This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 21500AMZ00537000** Revised: January 2017 (6th edition)* Revised: April 2008 (5th edition)

This package insert must be read carefully prior to use.
Fibrin degradation product assay kit(Classification No.: 30576000)

using a spectrophotometer, allowing quantitative
measurement of the D-dimer concentration in thesample.
2. Features
1) Assay range is wide as up to 60 μg/mL which
can be measured without dilution.
2) Either plasma or serum can be used assamples.
3) Applicable to various automated analyzers.

Nanopia D-dimer
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＊＊

Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples
Plasma (citrated plasma) and serum may beused. When using serum, it should be sampledwith specific tubes for FDP containing
thrombin and aprotinin.
2) Storage of samples5)
If the isolated serum or plasma sample cannot
be tested on the same day, specimens should
be stored as follows: Specimens may be stored
up to 1 day at 2–10C and 1 month at -80C.
The freeze-thaw cycle for a sample is limited
to one time only.

in this package insert. Reliability of resultscannot be guaranteed if there are any
deviations from the instructions in thispackage 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.

Bring samples to room temperature (15–30C) before use.
2. Interfering substances
Assay results are not hardly affected by freebilirubin (up to 17 mg/dL), conjugated bilirubin(up to 21 mg/dL), hemoglobin (up to 500 mg/dL),
chyle formazin turbidity (up to 1960 FTU), or
rheumatoid factors (up to 500 IU/mL).
3. Others
1) Always use D-dimer Calibrator for calibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

Description (Kit Components) ＊＊Component : Ingredients
D-dimer Buffer Solution 1
D-dimer Latex Reagent 2:
Anti-humanD-dimermousemonoclonal antibody-coated latex
Intended Use
Measurement of D-D dimer concentration inplasma or serum

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): D-dimer Buffer 1 is ready to use.
Reagent (2): D-dimer Latex Reagent 2 is ready touse.
Invert the P-FDP Latex Reagent 2 gently to mix
before use, and check that there is no formation offoam.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

D-dimer (D-D dimer) is a kind of fibrin/fibrinogendegradation product (FDP) that is produced whenstabilized fibrin, which has been cross-linked by
active factor XII, is degraded by plasmin. There arevarious molecular species of D dimer in the blood,
such as YY/DXD, YD/DY, DD/E, and DDcomplexes.
An increase of the blood level of D-dimer indicatesthat thrombi are being formed in vivo and that thefibrinolysis system has been activated. D-dimer isknown to increase in various diseases, such asmalignancies, obstetric diseases, vascular diseases,and disseminated intravascular coagulation (DIC).

Sample+12 L

Assay Principle
1. Assay Principle
D-dimer in the sample reacts with the mouseanti-human D-dimer monoclonal antibody-coatedlatex, resulting in agglutination of the latex
particles and an elevation of turbidity. The
resulting turbidity changes are then measured

Reagent 37C(1)100 L 5 min

Reagent 37CMeasurement(2)(Absorbance I※)
100 L 35 sec
37C Measurement
1.4 min(Absorbance II※)
Calculation ofconcentration

13) Do not replenish the reagents.
4) Do not mix latex reagents from different kit lot
numbers.
5) 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.

※Absorbance I and II: The difference in absorbance
between 570 nm and 800 nm
Calibrationmaterial:
D-dimer
Calibrator(Manufacture's assigned value)
Reagent blank: Purified water or saline

Assessment of Assay Results
1. Reference standard range1)≤ 1.0 μg/mL
2. There may be reactions or interfering reactions
with non-target substances. If plasma withdifficult sampling was used, falsely high values
may be obtained. If assay results appear to beunreliable, repeat the measurement (if necessary,after dilution) or try another analytical methods.
Performance
1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.01/min
2) Sensitivity: The change in absorbance is 0.01–0.05/min per 10 µg/mL of D-dimer.
2. Accuracy: 85–115% of the expected assay value
3. Within-run reproducibility:
Coefficient of variation ≤ 10%(Test methods used for 1. –3. are in-housemethods.)
4. Measurement Range4): (On Hitachi 7170
automated analyzer)
0.5–60 μg/mL
5. Correlation4)
1) Plasma N=120 r=0.99 y=0.97x+0.81
Control method: Approved in vitro diagnostic
product (latex immuno-turbidimetric assay)
2) Serum
N=67 r=0.99 y=0.97x－0.79
Control method: Comparison with the values
obtained simultaneously with the plasma
samples.
6 Standard Material.
Fibrin degradation product (in-house referencestandard)

Storage and Shelf Life ＊＊1. Storage temperature: 2–10C
2. Shelf life: 2 years from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging
NamePackage
D-dimer Buffer(1)
1 × 10 mL
Solution 1Nanopia
D-dimerD-dimer Latex(2)
1 × 10 mL
Reagent 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
＊＊References ＊1) Kurokawa K. et al.: Laboratory test data book
2013–2014, 385, 2013.
2) Takada A. et al.: J Jpn Soc Clin Labo Autom, 30,721, 2005.
3) Kikuchi M. et al.: J Jpn Soc Lab Hematol, 6, 349,
2005.
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) Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in theD-dimer Buffer Solution 1 and D-dimer Latex
Reagent 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 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.

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

Manufacturer ＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2