This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218048**Revised: January 2017 (10th edition)*Revised: September 2013 (9th edition)

This package insert must be read carefully prior to use.
Triglyceride assay kit(Classification No.: 30182000)

kinase (GK) in the presence of adenosine
triphosphate (ATP). Then hydrogen peroxide is
produced by glycerol-3-phosphate oxidase (GPO),
after which hydrogen peroxide is decomposed
into water and oxygen by catalase and theseproducts are eliminated.
Second reaction: In the presence of LPL in TG-N
enzyme solution 2, triglycerides in the sample are
rapidly hydrolyzed to glycerol and fatty acids.
The glycerol thus formed is converted toglycerol-3-phosphate by the action of GK in thepresence of ATP, which is then converted tohydrogen peroxide in the presence of GPO.
Hydrogen peroxide causes oxidative condensationof4-aminoantipyrine
andN-ethyl-N-sulfobutyl-m-toluidine (ESBmT) in thepresence of peroxidase (POD) to form a
red-purple color. The triglyceride content isdetermined by measuring the absorbance of thesample. The influence of ascorbic acid is blocked
by ascorbate oxidase.

QUALIGENT TG
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.

First reaction:
GK
Glycerol + ATP Glycerol-3-phosphate + ADP
Glycerol-3-phosphate + O2
Dihydroxyacetone phosphate
CatalaseH2O2
H2O + O2

Description (Kit Components) ＊＊Component: IngredientsTG Enzyme Solution 1:
Glycerol kinase (microbial origin)
Glycerol-3-phosphate oxidase(microbial origin)
Catalase
Adenosine triphosphate disodium
N-ethyl-N-sulfobutyl-m-toluidine
sodiumGood’s buffer
TG Enzyme Solution 2:
4-Aminoantipyrine
Lipoprotein lipase
Peroxidase
Good’s buffer

GPO

H2O2 +Second reaction:
Triglycerides

LPL

Glycerol + ATP

Glycerol + Fatty acids

GK

Glycerol-3-phosphate +ADP

Glycerol-3-phosphate + O2
Dihydroxyacetone phosphate
H2O2 + ESBmTRed-purple color+GPO

H2O2 +

4-Aminoantipyrine

POD

2. Features
1) The measurements of triglycerides and otheranalyte (such as free cholesterol andnon-esterified fatty acids) are hardly affectedby cross contamination.
2) Free glycerol is eliminated by the enzymatic
method.
3) Bilirubin, hemolysis, ascorbic acid and chylehave minimal effects on results.

Intended Use
Measurement of triglyceride in serum or plasma
Triglycerides are formed by esterification between 3
fatty acid molecules and 1 glycerol molecule, and are
the major component of lipids throughout the body.
Measurement of triglycerides is considered to be
useful for elucidating abnormalities of lipid
metabolism. Attention has especially been focused on
the association of triglycerides with arteriosclerosis
and coronary artery disease.

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma andEDTA plasma) may be used.
2) Storage of samples1)
If the isolated serum or plasma sample cannot

Assay Principle
1. Assay Principle
First reaction: Free glycerol in the sample isconverted to glycerol-3-phosphate by glycerol1be tested on the same day, specimens should
be stored as follows:
2–10oC: for tests within 1 weeks≤ -20C: for tests after more than 1 week
Bring samples to room temperature (15–30℃) before use.
3) Measurement of heparinized samples may
yield artificially low values because
decomposition of triglycerides is promoted.5
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), andascorbic acid (50 mg/dL).
3. Others
1) Always use Cholestest N Calibrator forcalibration.
However, use QUALIGENT N Calibrator for
LABOSPECT
008(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.

methods.
Performance
1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.05
2) Sensitivity: The absorbance is 0.09–0.17 per
200 mg/dL of triglycerides.
2. Accuracy: 90–110 % of the expected assay
value
3. Within-run Reproducibility:
Coefficient of variation ≤3 %(The test method used for 1–3 is that of Sekisui
Medical Co., Ltd.)
4. Measurement Range6): (On a Hitachi 9000
series automated analyzer)
3–2000 mg/dL
5. Correlation6)
1)Serum N=70 r=0.999 y=0.98x–2.63
Control method: Approved in vitro diagnostic(enzymatic method)
2) Plasma N=71 r=0.999 y=0.99x –0.46
Control method: Approved in vitro diagnostic(enzymatic method)
6. Standard Material
Reference standard for lipid assay (ReferenceMaterial Institute for Clinical ChemistryStandards)＊ ＊Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): TG Enzyme Solution 1 is ready touse.
Reagent (2): TG Enzyme Solution 2is ready touse.
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.

＊ ＊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) TG enzyme solution 2 contains 0.0005 w/v%
sodium azide to inhibit catalase activity. If thissolution is accidentally ingested or comes into
contact with the eyes or skin, immediately rinse
the area with water and seek medical treatment,if necessary.
4) Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in theTG Enzyme Solution 2. Therefore, if the reagent
comes in contact with skin or clothes, rinse
immediately with ample water, and consult thedoctor if skin irritation 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

Sample Reagent (1) 37C Measurement+───▶
※2 L180 L
5 min (Absorbance I )Reagent (2) 37C Measurement───▶
※60 L
5 min (Absorbance II )───▶

Calculation ofconcentration※

Absorbance I and II: The difference in absorbance
between 700 nm and 600 nm.
Calibration material: Cholestest N Calibrator
Use
QUALIGENTNCalibrator
forLABOSPECT 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: 40–234 mg/dL
Female: 30–117 mg/dL
2. Diagnostic criterion3)
Hypertriglyceridemia: ≥ 150 mg/dL
3. There may be reactions or interfering reactions １with non-target substances. If assay results appearto be unreliable, repeat the measurement (ifnecessary, after dilution) or try another analytical2

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) TG Enzyme Solution 2 contains 0.0005 W/v%
sodium azide to prohibit activity of catalase. It
can react with lead or copper pipes to produce
the highly explosive metal azide. Therefore, thereagent should be flushed with large amounts ofwater during disposal.
4. Other precautions
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge before.

ContactSEKISUI MEDICAL CO., LTD.
international@sekisui.com
nufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan

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 ＊＊Name

Package contents
TG Enzyme Solution
1Set
1 × 27.0 mL(Cassette for×2
Hitachi 9000 TG Enzyme Solution
series)2
1 × 9.0 mL
QUALIGENTTG
TG Enzyme Solution
L set1(Set for1 × 47 mL
Hitachi×2
TG Enzyme Solution
LABOSPECT2series)
1 × 16 mL
References ＊＊1) Sasaki M. et al.: Sampling of constituents of thehuman body, 263, Kodansha, 1972.
2) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 514,
Kanehara Shuppan, 2015.
3) Japan Atherosclerosis Society, ed. 2012 Japan
Atherosclerosis Society (JAS) Guidelines forPrevention of Atherosclerotic Cardiovascular
Diseases, 13.
4) Tamura K. et al.: J Med Pharm Sci, 49, 791, 2003.
5) Shirai K.: Modern Med Lab, 21, 3, 211, 1993.
6) In house data, SEKISUI MEDICAL CO., LTD.

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