min at room temperature.

EQUIPMENTS NEEDED BUT NOT PROVIDED

5. Read the absorbance (A) of samples and
 Spectrophotometer or colorimeter measuring at
Standard, against Blank. The colour is stable
540 nm.
for at least 30 minutes.
 Matched cuvettes 1.0 cm light path.
 General laboratory equipment. CALCULATIONS
Total protein Biuret Colorimetric
(A) Sample - (A) Blank X 7 (Standard conc.)= g/dL of total
PRECAUTIONS (A) Standard - (A) Blank protein in the sample
For In-Vitro diagnostic and professional use only  Copper (II) sulphate: Environmentally dangerous
(N). REFERENCE VALUES
Store at 2° to 8° C  R: Harmful to aquatic organisms may cause long- Adults: 6.6 – 8.3 g/dL
term adverse effects in the aquatic environment. Newborn: 5.2 – 9.1 g/dL
INTENDED USE  This material and its container must be disposed NOTE
For the quantitative determination of total protein of as hazardous waste. These values are for orientation purposes; each
concentration in human serum or plasma.  Avoid release to the environment. Refer to special laboratory should establish its own reference range.
instructions/safety data sheets.
INTRODUCTION QUALITY CONTROL
Proteins are macromolecular organic compounds, widely PREPARATION  If control values are found outside the defined
distributed in the body. They act as structural and Reagents are ready to use. range, check the instrument, reagents and
transport elements. Serum proteins are divided into calibrator for problems.
STORAGE AND STABILITY
albumin and globulins.  Each laboratory should establish its own Quality
The determination of total proteins is useful in the  All components of the kit are stable until the
expiration date on the label when stored tightly Control scheme and corrective actions if controls
detection of: do not meet the acceptable tolerances.
closed at 2-8°C protected from light and
 High protein levels caused by hemoconcentration
contaminations prevented during their use. PERFORMANCE CHARACTERISTICS
like in dehydration or increase in the
concentration of specific proteins.  Do not use reagents over the expiration date. Measuring range:
 Low protein levels caused by hemodilution by  Signs of reagent deterioration: From detection limit of 0,007 g/dL to linearity limit of 14
impared synthesis or loss (as by hemorrhage) or  Presence of particles and turbidity. g/dL.
excessive protein catabolism.  Blank absorbance (A) at 540 nm > 0.22. If the results obtained were greater than linearity limit,
Clinical diagnosis should not be based on a single test SAMPLES dilute the sample to half with NaCl 9 g/L and multiply the
result; it should integrate clinical and other laboratory Serum or heparinized plasma. result by 2.
data. Sample is stable for 1 month in the refrigerator (2-8°C). Precision:
Intra-assay (n=20) Inter-assay (n=20)
PRINCIPLE PROCEDURE
Proteins give an intensive violet-blue complex with copper 1. Assay conditions: Mean (g/dL) 6.53 4.89 6.77 5.08
salts in an alkaline medium. Iodide is included as an Wavelength:………………………..……… 540 (530-550) nm SD 0.01 0.01 0.07 0.05
antioxidant. Cuvette light path: …………………………………….…..…1 cm. CV (%) 0.15 0.20 1.03 0.98
The intensity of the color formed is proportional to the Temperature:…………..…………………………37°C / 15-25°C
total protein concentration in sample. 2. Adjust the instrument to zero with distilled Sensitivity:
REAGENTS water. 1 g/dL = 0,0825 A.
R Sodium potassium tartrate 15 mmol/L 3. Pipette into a cuvette: Accuracy:
Biuret Sodium iodide 100mmol/L Blank Standard Sample Results obtained using ATLAS reagents (y) did not show
Potassium iodide 5 mmol/L R (mL) 1.0 1.0 1.0 systematic differences when compared with other
Copper (II) sulphate 5 mmol/L Standard (µL) -- 25 -- commercial reagents (x).
Sodium hydroxide 1000 mmol/L Sample (µL) -- -- 25 The results obtained using 50 samples were as follow:
TOTAL PROTEIN Bovine albumin primary Standard 7 g/dL 2
4. Mix and incubate for 5 min at 37°C or for 10 Correlation coefficient (R) : 0.97002.
STD
Regression equation: y= 0.954x + 0.511. Atlas Medical
The results of the performance characteristics depend on Ludwig-Erhard Ring 3
the analyzer used. 15827 Blankenfelde-Mahlow
INTERFERENCES Germany
Hemoglobin and lipemia. Tel: +49 - 33708 – 3550 30
A list of drugs and other substances interfering with total Email: Info@atlas-medical.com
protein determination has been reported.
PPI1463A01
NOTES Rev A (02.09.2019)
1. Calibration with the aqueous standard may cause Temperature
a systematic error in automatic procedures. In Catalogue Number
limit
these cases, it is recommended to use a serum In Vitro diagnostic
Caution
Calibrator. medical device
2. Use clean disposable pipette tips for its Contains sufficient Consult
dispensation. for <n> tests and instructions for
3. Total protein standard: Proceed carefully with this Relative size use (IFU)
product as, due its nature, it can get contaminated Batch code Manufacturer
easily.
Fragile,
REFERENCES Use-by date
handle with care
1. Koller A. Total serum protein. Kaplan A et al.
Do not use if
Clin Chem The C.V. Mosby Co. St Louis. Toronto. Manufacturer fax
package is
Princeton 1984; 1316-1324 and 418. number
damaged
2. Young DS. Effects of drugs on Clinical Lab. Tests,
Manufacturer Date of
4th ed AACC Press, 1995.
telephone number Manufacture
3. Young DS. Effects of disease on Clinical Lab.
Tests, 4th ed AACC 2001. Keep away from
Keep dry
4. Burtis A et al. Tietz Textbook of Clinical sunlight
Chemistry, 3rd ed AACC 1999.
5. Tietz N W et al. Clinical Guide to Laboratory
Tests, 3rd ed AACC 1995.