This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20800AMZ10019000** Revised: January 2017 (7th edition)* Revised: April 2008 (6th edition)

This package insert must be read carefully prior to use.
Urea nitrogen assay kit(Classification No.: 42849002)

decreases. The urea nitrogen content isdetermined by measuring the change ofabsorbance.

Pureauto S UN

UreaseUrea ────▶ 2NH3+CO2General 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 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.

GLDH
NH3 + α-Ketoglutaric acid + NADPH ────▶
Glutamic acid + H2O + NADP
2. Features
1) The influence of endogenous ammonia iseliminated.
2) Analytical results are hardly affected byhemolysis or bilirubin, because the rate
method is used.
3) Liquid reagents, ready-to-use.
4) Applicable to various automated analyzers.
＊ ＊Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum, plasma, or urine (1:21 dilution) 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:
2–10C: for tests within 1 week
≤ -20C: for tests after more than 1 week
Bring samples to room temperature (15–30C) before use.
Urine samples should be tested on the sameday.
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), ascorbicacid (up to 50 mg/dL), or ammonia (up to 4mg/dL).
3. Others
1) Always use Anaserum UN standard solution,
Seronorm Human, or Seronorm Multicalibrator
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
UN Coenzyme Solution 1:
Nicotinamide adenine dinucleotide
phosphate (reduced form)
α-Ketoglutaric acid
Carbonate buffer
UN Enzyme Solution 2:
Urease (sword bean origin)
Glutamate dehydrogenase (yeast origin)
N,N-bis (2-hydroxyethyl)
Glycine buffer
Intended Use
Measurement of urea nitrogen in serum, plasma
or urine
Urea is the final product of protein metabolism. It isreleased into the blood from the liver and theneliminated from the body via the kidneys.
In patients with nephropathy, the blood urea nitrogenlevel increases because of impaired excretion.
Abnormal values are seen in patients with heartdisease, liver disorder, dehydration, or hemorrhage(especially gastrointestinal hemorrhage), as well as
those with nephropathy.

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): UN Coenzyme Solution 1 is ready touse.
Reagent (2): UN Enzyme Solution 2 is ready to use.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. Assay procedure is indicatedbelow.

Assay Principle
1. Assay Principle
Urea is degraded by urease to produce ammonia.
When glutamate dehydrogenase (GLDH) acts onammonia and α-ketoglutaric acid, glutamic acid isproduced. At the same time, NADPH is converted
to NADP, and the absorbance at 340 nm1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
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CSample Reagent (1)+────▶
7 μL
280 μL
5 min
37C
Reagent (2)Measurement────▶
※70 μL
120–300 s (Absorbance )Calculation of────▶
concentration※

Absorbance: The difference in absorbance
between 405 nm and 340 nm
Calibration material: Anaserum UN standard
solution, Seronorm Human, or Seronorm
Multicalibrator (Manufacture's assigned value)
Reagent blank: Purified water or saline

Assessment of Assay Results ＊＊1. Reference standard range
In blood: 8–20 mg/dL2)
In urine: 6.5–13.0 g/day3)
2. There may be reactions or interfering reactions with
non-target substances. If assay results appear to beunreliable, repeat the measurement (if necessary,after dilution) or try another analytical methods.
Performance ＊＊1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.05
2) Sensitivity: The change of absorbance is0.020–0.045/min per 30 mg/dL of urea
nitrogen.
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-housemethods.)
4. Measurement Range4): (On Hitachi 7070
automated analyzer)
0.5–200 mg/dL
5. Correlation4)
1) Serum N=100 r=0.999 y=1.00x–0.23
Control method: Approved in vitro diagnostic(urease-GLDH method)
2) Plasma N=100 r=0.999 y=1.03x –0.19
Control method: Approved in vitro diagnostic(urease-GLDH method)3) Urine (1:21 dilution)
N=50 r=0.999 y=1.01x –9.09
Control method: Approved in vitro diagnostic(urease-GLDH method)
6. Standard Material
SRM912 (NIST)＊

Storage and Shelf Life ＊＊1. Storage temperature: 2–10C
2. Shelf life: 1year from the date of manufacture(The expiration date is printed on the outerpackage.)
PackagingNamePackageUN(1)
Coenzyme
2 × 400 mL
Pureauto S
Solution 1UNUN Enzyme(2)
4 × 100 mL
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. Tokyo: Kodansha; 1972. Japanese.
2) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. Tokyo;Kanehara Shuppan; 2015. Japanese.
3) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. Tokyo:
Kanehara Shuppan; 2015. Japanese.
4) SEKISUI MEDICAL CO., LTD. In house data.
Japanese.

＊Precautions for Use or Handling ＊1. Precautions for Handling (to Ensure Safety)
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. 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.

Contact ＊SEKISUI MEDICAL CO., LTD.
international@sekisui.com＊＊＊

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