This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20800AMZ00125000** Revised: January 2017 (11th edition)* Revised: April 2008 (10th edition)

This package insert must be read carefully prior to use.
Apolipoprotein C-III assay kit(Classification No.: 44391000)

Apolipoprotein C-III in samples+ Anti-human apolipoprotein C-III goatpolyclonal antibody
───▶Turbidity caused by an antigen-antibody
reaction
2. Features
1) The γ-globulin fraction of anti-humanapolipoprotein C-III goat serum is used for theproduct having high specificity.
2) Due to the self-sample blank method,measurement can be performed rapidly andaccurately.
3) Sample dilution is not required.
4) Reagent preparation is not required.

Apo C-III Auto・N ”DAIICHI”
General Precautions
1. This product is for in vitro diagnostic use, and mustnot 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 if required.
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.

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma may be used.
2) Storage of samples1)
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 2 weeks
Bring samples to room temperature (15–30°C)
before use.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 40 mg/dL), conjugated bilirubin(up to 40 mg/dL), hemoglobin (up to 1000mg/dL), or Intralipos (up to 5%).
2) This reagent has been devised so that
hyperlipidemia
samples,
especiallychylomicron-abundant samples, can also bemeasured accurately. However, if the analyticalresult is extremely higher or lower than thoseof
otherlipidparameters,
perform
remeasurement by other methods.
3. Others1) Calibration material
Use Apo Auto ・ N “DAIICHI” Calibrator(manufactured by SEKISUI MEDICAL CO.,LTD.) as the standard solution for one-pointcalibration and Apo Auto ・ N Highcalib CE(manufactured by SEKISUI MEDICAL CO.,LTD.) as the standard solution for multi-pointcalibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

Description (Kit Components) ＊＊Component: Ingredients
Buffer
: 2-Amino-2-hydroxymethyl-1,3-propanediol buffer
Macrogol
Antibody Solution: Anti-human apolipoprotein CIII goat polyclonal antibody
Intended Use
Measurement of apolipoprotein C-III in serum or
plasmaLipoprotein is composed of lipid and protein, and theprotein part is called apolipoprotein. Apolipoprotein
is closely related to the pharmacokinetics oflipoprotein.
Apolipoprotein C-III is widely distributed in very low
density lipoprotein (VLDL) and high density
lipoprotein (HDL). It is known to exhibit an inhibitory
effect on lipoprotein lipase (LPL) noted on the surfaceof vascular endothelial cells.
Assay Principle
1. Assay Principle
Apolipoprotein C-III in samples causes anantigen-antibody reaction with anti-humanapolipoprotein C-III goat polyclonal antibody,resulting in the occurrence of turbidity. The
amount of apolipoprotein C-III is determined bymeasuring the degree of turbidity.

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

13) Sodium azide is added as an antiseptic agent in
the Antibody Solution. Therefore, if the reagent
comes in accidentally contact with eyes, mouthor skin, rinse immediately with ample water as
first aid, and consult the doctor if required.
4) ProClin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in theBuffer. Therefore, if the reagent comes in contact
with skin or clothes, rinse immediately with
ample water, and consult the doctor if skinirritation develops.
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 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 assodium 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 is added as an antiseptic agent in theAntibody Solution. It can react with lead orcopper pipes to produce the highly explosive
metal azide. Therefore, the reagent should beflushed with large amounts of water when
disposing.
4. Other precautions
Do not use the containers for other purposes.

37CMeasurement
Sample Reagent (1)+────▶
(Absorbance I※)
8 L300 L
5 min
37CMeasurement
Reagent (2) ────▶
5 min(Absorbance II※)
100 L
Calculation ofconcentration

────▶
※

Absorbance I and II: The difference in absorbance
between 800 nm and 340 nm.
Calibration material: Apo Auto ・ N “DAIICHI”
Calibrator or Apo Auto ・ N Highcalib CE(Manufacture's assigned value).
Reagent blank: Purified water or saline

Assessment of Assay Results
1. Reference standard range4)
5.5–9.5 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.
Performance
1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.20
2) Sensitivity: The change of absorbance is 0.20–0.55 per 7.5 mg/dL of apolipoprotein C-III.
2. Accuracy: 80–120% of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 5%(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range6): (On Hitachi 7150
automated analyzer)
0.1–22 mg/dL
5. Correlation6)
1) Serum N=50 r=0.976 y=0.95x+0.58
Control method: Single immunodiffusion
method2) Plasma N=50 r=0.986 y=1.07x-0.77
Control method: Single immunodiffusion
method
6. Standard Material
Purified apolipoprotein C-III (in-housereference standard)＊

Storage and Shelf Life ＊＊1. Storage temperature: 2–10C
2. Shelf life: 13 months from the date of manufacture(The expiration date is printed on the outer package.)＊Precautions for Use or Handling ＊1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled asa material possibly infected with HIV, HBV,HCV, or other viruses. To prevent infection, use
disposable gloves and avoid mouth pipetting
during the test.
2) Apo Auto ・ N “DAIICHI” Calibrator and Apo
Auto ・ N Highcalib CE contain human-derived
components that have been shown to be negativefor HBs antigens, HIV antibodies (AIDS virus
antibodies), and HCV antibodies. However,these reagents (as well as the samples) should beconsidered potentially infectious and handledwith great care.

Packaging ＊＊Name
Apo C-III Auto・
N ”DAIICHI”

Package(1)

Buffer

1×45 mL(2)

AntibodySolution

1×15 mL

References ＊1) Sakai Y. et al.: Anal. Biochem, 137, 1, 1984.
Itakura H: Fundamental and Clinical Medicine ofApoprotein, 82, Daiichi Chemical, 1985.

23) Akanuma Y et al.: J Jpn Atheroscl, 12, 1283, 1984.
4) Sakurabayashi I. et al.: Clinica Chimica Acta, 312,87, 2001.
5) Nakamura H: Japan Medical Journal, 3775, 23,
1996.
6) 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, Japan

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