This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218041** Revised: January 2017 (8th edition)* Revised: September 2013 (7th edition)

This package insert must be read carefully prior to use.
HDL-cholesterol assay kit(Classification No.: 30169000)

Assay Principle
1. Assay Principle
In this assay system, HDL-cholesterol isselectively solubilized, and rapidly undergoes an
enzymatic reaction due to the use of special
surfactants with different effects on HDL andotherlipoproteins(LDL,VLDLandchylomicron).
Therefore, only HDL-cholesterol is specificallymeasured.
Surfactant
HDL, LDL, VLDL, Chylomicron
HDL is solubilized
Cholesterol esterase
HDL-cholesterol
Δ4-cholestenone + H2O2
Cholesterol oxidase
Peroxidase
H2O2 + ESBmT + 4-Aminoantipyrine
Red-purple color

QUALIGENT HDLGeneral 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.

2. Features
1) This product is used to measure
HDL-cholesterol by the direct method.
2) Because it does not contain Mg salt, there is
no heavy burden imposed on analyzers.
＊ ＊Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma andEDTA plasma) may be used.
2) Storage of samples4)5)
If the isolated serum or plasma sample cannot
be tested on the same day, specimens shouldbe stored as follows:
2–10C: for tests within 1 week
≤ -20C: for tests after more than 1 week
Do not re-freeze.
Bring samples to room temperature (15–30C)
before use.
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), ascorbic
acid (up to 50 mg/dL), formazin turbidity (up to3000 FTU), or Intralipos (up to 5%).
3. Others
1) Always use Cholestest N Calibrator forcalibration.
However, use QUALIGENT N Calibrator for
LABOSPECT008(manufacturedbySEKISUI MEDICAL) as the calibrationmaterial with a Hitachi LABOSPECT 008
Automated Analyzer.
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: IngredientsHDL Enzyme Solution 1:
N,N-bis(4-sulfobutyl)-m-toluidine
disodium (DSBmT)
Cholesterol oxidase (microbialorigin)
Peroxidase
Good’s buffer
HDL Enzyme Solution 2:
4-Aminoantipyrine
Cholesterol esterase
Surfactant
Good’s bufferIntended Use
Measurement of HDL-cholesterol in serum orplasma
Cholesterol that exists in HDL (High Density
Lipoprotein fraction is called HDL-cholesterol. The
Framingham study (1977) and other studies haveshown that a low level of HDL-cholesterol is a risk
factor for ischemic heart disease.1
HDL-cholesterol is decreased in patients withcoronary artery disease, hyperlipidemia, smoking,obesity, diabetes, and hepatic dysfunction, while it isincreased by alcohol intake and by adequate exercise.
The HDL-cholesterol concentration also varies
depending on age, gender, and hereditary factors.

＊ ＊Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents

1Reagent (1): HDL Enzyme Solution 1
is ready to use.
Reagent (2): HDL Enzyme Solution 2
is ready to use.
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.
Sample Reagent (1)+2 L
180 L
Reagent (2)
60 μL

37C
5 min
37C5 min＊ ＊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)Cholestest N Calibrator and QUALIGENT N
Calibrator for LABOSPECT 008 containhuman-derived components that have beenshown to be negative for HBs antigens, HIVantibodies (AIDS virus antibodies), and HCV
antibodies. However, these reagents (as well asthe samples) should be considered potentially
infectious and handled with great care.
3) Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in theHDL Enzyme Solution 1and HDL Enzyme
Solution 2. Therefore, if the reagent comes incontact 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 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 orautoclaved 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.
4. Other precautions
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge before.

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

Absorbance I and II: The difference in absorbance
between 700 nm and 600 nm
Calibration material: Cholestest N Calibrator
Use
QUALIGENTNCalibratorforLABOSPECT 008 (manufactured by SEKISUIMEDICAL) as the calibration material with aHitachi LABOSPECT 008 Automated Analyzer.
Manufacture's assigned value)
Reagent blank: Purified water or saline

Assessment of Assay Results ＊＊1. Reference standard range2)
Male: 38–90 mg/dL
Female: 48–103 mg/dL
2. Diagnostic criterion3)
Low-HDL cholesterolemia: < 40 mg/dL
3.
There may be reactions with non-target
substances in the samples or interfering reactions.
If assay results appear to be unreliable, repeat themeasurement (if necessary, after dilution) or try
another analytical methods.
Performance ＊＊1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.05
2) Sensitivity: 0.07–0.17 per 100 mg/dL ofHDL-cholesterol.
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 Range5): (On a Hitachi 9000 series
automated analyzer)
2–150 mg/dL
5. Correlation5)
1) Serum N=70 r=0.999 y=0.98x+1.01
Control method: Approved in vitro diagnostic(Direct method)
2) Plasma N=60 r=0.999 y=1.03x –0.98
Control method: Approved in vitro diagnostic(Direct method)
6. Standard Material
Certified Reference Material for Measurement ofHDL Cholesterol, LDL Cholesterol andTriglycerides in Human Serum (Reference
Material Institute for Clinical ChemistryStandards)

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.)

2PackagingName

QUALIGENTHDL＊＊＊Package
HDL Enzyme
Solution 1Set
1 × 27.0 mL(Cassette forHitachi 9000
HDL Enzymeseries)
Solution 2
1 × 9.0 mL
HDL Enzyme
Solution 1L set
1 × 48 mL(Set for HitachiLABOSPECTHDL Enzymeseries)
Solution 2
1 × 16 mL×2×2

References ＊＊1) Gordon T. et al.: Am J Med, 62, 707, 1977.
2) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 520,
Kanehara Shuppan, 2015.
3) Japan Atherosclerosis Society, ed. 2012 Japan
Atherosclerosis Society (JAS) Guidelines forPrevention of Atherosclerotic CardiovascularDiseases, 13.
4) Kodajima N. et al.: J Med Pharm Sci, 46, 235,
2001.
5) 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
This product uses a patent related to HDL-C
measuring reagent and method (patent No. 3288033),
and patent application (PCT/JP00/03860).

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