This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20300AMZ00140000** Revised: February 2022 (13th edition)* Revised: March 2021 (12th edition)

This package insert must be read carefully prior to use.
Class II Biochemical Test Series (General)(Classification No.: 80022002)
Phosphorus/inorganic phosphorus assay kit(Classification No.: 30191002)

Reduction
Phosphomolybdic acid ─▶ Molybdenum blue(blue color)p-Methylaminophenol sulfate
2. Features
1) Reagent preparation is not required.
*2) Chemical method, Phosphomolybdic acid
reduction assay.

Clinimate IP‐2
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
with clinical 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. Precautionsfor Assessment” in the “Assessment of AssayResults” 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, plasma (heparin plasma, EDTA
plasma, and citrated plasma) and urine may
be used.
2) Storage of samples1) 6)
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 within 2–3 months
Bring samples to room temperature (15–30C)
before use.
Urine samples should be tested on the sameday.
If samples cannot be measured on the same day,store in a refrigerator (4C) or freeze (-20C orlower). Samples have been shown to be stablefor 1 week with refrigeration or frozen.
2. Interfering substances
1) Assay results are not affected by bilirubin (upto 20 mg/dL).
2) Hemolysis of samples may cause positive error
in assay results.
3. Others*1) Always use Serum Multicalibrator (SEKISUI),
Seronorm Multicalibrator, or Anaserum IP
Standard Solution for calibration.
2) Precautions for assay range
If the concentration of sample exceeds assayrange, dilute the sample with saline and repeat
the measurement.

* Description (Kit Components)
Component: Ingredients
IP‐2 Coloring Solution 1
IP‐2 Coloring Solution 2: Ammonium molybdate

Dosage/Administration (Assay Procedure)
1. Preparation of reagents
Reagent (1):
IP‐2 Coloring Solution 1 is ready to use.
Reagent (2):IP‐2 Coloring Solution 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.

Intended Use
Measurement of inorganic phosphorus in serum,plasma or urine
Assay Principle
1. Assay Principle
Inorganic phosphorus binds to molybdate to form
phosphomolybdic acid, which is then reduced byp-methylaminophenol to form molybdenum blue.
The inorganic phosphorus content is determinedby measuring the absorbance of molybdenum
blue.

Sample+5 L

Inorganic phosphorus + Molybdate ───▶
Phosphomolybdic acid1Reagent 37CMeasurement(1)──▶
(Absorbance I†)
3min300 μL
Calculation
Reagent 37CMeasurement
(2)
──▶
of─▶
†
100 μL 4.5 min (Absorbance II )concentration

2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.

† Absorbance I and II :The difference in absorbance between 600 nm
and 700 nm
Calibration material:
Serum Multicalibrator (SEKISUI), Seronorm
Multicalibrator, or Anaserum IP Standard
Solution (Manufacture's assigned value)
Reagent blank: Purified water or saline**4) The product should be tightly stoppered
and stored as instructed when not in use.
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 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.

Assessment of Assay Results
1. Reference IntervalSerum2): 2.7–4.6 mg/dL (Within the JCCLS
common standard)
Urine3): 400-800 mg/day*2. Precautions for Assessment
There may be reactions or interfering reactions
with non-target substances. If assay resultsappear to be unreliable, repeat the measurement(if necessary, after dilution) or try anotheranalytical methods.
Performance
1. Sensitivity
1) Reagent blank:
Absorbance being equal to or lower than 0.03
2) Sensitivity:
The absorbance is 0.44–0.54 per 20 mg/dL ofinorganic phosphorus.
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 Range6) (On Hitachi 7170S
automated analyzer): 0.2–35.0 mg/dL
5. Correlation6):
1) Serum N = 60 r = 0.999 y = 0.99x + 0.11
Control method: Approved in vitro diagnostics(Fiske-Subbarow method)
2) Plasma N = 60 r = 0.999 y = 0.99x - 0.11
Control method: Approved in vitro diagnostics（Enzymatic method）
3) Urine N = 60 r = 0.999 y = 1.01x - 0.08
Control method: Approved in vitro diagnostics(Fiske-Subbarow method)
6. Standard Material:
SRM200 (NIST)

Storage and Shelf LifeName

Storagetemperature

Shelf life

1 year fromIP‐2
the date of
2–10CColoring
manufacture
Clinimate Solution 1
IP‐2
1 year from
IP‐2Roomthe date ofColoring
temperature
manufacture
Solution 2(The expiration date is printed on the outer package.)
Packaging
NamePackage
IP‐2 Coloring(1)
2 × 100 mL
Solution 1
Clinimate
IP-2
IP‐2 Coloring(2)
2 × 50 mL
Solution 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.

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) IP‐2 Coloring Solution 1 and IP‐2 Coloring
Solution 2 contain sulfuric acid. If any reagent
is accidentally ingested or contacted with eyesor skin, immediately wash the area with waterand seek 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.

References
1) Sasaki M. et al. Sampling of constituents of thehuman body. Tokyo: Kodansha; 1972. Japanese.
* 2) Kanai M, editor. Kanai’s manual of clinicallaboratory medicine. 35th ed. Tokyo: Kanehara
Shuppan; 2020. Japanese.
3) Kanai M, editor. Kanai’s manual of clinicallaboratory medicine. 32th ed. Tokyo: Kanehara
Shuppan; 2005. Japanese.
4) Yamamura Y. (supervisor): Medical and ChemicalExperimentations 3B, Clinical Chemistry I,
Tokyo: Nakayama Shoten, 1973. Japanese.
5) SEKISUI MEDICAL CO., LTD. In house data.
Japanese.

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

Manufacturer
SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo 1030027 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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