This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Certification No. 222ADAMX00008000**Revised: January 2017 (4th edition)*Revised: April 2011 (3rd edition)

This package insert must be read carefully prior to use.
Activated partial thromboplastin time assay kit(Classification No.: 38553000)

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 with3.2% 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 (It isparticularly
importanttoperform
centrifugation so that the platelet count of
the plasma sample is < 10000/μL.)(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 1 hour of separation.2)
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 clotting time may be prolonged byheparin.
3) It may also be prolonged by aminoglycosideantibiotics.

Coagpia APTT-NGeneral 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
APTT Reagent:
Phospholipid(derived from rabbit brain)
Ellagic acid
Calcium Chloride Solution:
Calcium Chloride

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
APTT Reagent is ready to use.
Calcium Chloride Solution is ready to use.
2. Assay Procedure
This product is compatible with various types ofblood coagulation analyzer. An example of theassay procedure is indicated below.

Intended Use
Measurement of activated partial thromboplastin
time (APTT) using plasma

Plasmasample50 μL

APTT assay is widely used as a screening test for
intrinsic coagulation factors, for monitoring patientson heparin therapy, or for measuring coagulation
factor inhibitors.1)

37C
Measurement of clotting time──▶

Assay Principle
To the plasma sample, add sufficient phospholipidand ellagic acid to activate contact factors (Factor XII,
prekallikrein, high molecular weight kininogen).
Then add the Calcium Chloride Solution, andmeasure the APTT as the time (coagulation time) inseconds from addition of the solution until fibrin
production.
＊APTTCalcium Chloride
37C37CReagentSolution──▶
──▶
50 μL
50 μL

3. Precautions for testing1) Before use, gently mix the APTT Reagent andCalcium Chloride Solution by inversion. At
this time, avoid vigorous mixing.
2) After completion of measurement, tightly
close the container, and store at 2–10°C.
Assessment of Assay Results ＊＊1. Reference standard range3)
24–39 seconds Because the standard range ofAPTT varies between instruments, please＊

Procedural Precautions ＊1. Properties of Samples and Sampling Methods

1determine it at each laboratory.
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.

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 the Calcium Chloride Solution. It canreact with lead or copper pipes to produce thehighly explosive metal azide. Therefore, thereagent should be flushed with large amounts ofwater during disposal.
4. Other precautions
Do not use the containers for other purposes.

Performance ＊＊1. Sensitivity
The APTT is 25–35 seconds with normal plasma
and 72–119 seconds with 1:4 diluted normal
plasma.
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 Range3): (Coapresta 2000)
20–200 seconds
5. Correlation3)
1) N=95
r=0.969
y=0.97x–0.9
Control method: Approved in vitro diagnostic(clotting time method)2) N=92
r=0.955
y=0.98x+0.1
Control method: Approved in vitro diagnostic(clotting time method)＊ ＊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
NameCoagpia APTT-N

Package

APTT Reagent

10 × 4 mL

Calcium Chloride
Solution

10 × 4 mL

Constituent 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) Sodium azide is added as an antiseptic agent in
theCalcium Chloride Solution. Therefore, if
the reagent comes in accidentally contact witheyes, mouth or skin, rinse immediately withample water as first aid, and consult the doctor
if required.
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 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

References ＊＊1) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 393,
Kanehara Shuppan, 2015.
2) Edited by the Japanese Society for Laboratory
Hematology: J Jpn Soc Lab Hematol, 17(2), 149–157, 2016.
3) 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, Japan2