Ferritin (FERR)
Quantitative immunoturbidimetric
test on Ferritin
Diagnostic Use
The iron in the human serum is bound to a complex
protein, called the Ferritin. The Ferritin can contain
from 2000 up to around 4000 Iron atoms.
2 protein subunits form the ferritin, contained in tissues of
e.g. tumors, placenta, myocard, bone marrow, spleen and
liver.
Iron storage and all pathological conditions of the related
metabolisms are the targets of Ferritin determinations in
clinical diagnosis.
Test Principle
Immunturbidimetric agglutination reaction, "latexenhanced", of the antigen Ferritin and polyclonal antibodies
on human Ferritin.
The increase of the absorbance in a cuvette system is
measured photometrically.
Wavelength
Cuvette
Temperature
Measure
570 nm
1 cm lightpath
37 °C
Against Reagent Blank

ReagentSample/
Blank
Cal/Con
Sample / Cal / Con
25 µl
Saline
25 µl
R1
500 µl
500 µl
Mix, incubate for 3 min, then add :
R2
250 µl
250 µl
Mix, incubate for exactly 1 min , read absorbance A1 ,
incubate for exactly 4 min and read absorbance A2 .
A = (A2–A1) Sample/Cal/Con
Note:
You have to adjust the above given volumes to your analyzer
system. So the final volumes can be much lower, yielding
more tests !
Reagents
R1 (Buffer)
Glycin buffered saline (pH 8.5)
R2 (Antiserum)
Glycin buffered saline (pH 8.5)
Anti-human Ferritin antibodies bound on
latex particles
Calculation
The concentration is calculated through a calibration curve
using a suitable mathematical procedure e.g. logit/log.
The calibration curve is established by 4 calibrators of
different concentrations and NaCl-solution (9 g/l) for the
determination of zero.
Stability of the calibration is at least 4 weeks.
Preparation and Stability
Reagent Preparation
Liquid reagents, ready for use
Note:
R2 must be mixed thoroughly before us.
Repeat mixing each time before using R2.
Applications for most automated systems are
available on request
Stability and Storage
The reagents are stable until expiry date when
kept at 2-8°C and contamination is avoided
Calibration /Controls
For the calibration of automated photometric systems we
recommend Greiner Ferritin calibrators, for control use
Greiner control material.
The values are traceable on the WHO-reference material .
Do not freeze!
Reagents required but not supplied
Calibrators (“Cal”) and Controls (“Con”)
Saline (0.9%)
Warnings and precautions
Reagents contain Sodiumazide (0,95 g/l) as preservative.
Do not swallow! Avoid contact with skin and / or mucous
membranes !
Samples
Assay Procedure
Reference Values
Men
Women
Children
15 – 300 ng/ml
10 – 200 ng/ml
15 – 120 ng/ml
(This ranges are given for orientation only. Each laboratory should establish its own reference values)
Serum or plasma (EDTA, heparine, citrate).
Stability:
1 week at 2 - 8°C
>3 months at < -20°C
Page 1/2
Greiner Diagnostic GmbH - Unter Gereuth 10 - D-79353 Bahlingen-Germany
www.greiner-diagnostic.com
Literature
Performance Data
- Range / Linearity
The test can measure Ferritin-concentrations up to the
concentration of 1000 ng/ml.
At higher concentrations dilute the samples 1+1 with
NaCl-solution (9 g/l) . Multiply result by 2 .
- Hookeffect
Not observed up to 30,000 ng/ml.
- Specifity / Interferences
Greiner RF is specific on human RF.
There is no interference with ascorbic acid up to
30 mg/dl, bilirubine up to 60 mg/dl, hemoglobin up to
1000 mg/dl, and lipämia up to > 1000 mg/dl triglycerides for higher Ferritin levels, and up to 600 mg/dl
triglycerides for low Ferritin levels e.g. 50 ng/ml.
1. Wick M, Pingerra W, Lehmann P. Iron metabolism:
diagnosis and therapy of anemias. 3rd ed. Vienna,
New York: Springer Verlag,1996.
2. Worwood M. The laboratory assessment of iron status
– an update. Clin Chim Acta 1997;259:3-23.
3. Kaltwasser JP, Werner E. Diagnosis and clinical
evaluation of iron overload. Baillieres Clin Haematol
1989;2;363-89.
4. Baynes RD, Cook JD. Current issues in iron
deficiency. Curr Opin Hematol 1996;3:145-9.
5. Lee MH, Means RT Jr. Extremely elevated serum
ferritin levels in a university hospital: associated
diseases and clinical significance. Am J Med
1996;98:566-71.
6. Guder WG, Zawta B et al. The quality of diagnostic
samples . 1st ed. Darmstadt: GIT Verlag
- Sensitivity / Detection Limit
Low detection limit = 5 ng/ml
- Precision (n = 20)
Intra run
SAMPLE 1
SAMPLE 2
SAMPLE 3
Inter run
SAMPLE 1
SAMPLE 2
SAMPLE 3
mean
(ng/ml)
15
100
430
SD
[ng/ml]
0.60
0,68
0,83
CV
[%]
3,98
0.68
0,19
mean
(ng/ml)
16,5
105
429
SD
[ng/ml]
0,87
1,60
3,52
CV
[%]
5,31
1,52
0,82
- Correlation
A comparative study has been performed between the
Greiner method and another commercial reagent on >50
human serum samples. The parameters of linear
regression are as follows:
y = 0.89 x - 9.432.5 [ng/ml];
r = 0.997
SYMBOLS USED
For in vitro diagnostic medical use
Batch Code
Use by
Temperature limitation
Page 2/2
Greiner Diagnostic GmbH - Unter Gereuth 10 - D-79353 Bahlingen - Germany
www.greiner-diagnostic.com