This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20600AMZ01063000** Revised: June 2020 (10th edition)* Revised: January 2017 (9th edition)

This package insert must be read carefully prior to use.
Lipoprotein (a) assay kit(Classification No.: 41419000)

Lp (a) in samples+ Anti-human Lp (a) mouse monoclonal
antibody- coated latex──▶ Agglutination by antigen-antibody reaction
2. Features
1) The monoclonal antibody used has a highspecificity.
2) This product is not affected by interferingsubstances.
3) Thanks to the high sensitivity of this assay, lowconcentrations can also be measured accurately.
4) Because sample dilution or preparation ofreagents is not required, measurement can beperformed conveniently and rapidly.

Lp (a) Latex ”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 samples
The isolated serum (plasma) should be testedon the same day.
Samples are stable for 2 weeks at 2–10oC.
Freeze samples if storage for a longer period isrequired.
Refrigerated or frozen samples should bewarmed to room temperature (15–30oC)
before measurement and mixed gently toensure complete homogeneity.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 20 mg/dL), conjugated bilirubin (up to 20mg/dL), hemoglobin (up to 500 mg/dL), or
Intralipos (up to 5%).
3. Others
1) Always use Lp (a) latex standard serum L, M,and H for calibration.
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 Solution
Latex Reagent: Anti-human lipoprotein (a) mousemonoclonal antibody-coated latex
Intended UseMeasurement of lipoprotein (a) in serum or plasma
Lipoprotein (a) is a lipoprotein that contains Apo (a)as its apoprotein. It is extremely similar to low-density
lipoprotein (LDL) in both lipid composition andstructure.
Lipoprotein (a) was discovered by Berg in 1963, butlittle importance was attached to it initially because thephysiological or pathological significance was unclear.
At present, Lipoprotein (a) is attracting attention as alipid that plays a role in the progression ofarteriosclerosis independently of other lipids.
In 1987, McLean et al. found that the primary structureof Apo (a) is partially homologous with the structureof plasminogen. Since then, Apo (a) has been studied
actively as a key connection between lipids and blood
coagulation factors.

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): Buffer Solution is ready to use.
Reagent (2): Latex Reagent is ready to use.
Before using this product, gently invert the Latex
Reagent bottle to mix it thoroughly, and check that
there are no bubbles.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Assay Principle
1. Assay Principle
In a sample, lipoprotein (a) (Lp (a)) reacts with
anti-human Lp (a) mouse monoclonal antibodysensitized latex beads to cause agglutination of thebeads. The Lp (a) concentration is determined bymeasuring the change of turbidity due to thisagglutination reaction.

Sample +5 μL

Reagent 37°C
(1)
─▶
300 μL 5 min

Reagent (2)100 μL

37°C

──▶

Measurement(Absorbance I※)

1 min
37°CCalculation ofMeasurement─▶
─▶
concentration(Absorbance II※)
4 min1※reagents, 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 agentin
the Buffer 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.

Absorbance I and II: Absorbance at 600 nm
Calibration material: Lp (a) latex standard serum L,M, and H (Manufacture's assigned value)
Reagent blank: Purified water or saline

Assessment of Assay Results
1. Reference standard range4)≤ 30.0 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 0.02
2) Sensitivity: The absorbance is 0.04–0.20 per
20.0 mg/dL of Lp (a).
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 7170automated analyzer)
1–100 mg/dL
5. Correlatio4)1)Serum N=50 r=0.992 y=1.08x–4.8
Control method: enzyme immunoassay
2) plasma N=50 r=0.997 y=1.06x+0.20
Control method: enzyme immunoassay
6. Standard Material
Purified lipoprotein (a) (in-house referencestandard)

Storage and Shelf Life ＊1. Storage temperature: 2–10C
2. Shelf life: 2 years from the date of manufacture(The expiration date is printed on the outerpackage.)

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) Lp (a) latex standard serum L, M, and H containcomponents of human origin that have beenshown to be negative for HBs antigens, HIVantibodies (AIDS virus antibodies), and HCV
antibodies. However, these reagents (as well as
the samples) should be considered potentially
infectious and handled with great care.
3) Sodium azide is added as an antiseptic agent in
the Buffer 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 Solution and Latex Reagent. Therefore, if
the reagent comes in contact with skin or clothes,rinse immediately with ample water, and consult
the doctor if skin irritation develops.
2. Precautions for use
1) This product should be stored as directed,
without freezing. Freezing can deteriorate thePackaging ＊＊Name
Lp (a) Latex”DAIICHI”

Package

Buffer Solution

1 × 61mL

Latex Reagent

1 × 20mL

Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References
1) Berg K.: Acta Pathol Microbiol Scand, 59, 369,1963.
2) Eaton D. L. et al.: Proc Natl Acad Sci, USA 84,3224, 1987.
3) Mclean J. W. et al.: Nature, 300, 132, 1987.
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