ノルディアGA（英文）2018年11 月1日 午後1時49分

This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.

203654-007
In Vitro Diagnostics
Certification No. 227ADEZX00129000** Revised: (November) 2018 (6th edition)* Revised: (November) 2017 (5th edition)

This package insert must be read carefully prior to use.
Glycated Albumin Kit(Classification code No. 44153000)

Second reaction
FAOD
Glycated amino acids + O2 + H2O
Glucosone + amino acids + H2O2NORUDIA GA

H2O2 + 4-aminoantipyrine + DSBmTPODGeneral Precautions**
1. This product is for in vitro diagnostic use only, 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 with eyes
and/or mouth, rinse immediately with ample water as
first aid, and consult the doctor if required.
5. Carefully read the operating instructions for each typeof automated analyzers prior to using this product.
Parameters for each type of analyzers are available,
and can be requested from SEKISUI MEDICAL CO.,LTD. if required.

2) Measurement of albumin
In the first reaction, reduced albumin is converted tooxidized albumin. In the second reaction,
bromocresol purple (BCP) acts on oxidized albumin
to produce an albumin-BCP conjugate. The albumin
level is determined by measuring the absorbance ofthis conjugate.
Albumin:First reaction
Reduced albumin
Second reaction
Oxidized albumin

Component:
GA Enzyme Solution 1:

IngredientsProtease
4-Aminoantipyrine
GA Enzyme Solution 2: Fructosyl amino acid oxidase
N,N-bis(4-sulfobutyl)-m-toluidine
disodium
ALB Buffer Solution 1:
Succinic acid
ALB Coloring Solution 2: Bromocresol purple
Calibrator 1:
Human serum
Calibrator 2:
Human serum

BCP

Albumin-BCP
conjugate

Correction formula: (GA level/albumin level) × 48.9 +1.9
2. Features
1) Ready-to-use liquid reagents.
2) Can be used with various automated analyzers.

Procedural Precautions* *Intended Use

1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (EDTA plasma, heparin plasmaand sodium fluoride-treated plasma) may be used.
2) Storage of Samples1)• After separation of serum (plasma), specimens
may be stored for up to 7 days in a refrigerator.
• If specimens cannot be measured within 7 days ofserum (plasma) separation, store them frozen(-30 ° C or lower). Avoid repeated freezing andthawing.
Stored specimens should be brought to room
temperature (15-30°C) before use.
3) The same specimen (serum or plasma) should be
used for measurement of both GA and albumin.
2. Interfering Substances
1) Assay results are not affected by free bilirubin (up to12.5 mg/dL), conjugated bilirubin (up to 12.5 mg/dL),
hemoglobin (up to 80 mg/dL), formazin turbidity (upto 3000 FTU), or ascorbic acid (up to 50 mg/dL).
2) Hemolysis leads to slight negative errors.
3) Penicillin G may be administered intravenously athigh doses for treatment of infective endocarditis,
sepsis, purulent meningitis, etc. In the presence ofhigh penicillin levels, albumin assay values may
decrease1 and this will cause the GA value (%) tobecome higher than the actual value.
4) Accurate GA values (%) may not be obtained inpatients with hypoalbuminemia.
5) Specimens from patients receiving amino acidinfusions should be measured with great care. In
particular, specimens should not be measured fromMeasurement of glycated albumin (GA) in serum orplasma
Glycated albumin (GA) is a glycation product of albumin(ALB), which is a protein that circulates in the blood.
Because the blood half-life of ALB is approximately 17days, GA assay results reflect the mean blood glucose
level over a period of 2-4 weeks before blood collection.
Therefore, GA is a useful index of glycemic control forpatients with diabetes.

Assay Principle**
1. Assay Principle
1) Measurement of GA
In the first reaction, glycated amino acids are cut out
from GA by a protease. In the second reaction,
fructosyl amino acid oxidase (FAOD) acts on theglycated amino acids to produce hydrogen peroxide,
which causes condensation of 4-aminoantipyrineand N,N-bis (4-sufobutyl)-m-toluidine disodium(DSBmT) in the presence of peroxidase (POD) toproduce a purple-red pigment. The GA level isdetermined by measuring the absorbance of thispurple-red pigment.

