Ferritin iFlash

Immunoassay Analyzer
Anti-Ferritin acridinium-ester-labeled
REF C86008 2×50 Tests R2
conjugate; 4.0 mL/pack; 0.05% ProClin 300.

Calibrator 1, 1 bottle, 1.0 mL, Tris buffer with

INTENDED USE CAL1
protein stabilizers, 0.05% ProClin 300.
The iFlash-Ferritin assay is a paramagnetic particle
chemiluminescent immunoassay (CLIA) for the Calibrator 2, 1 bottle, 1.0 mL, Ferritin in Tris
CAL2 buffer with protein stabilizers, 0.05% ProClin
quantitative determination of Ferritin specific antigen in
300.
human serum and plasma using the iFlash Immunoassay
Analyzer. Calibrator 3, 1 bottle, 1.0 mL, Ferritin in Tris
CAL3 buffer with protein stabilizers, 0.05% ProClin
SUMMARY AND EXPLANATION 300.
Ferritin is an iron storage protein (MW approx. 450,000)
that can incorporate different amount of iron in the form of MATERIALS REQUIRED (BUT NOT PROVIDED)
iron-(III)-hydroxide/phosphate (max.4500 iron ions/
REF C89999/C89959/C89949, iFlash Pre-Trigger
molecule). The iron represents approximately 25% of the
Solution: hydrogen peroxide solution.
total molecular weight.
REF C89998/ C89958/ C89948, iFlash Trigger Solution:
Clinically, a threshold value of 20 µg/L (or ng/mL) has
sodium hydroxide solution.
been proved useful in the detection of pre-latent iron
deficiency. Latent iron deficiency is defined as a fall below REF C89997, iFlash Wash Buffer: phosphate buffered
the 12 µg/L (ng/mL) Ferritin threshold. If the depressed saline solution with 0.05% ProClin 300.
Ferritin level is accompanied by hypochromic, microcytal REF C80001, iFlash Wash Buffer (10×): phosphate
anemia, then iron deficiency is present. buffered saline solution with 0.05% ProClin 300.
Numerous studies in the literature demonstrate the REF C89996, reaction vessels.
usefulness and necessity of serum Ferritin measurements Controls: Commercial controls could be used.
in combination with other parameters in determining the
rate and degree of body iron overload in thalassemia, WARNINGS AND PRECAUTIONS
sideroblastic anemia and the response of patients treated IVD For in vitro diagnostic use
with iron chelating agents.  No known test method can offer the complete
assurance that products derived from human sources
ASSAY PRINCIPLE
will not transmit infection. Therefore, all humanized
The iFlash-Ferritin assay is a sandwich immunoassay.
materials should be considered potentially infectious.
 Incubation: Ferritin in the sample, anti-Ferritin coated
 Exercise the normal precautions required for handling
paramagnetic microparticles and anti-Ferritin
all laboratory reagents.
acridinium-ester-labeled conjugate react to form a
 Disposal of all waste material should be in accordance
sandwich complex.
with local guidelines.
 Wash: The unbound materials are washed away from
 Wear gloves when handling specimens or reagents.
the solid phase in a magnetic field.
 Clean and disinfect all spills of specimens or reagents
 Trigger of signal: The Pre-Trigger and Trigger
using a suitable disinfectant.
Solutions are added to the reaction mixture. The
resulting chemiluminescent reaction is measured as  iFlash Trigger solution contains sodium hydroxide
relative light units (RLUs). (NaOH) and should be avoided contact with eyes.
 A direct relationship exists between the amount of REAGENT HANDLING
Ferritin in the sample and the RLUs detected by the
 The reagents may not be used after the stated
iFlash optical system.
expiration date.
 Results are determined via a calibration curve, which
 Avoid the formation of foam with all reagents.
is instrument-specifically generated by 3-point
calibration and a master curve provided via the  The reagents in the pack and calibrators are ready for
reagent QR code. use. Close the bottles of calibrator right after
calibration and store at 2–8°C.
REAGENTS  Do not pool reagents within a reagent kit or between
Reagent kit, 100 tests, 2 packs, 50 tests/pack reagent kits.
Anti-Ferritin coated microparticles, 3.5  Prior to loading the iFlash-Ferritin reagent pack on the
R1
mL/pack, 0.05% ProClin 300. system for the first time, resuspend the microparticles
by inverting the reagent pack 30 times slightly.
 For further information on reagent handling

