Iron FS* Ferene
Diagnostic reagent for quantitative in vitro determination of iron in serum or plasma on DiaSys
respons®920
Order Information Calibrators and Controls
Cat. No. 1 1911 99 10 921 DiaSys TruCal U calibrator is recommended for calibration. The
4 twin containers for 120 determinations each assigned values of the calibrator have been made traceable to the
®
NIST reference material SRM -682. For internal quality control
Method DiaSys TruLab N and P controls should be assayed. Each
Photometric test using Ferene laboratory should establish corrective action in case of deviations
in control recovery.
Principle
Cat. No. Kit size
Iron bound to transferrin is released in an acidic medium as ferric TruCal U 5 9100 99 10 063 20 x 3 mL
iron and is then reduced to ferrous iron in the presence of ascorbic 5 9100 99 10 064 6 x 3 mL
acid. Ferrous iron forms a blue complex with Ferene. The TruLab N 5 9000 99 10 062 20 x 5 mL
5 9000 99 10 061 6 x 5 mL
absorbance at 595 nm is directly proportional to the iron TruLab P 5 9050 99 10 062 20 x 5 mL
concentration. 5 9050 99 10 061 6 x 5 mL
3+
Transferrin (Fe )2 Ascorbic acid, Buffer 2+
2 Fe + Transferrin Performance Characteristics
Measuring range up to 1000 µg/dL iron (in case of higher concentrations
2+
Fe + 3 Ferene Ferrous Ferene (blue complex) re-measure samples after manual dilution with NaCl solution (9 g/L) or
use rerun function).
Reagents Limit of detection** 5 µg/dL iron
On-board stability 6 weeks
Components and Concentrations Calibration stability 6 weeks
R1: Acetate buffer pH 4.5 1 mol/L
Thiourea 120 mmol/L Interferences < 10% by
R2: Ascorbic acid 240 mmol/L Hemoglobin up to 50 mg/dL
Ferene 3 mmol/L Conjugated Bilirubin up to 60 mg/dL
Unconjugated Bilirubin up to 60 mg/dL
Thiourea 120 mmol/L
Lipemia (triglycerides) up to 2000 mg/dL
Storage Instructions and Reagent Stability Copper up to 200 µg/dL
The reagents are stable up to the end of the indicated month of Zinc up to 400 µg/dL
expiry, if stored at 2 – 8°C and contamination is avoided. Do not For further information on interfering substances refer to Young DS [2].
freeze the reagents! Reagents should be protected from light.
Precision
DiaSys respons containers provide protection from light.
Within run (n=20) Sample 1 Sample 2 Sample 3
Warnings and Precautions Mean [µg/dL] 87.2 175 277
1. Reagent 1: Danger. H315 Causes skin irritation. H318 Causes Coefficient of variation [%] 1.27 0.74 0.40
serious eye damage. P264 Wash hands and face thoroughly
Between run (n=20) Sample 1 Sample 2 Sample 3
after handling. P280 Wear protective gloves/protective
Mean [µg/dL] 90.5 174 279
clothing/eye protection/face protection. P305+P351+P338 If in Coefficient of variation [%] 0.97 1.20 0.63
eyes: Rinse cautiously with water for several minutes. Remove
contact lenses, if present and easy to do. Continue rinsing. Method comparison (n=111)
P310 Immediately call a poison center or doctor/physician. Test x DiaSys Iron FS Ferene (Hitachi 917)
®
2. Use only disposable material to avoid iron contamination. Test y DiaSys Iron FS Ferene (respons 920)
3. To avoid carryover interference, please take care of efficient Slope 1.01
washing especially after use of interfering reagents. Please Intercept 3.07 µg/dL
®
refer to the DiaSys respons 920 Carryover Pair Table. Coefficient of correlation 0.998
Carryover pairs and automated washing steps with the ** lowest measurable concentration which can be distinguished from zero
recommended cleaning solution can be specified in the system mean + 3 SD (n=20) of an analyte free specimen
software. Please refer to the user manual.
