Total protein FS*

Diagnostic reagent for quantitative in vitro determination of total protein in serum or plasma on
BioMajesty JCA-BM6010/C

Order Information Calibrators and Controls

Cat. No. 1 2311 99 10 962 For calibration, DiaSys TruCal U calibrator is recommended. For
R1: 6 x 315 tests internal quality control DiaSys TruLab N and P controls should be
R2: 6 x 315 tests assayed. Each laboratory should establish corrective action in
case of deviations in control recovery.
Method Cat. No. Kit size
Photometric test according to biuret method TruCal U 5 9100 99 10 063 20 x 3 mL
5 9100 99 10 064 6 x 3 mL
Principle TruLab N 5 9000 99 10 062 20 x 5 mL
Together with copper ions, proteins form a violet blue color 5 9000 99 10 061 6 x 5 mL
complex in alkaline solution. The absorbance of the color is directly TruLab P 5 9050 99 10 062 20 x 5 mL
proportional to the concentration. 5 9050 99 10 061 6 x 5 mL

Reagents Performance Characteristics

Components and Concentrations Measuring range up to 14 g/dL (140 g/L) protein
(in case of higher concentrations re-measure samples after manual
R1: Sodium hydroxide 100 mmol/L dilution or use rerun function)
Potassium sodium tartrate 17 mmol/L Limit of detection** 0.05 g/dL (0.5 g/L) protein
R2: Sodium hydroxide 500 mmol/L On-board stability 6 weeks
Potassium sodium tartrate 80 mmol/L Calibration stability 2 weeks
Potassium iodide 75 mmol/L
Copper sulphate 30 mmol/L Interferences < 10% by
Storage Instructions and Reagent Stability Ascorbate up to 30 mg/dL
Hemoglobin up to 500 mg/dL
The reagents are stable up to the end of the indicated month of Bilirubin (conjugated and unconjugated) up to 60 mg/dL
expiry, if stored at 2 – 25 °C, protected from light and Lipemia (triglycerides) up to 1000 mg/dL
contamination is avoided. Do not freeze the reagents!
Warnings and Precautions Precision
1. Reagents S24/25: Avoid contact with skin and eyes. Within run (n=20) Sample 1 Sample 2 Sample 3
2. Reagent 2 is irritating. R36/38: Irritating to eyes and skin. Mean [g/dL] 4.78 6.17 7.40
R52/53: Harmful to aquatic organisms, may cause long-term Mean [g/L] 47.8 61.7 74.0
adverse effects in the aquatic environment. S2: Keep out of Coefficient of variation [%] 0.57 0.52 0.35
the reach of children. S26: In case of contact with eyes, rinse Between run (n=20) Sample 1 Sample 2 Sample 3
immediately with plenty of water and seek medical advice. Mean [g/dL] 5.97 6.63 7.13
S37/39: Wear suitable gloves and eye/face protection. Mean [g/L] 59.7 66.3 71.3
S61: Avoid release to the environment. Refer to special Coefficient of variation [%] 1.00 1.00 1.15
instructions/safety data sheets.
3. Please refer to the safety data sheets and take the necessary Method comparison (n=100)
precautions for the use of laboratory reagents. Test x Competitor Total protein
4. In serum or plasma from patients who have received large Test y DiaSys Total protein FS
Slope 1.00
intravenous amounts of polydextrans too high values can be
Intercept 0.040 g/dL (0.40 g/L)
measured with the biuret method. In such cases an
Coefficient of correlation 0.998
alternative method (e.g. Kjeldahl) has to be used.
** lowest measurable concentration which can be distinguished from zero
Waste Management mean + 3 SD (n=20) of an analyte free specimen

Please refer to local legal requirements. Reference Range [2]

Reagent Preparation [g/dL]
The reagents are ready to use. The bottles are placed directly into Adults 6.6 - 8.8
the reagent trays. Children Female Male
1 - 30 day(s) 4.2 - 6.2 4.1 - 6.3
Specimen 1 - 6 month(s) 4.4 - 6.6 4.7 - 6.7
Serum or plasma 6 months - 1 year 5.6 - 7.9 5.5 - 7.0
Stability [1]: 1 - 18 year(s) 5.7 - 8.0 5.7 - 8.0
6 days at 20 – 25 °C Each laboratory should check if the reference ranges are
4 weeks at 4 – 8 °C transferable to its own patient population and determine own
at least one year at -20 °C reference ranges if necessary.

Discard contaminated specimens. Literature

1. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed.
Darmstadt: GIT Verlag; 2001; p. 42-3.
2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books
Verlagsgesellschaft; 1998. p. 644-7.
3. Johnson Am, Rohlfs EM, Silverman LM. Proteins. In: Burtis CA,
Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed.
Philadelphia: W.B Saunders Company; 1999. p. 477-540.

Manufacturer
DiaSys Diagnostic Systems GmbH
IVD Alte Strasse 9 65558 Holzheim Germany

Reagent information * fluid stable

Total protein FS
Chemistry code 10 231

Application for serum and plasma samples

This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time and
does not apply to any equipment modifications undertaken by unqualified personnel.

Analytical Conditions Endpoint method

R1 volume 80 Re.absorb (u) 9.999
R2e volume 0 Re. Absorb (d) -9.999
R2 volume 20
R1 diluent vol 0 Calculation Method Setting
R2e diluent vol 0 M-DET.P.I 0
R2 diluent vol 0 M-DET.P.m 41
Sample vol (S) 2 M-DET.P.n 42
Sample vol (U) 2 S-DET.P.p 17
Reagent 1 mix weak S-DET.P.r 18
Reagent 2e mix weak Check D.P.I. 0
Reagent 2 mix weak Limit value 0.003
Reaction time 10 Variance 10
Reac.type Inc
Sub-analy. Conditions
Name TP Reaction Rate Method
Digits 2 Cycle 2
M-wave L. 545 Factor 2
S-wave.L **** E2 corre Not do
Analy.mthd. EPA Blank (u) 9.999
Calc.mthd. STD Blank (d) -9.999
Qualit. judge No Sample (u) 9.999
Sample (d) -9.999
Analysis Test Condition Setting (M)
Sample Type Serum Urine Standards Setting
Reac. sample vol. 2 2 FV #
Diluent method No dil No dil BLK H 9.999
Undil. sample vol. 0 0 BLK L -9.999
Diluent volume 0 0 STD H 9.999
Diluent position 0 0 STD L -9.999
# entered by user

Application BioMajesty JCA-BM6010/C January 2011/1