This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 21000AMZ00558000**Revised: January 2017 (8th edition)*Revised: April 2008 (7th edition)

This package insert must be read carefully prior to use.
Protein C assay kit(Classification No.: 30588000)

measurement of protein C to prepare activatedprotein C. Activated protein C decomposes thesynthetic chromogenic substrate (S-2366) torelease p-nitroaniline. The activity of protein C inthe sample is determined through measurement ofreleased p-nitroaniline by colorimetry.

Testzym S PC
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.

ProtacProtein C

Activated protein CAAAA

AA

pNA

AApNA

(S-2366)
AAAA

Colorimetry

2. Features
1) 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 activated protein C.
4) This product shows good quantification andexcellent reproducibility.
5) Applicable to various automated analyzers.
＊＊

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 notbe used.
2) Storage of samples(1) If the isolated serum sample cannot be testedon 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.

Description (Kit Components) ＊＊Component
Ingredients
Activating Solution: Protac (Russell’s viper venom,
derived from Agkistrodon
contortrix contortrix)
Substrate Solution:
L-Pyroglutamyl-L-prolyl-Larginyl-p-nitroanilidehydrochloride (S-2366)
Intended Use
Measurement of protein C in plasma
Protein C is a vitamin K-dependent factor that is
synthesized in the liver. Activated protein C plays animportant role in the control of blood coagulation byproteolytic inactivation of Factors V and VII. It is
known that serious thrombosis can occur in patientswith congenital protein C deficiency. Measurement ofprotein C activity is essential when screening for athrombotic tendency. The blood level of protein C isaltered in patients with various diseases andsymptoms, e.g., it shows a decrease in patients withdisseminated intravascular coagulation (DIC) or liver
disorders and those on oral anticoagulant therapy.
Therefore, measurement of protein C activity isuseful when screening for these diseases, as well asfor analysis of disease pathology and estimation ofthe prognosis.
Assay Principle
1. Assay Principle
Add Protac (Russell’s viper venom) which
specifically activates protein C to the sample for

Dosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): Activating Solution is ready to use.

1

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)5 μL
200 μL

carefully as with samples, considering the riskof infectious.
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.
4. Other precautions
Do not use the containers for other purposes.

37C5 min37C
Reagent (2)100 μL 35–106 sec

Measurement(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: Purified water or saline

Assessment of Assay Results
1. Reference standard range
97  15 %2)(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 -0.02 to 0.02
2) Sensitivity: The difference of absorbance
between 100 % normal plasma andphysiological saline is from 0.050 to 0.075.
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 Range7): (On Hitachi 7170
automated analyzer)
5–180 %
5. Correlation7)
Plasma N=87 r=0.984 y=0.97x–2.35
Control method: Approved in vitro diagnostic(synthetic chromogenic substrate 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: 13 months from the date ofmanufacture(The expiration date is printed on the outerpackage.)
Packaging
NamePackage

Activating Solution

2 × 8 mL

Substrate Solution

2 × 8 mL

Testzym S PCConstituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊1) Esmon C.T.: Blood, 62, 1155, 1983.
2) Suzuki K. et al.: J Med Tech, 28, 25, 1984.
3) Sala N. et al.: Blood, 63, 1984.
4) Klein J.D. & Walker F.J.: Biochem, 25, 4175,1986.
5) Martinoli J.L. & Stocker K.: Thromb Res, 43, 253
1986.
6) Akatsu S. et al.: J Clin Lab Inst Reag, 21, 125,
1998.
7) In house data, 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 asa material possibly infected with HIV, HBV,HCV, or other viruses. To prevent infection, use
disposable gloves and avoid mouth pipetting
during the test.
2)
Normalplasma“Daiichi”
contains
human-derived components determined as
HBsAg-negative, HIV antibody (AIDS virusantibody) negative, and HCV antibody negative.
When using, however, it should be handled very

Contact ＊SEKISUI MEDICAL CO., LTD.
international@sekisui.com

2＊＊Manufacturer ＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan

Licensed by3