This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218101**Revised: January 2017 (7th edition)*Revised: September 2016 (6th edition)

This package insert must be read carefully prior to use.
Fibrinogen assay kit(Classification No.: 30541000)

fibrinogen level (mg/dL) from the calibration
curve plotted by using plasma samples withknown fibrinogen levels.

Coagpia Fbg

Procedural Precautions ＊＊1. Properties of Samples and Sampling Methods
1) Samples
Plasma (citrated plasma) can be used as thesample. Do not use plasma treated with ananti-coagulant other than sodium citrate.
2) Sampling method
Promptly mix the collected blood with 3.2%
sodium citrate at a volume ratio of 9:1,
centrifuge the mixture (1500G for at least 15
minutes or 2000G for at least 10 minutes) at
18–25°C within 1 hour, and store the resulting
plasma sample.
3) Storage of samples(1) After separation of plasma, store the plasma
sample at room temperature (18–25°C), andperform the test within 4 hours ofseparation.2) Test the plasma sample within 3days of separation if it is stored at 2–10°C
and within 4 days if it is stored at -28°C orlower.4)
Bring samples to room temperature (15–30C) before use.
(2) Immediately thaw frozen samples at 37°C toavoid degeneration of fibrinogen. Avoid
repeated freezing and thawing, or errors in
the assay results may occur.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 25 mg/dL), conjugated bilirubin (up to 25mg/dL), hemoglobin (up to 500 mg/dL), formazinturbidity (up to 3000 FTU), or heparin sodium (upto 8 U/mL).
3. Others
1) Always use Calibrator N for Coagpia
for calibration.
2) If the concentration of the plasma sample
exceeds the measurement range, dilute thesample 1:20 with the Sample Dilution Solution
and perform re-measurement.
3) A commercially available diluent may also beused as the Sample Dilution Solution. Pleasecontact SEKISUI MEDICAL CO., LTD. forfurther information about use of this product.

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.
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 ifrequired.
6. Carefully read the operating instructions for eachtype of blood coagulation analyzer prior to using
this product. Parameters for each type of analyzers
are available, and can be requested from SEKISUIMEDICAL CO., LTD. if required.
7. Perform a quality control test prior to assay toensure accuracy.
Description (Kit Components) ＊Component
Ingredients
Sample Dilution Solution
Thrombin Reagent:
Thrombin
Intended UseMeasurement of fibrinogen in plasma
Fibrinogen is one of the acute phase reactant proteinsproduced by hepatocytes. Its plasma level isincreased by acute infection, malignancy, andthrombotic diseases, while it is decreased by reduced
production due to parenchymal liver disease orenhanced consumption due to disseminatedintravascular coagulation (DIC).1 Measurement offibrinogen is performed to assess the pathologic
effects of these diseases and assist with diagnosis.

＊＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Sample Dilution Solution: Ready to use.
Thrombin Reagent: Ready to use.
2. Assay Procedure
This product is compatible with various types ofblood coagulation analyzer. An example of theassay procedure is indicated below.

Assay Principle
1. Assay Principle
Coagpia Fbg is a reagent for determination ofplasma fibrinogen based on the thrombin time
assay. Add a fixed amount of thrombin to thediluted plasma sample, and measure the time
(coagulation time) in seconds from addition ofthrombin until production of fibrin fromfibrinogen. Since the coagulation time depends
on the fibrinogen level, determine the plasma1

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 theSample Dilution Solution and Thrombin
Reagent 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, 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 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 orautoclaved 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.

(Sample preparation)
PlasmaSample Dilution
37Csample +Solution
──▶
10 μL
90 μL

Sample100 μL(Measurement of clotting time)
Sample +100 μLThrombinReagent
50 μL

37C
Measurement of──▶
clotting time

Calibration material: Calibrator N for Coagpia(Manufacture's assigned value)
3. Calculation of plasma fibrinogen level (mg/dL)
1) Dilute Calibrator N for Coagpia to 1:5, 1:10,
and 1:20 with the Sample Dilution Solution.
2) Add the Thrombin Reagent to each of the above
diluted samples, and measure the coagulationtime.
3) Plot the fibrinogen level (mg/dL) on the x-axis
and coagulation time on the y-axis to create acalibration curve. At this time, the fibrinogenlevels in the calibrator diluted 1:5, 1:10, and1:20 are specified as 2, 1, and 1/2 times theindicated values of the calibrator, respectively.
4) Dilute the plasma sample to 1:10 with theSample Dilution Solution, add the Thrombin
Reagent, and measure the coagulation time. Use
this time to calculate the fibrinogen level(mg/dL) from the calibration curve that waspreviously plotted.
Operations 1)–4) are performed automatically by
the analyzer (blood coagulation analyzer), and thefibrinogen level (mg/dL) is calculated.
4. Precautions for testing
After completion of measurement, tightly closethe container of this product, and store it in arefrigerator.
Assessment of Assay Results
1. Reference standard range3)
200–400 mg/dL

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 outer
package.)

Performance ＊＊1. Sensitivity
When the test is performed using normal plasma
diluted to 1:10 and 1:20, the coagulation time per
300 and 150 mg/dL of fibrinogen is 7–13 and 15–
24 seconds, respectively.
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 Range4): (Coagulex 800)
40–800 mg/dL
5. Correlation4)1) N=87
r=0.990y=1.03x+0.68
Control method: Approved in vitro diagnostic(clotting time method)
6. Standard Material
NIBSC Reference Standard 98/612 (NIBSC)

PackagingNamePackageSample Dilution
10 × 10 mL
Solution
Coagpia Fbg
Thrombin Reagent
10 × 3 mL
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊＊1) Edited by the Japanese Society for Laboratory
Hematology: Standard Laboratory Hematology,136–139, Ishiyaku Shuppan, 2003.
2) Edited by the Japanese Society for Laboratory
Hematology: J Jpn Soc Lab Hematol, 17(2), 149–157, 2016.

Precautions for Use or Handling ＊1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled23) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 402,Kanehara Shuppan, 2015.
4) 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, Japan3