Total protein FS*
Order Information Materials Required
Cat. No. Kit size Instrument General laboratory equipment
1 2311 99 10 972 R1 3 x 15.8 mL BX-3010 375 (3 x 125)
BX-4000 249 (3 x 83) Specimen
R2 3 x 6.5 mL BX-3010 375 (3 x 125) Human serum or heparin plasma
BX-4000 249 (3 x 83)
Stability [4]:
Intended Use 6 days at 20 – 25°C
4 weeks at 4 – 8°C
Diagnostic reagent for quantitative in vitro determination of total at least one year at –20°C
protein in human serum or heparin plasma on automated Sysmex
BX-Series. Only freeze once. Discard contaminated specimens.
Summary Calibrators and Controls
Measurement of total protein is a useful test in a variety of DiaSys TruCal U is recommended for calibration. TruCal U
disorders. Decreased total protein concentrations can be detected calibrator values have been made traceable to the biuret method.
in defective protein synthesis in the liver, protein loss due to Use DiaSys TruLab N and P for internal quality control. Each
impaired kidney function, intestinal malabsorption or nutritional laboratory should establish corrective action in case of deviations
deficiency. Elevated protein levels occur in chronic inflammatory in control recovery.
disorders, liver cirrhosis and dehydration. [1,2] Cat. No. Kit size
TruCal U 5 9100 99 10 063 20 x 3 mL
Method 5 9100 99 10 064 6 x 3 mL
Photometric test according to biuret method TruLab N 5 9000 99 10 062 20 x 5 mL
Proteins form a violet blue color complex with copper ions in 5 9000 99 10 061 6 x 5 mL
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 Exemplary data mentioned below may slightly differ in case of
R1: Sodium hydroxide 100 mmol/L deviating measurement conditions.
Potassium sodium tartrate 17 mmol/L
R2: Sodium hydroxide 500 mmol/L Measuring range up to 15 g/dL (150 g/L).
In case of higher concentrations re-measure samples after
Potassium sodium tartrate 80 mmol/L
manual dilution with NaCl solution (9 g/L) or use rerun function.
Potassium iodide 75 mmol/L
Copper sulphate 30 mmol/L Limit of detection** 0.01 g/dL (0.1 g/L)
Storage and Stability Onboard stability 2 weeks
The reagents are stable up to the date of expiry indicated on the Calibration stability 1 week
kit, if stored at 2 - 25°C and contamination is avoided. Protect
Interfering substance Interferences Analyte
reagents from light.
≤ 10% up to concentration
Warnings and Precautions 6.27 g/dL
Ascorbic acid 30 mg/dL
1. Reagent 1: Warning. H290 May be corrosive to metals. (62.7 g/L)
P234 Keep only in original packaging. P390 Absorb spillage 6.31 g/dL
to prevent material damage. Hemoglobin 500 mg/dL
(63.1 g/L)
2. Reagent 2: Warning. Contains: Potassium iodide. H290 Bilirubin (conjugated) 60 mg/dL 6.33 g/dL
May be corrosive to metals. H315 Causes skin irritation. H319 (63.3 g/L)
Causes serious eye irritation. H373 May cause damage to
organs through prolonged or repeated exposure. H412 6.34 g/dL
Bilirubin (unconjugated) 60 mg/dL
Harmful to aquatic life with long lasting effects. P234 Keep (63.4 g/L)
only in original packaging. P273 Avoid release to the 6.96 g/dL
environment. P280 Wear protective gloves/protective Lipemia (triglycerides) 1000 mg/dL
(69.6 g/L)
clothing/eye protection. P305+P351+P338 If in eyes: Rinse
9.27 g/dL
cautiously with water for several minutes. Remove contact 1000 mg/dL
(92.7 g/L)
lenses, if present and easy to do. Continue rinsing. P314 Get
medical advice/attention if you feel unwell. For further information on interfering substances refer to Young DS [5,6].
3. In serum or plasma of patients who have received large Precision BX-4000
intravenous amounts of polydextrans, too high values can be
Within run (n=20) Sample 1 Sample 2 Sample 3
measured with the biuret method. In such cases an
alternative method (e.g. Kjeldahl) has to be used. Mean [g/dL] 3.14 6.21 8.56
4. In very rare cases, samples of patients with gammopathy Mean [g/L] 31.4 62.1 85.6
might give falsified results [3].
