This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218100**Revised: February 2021 (6th edition)*Revised: January 2017 (5th edition)

This package insert must be read carefully prior to use.
Total protein assay kit for blood tests(Classification No.: 30181001)

2. Features
The measurement is hardly affected by turbidityof the solution.

QUALIGENT TP＊＊

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma, EDTA
plasma, citrated plasma and NaF-EDTAplasma) may be used.
2) Storage of samples
If the isolated serum or plasma sample cannot
be tested on the same day, specimens should
be stored as follows4):
2–10C: for tests within 1 mouth≤ -20C: for tests after more than 1 month.
Bring samples to room temperature (15–30C) before use.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 20 mg/dL), conjugated bilirubin (up to 20mg/dL), formazin turbidity (up to 3000 FTU), orascorbic acid (up to 50 mg/dL). Hemolyzed
samples result in artifactual elevation of theprotein level.
3. Others
1) Always use Serum Multicalibrator (SEKISUI),
Seronorm Multicalibrator, Seronorm Human orAnaserum ALB・TP 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 be
guaranteed 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.

＊＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent: TP Coloring Solution is ready to use.
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.

＊＊

Description (Kit Components) ＊Component : Ingredients
TP Coloring Solution:
Copper sulfate (II) pentahydrate
Intended Use
Measurement of total protein in serum or plasma

37C
Measurement
Sample Reagent+────▶
(Absorbance※)
2.1 L 180 L10 min────▶ Calculation ofconcentration

Total protein is the general term for all proteins withvarious functions. Changes of the total protein levelreflect change of physiological function and damage
or disease affecting organs/tissues of the body.
※Absorbance: The difference in absorbance between
700 nm and 546 nm
Calibration material: Serum Multicalibrator(SEKISUI), Seronorm Multicalibrator, Seronorm
Human or Anaserum ALB・TP Standard Solution(Manufacture's assigned value)
Reagent blank: Purified water or saline

Assay Principle
1. Assay Principle
Protein in the samples reacts with the Biuret
reagent to form a red-purple complex. The total
protein level is determined by measuring theabsorbance of this red-purple complex.
ProteinBiuret reagent
Complex (red-purple color)＊＊

Assessment of Assay Results ＊1. Reference standard range2)
6.6–8.1 g/dL (Within the JCCLS common standard)1

discarded 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 beforeuse.

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 0.05
2) Sensitivity: The absorbance is 0.21–0.25 per 6
g/dL of albumin.
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 a Hitachi 9000 seriesautomated analyzer)
0.3–12 g/dL
5. Correlation5)
1) Serum N=70 r=0.979 y=0.94x＋0.43
Control method: Approved in vitro diagnostic(Biuret test)
2) Plasma N=150 r=0.999 y=1.02x –0.11
Control method: Approved in vitro diagnostic(Biuret test)
6. Standard Material
SRM927 (NIST)

Storage and Shelf Life ＊1. Storage temperature: room temperature (1–30C)
2. Shelf life: 2 years from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging ＊NamePackage

QUALIGENTTPSet(Cassette forHitachi 9000series)

TPColoring
Solution
1 × 27.0 mL

×2

L set
(Set for HitachiLABOSPECTseries)

TP Coloring
Solution
1 × 46 mL

×2＊＊References ＊1) Gornall, A.G., et al.: J. Chem, 177, 751, 1949.
2) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 35th ed. Tokyo:
Kanehara Shuppan; 2020. Japanese.
3) Akiyoshi M., Shimizu F. (supervising editors):
Clinical laboratory methods and diagnosis course
14, Tokyo: Ishiyaku Shuppan; 1972. 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) The TP Coloring Solution is an alkaline
solution. If it is accidentally ingested or comes
into contact with the eyes or skin, immediately
rinse the area with water and seek 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 havebeen previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not perform the assay under direct sunlight
3. Precautions for Disposal1) 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 be

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

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