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Ferritin iFlash
Immunoassay Analyzer
precautions during system operation, refer to the  Carry out calibration, if necessary.
iFlash system operating instruction.  Place the calibrators CAL1, CAL2 and CAL3 in the
calibrator rack in the sample zone. Only keep
STORAGE AND STABILITY
calibrators open during calibration.
Storage:  Test application.
 Store at 2–8°C in an upright position.  Load samples (Use 20 μL of sample for each
 The kit may be used immediately after removal from determination in addition to the sample container and
2-8°C storage. system dead volumes).
 Click RUN, the iFlash System performs all the
Stability:
functions automatically and calculates the results.
 Unopened at 2–8°C: up to the stated expiration date.
 Opened at 2–8°C: 28 days. CALIBRATION

 Store on-board: 28 days.  Traceability: This assay has been standardized

nd
against the Human Ferritin 2 IS (80/578).
SPECIMEN COLLECTION AND PREPARATION  Every iFlash-Ferritin reagent kit has a QR code label
 Serum or plasma (lithium heparin, sodium heparin containing the specific information for calibration of the
potassium EDTA, and sodium citrate) are the particular reagent lot.
recommended samples. Other anticoagulants have  To perform an iFlash-Ferritin calibration, test CAL1.
not been validated for use with the iFlash-Ferritin CAL2 and CAL3 in duplicate, and the predefined
assay. master curve is adapted to the analyzer.
 Ensure that serum specimens to form complete clot  Once an iFlash-Ferritin calibration is accepted and
prior to centrifugation. stored, all subsequent samples may be tested without
 Centrifuge the specimens. further calibration unless:
 Store specimens at room temperature (20 to 25°C) for  After 28 days when using the same reagent lot.
no longer than 8 hours.  A reagent kit with a new lot number is used.
 If the testing will not be completed within 8 hours,  Controls are out of range.
refrigerate the samples at 2 to 8°C.
 Required by pertinent regulations.
 If the testing will not be completed within 3 days, or for
shipment of samples, freeze at -20°C or colder. MEASURING RANGE
 Frozen specimens must be mixed thoroughly after  0.5 –2,000 ng/mL
thawing.
QUALITY CONTROL
 The samples may be frozen for maximum 3 times.
Quality control materials should be run as single
 Centrifuged specimens with a lipid layer on the top, determinations at least once every 24 hours when the test
should be transferred only the clarified specimen is in use, once per reagent kit and after every calibration.
without the lipemic material. Include commercially available quality control materials
 Ensure that residual fibrin and cellular matter have that cover at least two levels of analyte. Follow
been removed prior to analysis. manufacturer’s instructions for reconstitution and storage.
 Use with caution in handling patient specimens to Each laboratory should establish mean values and
prevent cross-contamination. acceptable ranges to assure proper performance. Quality
 Do not use heat-inactivated samples. control results that do not fall within acceptable ranges
may indicate invalid test results.
 Ensure that the patient samples, calibrators and
controls are at ambient temperature (20–25°C) before RESULT
measurement. The iFlash system automatically calculates the analyte
 Due to the possible evaporation, specimens and concentration of each sample. The results are given in
calibrators on the analyzers should be measured ng/mL.
within 2 hours.
REFERENCE RANGE
ASSAY PROCEDURE A study of iFlash-Ferritin assay on samples from 360
 Refer to the system operating instruction or the online apparently healthy people of various age groups yielded
help system for detailed information on preparing the the following result:
system. Male: 30 ng/mL - 400 ng/mL
 The test-specific parameters stored in barcode on the
Female: 13 ng/mL - 150 ng/mL
reagent pack are read in. In case the barcode cannot
It is recommended that each laboratory establish its own
be read, enter the sequence numbers.
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Ferritin iFlash
Immunoassay Analyzer
expected reference range for the specific population. 1 5.99 0.43 7.18

