This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
** Revised: January 2017 (6th edition)* Revised: June 2016 (5th edition)

In Vitro Diagnostics
Certification No. 220ADAMX00136000

This package insert must be read carefully prior to use.
Cystatin C assay kit（Classification No.: 83002000 )EDTA plasma) may be used.
2) Storage of samples1)
If the isolated serum or plasma sample cannot
be tested on the same day, specimens should
be stored as follows:
2–10oC: for tests within 1 week

NORUDIA CYSTATIN CGeneral 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 beguaranteed 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.

≤ -80C: for tests after more than 1 week
Bring samples to room temperature(15–30oC) before use.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 20 mg/dL), conjugated bilirubin (up to 20mg/dL), hemoglobin (up to 500 mg/dL), formazinturbidity (up to 2000 FTU), or rheumatoid factors(up to 500 IU/mL).
3. Others
1) Always use Cystatin C Calibrator N for
calibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.
＊ ＊Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): Cystatin C Buffer Solution 1 isready to use.
Reagent (2): Cystatin C Latex Reagent 2 is readyto use.
Before using this product, gently invert theCystatin C Latex Reagent 2 bottle to mix it
thoroughly and check that there are no bubbles
2. Assay Procedure
This product is compatible with various types ofautomated analyzers. An example of the assay
procedure is indicated below.

Description (Kit Components)
Component: Ingredients
Cystatin C Buffer Solution 1
Cystatin C Latex Reagent 2:
Anti-human cystatin C mousemonoclonal antibody- coated latex
Intended Use
Measurement of cystatin C in serum or plasma

37°C
Sample Reagent (1)+────▶
2.4 μL120 μL

Cystatin C is a basic low-molecular protein. Cystatin
C has been reported to increase with a decrease ofglomerular filtration rate (GFR) and is correlatedwith aggravation of GFR.1)

5 min

Measurement(Absorbance I※)

Assay Principle
1. Assay Principle
In samples, an antigen-antibody reaction occurs
between cystatin C and anti-human cystatin C
mouse monoclonal antibody-coated latex,
resulting in agglutination and an increase ofturbidity. The concentration of cystatin C insamples is determined by measuring theagglutination as absorbance.
2. Features
1) Liquid reagents, ready-to-use.
2) Applicable to various automated analyzers.
＊37°C────▶
5 min────▶
※

Reagent (2)120 μL
Measurement(Absorbance II※)
Calculate ofconcentration

Absorbance I and II: The difference in absorbance
between 570 nm and 800 nm.
Calibration material: Cystatin C Calibrator N(Manufacture's assigned value)
Reagent blank: Saline

Assessment of Assay Results ＊1. Reference standard range2)
Male: 0.58–0.98 mg/L (mean age: 51.2)
Female: 0.52–0.88 mg/L (mean age: 51.9)
Analytical results were obtained in 501 healthy
donors (338 men and 163 women, mean age:51.4).
2. There may be reactions or interfering reactions＊

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma and1

with non-target substances. If assay resultsappear to be unreliable, repeat the measurement(if necessary, after dilution) or try anotheranalytical methods.

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.

Performance ＊1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.01
2) Sensitivity: The difference in absorbance
between cystatin C (0.5 mg/L) and reagent
blank is 0.015–0.045.
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 Range2): (On Hitachi 7180
automated analyzer)
0.1–10 mg/L
5. Correlation2)
1) Serum N=55 r=0.999 y=0.97x +0.08
Control method: Approved in vitro diagnostic(latex immune agglutination method)
2) Plasma N=58 r=0.998 y=0.93x+0.09
Control method: Approved in vitro diagnostic(latex immune agglutination method)
6. Standard Material
ERM-DA471/IFCC (IRMM)

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 outer package.)
PackagingNamePackage
Cystatin C Buffer
2 × 12 mL
Solution 1
NORUDIACYSTATIN C
Cystatin C Latex
2 × 12 mL
Reagent 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References
1) Grubb A.: Clin Nephrol, 38 Suppl 1, S20-7, 1992.
2) 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 preservative in theCystatin C Buffer Solution 1 and Cystatin C
Latex Reagent 2. Therefore, if the reagent
comes in contact with skin or clothes, rinse
immediately with ample water, and consult thedoctor if skin irritation develops.
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. Calibration
should be performed when changing to new lotof 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 121ºC for 20 minutes.
2）To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such asContact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2