Ferritin - Turbidimetric

REF 3140005 REF 3140010

1 x 50 mL 2 x 50 mL
CONTENTS
R1.Reagent 1 x 40 mL
CONTENTS
R1. Reagent 2 x 40 mL
Ferritin - Turbidimetric
R2. Reagent 1 x 10 mL R2. Reagent 2 x 10 mL
CAL. 1 x 3 mL CAL. 1 x 3 mL Latex Turbidimetry
For in vitro diagnostic use only

PRINCIPLE STORAGE AND STABILITY

The latex particles coated with anti human ferritin are 1. The reagents will remain stable until the expiration date
agglutinated when they react with samples that contain printed on the label, when stored tightly closed at 2-8ºC and
ferritin. The latex particles agglutination is proportional to contaminations are prevented during their use. Do not use
the concentration of the ferritin in the sample and can be the reagents after the expiration date.
measured by turbidimetry.1,2 2. Reagent deterioration: Presence of particles, turbidity and
increment of blank reagent.
REAGENTS COMPOSITION
SAMPLES
R1 Diluent. Glycine buffer, 20 mmol/L, pH 8.5.
Fresh serum. Stable 7 days at 2-8ºC or 3 months at –20ºC.
R2 Latex. Latex particles coated with polyclonal anti-
Samples with presence of fibrin should be centrifuged before testing.
human ferritin antibodies, pH 8.2.
Hemolyzed or contaminated samples are not suitable for testing.
CAL Calibrator. Ref 3940005 1x3 mL. Human ferritin.
Ferritin concentration is stated on the label vial and
it is trazable to the 3rd International Reference MATERIAL REQUIRED
Material for Ferritin, 94/572 WHO (NIBSC).
Precautions: The reagents contain sodium azide 0.95 g/L. - Thermostatic bath at 37ºC.
Avoid any contact with skin or mucous. - Spectrophotometer or photometer thermostatable at 37ºC with
The reagents from human donors have been given negative a 650 ± 20 nm filter.
results to anti-HIV 1/2, HBsAg and anti-HCV. Handle
cautiously is recommended.
PROCEDURE

REAGENT PREPARATION Preliminary Procedure

Prewarm the reagents and the photometer (cuvette holder) to
R1 Ready to use.
37ºC.
R2 Ready to use. Mix gently the vial by inversion
before use (Note 6).
Analytic Procedure
CAL Ready to use. 1. Using distilled water zero the instrument at 650 nm.
2. Pipette into a cuvette:
Calibration curve: Prepare dilutions of the Calibrator using
NaCl 9 g/L as diluent. Multiply the concentration of the
Calibrator by the corresponding factor indicated in the table Diluent: R1 0.8 mL
below to obtain the ferritin concentration of each point of the
curve. Sample/ Calibrator/ Water (Blank) 100 µL

Dilution 1 2 3 4 5
Latex: R2 0.2 mL
Ferritin-CAL (µL) -- 25 50 75 100
NaCl 9 g/L (µL) 100 75 50 25 -- 3. Mix well and record the absorbance inmediatelly (A1) and
Factor 0.0 0.25 0.5 0.75 1.0 after 8 minutes (A2) of the reagent R2 addition.

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Calculation - Precision:
Mean (µg/L) CV (%)
Calculate the absorbance difference (A2-A1) of each point of
the calibration curve and plot the values obtained against Intra-assay 65 3.56
the ferritin concentration of each calibrator dilution. Ferritin N = 10 178 1.87
concentration in the sample is calculated by interpolation of Inter-assay 65 5.16
its (A2-A1) in the calibration curve. N = 10 178 2.9

QUALITY CONTROLS - Accuracy: Results obtained with this reagents did not show
systematic differences when compared with commercial
reagents of similar characteristics. Studies of comparison are
Control sera are recommended to monitor the available on request.
performance of manual and automated assay procedures.
It is recommended to use Plasma Protein Control N-I (ref: - Interferences: Bilirubin (20 mg/dL), hemoglobin (10 g/L) and
3915010) and N-II (ref: 3915015). rheumatoid factors (600 IU/mL), do not interfere. Lipemia
Each laboratory should establish its own Quality Control interferes. Other substances may interfere8.
scheme and corrective actions if controls do not meet the
acceptable tolerances.
NOTES

1. Calibrator dilutions in plastic tubes should be avoided. Ferritin

REFERENCE VALUES3,7
antigen may coat to the walls of plastic tubes.
Children: 7 – 140 µg/L
2. This method may be used with different instruments. Any
Men: 20 – 250 µg/L
application to an instrument should be validated to demonstrate that
Women: 20 – 200 µg/L
results meets the performance characteristics of the method. It is
Each laboratory should establish its own reference range.
recommended to validate periodically the instrument. Contact to the
distributor for any question on the application method.

CLINICAL SIGNIFICANCE3-7 3. The linearity limit depends on the sample/reagent ratio, as well as
the analyzer used. It will be higher by decreasing the sample
Ferritin is the major iron storage compound in the body and volume, although the sensitivity of the test will be proportionally
is considered one of the most reliable indicators of iron decreased.
status of patients.
A clinical evaluation of serum ferritin is an index of iron 4. Heterophilic antibodies in human serum can react with reagent
stores. antibodies, interfering with in vitro immunoassays. Patients routinely
Whereas low serum concentrations of ferritin are always exposed to animals or to animal serum products can be prone to this
indicative of an iron deficiency, elevated concentrations can interference and anomalous values may be observed. Additional
occur for variety of reasons. Thus, although elevated information may be required for diagnosis.
concentrations often indicate an excessive iron intake, they
are also caused by liver disease, chronic inflammation and 5. Clinical diagnosis should not be made on findings of a single test
malignancies. Pregnant women, blood donors, hemodialysis result, but should integrate both clinical and laboratory data.
patients, adolescents and children are groups particularly at
risk. Plasma ferritin is also increased in patients with 6. For automatic instruments, avoid the presence of bubbles in
hemosiderosis or hemochromatosis. the reagents that may interfere with the assay results.

ANALYTICAL PERFORMANCE BIBLIOGRAPHY

- Linearity limit: Up to 300 µg/L, under the described 1. Newman DJ, Henneberry H, Price CP. Ann Clin Biochem 29: 122-42
assay conditions. Samples with higher concentrations (1992).
should be diluted 1/5 en ClNa 9 g/L and retested again. 2. Bernard A, Lauwerys R. J Immunol Methods. 71:141-147 (1984).
3. Wiedermann, Jonetz-Mentzel. Eur J Clin Chem Clin Biochem 31: 453
- Detection limit: Values less than 3.0 µg/L give non- - 457 (1993).
reproducible results. 4. Worwood M. Blood Rewiews. 4 : 259 - 269 (1990).
5. Lipschitz D, Cook JD, Finch CA. The New England J of Med 290:
- Analytical sensitivity: 2.07 mA / µg/L 1213-1216 (1974).
6. Mazza J, Barr RM, McDonald JWD. Can Med Assoc J 119: 884-886
- Prozone effect: Up to 4000 µg/L (1978).
7. Tietz Textbook of Clinical Chemistry, 3rd Ed. Burtis CA, Ashwood ER.
WB Saunders Co., (1999).
8. Young DS. Effects of drugs on clinical laboratory tests. 3th ed. AACC
Press (1997).
T3140-3/1308
R1.ing

QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS, S.L.U. Joaquim Costa 18 2ª planta. 08390 Montgat (Barcelona) SPAIN
ISO 9001 ISO 13485 Telf. (+34) 934 694 990; E-mail: info@linear.es ; website: www.linear.es NIF-VAT:B60485687