This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20300AMZ00140000** Revised: July 2019 (9th edition)* Revised: January 2017 (8th edition)

This package insert must be read carefully prior to use.
Class II General and Biochemical Test Series(Classification No.: 80022002)
Creatinine assay kit(Classification No.: 30161002)

1) This product shows high sensitivity andexcellent reproducibility.
2) Analytical results are hardly affected byinterfering substances, because the rate methodis used.

Clinimate CRE＊ ＊Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and urine may be used.
2) Storage of samples1)
If the isolated serum sample cannot be testedon the same day, specimens should be stored
as follows:
2–10oC: for tests within 1 week
≤ -20C: for tests after more than 1 week
Bring samples to room temperature (15–30oC)
before use.
Urine samples should be tested on the same day.
2. Interfering substances
Assay results are not affected by bilirubin (up to 20
mg/dL), hemoglobin (up to 500 mg/dL), or
ascorbic acid (50 mg/dL).
3. Others
1) Always use Anaserum CRE 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.
3) Due to individual differences in acetone bodies,pyruvic acid and other substances in healthy
human serum, compared to enzymatic methods
this assay yields results that are 0.2 - 0.3 mg/dL
higher.3)

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. 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 if required.
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.
Description (Kit Components) ＊Component: Ingredients
CRE Coloring Solution 1: Sodium hydroxide
Surfactant
CRE Coloring Solution 2: 2,4,6-Trinitrophenol
Intended Use
Measurement of creatinine in serum or urine

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

Creatinine is a degradation product of high-energy
creatine phosphate that is released into the blood fromthe muscles and nerves. Creatinine is filtered by therenal glomeruli and is excreted in the urine, mostly
without reabsorption.
Because the blood level of creatinine is increased inpatients with renal failure, uremia, and heart failure, it
plays an important role as an index of kidney functionin the diagnosis and evaluation of these diseases.
Assay Principle
1. Assay Principle
Creatinine reacts with 2,4,6-trinitrophenol (picricacid) in alkaline solutions to form red creatininepicrate. The creatinine content is determined bymeasuring the absorbance of this red sample.
Alkaline
Creatinine + Picric acid ──▶ Creatinine picrate(red color)

Sample+10 μL※

37C
Reagent (1)────▶
300 μL
5 min
37C Measurement
Reagent (2)
────▶
70 μL
(Absorbance※)
24–96 sec
Calculation of────▶
concentration

Absorbance: The difference in absorbance between
600 nm and 505 nm
Calibration material: Anaserum CRE standard
solution (Manufacture's assigned value)

2. Features1

Reagent blank: Purified water or saline

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.

Assessment of Assay Results
1. Reference standard range2)
Male: 0.8–1.2 mg/dL
Female: 0.6–0.9 mg/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 Life ＊1. Storage temperature: room temperature
2. Shelf life: 2 years from the date of manufacture(The expiration date is printed on the outer package.)

Performance
1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.01/min
2) Sensitivity: The change of absorbance is 0.07–
0.10/min per 10 mg/dL of creatinine.
2. Accuracy: 90–110% of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 3%
(Test methods used for 1. –3. are in-house methods.)
4. Measurement Range4): (On Hitachi 7170S
automated analyzer)
0.1–60.0 mg/dL
5. Correlation4)
1) Serum N=60 r=0.999 y=0.96x＋0.26
Control method: Approved in vitro diagnostic(enzymatic method)2) Urine N=10 r=0.999 y=1.08x＋0.01
Control method: Approved in vitro diagnostic(Jaffe method)
6. Standard Material
SRM914a (NIST)

Packaging
NamePackage
CRE Coloring(1)
4 × 100mL
Solution 1
Clinimate
CRE
CRE Coloring(2)
4 × 100mL
Solution 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊＊1) Sasaki M. et al.: Sampling of constituents of thehuman body, 106, Kodansha, 1972.
2) Kitamura M. (author and editor): Practical Clinical
Chemistry, 253, Ishiyaku Shuppan, 1974.
3) Kanai I and Kanai M. (author and editor): Kanai’s
manual of clinical laboratory medicine. 34nd ed.
475, Kanehara Shuppan, 2015.
4) In house data, SEKISUI MEDICAL CO., LTD.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com

Precautions for Use or Handling ＊1. Precautions for Handling (to Ensure Safety)
All samples 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
during the test.
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 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 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

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