This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20200AMZ00181000**Revised: February 2021 (12th edition)*Revised: January 2017 (11th 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)

measuring the absorbance of the red-purple colorcomplex. (With this method, the influence ofmagnesium is eliminated by adding 8hydroxyquinoline.)
Alkaline
Calcium + ο-Cresolphthalein complexone
Complex (red-purple color)

Autosera CA for PTS
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 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 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.

2. Features
1) This product specifically reacts with calcium.
2) The influence of magnesium is eliminated.
3) CA Reagent 1 is superimposed with synthetic
isoparaffin to stabilize the reagent byprotection from air.
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 (10 mg/dL).
2) Note: When samples from patients who havereceived gadolinium contrast medium aremeasured, false low results may be btained.2) 3)
3. Others
1) Always use Serum Multicalibrator (SEKISUI),Seronorm Multicalibrator, Seronorm Humanor Anaserum 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
CA Reagent 1
CA Reagent 2: ο-Cresolphthalein complexone
Intended Use
Measurement of calcium in serum or urine＊＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): CA Reagent 1 is ready to use.
Reagent (2): CA Reagent 2 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.

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, blood
coagulation, and neurotransmission.
Therefore, measurement of the blood level of calcium
is considered to be important for the diagnosis ofbone and endocrine diseases.
Assay Principle
1. Assay Principle
Calcium in the samples binds to ο-cresolphthaleincomplexone to form a complex with a red-purple
color. The calcium content is determined bySample +5 μL

１Reagent 37C Reagent 37CMeasurement(2)(1)(Absorbance※)
200μL
5 min
200 μL 5 min
Calculation ofconcentration

or heat.
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) When this product is used in some analyzers
equipped with plastic cells, the cells may beaffected. Contact SEKISUI MEDICAL todetermine compatibility.
4) Do not replenish the reagent or transfer it toanother container, because the thickness of thelayer of the superimposed synthetic isoparaffin
will be altered.
5) Do not perform the assay under direct sunlight6) Exercise caution. If the residual amount ofreagent is too small, there is a risk that synthetic
isoparaffin will enter the automated analyzer.
7) Use CA Reagent 1 after it has been let stand forat least 10 minutes.
8) Clean the cells every day after completion ofmeasurement.
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) Dispose of CA Reagent 2 after use together
with the superimposed synthetic isoparaffin as
industrial waste.
4. Other precautions
Do not use the containers for other purposes.

※Absorbance: The difference in absorbancebetween 660 nm and 600 nm.
Calibration material: Serum Multicalibrator(SEKISUI), Seronorm Multicalibrator, Seronorm
Human, or Anaserum CA Standard Solution.
(manufacture's assigned value)
Reagent blank: Purified water or saline＊＊

Assessment of Assay Results ＊1. Reference standard range4)
In serum: 8.8–10.1 mg/dL (Within the JCCLScommon 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 being 0.10–0.20
2) Sensitivity: The absorbance is 0.27–0.33 per10 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=60 r=0.986 y=1.03x–0.31
Control method: Approved in vitro diagnostic(OCPC method)2) Urine N=55
r=0.998
y=0.973x+0.41
Control method: Approved in vitro diagnostic(OCPC method)
6. Standard Material
SRM915（NIST）
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) CA Reagent 1 and CA Reagent 2 containmonoethanolamine and hydrochloric acid,respectively. If these substances are accidentally
ingested or come into contact with the eyes orskin, immediately implement first-aid measures
such as rinsing the area with water and seek
medical treatment if necessary.
3) Synthetic isoparaffin (used to protect CA
Reagent from exposure to air) belongs to theClass III petroleums under Category IV ofinflammable liquids according to the Fire
Service Act. Do not place it near an open flame

Storage and Shelf Life *1. Storage temperature: 2–10 C
2. Shelf life: 2 years from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging *NameAutosera CA for CA Reagent 1PTSCA Reagent 2＊＊Package2 × 50 mL
2 × 50 mLReferences ＊1) Sasaki M. et al. Sampling of constituents of the2human body. Tokyo: Kodansha; 1972. Japanese.
2) Hyunseok P.K. et al.: Clin Chem. 50:4 2004.
3) OMNISCAN INTRAVENOUS INJECTIONSYRINGE 32% (1st ed.) [Instructions for Use]March 2020. 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"Autosera" 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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