This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Certification No.21400AMZ00010000** Revised: January 2017 (10th edition)* Revised: March 2014 (9th edition)

This package insert must be read carefully prior to use.

Fibrin/fibrinogen degradation products assay kit(Classification No.: 30575000)

change in absorbance caused by thisagglutination is measured to determine the FDPlevel in the sample.
2. Features
1) Either plasma or serum can be used assamples.
2) Assay range is wide as up to 120 μg/mL which
can be measured without dilution.

Nanopia P-FDPGeneral 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
Citrated plasma and serum can be used.
When using serum, it should be sampledwith specific tubes for FDP containing
thrombin and aprotinin.
2) Storage of samples5)

Samples should be centrifuged
immediately after sampling and should betested on the same day. If samples cannot
be tested on the same day, they may be
stored up to 1 day at 4−8C and 1 month at-80C.
The freeze-thaw cycle for a sample is limited
to one time only.
Bring samples to room temperature(15−30C) before use.
2. Interfering Substances
Assay results are not affected by free bilirubin (upto 22 mg/dL), conjugated bilirubin (up to 19mg/dL), hemoglobin (up to 470 mg/dL), formazinturbidity (up to 2900 FTU), or rheumatoid factors(up to 470 IU/mL).
3. Others
1) Always use FDP Calibrator N 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
P-FDP Buffer Solution 1:
2-Amino-2-hydroxymethyl-1,3propanediol buffer
P-FDP Latex Reagent 2:
Anti-FDP mouse monoclonal
antibody-coated latex
Intended UseMeasurement
offibrin
andfibrinogendegradation products (FDP) in plasma or serum＊＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): P-FDP Buffer Solution 1 is readyto use.
Reagent (2): P-FDP Latex Reagent 2 is ready touse.
Invert the P-FDP Latex Reagent 2 gently to mix
before use, and check that there is no formationof foam.

Products
generatedfromfibrin/fibrinogendecomposition, which result from fibrinolysis due tothe action of plasmin, are collectively referred to asFDP.
An increase in the level of FDP in the blooddemonstrates in vivo hyperfi brinolysis, and is foundin several diseases such as malignant tumor, obstetricdiseases, vascular diseases or disseminatedintravascular coagulation syndrome (DIC). In
particular, DIC, which is known to develop due tosignificant hyperfibrinolysis or hypercoagulation, isdiagnosed and followed up by measuring the FDPlevel as one of the essential indices.
Assay Principle
1. Assay Principle
FDP in samples agglutinates with mouseanti-human FDP monoclonal antibody-coatedlatex through an antigen-antibody reaction. The1

2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.
Sample+6 L

Reagent 37C Reagent 37C───▶ (2)───▶ Measurement(1)
5 min 100 L 53 sec (Absorbance I※)
100 L37C───▶ Measurement
4 min. (Absorbance II※)
25 .sec
Calculation of───▶
concentration※

Absorbance I and II: The difference in absorbance
between 800 nm and 570 nm
Calibration material: FDP Calibrator N (in-houseindicated values)
Reagent blank: Purified water or saline

Assessment of Assay Result
1. Reference standard range1)< 5 g/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: absorbance being equal to or
lower than 0.02
2) Sensitivity: The absorbance is 0.01–0.1 per 10µg/mL of FDP.
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-house methods.)
4. Measurement
Range5): (On Hitachi 7170
automated analyzer)
2.5−120 g/mL
5. Correlation5)
1) Serum N=143 r=0.98 y=1.03x –0.21
Control method: Approved in vitro diagnostic(latex immunoturbidimetric)
2) Plasma N=127 r=0.992 y=0.96x+0.43
Control method: Comparison with serum
collected simultaneously and measured by thismethod (dedicated blood tube).
6. Standard Material
Purified fibrinogen (in-house reference standard)

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.
3) Do not mix latex reagents from different kit lotnumbers.
4) Do not replenish the reagents.
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.
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
P-FDP Buffer
1 × 10 mL
Solution 1
Nanopia P-FDP
P-FDP Latex
1 × 10 mL
Reagent 2Constituent reagents are available in otherconfigurations. For further details please contact
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 theP-FDP Buffer Solution 1 and P-FDP Latex＊＊References ＊1) Kurokawa K. et al.: Laboratory test data book
2013–2014, 383, 2013.
2) Amemiya N. et al.: J Jpn Soc Lab Hematol, 3, 143,2002.
3) Moriai R. et al.: J Med Pharm Sci, 47, 977, 2002.
4) Mitsuhashi H. et al.: Jpn J Clin Med, 57 (1999extra edition), 566, 1999.
5) In house data, SEKISUI MEDICAL CO., LTD.

2

Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan3