This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval** Revised: January 2017 (8th edition)* Revised: April 2008 (7th edition)

No. 20300AMZ00140000

This package insert must be read carefully prior to use.
Class II General and Biochemical Test Series(Classification No.: 80022002)
β-Lipoprotein assay kit(Classification No.: 44378000)

Procedural Precautions
1. Properties of Samples and Sampling Methods
1) Samples
Serum may be used.
2) Storage of samples2)
The isolated serum should be tested on thesame day.
2. Interfering substances
1) Assay results are not affected by bilirubin (upto 20 mg/dL) or ascorbic acid (up to 50mg/dL).
2) Hemolysis of blood samples result in
artifactual elevation of the β-lipoprotein level.
Perform re-measurement by another test
method if the results obtained are extremely
high compared with those of other related
variables.
3. Others
1) Use serum of known concentration as thecalibration material.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

Clinimate -LGeneral 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: -L Reactant 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.

Description (Kit Components) ＊＊Component: Ingredients
-L Reactant Solution: Heparin sodium (derivedfrom porcine intestinal mucosa)
Magnesium chloride

37°C
Measurement
SampleReagent+────▶
8 L350 L(Absorbance※)
7.5 minCalculation of────▶
concentration

Intended Use
Measurement of β-lipoprotein in serum
Lipo-protein in samples is classified as α-lipoprotein,β-lipoprotein, preβ-lipoprotein, chylomicron, etc.
Measurement of these lipoproteins has been reportedto be useful for the evaluation of lipid metabolism
disorder and hyperlipidemia.

※Assay Principle
1. Assay Principle
β-lipoprotein in samples forms an insoluble
complex together with heparin in the presence ofMg2+, resulting in the occurrence of turbidity.
The amount of β-lipoprotein is determined bymeasuring the degree of turbidity.
Mg2+β-lipoprotein in sample + Heparin──▶Turbidity

Assessment of Assay Results
1. Reference standard range
220–650 mg/dL
2. 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.

Absorbance: The difference in absorbance between
700 nm and 600 nm
Calibrationmaterial:
Serumofknown
concentration
Reagent blank: Purified water or saline

Performance
1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.012) Sensitivity: The absorbance is 0.19–0.30 per600 mg/dL of β-lipoprotein.
2. Accuracy: 90–110% of the expected assay value

2. Features
1) Single liquid method without any need forreagent preparation.
2) This reagent is characterized by high sensitivity
and good reproducibility.

13.

Within-run Reproducibility:Coefficient of variation≤ 3%(Test methods used for 1.–3. are in-house methods.)
4. Measurement Range3): (On Hitachi 7170S
automated analyzer)
10–1200 mg/dL
5. Correlation3)
Serum N=65 r=0.993 y=0.95x-4.01
Control method: Approved in vitro diagnostic(turbidimetric method)
6. Standard Material
Serum with known value (In-house referencestandard)＊

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

Clinimate -LNamePackage

-L Reactant Solution

4×100 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 pipettingduring the test.
2) Sodium azide is added as an antiseptic agent inthe -L Reactant Solution. Therefore, if thereagent comes in accidentally contact with eyes,mouth or skin, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
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 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 is added as an antiseptic agent inthe -L Reactant Solution. It can react with leador copper 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.

References ＊1) Kanai I and Kanai M. (author and editor): Kanai’s
manual of clinical laboratory medicine. 32nd ed.
548, Kanehara Shuppan, 2005.
2) Oda A et al.: Jpn J Clin Pathol (extra edition) 21,82, 1975
3) 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

Storage and Shelf Life ＊＊2