This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20300AMZ00140000** Revised: February 2021 (13th edition)* Revised: January 2017 (12th edition)

This package insert must be read carefully prior to use.
Class II General and Biochemical Test Series(Classification No.: 80022002)
Calcium assay kit(Classification No.: 30187002)

calcium content is determined by measuring theabsorbance of this complex. (With this method,the influence of magnesium is eliminated byadding 8-hydroxyquinoline-5-sulfonate.)
Calcium + ο-Cresolphthalein complexone
Alkaline────▶ Complex (red-purple color)
2. Features
1) This product specifically reacts with calcium.
2) The influence of magnesium is eliminated.

Clinimate CAGeneral 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 test
results. 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 inthis package 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 samples1)
If the isolated serum sample cannot be testedon the same day, specimens should be stored
as follows:

2–10C: for tests within 1 week
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 bilirubin (upto 20 mg/dL), hemoglobin (up to 500 mg/dL),or ascorbic acid (50 mg/dL).
2) When samples from patients who have dosedwith gadolinium contrast medium aremeasured, false low results may be obtained.2) 3)
3. Others
1) Serum Multicalibrator (SEKISUI), Seronorm
Multicalibrator, Seronorm Human orAnaserum CA 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
Calcium Alkaline Solution 1
Calcium Coloring Solution 2:
ο-Cresolphthalein complexone＊＊

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

Intended Use
Measurement of calcium in serum or urine
Calcium is mostly localized in the bones of the body,
but it also exists in other tissues and the serum. It
plays an important role in bone formation, bloodcoagulation, and neurotransmission.
Therefore, measurement of the blood level of calcium
is considered to be important for the diagnosis ofbone and endocrine diseases.

Sample + Reagent (1)5 μL
200 μL

37°C5 minReagent (2)200 μL

37°C
5 min

Measurement(Absorbance※)
Calculation ofconcentration

Assay Principle
1. Assay Principle
Calcium in the samples binds to ο-cresolphthaleincomplexone to form a red-purple complex. The※

Absorbance: The difference in absorbance
between 660 nm and 600 nm

1

Calibration material: Serum Multicalibrator(SEKISUI), Seronorm Multicalibrator, Seronorm
Human or Anaserum CA Standard Solution(Manufacture's assigned value)
Reagent blank: Purified water or saline

2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.
4) If atmospheric carbon dioxide is absorbed by
the reagent, the sensitivity of the color change
decreases due to a decrease of pH. Use thisproduct promptly after opening, and perform
calibration at regular intervals.
5) 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.
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 Calcium Coloring
Solution 2. It can react with lead or copper pipes
to produce the highly explosive metal azide.
Therefore, the reagent should be flushed withlarge amounts of water during disposal.
4. Other precautions
Do not use the containers for other purposes.

＊＊

Assessment of Assay Results ＊1. Reference standard range4)
In serum: 8.8–10.1 mg/dL (Within the JCCLS
common standard)
In urine: 0.1–0.3 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. Sensitivity
1) Reagent blank: Absorbance 0.10–0.20
2) Sensitivity: The absorbance is 0.29–0.37 per
10 mg/dL of calcium.
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)
0.2–20 mg/dL
5. Correlation5)
1) Serum N=65 r=0.997 y=0.98x + 0.11
Control method: Approved in vitro diagnostic(OCPC method)2) Urine N=51 r=0.997 y=0.96x –0.17
Control method: Approved in vitro product(enzymatic method)
6. Standard Material
SRM915 (NIST)

Storage and Shelf Life ＊Name

Storagetemperature
Room
temperature

Shelf life

Calcium
2 years from
Alkaline
the date ofmanufacture
Clinimate Solution 1
CACalcium
2 years from
2–10C
Coloring
the date ofSolution 2
manufacture(The expiration date is printed on the outer package.)

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) The Calcium Alkaline Solution 1 contains
monoethanolamine. If it is accidentally ingested
or comes into contact with the eyes or skin,
immediately wash with water and seek medicaltreatment, if necessary.
3) Sodium azide is added as an antiseptic agent in
the Calcium Coloring Solution 2. Therefore, if
the reagent comes in accidentally contact witheyes, mouth or skin, rinse immediately with
ample water as first aid, and consult the doctor
if required.
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.

Packaging
Name
Calcium Alkaline(1)
Solution 1
Clinimate CA
Calcium Coloring(2)

Solution 2

Package4 × 100mL
4 × 100mL

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) Hyunseok P. K. et al.: Clin. Chem, 50:4, 2004.
3) GE Healthcare Japan, OMNISCAN2INTRAVENOUS INJECTION SYRINGE 32%(1st ed. ) [Instructions for Use]. 2020 Mar.
Japanese.
4) Kanai M, editor. Kanai’s manual of clinicallaboratory medicine. 35th ed. Tokyo: Kanehara
Shuppan; 2020. Japanese.
5) 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"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.

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