This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218039**Revised: January 2017 (9th edition)*Revised: April 2008 (8th edition)

This package insert must be read carefully prior to use.
Complement component C3 assay kit(Classification No.: 30241001)

2) Assay results are not affected by normal
turbidity, bilirubin, or hemoglobin.
3) Reagent preparation is not required.
4) Applicable to various automated analyzers.

Immunotesta C3＊＊Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum may be used.
2) Storage of samples2)
If the isolated serum sample cannot be testedon the same day, specimens should be stored
as follows:
Bring samples to room temperature (15–30C) before use.
For assay over a longer period:  -20°C
2. Interfering substances
Assay results are not affected by bilirubin (up to40 mg/dL) or hemoglobin (up to 1000 mg/dL).
3. Others
1) Always use GAM complement calibrator
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. 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.
4. If the reagent accidentally comes in contact witheyes and/or mouth, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
5. 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.
6. Perform a quality control test prior to assay toensure accuracy.

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

Description (Kit Components) ＊＊Component: Ingredients
Buffer Solution 1 : Phosphate Buffer Solution
Antiserum 2:
Anti-human complement protein
C3 goat antiserum
Intended Use
Measurement of complement protein C3 in serum

37 C
Sample + Reagent (1)2.5 μL200 μL
5 min
Reagent (2) 37 CComplement components are a group of proteins
involved in defense against infections, immune
responses, and inflammatory responses.
There are two pathways for activation of complement.
Complement protein C3 acts at the junction of the twopathways, and it plays a central role in thecomplement system. It is a reliable indicator of
immune responses, inflammation, etc.

50 μL

5 min

Measurement(Absorbance I※)
Measurement(Absorbance II※)
Calculation ofconcentration※

Absorbance I and II : Absorbance at 600 nm
Calibration material: GAM complement calibrator(manufacture's assigned value)
Reagent blank: Purified water or saline

Assay Principle
1. Assay Principle
Complement protein C3 in samples undergoes anantigen-antibody reaction with anti-human
complement protein C3 goat antiserum (C3antiserum), resulting in turbidity. The C3 contentof the sample is determined by measuring theturbidity. This method is a two-point assay inwhich the values of the self-sampling blank aresubtracted.
C3+C3 antiserum

Assessment of Assay Results
1. Reference standard range3)
76–139 mg/dL
2. 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.

Antigen-antibody precipitate

2. Features
1) Sample dilution is not necessary.

Performance
1. Sensitivity11) Reagent blank: absorbance being equal to or
lower than 0.10
2) The absorbance is 0.17–0.50 per 200 mg/dL ofcomplement protein C3.
2. Accuracy: 90–110 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation: ≤ 5 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range4):(On Hitachi 7170S automated analyzer)
2.0–450 mg /dL
5. Correlation4)
1) Serum N=60
r=0.975
y=1.27x+3.6
Control method: SRID method
6. Standard MaterialIRMM（CRM470）

4. Other precautions
Do not use the containers for other purposes.
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
NamePackage
2 × 40 mL
Immunotesta Buffer Solution 1C3Antiserum 2
2 × 10 mL
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) Sodium azide is added as an antiseptic agent in
the Buffer Solution 1 and Antiserum 2.
Therefore, if the reagent comes in accidentallycontact with eyes, mouth or skin, rinse
immediately with ample water as first aid, andconsult the doctor if required.
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) 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 sodiumhypochlorite solution at a concentration ofgreater than 0.1% for longer than 1 hour or
autoclaved at 121 ºC 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) Sodium azide has been added as an antiseptic
agent in the Buffer Solution 1 and Antiserum 2.
It can react with lead or copper pipes toproduce the highly explosive metal azide.
Therefore, the reagent should be flushed withlarge amounts of water during disposal.

＊＊

References ＊1) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 763,
Kanehara Shuppan, 2015.
2) Medical Practice Editorial Board: Laboratory test
guide revised in 2015, Bunkodo, 676, 2015.
3) Murakami C. et al.: Clinical report, 24, 4609,
1990.
4) In house data, SEKISUI MEDICAL CO., LTD.
Contact ＊SEKISUI MEDICAL CO., LTD.
international@sekisui.com＊＊＊

Manufacturer
SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2