This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No.20400AMZ00177000** Revised: January 2017 (8th edition)* Revised: April 2008 (7th edition)

This package insert must be read carefully prior to use.
Leucine aminopeptidase assay kit(Classification No.: 38546000)

is applicable to automated analyzers.
2) Liquid reagents, ready-to-use.
3) The kit is based on the rate assay method, socoexisting substances have little effect.
4) Applicable to various automated analyzers.

Pureauto LAPGeneral 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 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 may be used.
2) Storage of samples1)
If the isolated serum sample cannot be testedon the same day, specimens should be stored
as follows:
2–10C: for tests within 1 week≤ -20C: for tests after more than 1 week
Bring samples to room temperature (15–30C) before use.
2. Interfering substances
Assay results are not affected by bilirubin (up to20 mg/dL) and hemoglobin (up to 400 mg/dL).
3. Others
1) For calibration, use the calibration factor
obtained with 4NA “Daiichi” (manufacturedby SEKISUI MEDICAL) for measuringcalibration factor.
2) Precautions for assay range
If the concentration of sample exceeds assayrange, dilute the sample with saline and repeat
the measurement.

Description (Kit Components) ＊＊Component: Ingredients
LAP Buffer Solution 1:
2-Amino-2-hydroxymethyl-1,3-propan
ediol buffer
LAP Substrate Solution 2:
L-Leucyl-p-nitroanilide・hydrochloride

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): LAP Buffer Solution 1 is ready touse.
Reagent (2): LAP Substrate Solution 2 is readyto use.
2. Assay Procedure
This product is compatible with various types ofautomated analyzers. An example of the assay
procedure is indicated below.

Intended Use
Measurement of leucine aminopeptidase in serum
Leucine aminopeptidase is an enzyme that isextremely widely distributed in human tissues such as
the intestinal mucosa, kidneys, muscles, liver, andpancreas. It hydrolyzes peptide bonds with
N-terminal leucine.
Serum leucine aminopeptidase activity increases inhepatobiliary disease, etc.

Sample Reagent (1) 37C+10 L
260 L ────▶
5 min
37C
Reagent (2) ────▶ Measurement
130 L 60-300 sec (Absorbance※)

Assay Principle
1. Assay Principle
When serum leucine aminopeptidase (LAP) actson L-leucyl-p-nitroanilide as the substrate,p-nitroaniline (yellow) is released. LAP activity
is determined by measuring the production
velocity of p-nitroaniline.
LAP
L-Leucyl-p-nitroanilide・hydrochloride
L-Leucine + p-Nitroaniline (yellow)

────▶
※

Calculation ofactivity

Absorbance: The difference in absorbance between
505 nm and 405 nm
Calibration: Conversion factor
Reagent blank: Purified water or saline

Assessment of Assay Results
1. Reference standard range3)
30–70 U/L
2. There may be reactions or interfering reactions
with non-target substances. If assay results

2. Features
1) This product is based on the GSCC
recommended method and modified so that it1

appear to be unreliable, repeat the measurement(if necessary, after dilution) or try anotheranalytical methods.

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 LAP Buffer Solution 1. It can react with leador copper pipes to produce the highly explosive
metal azide. Therefore, the reagent should beflushed with large amounts of water when
disposing.
4. Other precautions
Do not use the containers for other purposes.

Performance
1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.01/min
2) Sensitivity: The change of absorbance is
0.015–0.020/min per 100 IU/L ofleucine aminopeptidase.
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 Range4): (On Hitachi 7170S
automated analyzer)
1–1500 U/L
5. Correlatio4)
1) Serum N=86 r=0.999 y=1.06x+1.7
Control method: Approved in vitro diagnostic(L−leucyl-p-nitroanilide substratemethod)
6. Standard Material
Purified p-nitroaniline (in-house referencestandard)＊

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 outer
package.)
Packaging
Name
LAP Buffer(1)
Solution 1
LAP Substrate(2)
Solution 2

Pureauto LAP

Package4 × 100 mL
4 × 100 mL＊ ＊References ＊1) Sasaki M. et al.: Sampling of constituents of thehuman body, 223, Kodansha, 1972.
2) Kobayashi T, Omori S. J Clin Lab Inst Reag, 14,929, 1991.
3) Kanai M. (supervising editor): Kanai’s manualof clinical laboratory medicine. 34th ed. 586,Kanehara Shuppan, 2015.
4) 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) Sodium azide is added as an antiseptic agent in
the LAP Buffer Solution 1. 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 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 assodium 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.

Contact ＊SEKISUI MEDICAL CO., LTD.
international@sekisui.com＊ ＊Manufacturer ＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2