Protease

Oxidized albumin3) Calculation of the GA level (%)
The measured GA level is divided by the albumin
level and then corrected by the following formula toensure consistency with routine assay results(Lucica GA-L, Asahi Kasei Pharma Corporation).

Description (Kit Components)* *GA:
First reaction
GAPurple-red pigment

Glycated amino acids‑1‑3校

品名ノルディアGA（英文）

作業者印

管理者印校正者印コード

営業者印

203654-007
2018.11.01
シグマ紙業㈱ノルディアGA（英文）2018年11 月1日 午後1時49分

ノル

patients receiving infusions containing glucose premixed with amino acids, because false high assay
results may be obtained.2
3. Others1) Calibration materials
Use NORUDIA GA Calibrator as the calibrationmaterial.

unreliable, repeat the measurement (if necessary,after dilution) or try another analytical methods.

Performance* *1. Sensitivity
GA: 0.010-0.030 per 100 μmol/L
Albumin: 0.020-0.045 per 100 μmol/L
2. Accuracy
GA value (%): 95-105% of the expected assay value
3. Within-run Reproducibility
Coefficient of variation of GA value (%): < 3%
(Test methods used for 1.–3. are in-house methods.)
4. Measurement Range (On Hitachi 7180 automatedanalyzer)
6.0-64.1%
5. Correlation
1) SerumN = 110, r = 0.998, y = 1.00x + 0.04
Control method: Approved in vitro diagnostic(enzymatic method)
2) Plasma (sodium fluoride-treated plasma)N = 100, r = 0.997, y = 0.99x - 0.26
Control method: Approved in vitro diagnostic(enzymatic method)
6. Standard Calibration Materials
Certificated Reference Material for Measurement ofGlycated Albumin in Human Serum (JCCRM611)
Certified Reference Material for Measurement ofAlbumin in Human Serum (JCCRM613)

Dosage/Administration (Assay Procedure)** *1. Preparation of reagents
GA Reagent (1): GA Enzyme Solution 1 is ready touse.
GA Reagent (2): GA Enzyme Solution 2 is ready touse.
ALB Reagent (1): ALB Buffer Solution 1 is ready touse.
ALB Reagent (2): ALB Coloring Solution 2 is ready touse.
2. Method of calibrator preparation
1) Add exactly 1 mL of purified water to 1 vial of thisproduct, and mix it by using a wave rotor for
approximately 30 minutes or let it stand at room
temperature for approximately 30 minutes and thenmix gently by inversion.
2) When stored in a refrigerator, each calibrator isstable for 7 days after preparation (freezing isprohibited).
Stored calibrators should be brought to room
temperature (15-30°C) before use.
3) See the Attached Table for GA and albumin
concentrations. The albumin concentration varies
with each lot.
3. Assay Procedure
This product is compatible with various types ofautomated analyzers. An example of the assay
procedure is indicated below.
1) Measurement of GA
Specimen GA Reagent (1) 37°C Measurement+※1
3.2 μL120 μL
5 min. (Absorbance I )Precautions for Use or Handling** *1. Precautions for Handling (to Ensure Safety)
1) All specimens used in the test should be handled asa material possibly infected with HIV, HBV, HCV, orother viruses. To prevent infection, use disposable
gloves and avoid mouth pipetting during the test.
2) Sodium azide is contained in GA Enzyme Solution 1,and ProClin 300 that may cause skin irritation, etc. iscontained as the preservative in GA Enzyme
Solution 1, ALB Buffer Solution 1, and ALB Coloring
Solution 2. If any of these reagents are accidentally
ingested or come into contact with the eyes or skin,
immediately rinse the area with water and seek
medical treatment, if necessary.
3) The calibrators are calibration materials designed
exclusively for use with NORUDIA GA. Do not use
them for other purposes.
4) It may be difficult to dissolve the calibrators in coldwater. Therefore, dissolve calibrators in purified
water at approximately 20°C.
5) The calibrators are prepared from human blood
components that have been confirmed to be
negative for HBs antigens, HCV antibodies, and HIV
antibodies. However, wear gloves, etc., and handle
the calibrators with great care, because there is arisk of infection, as there is with specimens.
2. Precautions for Use1) This product should be kept in a tightly-stopped
container and stored as directed. Avoid freezing. Do
not use this product if it has been left open or if it
has been frozen because freezing can cause
deterioration of the reagents, leading to inaccurate
results.
2) Do not use expired reagents. Use of such reagentscannot guarantee the reliability of measurement
values.
3) Do not replenish the reagents.
4) Do not perform the assay under direct sunlight.
3. Precautions for Disposal
1) B e f o r e d i s p o s a l , u s e d s p e c i m e n s a n d t h e i rcontainers must be immersed in sodium hypochlorite
solution at a concentration of 0.1% or greater for 1hour or longer or autoclaved at 121°C for 20minutes.
2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilled area

