This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2Ｘ00197225001**Revised: January 2017 (5th edition)*Revised: July 2015 (4th edition)

This package insert must be read carefully prior to use.
Insulin assay kit(Classification No.: 30338000)

measuring the aggregation as the change ofabsorbance.
2. Features
1) Liquid reagents, ready-to-use.
2) Applicable to various automated analyzers.

NORUDIA Insulin
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
with clinical symptoms and other examination
results.
3. For the effects of an administered drug on themeasured value, carefully read the Precautions
for Use in the package insert of the drug,
especially the section about the effects onlaboratory test results.
4. This product should be used only as directed inthis package insert. Reliability of results cannot
be guaranteed if there are any deviations fromthe instructions in this package insert.
5. If the reagent accidentally comes in contact witheyes and/or mouth, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
6. Carefully read the operating instructions for eachtype of automaｔed analyzers prior to using thisproduct. Parameters for each type of analyzers
are available, and can be requested from Sekisui
Medical Co., Ltd.. if required.
7. Perform a quality control test prior to assay toensure accuracy.

Procedural Precautions ＊＊1. Properties of Samples and Sampling Methods
1) SamplesSerum and plasma (heparin plasma, EDTA
plasma and NaF-EDTA plasma) may be used.
2) Storage of samples1)
Centrifuge the sample immediately aftercollection, and perform measurement
promptly. If the sample cannot be measured
promptly, it may be stored for up to 24 hours
under refrigeration (2–10oC) or for
approximately 2 weeks in a freezer (-30oC orlower).
Assay results are not affected if
freezing/thawing is performed once or twice.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 20 mg/dL), conjugated bilirubin (up to20 mg/dL), formazin turbidity (up to 2000FTU), or rheumatoid factors (up to 500IU/mL).
2) Do not use hemolyzed samples, or low assayresults may be obtained due to theinsulin-degrading enzyme in erythrocytes.33) Assay results are not affected by gastrin (up to10 μg/mL), glucagon (up to 10 µg/mL),proinsulin (up to 12.2 ng/mL), secretin (up to10 µg/mL), or C-peptide (up to 3.9 µg/mL).
3. Others
1) Always use Insulin Calibrator for calibration.
2) Precautions for assay rangeIf the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.
The sample may be diluted up to 3:1 withphysiological saline.

Description (Kit Components)
Component: Ingredients
Insulin Buffer Solution 1
Insulin Latex Reagent 2:
Anti-humaninsulinmouse
monoclonal antibody-coated latex
Intended Use
Measurement of insulin in serum or plasma

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): Insulin Buffer Solution 1 is readyto use.
Reagent (2): Insulin Latex Solution 2 is ready touse.
Before using this product, gently invert theInsulin Latex Solution 2 bottle to mix it
thoroughly, and check that there are no bubbles.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Insulin is a hormone that is synthesized by β cells in
the islets of Langerhans in the pancreas and secreted
into the blood. It reduces the blood glucose level. The
blood level of insulin (immunoreactive insulin, IRI)
reflects pancreatic secretion of insulin and the insulinsensitivity of target tissues. It is commonly measured
to diagnose diseases associated with abnormal
glucose metabolism (diabetes and hypoglycemia) andto assess the status of these diseases.1),2)
Assay Principle
1. Assay Principle
In samples, an antigen-antibody reaction occurs
between insulin and anti-human insulin mousemonoclonal antibody-coated latex beads, resulting
in aggregation of the beads. The insulin
concentration in the sample is determined by1Sample+15 μL

Insulin Buffer Solution 1 and Insulin Latex
Reagent 2. Therefore, if the reagent comes incontact with skin or clothes, rinse immediatelywith ample water, and consult the doctor if skinirritation develops.
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 mix materials from different kit lotnumbers.
5) 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 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.

37C
Reagent
Reagent
3 C
(2)
(1)
150 μL Approx. 5 min 50 μL Approx. 40 sec

37CMeasurement
Calculation ofMeasurement※
Approx.
4 (Absorbance II※) concentration(Absorbance I )min 20 sec※

Absorbance I and II: The difference in absorbance
between 570 nm and 800 nm
Calibrationmaterial:
Insulin
Calibrator(manufacture's assigned value)
Reagent blank: Insulin Calibrator 1

Assessment of Assay Results
1. Reference standard range4)
Preprandial: 5 – 10 μU/mL
2. Precautions for Assessment
1) If there is anti-insulin antibody in the sample,
assay results may not reflect the actual blood
insulin level. In this case, comprehensive
clinical evaluation should be based on both theassay results and consideration of otherlaboratory data.
2) If the reagent reacts with non-target substancesin the sample, assay results may be affected. If
assay results appear unreliable, repeat themeasurement (if necessary, after dilution) or
try another analytical method.
Performance
1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.048
2) Sensitivity: The difference of absorbance
between insulin (10 µU/mL) and the reagent
blank is 0.014–0.050.
2. Accuracy: 85–115 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 10 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range5): (On Hitachi 7180
automated analyzer)
1–150 μU/mL
5. Correlation5)
1) Serum
N=85
r=0.989y=0.93x+0.81
Control method: Reported in vitro diagnostic(latex immuno-turbidimetric assay)
2) Plasma N=101
r=0.989y=0.93x+0.63
Control method: Comparison with the values forwhole blood samples obtained simultaneouslywith the serum samples.
6. Standard Material
1st WHO reference standard 66/304（NIBSC）＊＊

Storage and Shelf Life ＊1. Storage temperature: 2–10 C
2. Shelf life: 2 years from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging

NORUDIA
Insulin

Name
Insulin Buffer
Solution 1
Insulin Latex
Reagent 2Package
2 × 15 mL
2 × 5 mLReferences
1) Karasawa M. et al.: J Clin Lab Inst Reag, 29(5),479, 2006.
2) Wada K. et al. (author and editor): Laboratory test
guide 2013–2014, 470–471, Bunkodo, 2013.
3) Dohi K. et al.: J Clin Lab Inst Reag, 12(4), 843,1989.
4) Kanai M. (author and editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 737,Kanehara Shuppan, 2015.
5) 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) Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in the2Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan3