hemogloWiener
Standard
For standardization and control of hemoglobin assays
SUMMARY
For standardization and control of hemoglobin assays. It
allows not only the calibration of photometric instruments
but also the elimination of sources of error (either operative
or technical) that colored standards cannot detect, such as:
expirated or damaged reagents, miscalibrated pipettes and
micropipettes, careless handling or incorrect technique,
differences between reading tubes or cuvettes and reading
errors.
INSTABILITY OR DETERIORATION OF REAGENTS
Reagent deterioration is suspected whenever some sediment
or loss of color is evident.
PRINCIPLE
HemogloWiener Standard is a true hemoglobin standard
developed by Wiener lab., processed under the same
conditions as the sample. It is used for standardization
of colorimetric methods based on hemoglobin cyanide or
cyanmethemoglobin (Drabkin; van Kampen & Zijlstra, etc.).
ASSAY CONDITIONS
See the package insert of the reagent in use.
PROVIDED REAGENTS
S. Standard: vial containing stabilized native hemoglobin
solution.
Hemoglobin contents is spectrophotometrically determined
at 540 nm as hemoglobin cyanide with reagent according
to Van Kampen and Zijilstra (pH 7.2) considering a molar
absorptivity: 440.0 mmol-1 cm-1 in the equation:
D540 x 64,458
HiCN (mg/dl) =
44 x d x 10
where D540 is the obtained reading; 64,458, the Hemoglobin
molecular weight; d = 1.00 cm the pathlength and 10 is the
conversion factor from liters to deciliters.
NON-PROVIDED REAGENTS
Reagent used in a method based on hemoglobin determination as cyanmethemoglobin.
INSTRUCTIONS FOR USE
Provided Reagent: ready to use.
WARNINGS
The Provided Reagent is for "in vitro" diagnostic use.
Use the reagents according to the working procedures for
clinical laboratories.
The reagents and samples should be discarded according
to the local regulations in force.
STABILITY AND STORAGE INSTRUCTIONS
The Provided Reagent is stable two years in refrigerator
(2-10oC).
REQUIRED MATERIAL (non-provided)
- Spectrophotometer.
- Micropipettes and pipettes for measuring the stated volumes
- Tubes or spectrophotometric cuvettes
- Stopwatch.
PROCEDURE
HemogloWiener Standard should be used under the
same conditions as the sample.
See the procedure in the package insert of the reagent
in use.
STABILITY OF FINAL REACTION
See the package insert of the reagent in use.
CALCULATIONS
Standard (g/dl)
f=
S
where Standard (g/dl) is the hemoglobin concentration corresponding to the hemogloWiener Standard batch.
QUALITY CONTROL METHOD
Hemiglobin Cyanide solutions obtained with this Standard
comply with the specifications of the International Committee
for Standardization in Hematology (ICSH): OD540/505 =1.61;
turbidity (readings at 750 nm): lower than 0.002 O.D.; and
agree with the International Hemiglobin Cyanide Reference
Preparation obtained from the Rijks Instituut voor deer
Volksgezondheid (Utrech Netherlands).
PROCEDURE LIMITATIONS
See PROCEDURE LIMITATIONS in the package insert of
the reagent in use.
hemogloWiener Standard should not be used in methods
based upon oxygen binding capacity (oxyhemoglobin, etc.).
Control of sources of error: as it is a true hemoglobin solution, hemogloWiener Standard should be tested under the
same conditions as the sample; thus the same pipettes and
870640022 / 00 p. 5/6
micropipettes, reagent, photometer, etc. should be used. In
this way not only the reading instrument is calibrated but
also all methodological variables are controlled. The day-today variations in Standard readings detect operative errors,
defective materials or damaged reagents.
WIENER LAB. PROVIDES
Vial containing 1.5 ml (Cat. Nº 1450002).
SYMBOLS
The following symbols are used in packaging for Wiener lab.
diagnostic reagents kits.
C
This product fulfills the requirements of the European
Directive 98/79 EC for "in vitro" diagnostic medical devices
P Authorized representative in the European Community
REFERENCES
- Rice E.W. - J. Lab. Clin. Med. 71/2:319 (1968).
- Van Kampen, E.J.; Zijlstra, W.G. - Adv. Clin. Chem. 8/141
(1965).
- Rojkín, M.L.; Olguín de Mariani, M.C. y Drappo, G.A. - III
Con-greso Argentino de Bioquímica - Buenos Aires (1975).
V
"In vitro" diagnostic medical device
X
Contains sufficient for <n> tests
H
Use by
l
Temperature limitation (store at)

Do not freeze
F
Biological risks
Volume after reconstitution
Cont.
Contents
g
Batch code
M
Manufactured by:
Xn
Harmful
Corrosive / Caustic
Xi
i
Calibr.
b
b
c
h
Irritant
Consult instructions for use
Calibrator
Control
Positive Control
Negative Control
Catalog number
M Wiener Laboratorios S.A.I.C.
Riobamba 2944
2000 - Rosario - Argentina
http://www.wiener-lab.com.ar
Dir. Téc.: Viviana E. Cétola
Bioquímica
A.N.M.A.T. Registered product
Disp.: 1287/77
870640022 / 00 p. 6/6
Wiener lab.
2000 Rosario - Argentina
UR120607