GA Reagent (2) 37°C Measurement※1
40 μL
5 min. (Absorbance II )Calculation ofconcentration
2) Measurement of albumin
Specimen ALB Reagent (1) 37°C Measurement+※2
1.6 μL120 μL
5 min. (Absorbance III )ALB Reagent (2) 37°C Measurement※260 μL
5 min. (Absorbance IV )Calculation ofconcentration
3) Calculation of the GA level (%)
The measured GA level is divided by the albumin
level and then corrected by the following formula toensure consistency with routine assay results(Lucica GA-L, Asahi Kasei Pharma Corporation).
Correction formula: (GA level/albumin level)× 48.9 + 1.9※1

Absorbance I and II: The difference in absorbance
between 546 nm and 700 nm.
※2Absorbance III and IV: The difference in absorbance
between 600 nm and 660 nm.
Calibration materials: NORUDIA GA Calibrator(Manufacture's assigned value)

Assessment of Assay Results* *1. Reference standard range
11-16%3)
2. There may be reactions or interfering reactions with
non-target substances. If assay results appear to be‑2‑

ノルディアGA（英文）2018年11 月1日 午後1時49分

thoroughly with disinfectants such as sodium
hypochlorite solution at a concentration of greaterthan 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 in accordancewith the Water Pollution Control act or relatedregulations.
5) Sodium azide has been added as an antiseptic
agent in the GA Enzyme Solution 1. It can react withlead or copper pipes to produce the highly explosive
metal azide. Therefore, the reagent should beflushed with large amounts of water during disposal.
4. Other Precautions
Do not use the containers for other purposes.

Storage and Shelf Life*

1. Storage temperature: 2-10°C
2. Shelf life: 14 months from the date of manufacture(The expiration date is printed on the outer package.)

Packaging** *Name
GA Enzyme Solution 1
GA Enzyme Solution 2
ALB Buffer Solution 1
ALB Coloring Solution 2
NORUDIAGA

L SetCalibrator 1
Calibrator 2

Package contents2 × 40 mL
2 × 13.4 mL
2 × 40 mL
2 × 20 mL
GA R1：45.6mL×1
GA R2：15.2mL×1
ALB R1：45.6mL×1
ALB R2：22.8mL×1
3 × For 1 mL
3 × For 1 mL

References**
1) Ono M. et al.: Clinica Chimica Acta, 407, 75-76, 2009.
2) Kouzuma T. et al.: Clinica Chimica Acta, 346, 135143, 2004.
3) The Japan Diabetes Society: Guidelines for theTreatment of Diabetes Mellitus in Japan 2014-2015,9, Bunkodo, 2014.
4) In house data, SEKISUI MEDICAL CO., LTD.

Contact
International Business Department
SEKISUI MEDICAL CO., LTD.
international@sekisui.com

Manufacturer**
SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, JAPAN‑3‑