This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218075**Revised: January 2017 (8th edition)*Revised: April 2008 (7th edition)

This package insert must be read carefully prior to use.
Iron assay kit(Classification No.: 30379000)

Surfactant
Fe3 +Fe2+Acidity
Fe2+ + Ferrozine
Complex (red-purple color)

Clinimate FE

2. Features
1) Analytical results are hardly affected byinterferingsubstances,becausetheself-sampling blank method is employed.
2) Instruments are not damaged because strong
acids are not used.

General Precautions
1. This product is for in vitro diagnostic use, andmust not be used for any other purposes.
2. Clinicians should make a comprehensive clinicaldecision based on assay results in conjunction withclinical symptoms and other examination results.
3. This product should be used only as directed in thispackage insert. Reliability of results cannot be
guaranteed if there are any deviations from theinstructions in this package insert.
4. If the reagent accidentally comes in contact witheyes and/or mouth, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
5. Carefully read the operating instructions for eachtype of automated analyzers prior to using thisproduct. Parameters for each type of analyzers areavailable, and can be requested from SEKISUIMEDICAL CO., LTD. if required.
6. Perform a quality control test prior to assay toensure accuracy.

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum may be used.
2) Storage of samples2)
If the isolated serum sample cannot be testedon the same day, specimens should be stored
as follows:
2–10C: for tests within 1 week≤ -20C: for tests after more than 1 week
Bring samples to room temperature (15–30C) before use.
2. Interfering substances
1) Assay results are not affected by bilirubin (upto 20 mg/dL).
2) Measurement of hemolyzed blood samples
results in artifactual reduction of the serumiron level. Perform re-measurement by anothertest method if the results obtained areextremely low compared with those of otherrelated variables.
3. Others
1) Always use Anaserum FE/UIBC Standard
Solution for calibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

Description (Kit Components) ＊＊Component: Ingredients
FE Coloring Solution 1:
L-Ascorbic acidSurfactant
FE Coloring Solution 2:
Ferrozine sodium
Intended Use
Measurement of iron in serum
It has been reported that the serum iron level isinfluenced by iron intake, absorption of iron from thedigestive tract, red cell hemoglobin production in thebone marrow, and erythrocyte destruction among
other factors. It has also been reported to beinfluenced by damage to liver cells. Measurement ofserum iron plays an important role in the diagnosis of
diseases associated with abnormalities of such factors,
especially iron-deficiency anemia, hemolytic diseases,
hemorrhage, and liver disorders.

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): FE Coloring Solution 1 is ready touse.
Reagent (2): FE Coloring Solution 2 is ready touse.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Assay Principle
1. Assay Principle
Iron is bound to transferrin in the sample. It isseparated by the action of a surfactant under acidconditions, and is reduced from trivalent tobivalent by a reducing agent.
Bivalent iron binds to ferrozine to form a
red-purple complex. The iron content isdetermined by measuring the absorbance of thisred-purple color complex.

37CSample + Reagent (1)20 μL
300 μL
3 min
Reagent (2) 37C50 μL

4.5 min

Measurement(Absorbance I※)
Measurement(Absorbance II※)
Calculation ofConcentration1

※

autoclaved at 121 ºC for 20 minutes.
2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such as
sodium hypochlorite solution at a concentrationof greater than 0.1 %.
3) The reagents and treated samples should bediscarded as medical waste or industrial waste
according to the waste disposal regulations.
4) The reagents should be disposed of inaccordance with the Water Pollution Control act
or related regulations.
4. Other precautions
Do not use the containers for other purposes.

Absorbance I and II: The difference in absorbance
between 700 nm and 570 nm.
Calibration material: Anaserum FE/UIBC
Standard Solution (manufacture's assigned value)
Reagent blank: Purified water or saline

Assessment of Assay Results ＊＊1. Reference standard range3)
40–188 μg/dL
2. There may be reactions or interfering reactions
with non-target substances. If assay results appear
to be unreliable, repeat the measurement (ifnecessary, after dilution) or try another analyticalmethods.

Storage and Shelf LifePerformance1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.03
2) Sensitivity: The absorbance is 0.22–0.32 per1000 μg/dL of iron.
2. Accuracy: 90–110 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 5 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range4): (On Hitachi 7170S
automated analyzer)
6–1800 μg /dL
5. Correlation4)
Serum N=60
r=0.968
y=1.06x+1.44
Control method: Approved in vitro diagnostic(chemical assay)
6. Standard Material
SRM937（NIST）

Storagetemperature

NameClinimate
FE＊＊FE
Coloring
Solution 1
FEColoring
Solution 2

2–10°C
Roomtemperature

Shelf life
1 year fromthe date ofmanufacture
1 year fromthe date ofmanufacture

Packaging
Name
Clinimate
FE

Package
FE Coloring
Solution 1
FE Coloring
Solution 2(1)(2)

4 × 100 mL
4 × 50 mL＊＊References ＊1) Kitamura M. (author and editor): Clinical
Chemical Analysis V, 91, Tokyo Kagaku Dojin,
1967.
2) Sasaki M. et al.: Sampling of constituents of thehuman body, 147, Kodansha, 1972.
3) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 594,Kanehara Shuppan, 2015.
4) In house data, SEKISUI MEDICAL CO., LTD.

＊＊Precautions for Use or Handling ＊1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled
as a material possibly infected with HIV, HBV,HCV, or other viruses. To prevent infection, use
disposable gloves and avoid mouth pipetting
during the test.
2) FE Coloring Solution 1 and FE ColoringSolution 2 are acidic (pH 2.9–3.1). If thesesolutions are accidentally ingested or come into
contact with the eyes or skin, immediately
implemet first-aid measures such as rinsing thearea with water and seek medical treatment ifnecessary.
2. Precautions for use
1) This product should be stored as directed,
without freezing. Freezing can deteriorate thereagents, which can produce inaccurate results.
Therefore, avoid using the reagents which havebeen previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.
4) Do not perform the assay under direct sunlight
3. Precautions for Disposal1) Before disposal, used samples and theircontainers must be immersed in sodium
hypochlorite solution at a concentration ofgreater than 0.1 % for longer than 1 hour orContact ＊SEKISUI MEDICAL CO., LTD.
international@sekisui.com＊＊＊Manufacturer
SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2