This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Certification No. 220ADAMX00059000**Revised: January 2017 (6th edition)*Revised: November 2014 (5th edition)

This package insert must be read carefully prior to use.
Soluble fibrin monomer complex assay kit(Classification No.: 43421000)

agglutination of the latex.
2. Features
1) Fibrin monomers and SF created fromfibrinogen by thrombin are detected, but SF
that has undergone degradation by plasmin is
not detected. Fibrinogen/fibrin degradation
products and fibrinogen are not detected.
2) Applicable to various automated analyzers.

Nanopia SFGeneral 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 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
Plasma (citrated plasma) may be used. Do
not use plasma treated with an anti-coagulant
other than sodium citrate.
2) Storage of samples
After separation of plasma, store the sample ina refrigerator (2–10°C) and performmeasurement on the same day.
If measurement cannot be performed on theday of separation, the plasma sample may be
stored for up to 1 month at -30°C or below.
However, it may only be frozen and thawed
once.
Thaw frozen samples rapidly in a warm water
bath at 37°C.
Bring samples to room temperature (15–30C)
before use.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 20 mg/dL), conjugated bilirubin (up to20 mg/dL), formazin turbidity (up to 2000
FTU), rheumatoid factors (up to 200 IU/mL),or heparin sodium (up to 5 U/mL).
2) Assay results are not affected by hemoglobin(up to 50 mg/dL). However, do not measuresamples that are severely hemolyzed, because
artifactual elevation of the SF level may occur.
3. Others
1) Always use SF Calibrator for calibration.
2) Precautions for assay range
If the SF concentration in a sample exceeds
the measurement range, dilute the sample withnormal human plasma (SF < 3 µg/mL) andperform re-measurement.
3) Exercise caution, because contamination of thereaction mixture with thrombin may result in
artifactual elevation of the SF level.

Description (Kit Components)
Component
Ingredients
SF Buffer Solution 1
SF Latex Reagent 2: Anti-human SF mousemonoclonal antibody-coatedlatex※※
It is an abbreviation for anti-human soluble fibrin
monomer complex mouse monoclonal antibodycoated latex.
Intended Use
Detection of soluble fibrin monomer complex inplasma
An increase of soluble fibrin monomer complex (SF)in plasma reflects the formation of fibrin fromfibrinogen by thrombin in vivo. Therefore, it is used
as a molecular marker of coagulation to assess
thrombosis and prothrombotic states including DIC.1)＊＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): SF Buffer Solution 1 is ready to use.
Reagent (2): SF Latex Reagent 2 is ready to use.
Before using this product, gently invert the SF
Latex Reagent 2 bottle to mix it thoroughly, andcheck that there are no bubbles.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Assay Principle
1. Assay Principle
In samples, an antigen-antibody reaction occurs
between SF and anti-human SF mousemonoclonal antibody-coated latex, resulting in
agglutination of the latex.
The SF level in the sample is determined bymeasuring the change of absorbance due to1

Sample+3 μL

Reagent 37C
(1)
100 μL 5 min

Reagent(2)
100 μL

Measurement(Absorbance I※)

Measurement(AbsorbanceII※)
5 min

Calculation ofconcentration

37C

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 theSF Buffer Solution 1 and SF Latex Reagent 2.
Therefore, if the reagent comes in contact withskin or clothes, 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 materials from different kit lotnumbers.
5) Do not mix SF Latex Reagent 2 from different
kit lot numbers.
6) 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.

Assessment※Absorbance I and II: The difference in absorbance
between 570 nm and 800 nm.
Calibration material: SF Calibrator (Manufacture'sassigned value)
Reagent blank: Saline
3. Precautions for testing
After completion of measurement, tightly close
the vials containing SF Buffer Solution 1 and SF
Latex Reagent 2, and store in a refrigerator.
Assessment of Assay Results
1. Assessment criteria2)
Negative: < 7 µg/mL, Positive: ≥ 7 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.3) If assay results appear to beunreliable, repeat the measurement (if necessary,after dilution) or try another analytical methods.
Performance
1. Sensitivity
1) Reagent blank: Reagent blank: absorbancebeing equal to or lower than 0.01
2) Sensitivity: The absorbance is 0.02–0.10 per
10 µg/mL of SF.
2. Accuracy:
The result is negative when negative control
plasma is tested, while it is positive when positive
control plasma is tested.
3. Within-run Reproducibility:
The result is always negative when 10 samples ofnegative control plasma are tested simultaneously,
while it is always positive when 10 samples of
positive control plasma are tested simultaneously.
(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range4): (On Hitachi 7170
automated analyzer)
3–100 μg /mL
5. Correlation4)
1) Approved in vitro diagnostic (latex
immuno-turbidimetric assay)
N = 132, sensitivity (PPV) 96% (55/57),
specificity (NPV) 91% (68/75), total
concordance rate 93% (123/132)
2) Approvedinvitro
diagnostic(hemagglutination assay)
N = 132, sensitivity (PPV) 100% (54/54),
specificity (NPV) 90% (70/78), total
concordance rate 94% (124/132)
6. Standard MaterialPurified fibrin monomer (in-house referencestandard)
Precautions for Use or Handling

Storage and Shelf Life ＊＊1. Storage temperature: 2–10C
2. Shelf life: 2 years months from the date ofmanufacture(The expiration date is printed on the outerpackage.)
Packaging
NamePackage
SF Buffer Solution 1
1×10.5mL
Nanopia SF
SF Latex Reagent 2
1×10mL
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊＊1) Kanai M. (supervising editor): Kanai’s manual of＊＊2clinical laboratory medicine. 34th ed. 429,Kanehara Shuppan, 2015.
2) Edited by the Japanese Society for Laboratory
Hematology: Standard Laboratory Hematology,60–63, Ishiyaku Shuppan, 2003.
3) Wada H. et al.: Modern Med Lab, 34, 800, 2006.
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