This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20300AMZ00140000** Revised: March 2021 (11th edition)* Revised: January 2017 (10th edition)

This package insert must be read carefully prior to use.
Class II General and Biochemical Test Series(Classification No.: 80022002)
Magnesium assay kit(Classification No.: 30190002)

measuring the absorbance of this complex.
Mg2+ + Xylylazo violet I ─▶ Complex (red color)
2. Features
1) Single liquid method without any need forreagent preparation
2) This product specifically react withmagnesium.

Clinimate MGGeneral 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 for
Use 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 and urine may be used.
2) Storage of samples4)
If the isolated serum sample cannot be testedon the same day, specimens should be stored
as follows:

2–10C: for tests within 2 weeks≤ -20C: for tests within 1 mouth
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 bilirubin (up to30 mg/dL), hemoglobin (up to 500 mg/dL), orascorbic acid (100 mg/dL).
3. Others
1) Always use Serum Multicalibrator (SEKISUI),
Seronorm Multicalibrator or Anaserum MG
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.
＊＊Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent: MG Coloring Solution is ready to use.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

＊＊

Description (Kit Components) ＊Component: Ingredients
MG Coloring Solution: Xylylazo violet I
Intended Use ＊＊Measurement of Mg (magnesium) in serum orurine

37C Measurement
Sample Reagent+2 L
240 L 10 min (Absorbance※)

As an electrolyte, magnesium is widely distributed inthe body fluids, and is involved in various important
physiological function such as glycolysis andactivation of urea cycle enzymes.
The magnesium concentration in body fluids such asserum and urine is maintained within a relatively
narrow range. Therefore, measurement of magnesium
is useful for the diagnosis of various diseases.

※Calculation ofconcentration

Absorbance: The difference in absorbance
between 700 nm and 660 nm
Calibration material: Serum Multicalibrator(SEKISUI), Seronorm Multicalibrator or
Anaserum MG Standard Solution (Manufacture'sassigned value)
Reagent blank: Purified water or saline

Assay Principle
1. Assay Principle
Magnesium in samples binds to xylylazo violet I(xylidyl blue) to form a complex with a red color.
The magnesium content is determined by＊＊Assessment of Assay Results ＊1. Reference standard range3)
In blood: 1.8–2.4 mg/dL
In urine: 20.6–164.9 mg/day1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.

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.

Storage and Shelf Life ＊1. Storage temperature: 2–10C
2. Shelf life: 18 months from the date of manufacture(The expiration date is printed on the outerpackage.)

Performance
1. Sensitivity
1) Reagent blank: Absorbance 1.20–1.70
2) Sensitivity: The absorbance is 0.62–0.75 per
5.0 mg/dL of magnesium.
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 Range5): (On Hitachi 7170S
automated analyzer)
0.1–7.0 mg/dL
5. Correlation5)
1) Serum N=77 r=0.987 y=1.03x–0.21
Control method: Approved in vitro product(xylidyl blue method)2) Urine N=60 r=0.999 y=1.01x+0.02
Control method: Approved in vitro product(xylidyl blue method)
6. Standard Material
SRM929 (NIST)

PackagingNamePackage
MG Coloring
Clinimate MG
4 × 100mL
Solution
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
＊＊References ＊1) Monacelli R. et al.: Clin. Chim. Acta 1, 577, 1956.
2) Kitamura M. et al. (editors): Clinical ChemicalAnalysis V. Tokyo: Tokyo Kagaku Dojin； 1967.
Japanese.
3) Kanai M, editor. Kanai’s manual of clinicallaboratory medicine. 35th ed. Tokyo: Kanehara
Shuppan; 2020. Japanese.
4) Sasaki M. et al. Sampling of constituents of thehuman body. Tokyo: Kodansha; 1972. Japanese.
5) SEKISUI MEDICAL CO., LTD. In house data.
Japanese.

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) This product is alkaline. If it is accidentally
ingested or comes into contact with the eyes orskin, immediately wash the area with water andseek medical treatment, if necessary.
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 orautoclaved 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.

ContactSEKISUI MEDICAL CO., LTD.
international@sekisui.com

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

2