This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No.13A2X00197218068** Revised: January 2017 (7th edition)* Revised: August 2011 (6th edition)

This package insert must be read carefully prior to use.

Lactate dehydrogenase assay kit(Classification No.: 38504000)

decreases. LD activity is determined bymeasuring the percent change in absorbance.
LD
Pyruvic acid + NADH
Lactic acid + NAD
2. Features
1) This reagent is based on the method
recommended by the French Society ofClinical Biology (SFBC) and has been
modified so that it is compatible withautomated analyzers.
2) Wide assay range.
3) Liquid reagents, ready-to-use.
4) Applicable to various automated analyzers.

Pureauto S LD-P
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
with clinical symptoms and other examination
results.
3. This product should be used only as directed inthis package 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 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.

Procedural Precautions ＊＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and 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 follows.
Room temperature: for tests within 1 week
Please note that activity of samples maydecrease when refrigerated or frozen.
2. Interfering substances
1) Assay results are not affected by freebilirubin (up to 20 mg/dL) or conjugatedbilirubin (up to 20 mg/dL).
2) Because LD is contained in blood cells,
hemolyzed
samplesshow
artifactual
elevation of the LD level.
3. Others
1) Compatible with the JSCC Standards
Use Enzyme Calibrator Plus “Daiichi”(manufactured by SEKISUI MEDICAL CO.,LTD.) as the calibration material.
2) Compatible with the SFBC Standards
For calibration, use the factor specified foreach model by SEKISUI MEDICAL CO.,LTD.
3) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline andrepeat the measurement.

Description (Kit Components) ＊＊Component: Ingredients
LD-P Coenzyme Solution 1:
Nicotinamide adenine
dinucleotide (reduced form)
2-Amino-2-hydroxymethyl-1,3-propanediol buffer
LD-P Substrate Solution 2:
Sodium pyruvate
2-Amino-2-hydroxymethyl-1,3-propanediol buffer
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 heart, liver, andkidneys, as well as various solid tumors, leukemia,
and pernicious anemia, it plays an important role inthe diagnosis and follow-up of these diseases.

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): LD-P Coenzyme Solution 1 is readyto use.
Reagent (2): LD-P Substrate Solution 2 is readyto use.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Assay Principle
1. Assay Principle
Lactate dehydrogenase (LD) converts pyruvic
acid to lactic acid. The reaction also converts
NADH to NAD, and its absorbance at 340 nm

1

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,
avoid freezing.
Freezing can cause
deterioration of the reagents, leading toinaccurate results. Therefore, do not use theproduct if it has been previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.
4) 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.
4. Other precautions
Do not use the containers for other purposes.

37CSample Reagent (1)+────▶
6 L
270 L
5 min
Reagent (2)
90 L

※

37CMeasurement────▶
※
48–144 sec (Absorbance )Calculation of────▶
activity

Absorbance: The difference in absorbance
between 405 nm and 340 nm
Calibration material: Enzyme Calibrator Plus
“Daiichi” (Manufacture's assigned value) or thefactor
Reagent blank: Purified water or saline

Assessment of Assay Results ＊＊1. Reference standard range(Compatible with the JSCC Standards) 124–222
U/L4)(Compatible with the SFBC Standards) 233–497
U/L5)
2. There may be reactions or interfering reactions
with non-target substances. If assay resultsappear to be unreliable, repeat the measurement(if necessary, after dilution) or try anotheranalytical methods.
Performance ＊1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.010/min
2) Sensitivity: The change of absorbance is0.017–0.025/min per 200 U/L of LD activity.
2. Accuracy:90–110% of the expected assay value.
3. Within-run reproducibility:
Coefficient of variation ≤ 3%
(Test methods used for 1. –3. are in-housemethods.)
4. Measurement Range5): (On Hitachi 7070
automated analyzer)
8–2500 U/L
5. Correlation 5)
1) Serum N=122 r=0.999
y=1.07x–5.6
Control method: Approved in vitro diagnostic(enzyme activity measuring assay)
2) Plasma N=70 r=0.999 y=1.09x–5.5
Control method: Approved in vitro diagnostic(enzyme activity measuring assay )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: 1 year from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging
NamePackage
LD-P Coenzyme(1)
4 × 100 mL
Solution 1
Pureauto S
LD-P
LD-P Substrate(2)
2 × 100 mL
Solution 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊＊1) Kanai M. (editor): Kanai’s manual of clinicallaboratory medicin e. 32nd ed. 615, KaneharaShuppan, 2005.
2) Y. ARTUR et al.: Ann Biol Clin, 40, 160, 1982.
3) Sasaki M. et al.: Sampling of constituents of thehuman body, 217, Kodansha, 1972.
4) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 581,Kanehara Shuppan, 2015.
5) In house data, 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) Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in theLD-P Coenzyme Solution 1 and LD-P Substrate2

Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan3