This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 21600AMZ00478000** Revised: February 2022 (8th edition)* Revised: March 2021 (7th edition)

This package insert must be read carefully prior to use.
Phosphorus/inorganic phosphorus assay kit(Classification No.: 30191002)* 2. Features
Chemical method, Phosphomolybdic acid
reduction assay.

QUALIGENT IP

Procedural Precautions
1. Properties of Samples and Sampling Methods
1) Samples
Serum, plasma (heparin plasma, EDTA
plasma and citrated plasma) and urine may beused.
2) Storage of samples
If the isolated serum or plasma sample cannot
be tested on the same day, specimens should
be stored as follows1):
2–10C: for tests within 1 week≤ -20C: for tests after more than 1 week
Bring samples to room temperature (1530°C) before use.
Urine samples should be tested on the sameday.
If samples cannot be measured on the sameday, store in a refrigerator (4C) or freeze(-20C or lower). Samples have been shown
to be stable for 1 week with refrigeration orfrozen.
2. Interfering substances
1) Assay results are not affected by formazinturbidity (up to 3000 FTU) or ascorbic acid (upto 50 mg/dL).
2) Jaundice samples, hemolyzed samples may
result positive error.
3. Others*1) Always use Serum Multicalibrator (SEKISUI),
Seronorm Multicalibratoror Anaserum IP
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.

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

Dosage/Administration (Assay Procedure)
1. Preparation of reagents
Reagent (1):IP Coloring Solution 1 is ready to use.
Reagent (2):IP Coloring Solution 2 is ready to use.
2. Assay Procedure
This product is compatible with Hitachi
LABOSPECT series automated analyzer. Assayprocedure is indicated below.

Intended Use
Measurement of P (inorganic phosphorus) inserum, plasma or urine
Assay Principle
1. Assay Principle
Inorganic phosphorus binds to molybdate to form
phosphomolybdic acid, which is then reduced by
p-methylaminophenol to form molybdenum blue.
The inorganic phosphorus content is determined bymeasuring the absorbance of the molybdenum blue.

Sample2.0 L

Inorganic phosphorus + Molybdate ────▶
Phosphomolybdic acid
Reduction
Phosphomolybdic acid ─▶Molybdenum blue (blue color)p-Methylaminophenol sulfate

137°C Measurement
Reagent (1)──▶
100 μL(Absorbance I†)
5 min37°C Measurement
Reagent (2)──▶
+33 μL(Absorbance II†)
5 min
Calculate of──▶
concentration+been previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
**3) The product should be tightly stoppered andstored as instructed when not in use.
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 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
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge before.

† 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
Assessment of Assay Results
1. Reference IntervalSerum2):
2.7-4.6 mg/dL (Within the JCCLS commonstandard)
Urine3): 400-800mg/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 equal to or lower than 0.03
2) Sensitivity:
The absorbance is 0.44–0.54 per 20 mg/dL
inorganic 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-house methods.)
4. Measurement Range5) (On a Hitachi 9000 series
automated analyzer): 0.1–40.0 mg/dL
5. Correlation5):
1) Serum N = 70 r = 0.999 y = 0.99x + 0.10
Control method: Approved in vitro diagnostics(Fiske-Subbarow method)
2) Plasma N = 143 r = 0.999 y = 0.99x - 0.03
Control method: Approved in vitro diagnostics(Fiske-Subbarow method)3) Urine N = 60 r = 0.999 y = 1.01x - 0.10
Control method: Approved in vitro diagnostics(Fiske-Subbarow method)
6. Standard Material
SRM200 (NIST)

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

QUALIGENT IPPackage
L set(Set for Hitachi
LABOSPECTseries)

IP Coloring
Solution 1
1 × 46 mL
IP Coloring
Solution 2
1 × 16 mL

2References
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) 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) IP Coloring Solution 1 and IP Coloring Solution
2 contain sulfuric acid. If any reagent is
accidentally ingested or contacted with eyes orskin, immediately wash the area with water andseek medical treatment, if necessary.
2. Precautions for use1) This product should be stored as directed,
without freezing. Freezing can deteriorate thereagents, which can produce inaccurate results.
Therefore, avoid using the reagents which haveContacSEKISUI MEDICAL CO., LTD.
international@sekisui.com

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