Iron FS* Ferene

Order Information Waste Management

Cat. No. Kit size Refer to local legal requirements for chemical disposal regulations
1 1911 99 10 921 480 (4 x 120) as stated in the relevant SDS to determine the safe disposal.
Warning: Handle waste as potentially biohazardous material.
Intended Use Dispose of waste according to accepted laboratory instructions and
Diagnostic reagent for quantitative in vitro determination of iron in procedures.
human serum or heparin plasma on automated respons®920.
Reagent Preparation
Summary The reagents are ready to use. The bottles are placed directly into
Iron exists in the body as a component of hemoglobin and the reagent rotor.
myoglobin as well as bound to transferrin for the transport in plasma
and stored in ferritin. Increased iron concentrations occur in Materials Required
hemochromatosis and liver damage [1]. Malabsorption due to
General laboratory equipment
gastrointestinal diseases can cause decreased iron levels, and may
thus lead to anemia. Blood loss after gastrointestinal lesions or Specimen
heavy menstrual bleeding can generate anemia, too [2].
Human serum or heparin plasma
Method Only use suitable tubes or collection containers for specimen
Photometric test using Ferene collection and preparation.
Iron bound to transferrin (Fe3+) is completely released under acidic When using primary tubes, follow the manufacturer's instructions.
conditions and reduced to Fe2+. Iron forms a blue complex with
Ferene. The absorbance at 595 nm is directly proportional to the Separate serum/plasma at the latest 2 h after blood collection to
iron concentration. minimize hemolysis.

Ascorbic acid, Buffer Stability [4]:

Transferrin (Fe3+)2 ─────────────► 2 Fe2+ + Transferrin 7 days at 20 – 25°C
3 weeks at 4 – 8°C
Fe 2+
+ 3 Ferene ─────► Ferrous Ferene (blue complex) 1 year at -20°C
Reagents Only freeze once. Discard contaminated specimens.
Components and Concentrations
R1: Acetate buffer pH 4.5 1 mol/L Calibrators and Controls
Thiourea 120 mmol/L DiaSys TruCal U is recommended for calibration. Calibrator values
R2: Ascorbic acid 240 mmol/L have been made traceable to the NIST Reference Material SRM
Ferene 3 mmol/L 682. Use DiaSys TruLab N and P for internal quality control. All
Thiourea 120 mmol/L target values of the controls are traceable to DiaSys
reagent/calibrator system. Quality control must be performed after
Storage and Stability calibration. Control intervals and limits have to be adapted to the
Reagents are stable up to the date of expiry indicated on the kit, if individual requirements of each laboratory. Results must be within
stored at 2 – 8°C and contamination is avoided. Do not freeze and the defined ranges. Follow the relevant legal requirements and
protect from light. guidelines. Each laboratory should establish corrective action in
The open-vial stability of the reagent is 18 months until expiry date. case of deviations in control recovery.

Warnings and Precautions Cat. No. Kit size

TruCal U 5 9100 99 10 063 20 x 3 mL
1. Components contained in Iron FS Ferene are classified 5 9100 99 10 064 6 x 3 mL
according to EC regulation 1272/2008 (CLP) as follows: TruLab N 5 9000 99 10 062 20 x 5 mL
Reagent 1: Danger. Contains Dodecan-1-ol, 5 9000 99 10 061 6 x 5 mL
ethoxylated and Alcohols, C9-11-iso-, C10-rich, TruLab P 5 9050 99 10 062 20 x 5 mL
ethoxylated. H315 Causes skin irritation. H318 5 9050 99 10 061 6 x 5 mL
Causes serious eye damage. P264 Wash hands and
face thoroughly after handling. P280 Wear protective Performance Characteristics
gloves/protective clothing/eye protection. Measuring range up to 1000 µg/dL.
P305+P351+P338 IF IN EYES: Rinse cautiously with In case of higher concentrations re-measure samples after
water for several minutes. Remove contact lenses, if manual dilution with NaCl solution (9 g/L) or use rerun function.
present and easy to do. Continue rinsing. P310
Immediately call a POISON CENTER/doctor. Limit of detection** 5 µg/dL
Onboard stability 6 weeks
2. To avoid carryover interference, please take care of efficient
washing especially after use of interfering reagents. Please Calibration stability 6 weeks
refer to the DiaSys respons®920 Carryover Pair Table.
Interference by Interferences Analyte
Carryover pairs and automated washing steps with the
≤ 10% up to concentration
recommended cleaning solution can be specified in the system
[µg/dL]
software. Please refer to the user manual.
3. In very rare cases, samples of patients with gammopathy might Bilirubin (conjugated) 60 mg/dL 257
give falsified results [3]. Bilirubin (unconjugated) 60 mg/dL 251
4. In case of product malfunction or altered appearance that could
Copper 200 µg/dL 97.1
affect the performance, contact the manufacturer.
5. Any serious incident related to the product must be reported to Hemolysis 50 mg/dL 154
the manufacturer and the competent authority of the Member Lipemia (triglycerides) 2000 mg/dL 81.1
State where the user and/or patient is located.
6. Please refer to the safety data sheets (SDS) and take the Zinc 400 µg/dL 95.7
necessary precautions for the use of laboratory reagents. For For further information on interfering substances, refer to the literature
diagnostic purposes, the results should always be assessed [5,6].
with the patient’s medical history, clinical examinations and
other findings.
7. For professional use only.

