This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218082** Revised: January 2017 (5th edition)* Revised: August 2011 (4th edition)

This package insert must be read carefully prior to use.
Alkaline phosphatase assay kit for blood tests(Classification No.: 33165001)

Final concentration of the principal ingredientmatches with the final concentration stipulated in
the JSCC Recommendation for Enzyme
Activities.

QUALIGENT ALP

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
The isolated serum (plasma) should be testedon the same day.
If sample cannot be tested on the same day,they should be stored at or below -20C.1)
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 3000 FTU), Intralipos (up to 3%),or ascorbic acid (up to 50 mg/dL).
3. Others
1) Always use Enzyme Calibrator Plus “Daiichi”
for calibration.
2) Analysis range
If the activity of sample exceeds assay range,
dilute the sample with saline and repeat themeasurement.

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 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
Description (Kit Components) ＊＊Component: Ingredients
ALP Buffer Solution 1: Ethylaminoethanol buffer
Magnesium chloride
ALP Substrate Solution 2:
Disodium 4-nitrophenyl
phosphate
Intended Use
Measurement ofserum or plasma

Dosage/Administration (Assay Procedure)＊＊1. Preparation of reagents
Reagent (1): ALP Buffer Solution 1 is ready touse.
Reagent (2): ALP Substrate Solution 2 is ready touse.
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.

alkaline phosphatase (ALP) in

ALP is an enzyme that hydrolyzes phosphate
compounds at the optimal pH (alkaline). ALP activity
is high in organs/tissues such as the kidneys(proximal uriniferous tubule), small intestine(mucosa), osteoblasts, placenta, liver, and mammary
gland. Blood ALP activity is increased in bonedisease, hepatobiliary disease, pregnancy, andmalignancies.

37CSample Reagent (1)────▶
+
2.0 L133 L
5 min※Assay Principle ＊＊1. Assay Principle
4-Nitrophenol (yellow) is released when ALP insamples acts on 4-nitrophenyl phosphate as thesubstrate in ethylaminoethanol (EAE) buffer.
ALP activity is determined by measuring thevelocity of 4-nitrophenol production.
4-Nitrophenyl phosphate

37CSample Reagent(2)+────▶
67
L
2.0 L
114–299 secMeasurement(Absorbance※)────▶

Calculation ofactivity

Absorbance: The difference in absorbance
between 505 nm and 415 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 2)
106–322 U/L
2. There may be reactions or interfering reactions
with non-target substances. If assay results appear
to be unreliable, repeat the measurement (ifALP
Mg2+

4-Nitrophenol (yellow) + Phosphoric acid
2. Features1necessary, after dilution) or try another analyticalmethods.

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 ALP 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.

Performance ＊1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.002/min2) Sensitivity: The change of absorbance is0.010–0.030/min per 500 U/L of ALP activity.
2. Accuracy: 90–110% of the expected assay vale
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)
3–2000 U/L
5. Correlation 7)
1) Serum N=100 r=0.999 y=0.984x –4.7
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for EnzymeActivities
2) Plasma N=65 r=0.999 y=1.00x +3.2
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 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 ＊＊NameQUALIGENT
ALP

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 ALP Substrate 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, avoidfreezing. Freezing can cause deterioration of
the reagents, leading to inaccurate results.
Therefore, do not use the product if it has beenpreviously 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 orautoclaved at 121ºC for 20 minutes.
2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such asPackage
ALP Buffer
Set
Solution 1
1  17.3 mL(Cassette for
ALP Substrate
Hitachi 9000
Solution 2series)
1  8.7 mL
ALP Buffer
L set
Solution1
1  43 mL(Set for
Hitachi
ALP Substrate
LABOSPECT Solution 2series)
1  22 mL×2×2

References ＊＊1) Sasaki M. et al.: Sampling of constituents of thehuman body, 171, Kodansha, 1972.
2) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 558,Kanehara Shuppan, 2015.
3) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 19, 209, 1990.
4) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 19, 213, 1990.
5) Osawa S.: Med Tech, 20, 1022, 1992.
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, Japan2