This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218076**Revised: January 2017 (7th edition)*Revised: April 2008 (6th edition)

This package insert must be read carefully prior to use.
Unsaturated iron-binding capacity assay kit(Classification No.: 44236000)

Residual iron +(red-purple color)

Pureauto S UIBC

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum may be used.
2) Storage of samples
The isolated serum should be tested on thesame day.
Store samples at -20°C or lower.
Bring samples to room temperature (15–30C)
before use.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 20 mg/dL), conjugated bilirubin (up to20 mg/dL), or ascorbic acid (up to 50 mg/dL).
2) Measurement of hemolyzed blood samples
results in artifactual reduction of the UIBC
level. Perform re-measurement by another test
method if the results obtained are extremely
low compared with those of other related
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
UIBC Buffer Solution 1:
Ammonium ferrous sulfate
2-Amino-2-hydroxymethyl-1,3propanediol buffer solution
UIBC Coloring Solution 2:
Ferrozine sodium
L-Ascorbic acidunsaturatedComplex

2. Features
1) This product shows a high sensitivity andexcellent reproducibility.
2) Liquid reagents, ready-to-use
3) Applicable to various automated analyzers

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.
Perform a quality control test prior to assay toensure accuracy.

Intended Use
Measurement ofcapacity in serum

Ferrozine

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

iron-binding

Unsaturated iron-binding capacity (UIBC) means theamount of iron that can bind to unsaturated(unbound) transferrin. Unlike serum iron, UIBC
decreases in aplastic anemia and increases in irondeficiency anemia.
Assay Principle
1. Assay Principle
When a fixed excess of iron is added to serum,transferrin that is not bound to iron (unsaturatedtransferrin) binds to the added iron and forms
saturated transferrin, while the excess added iron
remains unbound. When ferrozine acts on theresidual iron, a red-purple complex is formed. TheUIBC is determined by measuring the absorbanceof the red-purple dye.

37 CSample + Reagent (1)20 μL
300 μL
5 min

Measurement(Absorbance I※)

Reagent (2) 37 C
75 μL
5 min

Measurement(Absorbance II※)
Calculation ofconcentration※

Absorbance I and II: The difference in absorbance
between 700 nm and 570 nm

Unsaturated transferrin + Iron (a fixed excessamount)
Saturated transferrin + Residual iron1

solutions 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.
5) Sodium azide has been added as an antiseptic
agent in the UIBC Buffer Solution 1. It canreact with lead or copper pipes to produce thehighly explosive metal azide. Therefore, thereagent should be flushed with large amounts ofwater during disposal.
4. Other precautions
Do not use the containers for other purposes.

Calibration material: Anaserum FE/UIBC
Standard Solution (manufacture's assigned value)
Reagent blank: Purified water or saline
Assessment of Assay Results
1. Reference standard range4)
Serum: Males, 172–256 (214  42) μg/dL
Female, 194–268 (231  37) 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.
Performance
1. Sensitivity
1) Reagent blank: absorbance being 0.20–0.30
2) Sensitivity: The absorbance is 0.09–0.15 per
500 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 Range5): (On Hitachi 7170S
automated analyzer)
20–800 μg/dL
5. Correlation5)
Serum N=100r=0.999
y=1.00x–2.8
Control method: Approved in vitro diagnostic(chemical assay)
6. Standard Material
SRM937（NIST）＊＊Storage and Shelf Life
1. Storage temperature: 2–10 C
2. Shelf life: 1 year from the date of manufacture(The expiration date is printed on the outerpackage.)

Packaging
NamePackage
UIBC Buffer(1)
4 × 100 mL
Solution 1
Pureauto S
UIBC
UIBC Coloring(2)
4 × 50mL
Solution 2
Constituent reagents are available in otherconfigurations. For further details please contact
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) Sodium azide is added as an antiseptic agent inthe UIBC Buffer Solution 1. Therefore, if thereagent comes in accidentally contact with eyes,mouth or skin, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
2. Precautions for Use1) 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 Disposal
1) 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 or
autoclaved at 121 ºC for 20 minutes.
2) To prevent infections from spilled samples orReferences ＊1) Horak E. et al.: A.J.C.P., 62, 133, 1974.
2) Ruutu R.: Clin Chim Acta, 61, 229, 1975.
3) Persijin J.P. et al.: Clin Chim Acta, 35, 91, 1971.
4) Karigome S: Jpn J Clin Med (Autumn extraedition) 40, 406, 1982.
5) In house data, SEKISUI MEDICAL CO., LTD.
Contact ＊SEKISUI MEDICAL CO., LTD.
international@sekisui.com＊＊

Manufacturer＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2