Iron FS Ferene – Page 1 844 1911 10 02 73 May 2024/1

 Additions and/or changes in the document are highlighted in grey.
Deletions are communicated via customer info by stating the edition
Precision
no. of the package insert/instruction for use.
Repeatability (n=20) Sample 1 Sample 2 Sample 3
DiaSys Diagnostic Systems GmbH
Mean [µg/dL] 87.2 175 277 Alte Strasse 9 65558 Holzheim
CV [%] 1.27 0.741 0.403 Germany
[Link]
Between day (n=20) Sample 1 Sample 2 Sample 3
Mean [µg/dL] 90.5 174 279 * Fluid Stable
CV [%] 0.968 1.20 0.633
Method comparison (n=111)
Test x DiaSys Iron FS Ferene
(Hitachi 911)
Test y DiaSys Iron FS Ferene
(respons®920)
Slope 1.01
Intercept 3.07 µg/dL
Coefficient of correlation 0.998
** lowest measurable concentration which can be distinguished from zero;
mean + 3 SD (n = 20) of an analyte free specimen.

Conversion Factor
Iron [µg/dL] x 0.1791 = Iron [µmol/L]

Reference Range [7]

[µg/dL] [µmol/L]
Children
2 weeks 63 – 201 11 – 36
6 months 28 – 135 5 – 24
12 months 35 – 155 6 – 28
2 – 12 years 22 – 135 4 – 24
Women
25 years 37 – 165 6.6 – 29.5
40 years 23 – 134 4.1 – 24.0
60 years 39 – 149 7.0 – 26.7
Pregnant women
12th week 42 – 177 7.6 – 31.6
At delivery 25 – 137 4.5 – 24.5
6 weeks post partum 16 – 150 2.9 – 26.9
Men
25 years 40 – 155 7.2 – 27.7
40 years 35 – 168 6.3 – 30.1
60 years 40 – 120 7.2 – 21.5
Each laboratory should check if the reference ranges are
transferable to its own patient population and determine own
reference ranges if necessary.

Literature
1. Wick et al, Clinical Aspects and Lab Iron Metabolism, Anemias.
Novel concepts, Springer,5th ed. Wien New York 2003 p141 –
147.
2. Fairbanks VF, Klee GG. Biochemical aspects of hematology.
In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical
Chemistry. 3rd ed. Philadelphia: W.B Saunders Company;
1999. p. 1642-1710.
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. 34-5.
5. 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.
6. Young DS. Effects on Clinical Laboratory Tests - Drugs
Disease, Herbs & Natural Products, [Link]
aaccweb/aacc/, accessed in March 2024. Published by AACC
Press and John Wiley and Sons, Inc.
7. Thomas L. Clinical Laboratory Diagnostics [Internet]. Prof.
Lothar Thomas; 2024 [cited 2024 May 13]. [Link]
[Link]

Iron FS Ferene – Page 2 844 1911 10 02 73 May 2024/1

 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

Application respons®920 May 2024/1