LIMITATIONS 2 103.86 4.44 4.27

 The iFlash-Ferritin assay is limited to the determination
of Ferritin in human serum or plasma (lithium heparin, The between run precision was determined by testing
sodium heparin, potassium EDTA, and sodium citrate). each sample in duplicate, two separate runs daily for 20
It has not been validated for use with other types of days, and calculating percent coefficient of variation
plasma. (%CV). The results of the study are shown below:
 The use of serum separator (gel) blood collection Sample Mean (ng/mL) SD %CV
tubes has been validated for use with this assay.
1 6.15 0.41 6.62
However, it is not possible to survey all manufacturers
or tube types. 2 99.53 3.79 3.80
 The upper limit of the measuring range of this assay is
2,000 ng/mL. Over-range samples may be diluted with
Analytical sensitivity
negative human serum and re-tested to obtain an
The detection limit representing the lowest measurable
estimate of the actual concentration.
analyte level is 0.5 ng/mL, which can be distinguished
 If the results are inconsistent with clinical evidence,
from zero. It is calculated as the value lying two standard
additional testing is suggested to confirm the result.
deviations above that of the lowest standard of the master
 For diagnostic purposes, the results should be curve (standard 1 + 2 SD, n = 20).
interpreted in light of the total clinical presentation of
the patient, including symptoms, clinical history results. REFERENCES
 Specimens from heparinized patients may be partially 1. Jacobs, A. 1985. Ferritin: An Interim Review. In
coagulated and erroneous results could occur due to Current Topics in Hematology, No. 5: 25-62. Alan R.
the presence of fibrin. Liss, Inc.
 The results from an alternative assays (i.e. EIA or RIA) 2. Crighton, R.R. 1974. Ferritin: Structure, Synthesis
may not be equivalent and cannot be used and Function. New England Journal of Medicine,
interchangeably. 284(25): 1413-1422.
 Samples containing an apparent Ferritin level as high 3. Alfrey, C.P., et. al. 1967. Characteristics of Ferritin
as 3,000,000 ng/mL did not exhibit a hook effect in the isolated from human marrow, spleen, liver and
iFlash-Ferritin assay. reticulocytes. Journal of Laboratory and Clinical
 The assay is unaffected by icterus (bilirubin < 65 Medicine, 70: 419-428.
mg/dL), hemolysis (Hb < 500 mg/dL), lipemia 4. Addison, G.M., et. al. 1972. An immunoradiometric
(Intralipid < 900 mg/dL) and total serum protein (< 9 assay for Ferritin in the serum of normal subjects and
g/dL). patients with iron deficiency and iron overload.
 No interference was observed from rheumatoid factors Journal of Clinical Pathology, 25: 326-329.
up to a concentration of 2,000 IU/mL. 5. Krause, M.D., Stolc, V. 1979. Serum Ferritin and bone
 No interference was observed from anti-nuclear marrow iron status. American Journal of Clinical
Pathology, 72(5): 817-820.
antibodies up to a concentration of 500 U/mL.
 No interference was observed from HAMA up to a
concentration of 600 ng/mL. SHENZHEN YHLO BIOTECH CO., LTD.

1st-4th Floor, No.5 Building, Lishan Industrial

PERFORMANCE CHARACTERISTICS
Area, Xinghai Road, Nanshan District,
Below are the representative performance data, and the Shenzhen 518054, P.R. China
results obtained in individual laboratories may differ.

Precision
Wellkang Ltd (www.CE-marking.eu)
The precision of iFlash-Ferritin was determined using
Ferritin reagents and controls. Two controls, consisting Suite B, 29 Harley St., London W1G 9QR, UK
low, and median concentration of Ferritin were assayed.
The within run precision was determined by testing each
sample in replicates of 10 (n = 10), and calculating percent
coefficient of variation (%CV). The results of the study are
shown below:
Sample Mean (ng/mL) SD %CV

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Ferritin iFlash
Immunoassay Analyzer
ANNEX A:
Explanation of abbreviation

Abbreviation Explanation

Product No.

Calibrator

Reagent

Number of tests

Manufactured by

EU Representative

EC Declaration of Conformity

Caution

Instructions for use

In vitro diagnostic medical

device

Lot No.

Date of manufacture

Expiry date

Biohazard Symbol

Pictograms for Caution

Pictograms for Hazardous to the

aquatic environment

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