Conversion factor
4. In very rare cases, samples of patients with gammopathy
might give falsified results [8]. Iron [µg/dL] x 0.1791 = [µmol/L]
5. Please refer to the safety data sheets and take the necessary Reference Range [3]
precautions for the use of laboratory reagents. For diagnostic
µg/dL µmol/L
purposes, the results should always be assessed with the Children
patient’s medical history, clinical examinations and other 2 weeks 63 – 201 11 – 36
findings. 6 months 28 – 135 5 – 24
6. For professional use only! 12 months 35 – 155 6 – 28
2 - 12 years 22 – 135 4 – 24
Waste Management
Women
Please refer to local legal requirements. 25 years 37 – 165 6.6 – 29.5
40 years 23 – 134 4.1 – 24.0
Reagent Preparation
60 years 39 – 149 7.0 – 26.7
The reagents are ready to use. The bottles are placed directly into Pregnant women
the reagent rotor. 12th gestational week 42 – 177 7.6 – 31.6
at term 25 – 137 4.5 – 24.5
Specimen 6 weeks postpartum 16 – 150 2.9 – 26.9
Serum or heparin plasma Men
Separate serum/plasma at the latest 2 h after blood collection to 25 years 40 – 155 7.2 – 27.7
minimize hemolysis. 40 years 35 – 168 6.3 – 30.1
60 years 40 – 120 7.2 – 21.5
Stability [1]:
7 days at 20 – 25°C Each laboratory should check if the reference ranges are
3 weeks at 4 – 8°C transferable to its own patient population and determine own
1 year at –20°C reference ranges if necessary.
Discard contaminated specimens. Freeze only once.
Page 1 - Reagent Information * fluid stable
Literature Manufacturer
st
1. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1 ed. DiaSys Diagnostic Systems GmbH
Darmstadt: GIT Verlag; 2001; p. 34-5. IVD Alte Strasse 9 65558 Holzheim Germany
2. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th. ed.
Volume 1 and 2. Washington, DC: The American Association for
Clinical Chemistry Press, 2000.
st
3. Thomas L. Clinical Laboratory Diagnostics. 1 ed. Frankfurt: TH-Books
Verlagsgesellschaft; 1998. p. 273-5.
4. Wick M. Iron metabolism and its disorders. In: Thomas L, editor.
st
Clinical laboratory diagnostics. 1 ed. Frankfurt: TH-Books
Verlagsgesellschaft; 1998. p. 268-73.
5. Fairbanks VF, Klee GG. Biochemical aspects of hematology. In: Burtis
rd
CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3 ed.
Philadelphia: W.B Saunders Company; 1999. p. 1642–1710.
6. Higgins T. Novel chromogen for serum iron determinations. Clin Chem
1981; 27: 1619.
7. Artiss JD, Vinogradov S, Zak B. Spectrophotometric study of several
sensitive reagents for serum iron. Clin Biochem 1981; 14: 311-15.
8. Bakker AJ, Mücke M. Gammopathy interference in clinical chemistry
assays: mechanisms, detection and prevention. ClinChemLabMed
2007;45(9):1240–1243.
Page 2 - Reagent Information
Iron FS Ferene
Application for serum and plasma
Test Details Test Volumes Reference Ranges
Test : FE Auto Rerun
Report Name : IRON Online Calibration
Unit : µg/dL Decimal Places : 2 Cuvette Wash
Wavelength-Primary : 578 Secondary : 700 Total Reagents : 2
Assay Type : 2-Point Curve Type : Linear Reagent R1 : FE R1
M1 Start : 15 M1 End : 15 Reagent R2 : FE R2
M2 Start : 33 M2 End : 33
Sample Replicates : 1 Standard Replicates : 3 Consumables/Calibrators:
Control Replicates : 1 Control Interval : 0 Blank/Level 0 0
Reaction Direction : Increasing React. Abs. Limit : 0.00 Calibrator 1 *
Prozone Limit % : 0 Prozone Check : Lower
Linearity Limit % : 0 Delta Abs./Min. : 0.00
Technical Minimum : 5.00 Technical Maximum : 1000.00
Y = aX + b a= : 1.00 b= : 0.00
* Enter calibrator value
Test Details Test Volumes Reference Ranges
Test : FE
Sample Type : Serum
Sample Volumes Sample Types
Serum
Normal : 11.00 µL Dilution Ratio : 1 X Urine
CSF
Increase : 15.00 µL Dilution Ratio : 1 X
Plasma
Decrease : 8.00 µL Dilution Ratio : 1 X Whole Blood
Other
Standard Volume : 11.00 µL
Reagent Volumes and Stirrer Speed
RGT-1 Volume : 180 µL R1 Stirrer Speed : Medium
RGT-2 Volume : 45 µL R2 Stirrer Speed : High
Test Details Test Volumes Reference Ranges
Test : FE
Sample Type : Serum
Reference Range : DEFAULT
Category : Male
Reference Range Sample Types
Serum
Lower Limit Upper Limit Urine
CSF
(µg/dL) (µg/dL)
Plasma
Whole Blood
Normal : 35.00 168.00 Other
Panic : 0.00 0.00
Page 3 – Application respons 920
®
February 2018/7