Safety precautions
For in vitro diagnostic use only.
Do not pipette by mouth.
Exercise the normal precautions required for handling
laboratory reagents.
Total Proteins
*Procedure
Colorimetric Method
Principle
Serum Proteins, in alkaline solution and in presence of
copper ions (Biuret Reagent), form a pink - coloured
complex.
Intensity of the colour is direct proportional to the Protein
concentration
Reagent Composition, Contents and Safety warnings
R2. Reagent
Sodium Potassium Tartrate
Sodium Hydroxide
Potassium Iodide
Copper Sulphate
R1. Standard
Bovine Albumin
Pipette into cuvettes
Distilled water
Sample
Standard
Reagent 2
Blank
20 µl
Sample
standard
20 µl
1 ml
1 ml
20 µl
1 ml
Mix, incubate for 10 minutes at Room Temperature.
Read the absorbance of Calibrator and Samples against
the Blank at Wavelength of 540 nm.
*Calculation
21 mmol/l
750 mmol/l
6 mmol/l
6 mmol/l
6 g/dl
The Reagent is classified as C = Corrosive
Content: SODIUM HYDROXIDE
Risk:
R34 Causes burn
S26 In case of contact with eyes, rinse immediately with
plenty of water and seek medical advise
S45 In case of accident or if you feel unwell, seek medical
advice immediately (show the label where possible)
S61 Avoid release to the environment. Refer to special
instructions/ safety data sheets
S36/37/39 Wear suitable protective clothing, gloves and
eye / face protection
Storage and Stability of Reagents
Store the Reagent at Room Temperature and the
Calibrator at 2 - 8°C.
All the components are stable until the stated expiration
date if tightly closed.
Preparation and Stability of Working solution
Reagents:
liquid and ready to use
Bring reagents at Room Temperature before use.
Sample
Fresh serum free of haemolysis. Heparin or EDTA Plasma
Comparation between this method (y) and another
commercial one (x), gave the following results:
N = 20
r = 0.98467
y = 0.99x + 0.20
F. INTERFERENCES
Haemoglobin till to 50 mg/dl does not interfere
Bilirubin till to 20 mg/dl does not interfere
Quality Control
Control sera are recommended to monitor the performance
of manual and automated assay procedures.
Bibliography
1. Henry R. J.: Clinical Chemistry, Hoeber, N.Y., 413 (1976)
2.Tietz N. W.: Fundamentals of Clin. Chem., Saunders Co.,
Philadelphia, PA 302
(1970)
For in vitro diagnostic use only.
The following symbols are used on labels
For in vitro diagnostic use
A Sample
TOTAL PROTEIN (g/dl) =
x standard Value
A standard
Reference Values
6.0 - 8.0 g/dl *
* F. Pasquinelli: Diagnostica e Tecniche di Laboratorio;
Vol.1, first part p. 666 (1979)
These values should only be used as a guideline.
Each laboratory should establish its Normal Reference
Range
Performance Characteristics
A. LINEARITY LIMIT
The reaction is linear till to 10 g/dl
For higher value dilute sample 1:2 with distilled water,
repeat the test and multiply the value by 2
B. DETECTION LIMIT
Values less than 0.3 g/dl give non - reproducible
results
C. INTRA - ASSAY PRECISION (N = 20 replicates)
Mean (g/dl)
SD
CV%
Control 1
5.32
0.15
2.76
Control 2
4.81
0.11
2.23
D. INTER - ASSAY PRECISION (20 replicates for 3 days)
Mean (g/dl)
SD
CV%
Control 1
5.50
0.14
2.64
Control 2
4.81
0.13
2.73
E. ACCURACY
Use by (last day of the month)
Temperature limitation
Batch Code