This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20800AMZ10022000**Revised: January 2017 (8th edition)*Revised: April 2008 (7th edition)

This package insert must be read carefully prior to use.
α2-Antiplasmin assay kit(Classification No.: 30574000)

p-nitroaniline. Because the residual activity ofplasmin depends on the activity of α2-plasmin
inhibitor in the sample, α2-plasmin inhibitor
activity can be determined through measurementof the released p-nitroaniline by colorimetry.

Testzym S APL
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. This product should be used only as directed in thispackage insert. Reliability of results cannot be
guaranteed 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.

α2-Plasmin
inhibitor

Plasmin

α2-Plasmin
inhibitor
PlasminPlasmin(Residual activity)(Inactive)
AA AA AA(S-2251)
AAAAAApN
ApN
A
Colorimetry

2. Features1) Dilution of the sample is not necessary.
2) Liquid reagents, ready-to-use.
3) The synthetic chromogenic substrate used inthis product shows extremely high specificity
for plasmin.
4) The physiological activity of α2-plasmin
inhibitor is measured without influence ofother plasmin inhibitors.
5) This product shows good quantification andexcellent reproducibility.
6) Applicable to various automated analyzers.

Description (Kit Components) ＊＊Component
Ingredients
Plasmin Solution:
Plasmin (human origin)
Substrate Solution: H-D-valyl-L-leucyl-L-lysyl-pnitroanilide dihydrochloride(S-2251)＊ ＊Procedural Precautions ＊1. Properties of Samples and Sampling Methods
1) Samples(1) Plasma (citrated plasma) may be used.
(2) Heparin plasma or EDTA plasma should
not be used.
2) Storage of samples1)(1)If the isolated plasma sample cannot betested on the same day, specimens should
be stored as follows:
2–10C: for tests within 1 week≤ -20C: for tests within 1 month
Bring samples to room temperature (15–30C) before use.
(2) Avoid repeated freezing and thawing, orerrors in the assay results may occur.
(3) Use plastic containers and test tubes fordilution and / or storage of plasma.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 50 mg/dL), conjugated bilirubin (up to 50mg/dL), or hemoglobin (up to 1000 mg/dL).
3. Others
1) Always use Normal plasma “Daiichi” forcalibration.
2) Precautions for assay range
If the activity of sample exceeds assay range,
dilute the sample with saline and repeat themeasurement.

Intended Use
Measurement of α2-plasmin inhibitor in plasma
α2-plasmin inhibitor is one of the most important
inhibitory factors that regulates fibrinolysis in theblood. It has attracted attention as an indicator of invivo hyperfibrinolysis. The blood level of α2-plasmin
inhibitor is altered in patients with various diseases
and symptoms, e.g., it shows a marked decrease inpatients who have disseminated intravascular
coagulation (DIC) and liver disorders. Therefore,
measurement of α2-plasmin inhibitor activity isuseful when screening for these diseases, as well as
for analysis of disease pathology, estimation of the
prognosis, and evaluation of the effect of fibrinolytic
therapy.
Assay Principle
1. Assay Principle
When a fixed excess of plasmin is added to asample for measurement of α2-plasmin inhibitor,
the α2-plasmin inhibitor in the sample
immediately binds to plasmin and forms aninactive complex (plasmin/α2-plasmin inhibitor).
When the substrate is added to the sample, it isdecomposed by residual plasmin to release1

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): Plasmin Solution is ready to use.
Reagent (2): Substrate Solution is ready to use.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.
Sample + Reagent (1)4 μL
200 μL

contains
human-derived
components
determined as HBsAg-negative, HIV antibody(AIDS virus antibody) negative, and HCV
antibody negative. When using, however, it
should be handled very carefully as withsamples, considering the risk of infectious.
3) Sodium azide is added as an antiseptic agent inthe Plasmin Solution and Substrate Solution.
Therefore, if the reagent comes in accidentallycontact with eyes, mouth or skin, rinse
immediately with ample water as first aid, andconsult the doctor if required.
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 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.
5) Sodium azide has been added as an antiseptic
agent in the Plasmin Solution and Substrate
Solution. It can react with lead or copper pipes
to produce the highly explosive metal azide.
Therefore, the reagent should be flushed withlarge amounts of water during disposal.
4. Other precautions
Do not use the containers for other purposes.

37C5 min37C
Measurement
Reagent (2)※80 μL 70–142 sec (Absorbance )Calculation ofactivity※Absorbance : The difference in absorbance
between 405 nm and 505 nm.
Calibration material: Normal plasma “Daiichi”(Manufacture's assigned value)
Reagent blank: Saline

Assessment of Assay Results
1. Reference standard range
114.4  20.7 %2)
80–130 %3)(Relative to healthy volunteers [100%])
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: Reagent blank: absorbancevariation being from 0.25 to 0.58
2) Sensitivity: The difference of absorbance
between100%
normalplasmaandphysiological saline is -0.17 to -0.07.
2. Accuracy: 90–110 % of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤5 %(Test methods used for 1.–3. are in-housemethods.)
4. Measurement Range6): (On Hitachi 7170
automated analyzer)
14–130 %5. Correlation6)
Plasma N=80
r=0.990y=0.93x+5.29
Control method: Approved in vitro diagnostic(synthetic chromogenic substrate method)
6. Standard Material
In-house reference standard (pooled plasma
obtained from healthy volunteers)＊＊

Storage and Shelf Life ＊＊1. Storage temperature: 2–10C
2. Shelf life: 13 months from the date ofmanufacture(The expiration date is printed on the outerpackage.)
Packaging＊

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) Plasmin Solution and Normal plasma “Daiichi”

NamePackage

Plasmin Solution

2 × 5.0 mL

Substrate Solution

1 × 4.0 mL

Testzym S APL
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.

2

References ＊1) Naito K., Aoki N.: Thromb Res, 12, 1147, 1978.
2) Asai M. et al.: J Med Tech, 27, 933, 1983.
3) Fujimaki M: Thrombi and Hemorrhage, DIC
Made Simple, Murakami K. (supervisor), Masuda
T. (editor), 114, Yodosha, 1981.
4) Kondo H. et al.: J Clin Lab Inst Reag, 19, 289,1996.
5) Kotani T. et al.: J Jpn Soc Clin Labo Autom, 21,285, 1996.
6) 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

Licensed by3