT Nº 19313
EXP 2012-03
SUSTRATOS / SUBSTRATES
Analytical uncertainty
COMPONENTE
VALOR
RANGO
COMPONENT
VALUE
RANGE
UNIDAD
METODO
2 SD
UNIT
1 SD
METHOD
Albúmina
Albumin
40.0
4.01
33.8-46.2
3.38-4.62
3.10
0.31
6.20
0.62
g/L
g/dL
Colorimetric method
Bromocresol Green (BCG)
Bilirrubina Directa
Direct Bilirubin
13.68
0.80
10.68-16.68
0.7-0.9
1.50
0.10
3.0
0.10
µmol/L
mg/dL
Colorimetric method
Modified Jendrassik & Grof
Bilirrubina Total*
Total Bilirubin*
31.8
1.86
25.1-40.1
1.47-2.35
3.35
0.20
6.70
0.39
µmol/L
mg/dL
Colorimetric method
Modified Jendrassik & Grof
Calcio
Calcium
2.32
9.30
2.09-2.55
8.38-10.2
0.12
0.46
0.23
0.92
mmol/L
mg/dL
Cresolphtalein complexone OC
Calcio
Calcium
2.275
9.10
2.03-2.51
8.18-10.02
0.12
0.46
0.24
0.92
mmol/L
mg/dL
Colorimetric , Arsenazo III
Cloruros
Chloride
99.9
93.9-106
3.00
6.00
mmol/L
Colorimetric method
Colesterol total
Total Cholesterol
4.24
164
3.64-4.84
140-188
0.30
12.0
0.60
24.0
mmol/L
mg/dL
Enzymatic colorimetric method
Cholesterol Oxidase
Creatinina
Creatinin
132.6
1.51
111-154.2
1.26-1.76
10.80
0.13
21.60
0.25
µmol/L
mg/dL
Kinetic colorimetric method.
Jaffé rate blanked compensated
(-18 mmol/l)
Fósforo inorgánico
1.42
4.40
1.20-1.64
3.72-5.08
0.11
0.34
0.22
0.68
mmol/L
mg/dL
Phosphomolybdate enzymatic
Colorimetric method
Fósforo inorgánico
Phosphorus
inorganic
1.45
4.53
1.21-1.69
3.83-5.23
0.12
0.35
0.24
0.70
mmol/L
mg/dL
Phosphomolybdate UV
Ultraviolet method
Glucosa
Glucose
6.27
114
5.37-7.17
98-130
0.45
8.0
0.90
16.0
mmol/L
mg/dL
Glucose Oxidase. Endpoint.
Enzymatic colorimetric method.
Hierro
Iron
17.6
98.8
17.6-14.5
81.5-116.1
1.55
8.65
3.10
17.30
μmol/L
μg/dL
Colorimetric method.
Endpoint.
Magnesium
Magnesio
0.82
2.01
0.7-0.94
1.73-2.29
0.06
0.14
0.12
0.28
mmol/L
mg/dL
Colorimetric method
Calmagita
Potasio
Potassium
3.92
3.61-4.23
0.16
0.31
mmol/L
ISE method-direct
Proteinas Totales
Total Protein
59.0
5.92
53.6-64.4
5.38-6.46
2.70
0.27
5.40
0.54
g/L
g/dL
Sodio
Sodium
142
133-151
4.50
9.00
mmol/L
ISE method-direct
TIBC
41.8
234
33.0-50.6
184-284
4.40
25.0
8.80
50.0
μmol/L
Colorimetric method
Saturation
Phosphorus inorganic
μg/dL
Colorimetric method
Biuret endpoint
*23.04.09 Valor corregido / Corrected value
QUALITY SYSTEM CERTIFIED
ISO 9001 ISO 13485
LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAIN
Telf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es
HUMAN MULTISERA NORMAL
REF 1980005
LOT Nº 19313
EXP 2012-03
COMPONENTE
VALOR
RANGO
Analytical uncertainty
UNIDAD
METODO
COMPONENT
VALUE
RANGE
1 SD
2 SD
UNIT
METHOD
Triglicéridos
Triglycerides
1.11
98.4
1.01-1.21
82.6-114.2
0.10
7.9
0.10
15.8
mmol/L
mg/dL
Enzymatic colorimetric method
Lipase/GOD-PAP no correction
Urea
Urea
7.57
45.5
6.47-8.67
38.9-5.21
0.55
3.30
1.1
6.60
mmol/L
mg/dL
Enzymatic colorimetric method
Ureasa Berthelot
Urea
Urea
7.85
47.2
6.73-8.7
40.5-53.9
0.56
3.35
1.12
6.70
mmol/L
mg/dL
UV Enzymatic method
Urease kinetic
Acido urico
Uric acid
0.38
