This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 21600AMZ00527000**Revised: January 2017 (5th edition)*Revised: April 2008 (4th edition)

This package insert must be read carefully prior to use.
Prostate specific antigen assay kit(Classification No.: 37286000)

determined by measuring the agglutination as thechange of absorbance.
2. Features
1) This product is a reagent for measuring theserum PSA concentration based on latex
immunonephelometry. It can conveniently andaccurately measure serum PSA levels.
2) PSA can be measured using general-purpose
biochemical automated analyzers.
3) This product has a wide measurement range
from very low to high concentrations.

Nanopia PSA
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.

＊＊Procedural Precautions＊
1. Properties of Samples and Sampling Methods
1) Samples
Serum may be used.
2) Storage of samples1)
Centrifuge the sample immediately aftercollection, and perform measurement on thesame day. If measurement cannot beperformed on the day of separation, it may be
stored for up to 1 week under refrigeration(2–10oC) or for 1 month in a freezer (-20oC orlower). It may only be frozen and thawed
once.
Bring samples to room temperature (15–30
C) before use.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 50 mg/dL), conjugated bilirubin (up to50 mg/dL), hemoglobin (up to 500 mg/dL),
formazin turbidity (up to 2000 FTU),
rheumatoid factors (up to 500 IU/mL), orascorbic acid (up to 100 mg/dL).
2) Erroneous results may be obtained if thesample contains a substance other than PSA,
such as immunoglobulin, that can react withthe mouse monoclonal antibody.
3. Others
1) Before use, invert the Reagent (2) bottle tomix it thoroughly.
2) Always use PSA Calibrator for calibration.
3) Precautions for assay rangeIf the PSA concentration in the sample
exceeds the measurement range, dilute thesample with a separately sold PSA Sample
Dilution Solution (manufactured by SEKISUIMEDICAL CO., LTD.), and perform
re-measurement.

Description (Kit Components) ＊＊Component: Ingredients
PSA Buffer Solution 1:
N-(2-Hydroxyethyl)piperazine-N'2-ethane sulfonic acid) (HEPES)
buffer solution
PSA Latex Reagent 2:
Anti-human
PSA
mouse
monoclonal antibody-coated latex
Intended Use
Measurement of prostate specific antigen (PSA) inserum
PSA is a glycoprotein with a molecular weight ofapproximately 34000 that is specifically produced byglandular epithelial cells in the prostate. PSA isreleased into the blood when glandular epithelial cells
are damaged by prostate cancer or other prostate
abnormalities. Measurement of the blood level of
PSA is widely used in the urology field for diagnosis
of prostate cancer and for monitoring the response totreatment. PSA has great significance as a prostatecancer marker.1 Usefulness of the blood level of PSA
in screening for early detection of prostate cancer has
also attracted attention.

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): PSA Buffer Solution 1 is ready touse.
Reagent (2): PSA Latex Reagent 2 is ready touse.
Before using this product, gently invert the PSA
Latex Solution 2 bottle to mix it thoroughly, andcheck that there are no bubbles.
2. Assay Procedure

Assay Principle
1. Assay Principle
In samples, an antigen-antibody reaction occurs
between PSA and anti-human PSA mousemonoclonal antibody-coated latex beads, resultingin agglutination of the beads. The PSA content is1

This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Sample +8 μL

Reagent 37 C(1)
100 μL 5 min
37 CReagent (2)100 μL

Measurement(Absorbance I※)

Measurement(Absorbance II※)

Calculation ofconcentration

5 min2) Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in thePSA Buffer Solution 1 and PSA Latex Reagent
2. If the reagent comes in contact with skin orclothes, rinse immediately with ample water,
and consult the doctor if skin irritation
develops.
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 mix reagents from different lots because
it may lead to inaccurate results.
5）Do not perform the assay under direct sunlight
3. Precautions for Disposal1) 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 121 ºC 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.

※Absorbance I and II: The difference in absorbance
between 570 nm and 800 nm.
Calibration material: PSA calibrator(Manufacture's assigned value)
Reagent blank: Calibrator with the PSA
concentration of 0 ng/mL

Assessment of Assay Results ＊＊1. Reference standard range2)
Normal: ≤ 1.1 ng/mL
Cut-off value: ≤ 4.0 ng/mL
Gray zone: 4.1–10.0 ng/mL
Abnormal: ≥ 10.1 ng/mL
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.
Performance
1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.15
2) Sensitivity: The change of absorbance is 0.01–0.15/min per 10 ng/mL of PSA (PSA 1–20ng/mL).
2. Accuracy: 80–120 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation: ≤ 10 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range5): (On Hitachi 7170
automated analyzer)
0.5–100 ng/mL
5. Correlation5)
Serum N=84
r=0.980y=0.97x–0.59
Control method: Approved in vitro diagnostic(Two-site IRMA method※)※
two−site immunoradiometric assay method
6. Standard Material
National Institute for Biological Standards andControl (96/970) (WHO International Standard
Material [90:10])※
National institute for biological standards andcontrol

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.)
PackagingNamePackage
PSA Buffer Solution 1
1 × 10 mL
NanopiaPSA
PSA Latex Reagent 2
1 × 10 mL
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
＊＊References ＊1) Kuriyama M. et al.: Comprehensive blood andurine chemical tests and immunological tests (4).
Jpn J Clin Med, 57, 520 (1999 extra edition).
2) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 601,Kanehara Shuppan, 2015.
3) Watanabe H. et al.: J Med Pharm Sci, 53, 831,2005.
4) Ohira S. et al.: J Med Pharm Sci, 55, 139, 2006.
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Contact ＊SEKISUI MEDICAL CO., LTD.
international@sekisui.com＊＊＊Manufacturer
SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan

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