5. Please refer to the safety data sheets and take the necessary CV [%] 0.406 0.483 0.356
precautions for the use of laboratory reagents. For diagnostic Between day (n=20) Sample 1 Sample 2 Sample 3
purposes, the results should always be assessed with the Mean [g/dL] 3.59 6.12 9.54
patient’s medical history, clinical examinations and other
findings. Mean [g/L] 35.9 61.2 95.4
6. For professional use only. CV [%] 0.934 0.680 0.823
Waste Management
Refer to local legal requirements.
Reagent Preparation
The reagents are ready to use. The bottles are placed directly into
the reagent rotor.
Total protein FS – Page 1 844 2311 41 02 00 April 2021/1
Method comparison (n=106)
Test x Total protein FS
(BioMajesty 6010C)
Test y Total protein FS
(BX-4000)
Slope 1.02
Intercept –0.018 g/dL (–0.181 g/L)
Coefficient of correlation 0.999
** lowest measurable concentration which can be distinguished from zero;
mean + 3 SD (n = 20) of an analyte free specimen.
Reference Range [1]
[g/dL]
Adults 6.6 – 8.8
Children Female Male
1 – 30 day(s) 4.2 – 6.2 4.1 – 6.3
1 – 6 month(s) 4.4 – 6.6 4.7 – 6.7
6 months – 1 year 5.6 – 7.9 5.5 – 7.0
1 – 18 year(s) 5.7 – 8.0 5.7 – 8.0
Each laboratory should check if the reference ranges are
transferable to its own patient population and determine own
reference ranges if necessary.
Literature
1. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt:
TH-Books Verlagsgesellschaft; 1998. p. 644-7.
2. 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.
3. Bakker AJ, Mücke M. Gammopathy interference in clinical
chemistry assays: mechanisms, detection and prevention.
ClinChemLabMed 2007;45(9):1240-1243.
4. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
1st ed. Darmstadt: GIT Verlag; 2001; p. 42-3.
5. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
ed. Volume 1 and 2. Washington, DC: The American
Assocation for Clinical Chemistry Press 2000.
6. Young DS. Effects on Clinical Laboratory Tests - Drugs
Disease, Herbs & Natural Products, https://clinfx.wiley.com/
aaccweb/aacc/, accessed in April 2021. Published by AACC
Press and John Wiley and Sons, Inc.
DiaSys Diagnostic Systems GmbH
Alte Strasse 9 65558 Holzheim Germany
www.diasys-diagnostics.com
* Fluid Stable
Total protein FS – Page 2 844 2311 41 02 00 April 2021/1
Total protein FS Chemistry Code 100 71
Chemistry Parameters 1 Sysmex BX-3010 Chemistry Analyzer
Analytical Parameters
Method No. * Method Name TP Reagent Name Reagent (µL) Water (µL)
Print Name Total protein MethodColor R1 TP 100
Sample Type Serum R2 TP 25
Unit g/dL Diluent Disable
Assay Type End Sample Ppt. Wash Disable
Measuring points Start End Stirring Speed R1 Middle R2 Middle
1 22 – 23
2 45 – 46
Normal Range
No. Normal Range Name Min Max
Wave Length 1 Male-G1 * *
Prim. 546 Sec. Disable 2 Male-G2 * *
3 Male-G3 * *
4 Female-G1 * *
Normal Sample Volume (µL) Diluted Sample (µL) Diluent (µL) Technical Range
Low Normal High (Conc) 0.02 – 15
Diluent 0.0 < 2.5 < 0.0 (mAbs/10) * – *
Rerun (High/Prozone)
Diluent 0.0 < 2.5 < 0.0 Previous Result Comparison (%) * * %
Rerun (Low)
Diluent 0.0 < 2.5 < 0.0 Abnormal Range (Conc) * – *
Panic Range (Conc) * – *
Decimal Point 2 Profile SI Disable
*Entered by user
Chemistry Parameters 2 Sysmex BX-3010 Chemistry Analyzer
Analytical Parameters
Method No. * Method Name TP Sample Serum
Limit Checks Blank measurement
Duplicate Limit 50 mAbs/10 Blank measurement:
Disable reagent blank and C1 blank
Sensitivity Limit 2000 mAbs/10
Measurement of Reagent Blank during Run:
Linearity Limit % None
(mAbs/10)/min Reagent blank measurement at calibration:
Reagent blank (No sample)
Prozone Limit Higher %
The number of measurement:
Duplicate
SL1-S – SL1-F Reagent blank limit checks:
Duplicate Limit 20 mAbs/10
SL2-S – SL2-F
Sensitivity mAbs/10 Instrument Factor
Absorbance Limit a 1.00 b 0.00
Abs. in reaction Increase
Limit 25000 mAbs/10
Application BX-3010 Page 3 of 6
Total protein FS Chemistry Code 100 71
Calibration Registration Sysmex BX-3010 Chemistry Analyzer
Analytical Parameters
Reagent Lot No.
