This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218034**Revised: February 2021 (10th edition)*Revised: January 2017 (9th edition)

This package insert must be read carefully prior to use.

Total protein assay kit for blood tests(Classification No.:30181001)

Biuret reagent
Protein in the sample
Complex(Red-purple color)
2. Features
1) Single liquid method without any need forreagent preparation.
2) The measurement is hardly affected byturbidity of the solution.

Clinimate TP
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 and plasma (heparin plasma, EDTAplasma, citrate plasma and NaF-EDTA plasma)
may be used.
2) Storage of samples3)
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 month≤ -20C: for tests after more than 1 month
Bring samples to room temperature (15–30C)
before use.
2. Interfering substances
Icteric and hemolyzed blood samples cause
negative and positive measurement errors,
respectively. Perform re-measurement by anothertest method if the results obtained are extremely
low or high compared with those of other relatedvariables.
3. Others
1) Always use Serum Multicalibrator (SEKISUI),
Seronorm Multicalibrator, Seronorm Humanor Anaserum ALB/TP Standard Solution forcalibration.
2) Analysis range
If the concentration of sample exceeds assay
range, dilute the sample with saline andrepeat the measurement.

＊＊

Description (Kit Components) ＊Component: Ingredients
TP Coloring Solution:
Copper sulfate (II) pentahydrate＊＊

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

Intended Use
Measurement of total protein in serum or plasma
Total protein is the general term for all proteins withvarious functions. Changes in total protein levels
reflect change of physiological function and damage
or disease affecting organs/tissues of the body.

Sample + Reagent
5 μL
350 μL

Assay Principle
1. Assay Principle
Protein in the samples reacts with the Biuret
reagent to form a red-purple complex. The
amount of total protein is determined bymeasuring the absorbance of this red-purple
complex.

37C
7.5 min

Measurement(Absorbance※)
Calculation ofconcentration※

Absorbance: The difference in absorbance
between 700 nm and 546 nmCalibration material: Serum Multicalibrator(SEKISUI), Seronorm Multicalibrator, Seronorm
Human or Anaserum ALB/TP Standard Solution(Manufacturer’s assigned value)

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Reagent blank: Purified water or saline

2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such as
sodium hypochlorite solution at aconcentration of 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 standard range 2)
6.6–8.1 g/dL (Within the JCCLS commonstandard)
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 0.052) 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 Hitachi 7170S
automated analyzer)
0.1–13.0 g/dL
5. Correlation5)
1) Serum N=60 r=0.972 y=1.08x –0.61
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
2. Shelf life: 2 years from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging
Name
Package
TP Coloring
Clinimate TP
4 × 100 mL
Solution
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
＊＊References ＊1) Kitamura M. et al. Practical Clinical Chemistry.
Tokyo: Ishiyaku Shuppan; 1974. Japanese.
2) Kanai M, editor. Kanai’s manual of clinicallaboratory medicine. 35th ed. Tokyo: Kanehara
Shuppan; 2020. Japanese.
3) Sasaki M. et al. Sampling of constituents of thehuman body. Tokyo: Kodansha; 1972. Japanese.
4) Nakahara M. et al.: Jpn J Med Tech, 45, 1106,
1996. 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 contains sodiumhydroxide. If it is accidentally ingested orcomes into contact with the eyes or skin,
immediately rinse with water and seek medicaltreatment, if necessary.
2. Precautions for use
1) This product should be stored as directed,
avoid freezing. Freezing can cause
deterioration of the reagents, leading toinaccurate results. Therefore, do not use theproduct if it has been previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.
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.

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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