This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 22200AMX00279000**Revised: January 2017 (4th edition)*Revised: June 2011 (3rd edition)

This package insert must be read carefully prior to use.
Prothrombin time assay kit(Classification No.: 30539000)

by thromboplastin. Factors X, V, and II are also
activated successively, resulting in the production offibrin. To measure the PT with this product, the time(clotting time) is measured in seconds from additionof tissue thromboplastin and calcium to a plasma
sample until fibrin production.

Coagpia PT-N
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.

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(1) Promptly mix the collected blood with
3.2% sodium citrate at a volume ratio of
9:1, centrifuge the mixture (1500G for atleast 15 minutes or 2000G for at least 10minutes) at 18–25°C within 1 hour, andstore the resulting plasma sample.2(2) At the time of blood collection, avoid
contamination with tissue fluid and mixing
with too much or too little sodium citrate,or accurate results may not be obtained.
3) Storage of samples
Perform the test immediately after separationof plasma. Store the plasma sample at room
temperature (18–25°C), and perform the test
within 4 hours of separation.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 20 mg/dL), conjugated bilirubin (up to20 mg/dL), hemoglobin (up to 500 mg/dL), orformazin turbidity (up to 3000 FTU).
2) The PT tends to be prolonged when measuring
samples from patients on anticoagulant
therapy.
3) The PT tends to decrease when plasma
samples are contaminated by tissue
thromboplastin.
3. Others
Always use Calibrator N for Coagpia forcalibration.

Description (Kit Components)
Component
Ingredients
Thromboplastin Reagent: Thromboplastin(derived from rabbit brain)
Calcium chloride
Intended Use
Measurement of prothrombin time (PT) using
plasmaThis product is mainly used for assisting thediagnosis of various diseases due to extrinsic
coagulation dysfunction. It is also used formonitoring oral anticoagulant therapy.
The PT test was developed by Quick in 1935 andmeasures the time required for coagulation. It reflects
the activity of coagulation Factor II (prothrombin),Factor V, Factor VII, and Factor X, as well as theleveloffibrinogen.
Becausethistest
comprehensively assesses the activity of thesecoagulation factors, it is essential when screening fora bleeding tendency. It is also commonly used forevaluating the effectiveness of treatment with the oral
anticoagulant warfarin and adjusting the dosage.1Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagent
Thromboplastin Solution: Add the specified
amount of purified water to 1 vial of theThromboplastin Reagent, and dissolve it toprepare the Thromboplastin Solution. Afterdissolution, the Thromboplastin Solution is stablefor 8 days at 2–10°C. Stir this product before use(stir with a stirring bar as required when it isattached to the unit).
2. Assay Procedure
This product is compatible with various types ofblood coagulation analyzer. An example of theassay procedure is indicated below.

Assay PrincipleWhen thromboplastin and calcium are added toplasma samples, coagulation Factor VII is activated1

Plasmasample
50 μL

rinse immediately with ample water as first aid,
and consult the doctor if required. Handle theprepared Thromboplastin Solution similarly.
2. Precautions for use
1) This product should be stored as directed. Closethe cap of the vial containing the prepared
Thromboplastin Solution, and store it at 2–10°C
with protection from freezing. Avoid freezing.
Do not use this product if it has been frozen
because freezing can cause deterioration of thereagents, leading to inaccurate results.
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 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.
5) Sodium azide has been added as an antiseptic
agent in this product. It can react with lead orcopper pipes to produce the highly explosivemetal azide. Therefore, the reagent should beflushed with large amounts of water during
disposal. Handle the prepared Thromboplastin
Solution similarly.
4. Other precautions
Do not use the containers for other purposes.

37C
Thromboplastin Solution────▶
100 μL
37C────▶ Measurement of clotting time

Calibration material: Calibrator N for Coagpia(Manufacture's assigned value)
3. Precautions for testing
1) Before dissolution, warm the Thromboplastin
Reagent to room temperature (15–30°C).
2) Add the specified amount of purified water to1 vial of the Thromboplastin Reagent, fit the
inner stopper, mix gently, and let stand for 30
minutes at room temperature (15–30°C).
After confirming that the contents of the vial
are completely dissolved, gently mix thesolution by inversion before use. At this time,
avoid vigorous mixing.
3) After completion of measurement, tightly
close the container, and store at 2–10°C.
Assessment of Assay Results ＊＊1. Reference standard range3)
80–120 % (PT activity)
2. Precautions for Assessment
There may be reactions or interfering reactions
with non-target substances. If assay results appear
to be unreliable, repeat the measurement or try
another analytical methods.
Performance ＊＊1. Sensitivity
When the test is performed using normal plasma
or 1:4 diluted normal plasma, the PT is ≤ 14
seconds and 25–42 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): (Coapresta 2000)
5–130 %
5. Correlation4) (Coapresta 2000)
1) N=138
r=0.994y=0.96x–1.6
Control method: Approved in vitro diagnostic(clotting time method)2) N=138
r=0.985 y=1.03x–5.1
Control method: Approved in vitro diagnostic(clotting time method)
6. Standard Material
Pooled plasma obtained from healthy volunteers(in-house reference standard)＊ ＊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.)
Packaging
Name
Thromboplastin
Coagpia PT-N
Reagent

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) Sodium azide is added as an antiseptic agent inthis product. Therefore, if the reagent comes in
accidentally contact with eyes, mouth or skin,

Package
10×for 4mL

Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊＊1) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 395,
Kanehara Shuppan, 2015.
2) Edited by the Japanese Society for Laboratory2Hematology: J Jpn Soc Lab Hematol, 17(2), 149–157, 2016.
3) Laboratory Test Data Book, Igaku-Shoin, 315,2001–2002.
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, Japan

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