This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Certification No. 229ADEZX00007000**Revised: November 2019(6th edition)*Revised: July 2019(5th edition)
This package insert must be read carefully prior to use.

Kit for IL-1a/IL-1b/IL-1RA/IL-2r/IL-6r(Classification No. 30619000)

and rat monoclonal anti-human IL-2R antibody
conjugated to latex beads, forming latex agglutinates.
The degree of agglutination is detected as absorbancechange to determine the sIL-2R level.
2. Features
1) Liquid reagents, ready-to-use.
2) Applicable to various automated analyzers.

Nanopia IL-2R
General Precautions
1. This product is for in vitro diagnostic use, and mustnot 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. 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 on laboratory test results. Please also
read section 2.3 "Cross-reactivity", under "Procedural
Precautions" carefully, as well as section 2"Precautions for Assessment" under "Assessment ofAssay Results".
4. This product should be used only as directed in thispackage insert. Reliability of results cannot beguaranteed if there are any deviations from theinstructions in this package insert.
5. If the reagent accidentally comes in contact with eyes
and/or mouth, rinse immediately with ample water as
first aid, and consult the doctor if required.
6. Carefully read the operating instructions for each typeof automated analyzers prior to using this product.
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 to ensure
accuracy.

Procedural Precautions
1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma and EDTAplasma) may be used.
2) Storage of samples(1) After separation of serum (plasma), samples may
be stored refrigerated (2–10C) for up to 7 days.
If samples cannot be analyzed within 7 days after
separation, store at −20C or lower and analyze
within 2 months. Stored samples should be
brought to room temperature (15–30C) beforeuse.
(2) Frozen samples should be thawed at room
temperature or in a water bath. Mix thoroughly
before analyzing.
(3) Samples may be frozen and thawed up to twice.
2. Interfering Substances
1) Assay results are not affected by free bilirubin (upto 20 mg/dL), conjugated bilirubin (up to 20 mg/dL),
hemoglobin (up to 500 mg/dL), formazin turbidity(up to 1500 FTU), or rheumatoid factors (up to 500
IU/mL).
2) Specimens from antibody drug-treated patients may
not show accurate sIL-2R values.
3) Cross-reactivity
Assay results are not affected by each of thefollowing substances (up to 1 µg/mL).
Substance
IL-1α, IL-1β, IL-2, IL-4, IL-6, IL-8, IFN-γ,TNFα, and IL-2Rβ
3. Other
1) Calibration Material
Use Nanopia IL-2R Calibrator N (manufactured bySEKISUI MEDICAL CO., LTD.) for calibrationand perform a multi-point calibration.
2) Precautions for assay range
If the concentration of sample exceeds assay range,
dilute the sample with saline and repeat themeasurement.

Description (Kit Components)
Component
Ingredients
IL-2R Buffer Solution 1
IL-2R Latex Reagent 2: Mouse monoclonal anti-human
IL-2R antibody-coated latex
Rat monoclonal anti-human
IL-2R antibody coated latex
Intended Use
Measurement of soluble interleukin-2 receptor (sIL-2R)
concentration in serum or plasma
The interleukin-2 receptor (IL-2R) is a protein expressedon the surface of T cells and B cells activated by antigenic
stimulation. Measuring that part of IL-2R released intoblood (the  chain) is useful in the diagnosis of nonHodgkin’s lymphoma, adult T cell leukemia (ATL), andmonitoring-patients after definitive diagnosis of nonHodgkin’s lymphoma or ATL .1),2),3),4)Dosage/Administration (Assay Procedure)
1. Preparation of reagents
Reagent (1): IL-2R Buffer Solution 1 is ready to use.
Reagent (2): IL-2R Latex Reagent 2 is ready to use.
Mix Reagent 2 by gentle inversion prior to use, being
careful to avoid the formation of bubbles.
2. Assay Procedure
This product is compatible with various types ofautomated analyzers. An example of the assay
procedure is indicated below.

