This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197219005** Revised: January 2017 (4th edition)* Revised: August 2011 (3rd edition)

This package insert must be read carefully prior to use.
Alanine aminotransferase assay kit(Classification No.: 38556000)

its absorbance at 340 nm decreases.
ALT activity is determined by measuring thevelocity of the decrease in NADH.
ALTL-alanine + α-Ketoglutaric acidPyruvic acid + Glutamic acidQUALIGENT ALT-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.

LDPyruvic acid + NADH
Lactic acid +NAD
2. Features
Final concentration of the principal ingredientmatches with the final concentration stipulated
in the JSCC Recommendation for Enzyme
Activities.
Procedural Precautions
1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma, EDTAplasma, citrated plasma and NaF-EDTAplasma) may be used.
2) Storage of samples
If the isolated serum or plasma sample cannot
be tested on the same day, specimens should
be stored as follows7):
2–10C: for tests within 2 weeks≤ -20C: for tests after more than 2 weeks
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), formazinturbidity (up to 2500 FTU), or ascorbic acid (upto 50 mg/dL).
3. Others
1) Always use Enzyme Calibrator Plus “Daiichi”
for calibration.
2) Precautions for assay range
If the activity of sample exceeds assay range,
dilute the sample with saline and repeat themeasurement.

Description (Kit Components) ＊＊Component: Ingredients
ALT-L Enzyme Solution 1:
Lactate dehydrogenase
Nicotinamide adenine
dinucleotide (reduced form)
L-alanine
ALT-L Substrate Solution 2:
L-alanineα-Ketoglutaric acid
2-Amino-2-hydroxymethyl-1,3-propanediol buffer
Intended Use
Measurement of alanine aminotransferase (ALT)
in serum or plasma

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): ALT-L Enzyme Solution 1 is readyto use.
Reagent (2): ALT-L Substrate Solution 2 isready to use.
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.

ALT is an enzyme (aminotransferase) that catalyzes
the transfer of an amino group between amino acids
and α-keto acids. It is widely distributed in themyocardium, liver, and brain.
Blood ALT activity is markedly elevated in hepaticand biliary tract diseases, particularly acute hepatitis.
It is also elevated in myocardial infarction.
Assay Principle
1. Assay Principle
ALT catalyzes a reaction producing pyruvic acidand glutamic acid from L-alanine andα-ketoglutaric acid. The resulting pyruvic acidis converted to lactic acid and NAD by lactate
dehydrogenase (LD) in the presence of NADH.
The reaction also converts NADH to NAD, andSample Reagent (1)+ 100 L
5.5 L37C5 min37C

Measurement
Reagent (2)※50 L
74–299 sec (Absorbance )Calculation ofactivity

1※

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 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 in
the ALT-L Substrate Solution 2. It can react withlead or copper pipes to produce the highly
explosive metal azide. Therefore, the reagent
should be flushed with large amounts of water
when disposing.
4. Other precautions
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge before
use.

Absorbance: The difference in absorbance
between 546 nm and 340 nm
Calibration material: Enzyme Calibrator Plus
“Daiichi” (Manufacture’s assigned value)
Reagent blank: Purified water or saline

Assessment of Assay Results ＊＊1. Reference standard range8)
Male:
10–42 U/LFemale: 7–24 U/L ( 45 years)
9–32 U/L (> 45 years)
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: change in absorbance being
equal to or lower than 0.012/min
2) Sensitivity: Absorbance variation is 0.017–0.024/min per 100 U/L of ALT activity.
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. Analysis range9): (On Hitachi 9000 series
automated analyzer)
3–1500 U/L
5. Correlation 9)
1) Serum N=50 r=0.999 y=0.97x –0.04
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for Enzyme
Activities.
2) Plasma N=60 r=0.999 y=0.98x +0.54
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for Enzyme
Activities.
6. Standard Material
Enzyme Calibrator Plus, the calibration material
used for this product, is in line with the JapaneseStandard for Certified Enzyme ReferenceMaterials

Storage and Shelf Life ＊＊1. Storage temperature: 2–10C
2. Shelf life: 9 months from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging

＊＊

Name

Precautions for Use and 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) Sodium azide is added as an antiseptic agent in
the ALT-L Substrate Solution 2. Therefore, if
the reagent comes in accidentally contact witheyes, mouth or skin, rinse immediately with
ample water as first aid, and consult the doctor
if required.
2. Precautions for use
1) This product should be stored as directed,
without freezing. Freezing can deteriorate thereagents, which can produce inaccurate results.

QUALIGENT
ALT-LPackage
ALT-L Enzyme
Solution 1
Set115.0 mL(Cassette for
ALT-L
Hitachi 9000
Substrateseries)
Solution 2
1  7.5 mL
ALT-L Enzyme
L set
Solution 1
1  40 mL(Set for
ALT-L
Hitachi
Substrate
LABOSPECT
Solution 2series)
1  20 mL×2×2

Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊＊1) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 18, 250, 1989.
2) Japan Society of Clinical Chemistry: Jpn J Clin

2Chem, 18, 255, 1989.
3) Kotani K. et al.: J Clin Lab Inst Reag, 16, 153,1993.
4) Kotani K. et al.: J Jpn Soc Gastroenterol, 91, 154,1994.
5) Osawa S.: Med Tech, 20, 1022, 1992.
6) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 25, 135, 1996.
7) Sasaki M. et al.: Sampling of constituents of thehuman body, 211, Kodansha, 1972.
8) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 579,
Kanehara Shuppan, 2015.
9) 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, Japan3