6.55
0.59-0.22
5.76-7.34
0.02
0.40
0.05
0.79
mmol/L
mg/dL
Enzymatic colorimetric method
Uricase Peroxidase
ENZIMAS / ENZYMES
Analytical uncertainty
COMPONENTE
VALOR
RANGO
COMPONENT
VALUE
RANGE
UNIDAD
METODO
2 SD
UNIT
1 SD
METHOD
Fosfatasa acida
Acid phosphatase
5.90
18.2
24.1
3.95-7.85
12.2-24.2
16.1-32.1
0.91
3.00
4.00
1.81
6.00
8.00
U/L
U/L
U/L
Non prostatic. 1-Naphthyl Phosphatase Kinetic 37ºC
Prostatic. 1-Naphthyl Phosphatase Kinetic 37ºC
Total. 1-Naphthyl Phosphatase Kinetic 37ºC
With Pentane diol Activation. Colorimetric method
Fosfatasa alcalina
Alkaline
phosphatase
268
208
169
227-309
176-240
143-195
20.50
16.0
13.0
41.0
32.0
26.0
U/L
U/L
U/L
Diethanolamine buffer DEA, 37ºC. Colorimetric
Diethanolamine buffer DEA, 30ºC. Colorimetric
Diethanolamine buffer DEA, 25ºC. Colorimetric
ALT/GPT
32.2
22.2
15.2
24.2-40.2
16.2-28.2
10.2-20.2
4.0
3.0
2.5
8.0
6.0
5.0
U/L
U/L
U/L
TRIS Buffer no P5PIFCC/SFBC 37ºC. UV enzymatic
TRIS Buffer no P5PIFCC/SFBC 30ºC. UV enzymatic
TRIS Buffer no P5PIFCC/SFBC 25ºC. UV enzymatic
Amilasa
Amylase
93
86.1-106.8
6.9
13.8
U/L
R. Liquid stable pNPG 37ºC
AST/GOT
32
21
14
25-39
16-26
11-17
3.5
2.5
1.5
7.0
5.0
3.0
U/L
U/L
U/L
TRIS no P5PIFCC/SFBC 37ºC. Colorimetric enzymatic
TRIS no P5PIFCC/SFBC 30ºC. Colorimetric enzymatic
TRIS no P5PIFCC/SFBC 25ºC. Colorimetric enzymatic
Colinesterasa
Cholinesterase
5042
4034-6050
504.00
1008.0
U/L
Enzymatic colorimetric Butyrylthiocholin (37º)
CK Total
219
137
93
179-259
112-162
76-110
20.0
12.50
8.5
40.0
25.0
17.0
U/L
U/L
U/L
CK-NAC substrate start (DGKC) 37ºC. UV enzymatic
CK-NAC substrate start (DGKC) 30ºC. UV enzymatic
CK-NAC substrate start (DGKC) 25ºC. UV enzymatic
GGT
GGT
50
40
32
43-57
34-46
27-37
3.5
3.0
2.5
7.0
6.0
5.0
U/L
U/L
U/L
G Glutamyl-3-Carbo-4-nitroanilide 37ºC.
G Glutamyl-3-Carbo-4-nitroanilide 30ºC
G Glutamyl-3-Carbo-4-nitroanilide 25ºC
Colorimetric enzymatic method
LDH
LDH
447
327
235
381-513
279-375
203-267
33.0
24.0
17.0
66.0
48.0
32.0
U/L
U/L
U/L
P→L SFBC 37ºC
P→L SFBC 30ºC
P→L SFBC 25ºC
QUALITY SYSTEM CERTIFIED
ISO 9001 ISO 13485
LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAIN
Telf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es
HUMAN MULTISERA NORMAL
REF 1980005
LOT Nº 19313
EXP 2012-03
ELECTROPHORESIS / ELECTROFORESIS
COMPONENTE
VALOR
RANGO
Analytical uncertainty
METODO
COMPONENT
VALUE
RANGE
1 SD
2 SD
METHOD
Albúmina
Albumin
62.0
55.9-68.1
3.05
6.10
% of total Protein (Beckman Capillary)
Alpha-1-globulin
12.0
9.1-14.9
1.44
2.88
% of total Protein (Beckman Capillary)
Alpha-2-globulin
8.3
6.3-10.3
1.00
1.99
% of total Protein (Beckman Capillary)
beta-globulin
7.7
5.9-9.6
0.93
1.85
% of total Protein (Beckman Capillary)
Gamma-globulin
10.0
7.6-12.4
1.20
2.40
% of total Protein (Beckman Capillary)
B1980-1/0406
QUALITY SYSTEM CERTIFIED
ISO 9001 ISO 13485
LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAIN
Telf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es