Assay Principle
1. Assay PrinciplesIL-2R in the specimen reacts with mouse monoclonalanti-human IL-2R antibody conjugated to latex beads

1Precautions for Use or Handling
1. Precautions for Handling (to Ensure Safety)
1) All specimens used in the test should be handled asa material possibly infected with HIV, HBV, HCV,or other viruses. To prevent infection, use
disposable gloves and avoid mouth pipetting duringthe test.
2) Proclin
300, which possesses skin-irritative
potential, is added as an antiseptic agent to the IL2R Buffer Solution 1 and IL-2R Latex Reagent 2.
Therefore, if the reagent comes in contact with skinor clothes, rinse immediately with ample water, andconsult the doctor if skin irritation develops.
2. Precautions for Use1) This product should be stored as directed in atightly-stopped container. Avoid freezing. Do not
use this product if it has been frozen because
freezing can cause deterioration of the reagents,
leading to inaccurate results.
2) Do not use expired reagents. Use of such reagentscannot guarantee the reliability of measurement
values.
3) Do not replenish the reagents.
4) Do not mix reagents from different kit lot numbers.
5) Do not perform the assay under direct sunlight.
3. Precautions for Disposal
1) Before disposal, used samples and their containers
must be immersed in sodium hypochlorite solution
at a concentration of greater than 0.1% for longer
than 1 hour or autoclaved at 121ºC for 20 minutes.
2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilled area
thoroughly with disinfectants such as sodium
hypochlorite solution at a concentration of greaterthan 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 in accordancewith the Water Pollution Control act or relatedregulations.
4. Other Precautions
Do not use the containers for other purposes.

37C37CSample
Reagent 1
Reagent 2 ────▶
Measurement+────▶
5.6 L120 L Approx. 40 L Approx.
.
(absorbance I※)
1min
5 min
37C────▶ Measurement
Approx.
(absorbance II※)
.
4 min
────▶

Calculate ofconcentration.

※

Absorbance I and II : The difference in absorbance
between 570 nm and 800 nm.
Calibration material: IL-2R Calibrator N forNanopia (Manufacturer’s assigned value)
Reagent blank : Purified water or saline＊＊＊

Assessment of Assay Results
1. Reference Range
Each institution should determine its own reference
range. However, for informational purpose only, thefollowing external3) and in-house5) ranges areprovided.
1) 122－496U/mL3)
2) 204－587U/mL5)
2. Precautions for Assessment
There may be reactions or interfering reactions with
non-target substances. If assay results appear to beunreliable, repeat the measurement (if necessary, afterdilution) or try another analytical methods.
Performance
1. Sensitivity
The Absorbance difference between saline andCalibrator 3 used as a specimen is 46.4－103.0 mAbs
per 2,000 U/mL of IL-2R.
2. Accuracy
85－115% of the expected assay value.
3. Within-run Reproducibility
Coefficient of variation  15%(Test methods used for items 1 to 3 above are in-housemethods.)
4. Measurement Range5) (On Hitachi 7180 automatedanalyzer)
50－10,000 U/mL
5. Correlation5)
1) SerumN = 254r = 0.978
y = 1.05x + 23.9
Control method 1: Approved in vitro diagnostic(enzyme immunoassay)
N = 259
r = 0.986
y = 0.90x + 55.2
Control method 2: Approved in vitro diagnostic(chemiluminescent enzyme immunoassay)
2) Plasma
Heparin plasma:N = 244r = 0.998
y = 1.00x + 5.5
EDTA plasma:N = 57r = 0.999
y = 0.97x + 4.2
Control method: Comparison with the values forserum specimens obtained simultaneously withplasma specimens.
6. Standard Material
In-house standard material (purified recombinanthuman IL-2R solution)

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 outer package.)
Packaging
NamePackage
IL-2R Buffer Solution 1
2 × 18 mL
Nanopia IL-2R
IL-2R Latex Reagent 22 × 7 mL
Constituent reagents are available in other configurations.
For further details please contact SEKISUI MEDICALCO., LTD.
References
1) Yamamoto J, Harikae H: Diagnosis and Treatment 97(9) 244 (2009).
2) Kato H, Ogura M: Japanese Journal of Cancer andChemotherapy 32 (6) 883 (2005).
3) Medical Practice Editing Committee: Guide for2

Laboratory Tests, 2015 revision 1014 (2015).
4) Japanese Society of Laboratory Medicine Guideline
Preparation Committee: Guidelines for Laboratory
Tests JSLM2015, 414 (2015).
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, Japan3