This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218098** Revised: January 2017 (5th edition)* Revised: August 2011 (4th edition)

This package insert must be read carefully prior to use.
Lactate dehydrogenase assay kit(Classification No.: 38504000)

2. Features
Final concentration of the principal ingredientmatches with the final concentration stipulated
in the JSCC Recommendation for EnzymeActivities.

QUALIGENT LDGeneral 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 be
guaranteed 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 (heparin plasma andcitrated plasma) 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 follows4).
Room temperature: for tests within 1 week
Please note that activity of samples may
decrease when refrigerated or frozen.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 20 mg/dL), conjugated bilirubin (up to 20mg/dL), formazin turbidity (up to 3000 FTU), or
ascorbic acid (up to 50 mg/dL).Because LD iscontained in blood cells, hemolyzed samples
show artifactual elevation of the LD level.
3. Others
1) Always use Enzyme Calibrator Plus “Daiichi”
for calibration.
2) Precautions for assay rangeIf the activity of sample exceeds assay range,
dilute the sample with saline and repeat themeasurement.

Description (Kit Components) ＊＊Component: Ingredients
LD Substrate Solution 1:
L-Lithium lactate
Diethanolamine buffer
LD Coenzyme Solution 2:
Nicotinamide adenine
dinucleotide (oxidized form)

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): LD Substrate Solution 1 is ready touse.
Reagent (2): LD Coenzyme Solution 2 is ready touse.
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. An example of the assay procedure isindicated below.

Intended Use
Measurement of lactate dehydrogenase in serumor plasma
Lactate dehydrogenase catalyzes hydrogen transfer
reactions between lactic acid and pyruvic acid. It is
widely distributed in all tissues of the body.
Since the blood level of lactate dehydrogenase isincreased in various diseases of the heart, liver, andkidneys, as well as various solid malignancies,
leukemia, and pernicious anemia, it plays animportant role in the diagnosis and follow-up of thesediseases.

37C
Sample Reagent (1)+────▶
4.0 L100 L
5 min
37C
Measurement
Reagent (2)────▶
50 L(Absorbance ※)41–162 sec
Calculation of────▶
activity

Assay Principle ＊＊1. Assay Principle
In samples, Lactate dehydrogenase (LD)catalyzes conversion of lactic acid to pyruvic
acid in a diethanolamine buffer. The reaction also
converts NAD to NADH, and its absorbance at
340 nm increases. LD activity is determined bymeasuring the velocity of NADH production.
Lactic acid + NADLD※

pyruvic acid + NADH

1

Absorbance: The difference in absorbance
between 405 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 range 5)
124–222 U/L
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.

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.
5) Sodium azide has been added as anantisepticagent in the LD Coenzyme Solution 2.
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
use.

Performance ＊1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.005/min
2) Sensitivity: The change in absorbance is0.029–0.035/min per 200 U/L of LD 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. Measurement Range7): (On a Hitachi 9000 series
automated analyzer)
5–750 U/L
5. Correlation 7)
1) Serum N=70 r=0.999 y=1.00x +1.1
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for Enzyme
Activities.
2) Plasma N=66 r=0.999 y=1.00x +4.6
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for Enzyme
Activities.
6. Standard MaterialEnzyme Calibrator Plus, the calibration material
used for this product, is in line with the JapaneseStandard for Certified Enzyme Reference
Materials.

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 ＊＊NamePackage
LD
Substrate
Set
Solution 1
115.0 mL(Cassette for×2
LD
Hitachi 9000
Coenzymeseries)
Solution 21
 7.5 mLQUALIGENTLDLD
Substrate
L set
Solution 11  40 mL(Set for×2
HitachiLDLABOSPECT Coenzymeseries)
Solution 21  20 mL
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.

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) Sodium azide is added as an antiseptic agent inthe LD Coenzyme Solution 2. Therefore, if thereagent comes in accidentally contact with eyes,mouth or skin, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
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

References ＊＊1) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 19, 228, 1990.
2) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 19, 232, 1990.
3) Osawa S.: Med Tech, 20, 1022, 1992.
4) Sasaki M. et al.: Sampling of constituents of thehuman body, 217, Kodansha, 1972.
5) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 581,
Kanehara Shuppan, 2015.

26) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 25, 135, 1996.
7) 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