This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 21600AMZ00493000** Revised: February 2021 (7th edition)* Revised: January 2017 (6th edition)

This package insert must be read carefully prior to use.
Uric acid assay kit(Classification No.: 30183002)(TOOS) to form a complex with a red-purple
color. The uric acid content is determined bymeasuring the absorbance of this complex.
The influence of ascorbic acid in samples isblocked by ascorbate oxidase.

QUALIGENT UAUricase
Uric acid + 2H2O + O2 ────▶ Allantoin +H2O2 + CO2Peroxidase
H2O2 + TOOS + 4-Aminoantipyrine ────▶
Red-purple color
2. Features
1) Wide assay range.
2) Bilirubin, hemolysis and ascorbic acid haveminimal effects on results.

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 withclinical symptoms and other examination results.
3．For the effects of an administered drug on themeasured value, carefully read the Precautions forUse in the package insert of the drug, especiallythe section about the effects on laboratory testresults. Please also read carefully the “2.
Interfering Substances,” in the “ProceduralPrecautions” section, as well as “2. Precautions forAssessment” in the “Assessment of Assay Results”
section, of this package insert.
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 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 areavailable, and can be requested from SEKISUIMEDICAL 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) Samples
Serum, plasma (heparin plasma, EDTA
plasma, citrated plasma and NaF-EDTAplasma) or urine may be used.
2) Storage of samples
If the isolated serum or plasma sample cannot
be tested on the same day, specimens should
be stored as follows5):
2–10C: for tests within 5 days
≤ -20C: for tests after more than 5 days
Bring samples to room temperature (15–30C)
before use.
Urine samples should be tested on the sameday.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 20 mg/dL), conjugated bilirubin (up to20 mg/dL), hemoglobin (up to 500 mg/dL),ascorbic acid (up to 50 mg/dL), or formazinturbidity (up to 3000 FTU).
2) When samples from patients withhyperglobulinemia are measured, turbidity
may occur and abnormal values may beobtained after addition of the first reagent.
3) When samples from patients receiving uric aciddegrading enzyme preparations for cancer
chemotherapy are measured, the uric acidlevel obtained may be lower than the actuallevel.
3. Others
1) Always use Serum Multicalibrator (SEKISUI),
Seronorm Multicalibrator, Seronorm Human orAnaserum UA-E Standard Solution forcalibration.
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
UA Enzyme Solution 1:
N-ethyl-N-(2-hydroxy-3sulfopropyl)-m-toluidine sodium
UA Enzyme Solution 2:
Uricase4-Aminoantipyrine
Intended Use
Measurement of uric acid in serum, plasma, orurine
Uric acid is a metabolite of purines, andhyperuricemia causes gout. It is also known that theuric acid concentration increases when renal
excretion is impaired.
Assay Principle
1. Assay Principle
Uric acid is oxidized by uricase to producehydrogen peroxide. Hydrogen peroxide causes
oxidative condensation of 4-aminoantipyrine andN-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine

1＊＊Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): UA Enzyme Solution 1 is ready touse.
Reagent (2): UA Enzyme Solution 2is ready touse.
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.

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 theUA Enzyme Solution 1. Therefore, if thereagent comes in contact with skin or clothes,rinse immediately with ample water, and consult
the doctor if skin irritation develops.
3) Sodium azide is added as an antiseptic agent in
the UA Enzyme Solution 2. Therefore, if thereagent comes in accidentally contact with eyes,mouth or skin, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
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 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.
5) Sodium azide has been added as anantisepticagent in the UA Enzyme Solution 2. It
can react with lead or copper pipes to produce
the highly explosive metal azide. Therefore, thereagent should be flushed with large amounts ofwater during disposal.
4. Other precautions
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge before.

37CMeasurement───▶
(Absorbance I※)
5 min
37C Measurement
Reagent (2)───▶
(Absorbance II※)
50 μL
5 min
Calculation of────▶
concentration

Sample + Reagent (1)2.5 μL100 μL※

Absorbance I and II: The difference inabsorbance between 800 nm and 600 nm.
Calibration material: Serum Multicalibrator(SEKISUI), Seronorm Multicalibrator, Seronorm
Human or Anaserum UA-E Standard Solution(Manufacture's assigned value)
Reagent blank: Purified water or saline.
＊＊

Assessment of Assay Results ＊1. Reference standard range
In blood6): male, 3.7–7.8 mg/dL
female, 2.6–5.5 mg/dL
In urine7): 0.4–1.2 g/day
2. Precautions for Assessment
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.
Performance
1. Sensitivity1) Reagent blank: absorbance being equal to or
lower than 0.052) Sensitivity: The absorbance is 0.26–0.39 per 20
mg/dL of uric acid.
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 Range8): (On a Hitachi 9000 series
automated analyzer)
0.2–100 mg/dL
5. Correlation8)
1) Serum N=100 r=0.999 y=0.99x–0.13
Control method: Approved in vitro diagnostic s(enzymatic method)
2) Plasma N=140 r=0.999 y=1.00x –0.04
Control method: Approved in vitro diagnostics(enzymatic method)3) Urine
N=50
r=0.999
y=0.98x –0.13
Control method: Approved in vitro diagnostics(enzymatic method)
6. Standard Material
SRM913 (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 outer package.)2

Packaging ＊NameQUALIGENT
UASet(CassetteforHitachi
9000series)
L set(Set forHitachi
LABOSP
ECTseries)

Package
UA Enzyme
Solution 1
1 × 15.0 mL
UA Enzyme
Solution 2
1 × 7.5 mL
UA Enzyme
Solution 1
1 × 40 mL
UA Enzyme
Solution 2
1 × 20 mL×2×2

Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
＊＊References ＊1) Gochman, N., et al. Clin. Chem, 17, 1154, 1971.
2) Meites, S., et al. Clin. Chem, 19, 675, 1973.
3) Kabasakalian, P., et al.: Clin. Chem, 20, 606, 1974.
4) Sakamoto S. Med Tech, 26, 7, 783. 1998.
Japanese.
5) Sasaki M. et al. Sampling of constituents of thehuman body, Tokyo: Kodansha; 1972. Japanese.
6) Kanai M. (supervising editor). Kanai’s manual ofclinical laboratory medicine. 35th ed. Tokyo:Kanehara Shuppan; 2020. Japanese.
7) Kanai M. (supervising editor). Kanai’s manual ofclinical laboratory medicine. 34th ed. Tokyo:
Kanehara Shuppan; 2015. Japanese.
8) SEKISUI MEDICAL CO., LTD. In house data.
Japanese.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com

Manufacturer ＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan"QUALIGENT" and "Anaserum" are trademarks orregistered trademarks of SEKISUI MEDICAL CO.,LTD. in Japan and/or other countries.
All other brands, product names and service names
are trademarks or registered trademarks of theirrespective companies.

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