Method No. * (R1) * Last
(R2) *
Method Name TP
Sample Type Serum
Replication Duplicate
Check Interval 7
Test without calibration
Disable
Calibration Type Linear
Reagent Lot New Add The calibration curve is lot dependent
Calibrator Name TruCal U
Conc. WORK MASTER Calibr. Lot No. All
Automatic entry Automatic entry
C1 0 * Reagent blank mAbs/10 Last
Automatic entry Automatic entry
C2 * *
Automatic entry
C3 * Blank mAbs/10 Last
C4 *
C5 * Calibration Curve Conc.
C6 *
C7 * Absorbance mAbs/10 Recalculation
K Automatic entry
C1 Blank
Reagent Blank for C1
*Entered by user
Application BX-3010 Page 4 of 6
Total protein FS Chemistry Code 100 71
Chemistry Parameters Sysmex BX-4000 Chemistry Analyzer
Analytical Parameters
Method * Name TP Reagent Name Reagent (µL) Water (µL)
Print Name Total protein R1 TP 150
Sample Serum R2 Enable TP 38
Unit g/dL
Assay Type End Diluent Enable
Measuring points Start End Decimal Points 2
1 33 – 34
Enable 2 67 – 68
Normal Range
No. Normal Range Name Min Max
Wave Length 1 Male-G1 * *
Prim. 546 Sec Disable 2 Male-G2 * *
3 Male-G3 * *
4 Female-G1 * *
Normal Sampling Sample (µL) Diluent (µL) Technical Range
Dilution 3.8 (Conc) 0.02 – 15
Rerun (High/Prozone) (mAbs/10) –
Dilution 3.8
Rerun (Low)
Dilution 3.8 Reagent Name
SPT Wash Enable
Stirring Speed R1 Middle R2 Middle
*Entered by user
Chemistry Parameters Sysmex BX-4000 Chemistry Analyzer
Analytical Parameters
Method No. * Name TP Sample Serum
Limit Checks Blank measurement
Duplicate Limit 50 mAbs/10 Blank measurement:
Disable reagent blank and S1 blank
Sensitivity Limit 2000 mAbs/10
Measurement of Reagent Blank during Run:
Linearity Limit % (mAbs/10)/min None
Prozone Limit % Upper Reagent blank measurement at calibration:
Reagent blank (No sample)
SL1-S – SL1-F
The number of measurement:
SL2-S – SL2-F Duplicate
Sensitivity mAbs/10 Reagent blank limit checks:
Duplicate Limit 20 mAbs/10
Absorbance Limit
Reaction Increase Instrument Factor
Limit 25000 mAbs/10 a 1.00 b 0.00
Application BX-4000 Page 5 of 6
Total protein FS Chemistry Code 100 71
Registration Calibration Sysmex BX-4000 Chemistry Analyzer
Analytical Parameters
Method * Name TP R Lot No. R1 * Last
R2 *
Sample Serum
Sampling Duplicate
Check Interval 7 days
Auto Change Lot Full Calibration
Auto Interval hours
Type Linear Lot New
Material Name TruCal U The calibration curve is lot dependent
Reagent blank mAbs/10 Last
Conc. WORK MASTER Lot No. (S) All
Automatic entry Automatic entry Automatic entry
S1 0 Blank mAbs/10 Last
Automatic entry Automatic entry
S2 *
S3 * Type Conc.
S4 *
S5 * Absorbance mAbs/10 Recalculation
S6 *
S7 *
K Automatic entry
S1 Blank Reagent Blank for S1
*Entered by user
Application BX-4000 Page 6 of 6 April 2021/1
