This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218033**Revised: February 2021 (10th edition)*Revised: January 2017 (9th edition)

This package insert must be read carefully prior to use.
Albumin assay kit for blood tests(Classification No.: 30155001)

2. Features
Assay results are hardly affected by interfering
substances in samples such as bilirubin,
hemolyzed blood, or ascorbic acid.

Autosera ALB
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. For the effects of an administered drug on themeasured value, carefully read the Precautions for
Use in the package insert of the drug, especiallythe section about the effects on laboratory testresults. Please also read carefully the “2.
Interfering Substances,” in the “ProceduralPrecautions” section, as well as “2. Precautions forAssessment” in the “Assessment of Assay Results”
section, of this package insert.
4. 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.
5. 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.
6. 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.
7. 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 samples3)
If the isolated serum sample cannot be testedon the same day, specimens should be stored
as follows:
2–10C: for tests within 1 month≤ -20C: for tests after more than 1 month
Bring samples to room temperature (15–30C) before use.
2. Interfering substances
Assay results are not affected by bilirubin (up to20 mg/dL) or hemoglobin (up to 500 mg/dL).
3. Others
1) Always use Serum Multicalibrator(SEKISUI), Seronorm Multicalibrator,Seronorm Human or Anaserum ALB/TP
Standard Solution for calibration.
2) Precautions for assay range
If the concentration of sample exceeds assayrange, dilute the sample with saline and repeat
the measurement.
＊＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): ALB Reagent is ready to use.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

＊＊Description (Kit Components) ＊Component: Ingredients
ALB Reagent: Bromocresol green

37C Measurement
Sample + Reagent (1)3 μL
350 μL 10 min (Absorbance※)

Intended Use
Measurement of albumin in serum

Calculation ofconcentration

Albumin accounts for 50% to 70% of total protein inserum. It plays an important role in maintaining thecolloid osmotic pressure and in transporting various
substances through the blood, including drugs.
Because albumin is synthesized in the liver, it ismeasured as an important index of parenchymal liverdisease and disorders of systemic protein metabolism.

※Absorbance: The difference in absorbance
between 700 nm and 660 nm.
Calibration material: Serum Multicalibrator(SEKISUI), Seronorm Multicalibrator, Seronorm
Human, or Anaserum ALB/TP Standard Solution.
(manufacture's assigned value)
Reagent blank: Purified water or saline

Assay Principle
1. Assay Principle
Albumin in the sample binds to bromocresol
green to form a complex with a blue-green color.
The albumin content is determined by measuring
the absorbance of the blue-green color complex.

＊＊

Assessment of Assay Results ＊1. Reference standard range4)
4.1–5.1 g/dL (Within the JCCLS commonstandard)
2. Precautions for Assessment
There may be reactions or interfering reactions
with non-target substances. If assay results appear
to be unreliable, repeat the measurement (ifAlbumin in a sample + Bromocresol green
Colored complex (blue-green color)1necessary, after dilution) or try another analyticalmethods.

or copper pipes to produce the highly explosive
metal azide. Therefore, the reagent should beflushed with large amounts of water during
disposal.
4. Other precautions
Do not use the containers for other purposes.

Performance ＊＊1. Sensitivity
1) Reagent blank: absorbance being equal to orlower than 0.10
2) Sensitivity: The absorbance is 0.35–0.45 per 5.3
g/dL of albumin.
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 7170S
automated analyzer)
0.1–6.0 g/dL
5. Correlation5)
SerumN=71
r=0.999
y=1.00x–0.02
Control method: Approved in vitro diagnostic(BCG method)
6. Standard Material
SRM927 (NIST), CRM470 (IRMM)

Storage and Shelf Life ＊1. Storage temperature: room temperature
2. Shelf life: 2 years from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging ＊Name
Autosera ALB

ALB Reagent

Package4 × 50 mL
4 × 95 mL＊＊

References ＊1) Kitamura M. et al. Practical Clinical Chemistry.
Tokyo: Ishiyaku Shuppan; 1974. Japanese.
2) Kanai M, editor. Kanai’s manual of clinicallaboratory medicine. 33th ed. Tokyo: Kanehara
Shuppan; 2010. Japanese.
3) Sasaki M. et al. Sampling of constituents of thehuman body. Tokyo: Kodansha; 1972. Japanese.
4) Kanai M, editor. Kanai’s manual of clinicallaboratory medicine. 35th ed. Tokyo: Kanehara
Shuppan; 2020. Japanese.
5) SEKISUI MEDICAL CO., LTD. In house data.
Japanese.

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 ALB Reagent. Therefore, if the reagent
comes in accidentally contact with eyes, mouthor 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.
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.
4) The reagents should be disposed of inaccordance with the Water Pollution Control act
or related regulations.
5) Sodium azide has been added as an antiseptic
agent in the ALB Reagent. It can react with lead

Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com

Manufacturer ＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan"Autosera" and "Anaserum" are trademarks orregistered trademarks of SEKISUI MEDICAL CO.,LTD. in Japan and/or other countries.
All other brands, product names and service names aretrademarks or registered trademarks of their respective
companies.

2