This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218022** Revised: January 2017 (7th edition)* Revised: September 2013 (6th edition)

This package insert must be read carefully prior to use.
C-reactive protein assay kit(Classification No.: 30499000)

CRP in samples + Anti-CRP antibody-coated latex───▶ Agglutination by antigen-antibody
reaction
2. Features
1) This product has a wide measurement range
from low to high concentrations.
2) There is no prozone phenomenon up to highconcentration (100 mg/dL).
3) Cells are seldom contaminated.

QUALIGENT CRP
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 beguaranteed 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.

Procedural Precautions ＊＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma, EDTAplasma and citrated plasma) may be used.
2) Storage of samples1)2)
The isolated serum (plasma) should be testedon the same day.

If samples cannot be measured on the sameday, store in a refrigerator for up to 7 days andsubsequently freeze at below -20C.
Bring samples to room temperature (15–30C) before use.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 50 mg/dL), conjugated bilirubin (up to 50
mg/dL), hemoglobin (up to 1000 mg/dL), orascorbic acid (100 mg/dL).
3. Others
1) Always use Nanopia CRP Calibrator A forcalibration.
2) Precautions for assay range
If the concentration of sample exceeds assay
range, dilute the sample with saline and repeat
the measurement.

Description (Kit Components) ＊＊Component: Ingredients
CRP Buffer Solution 1:
2-Amino-2-hydroxymethyl-1,3propanediol buffer
CRP Latex Reagent 2:
Anti-human C-reactive protein
mouse monoclonal
antibody-coated latex＊ ＊Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): CRP Buffer Solution 1 is ready to use.
Reagent (2): CRP Latex Reagent 2 is ready to use.
Before using this product, gently invert the reagent
bottles to mix them thoroughly, and check that
there are no bubbles.
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.

Intended Use
Measurement of C-reactive protein in serum orplasma
C-reactive protein (CRP) is a protein that is produced
as part of the inflammatory response or due to tissue
necrosis. It reacts with C-polysaccharide to form aprecipitate in the presence of calcium ion.
Measurement of CRP is reported to be useful for
determining whether or not an inflammatory process
is occurring. It is also measured for follow-up andevaluation of the response to treatment.

Sample Reagent (1)+2 L 100 L

Assay Principle
1. Assay Principle
In samples, an antigen-antibody reaction occurs
between CRP and anti-human C-reactive protein
mousemonoclonal
antibody-coatedlatex(anti-CRP antibody-coated latex), resulting in
agglutination of the beads. The CRP content isdetermined by measuring the agglutination as thechange of absorbance.

37C
5 min

Reagent (2)100 L

37C Measurement
35 sec(Absorbance I※)

37C
4 min
25 secMeasurement(Absorbance II※)
Calculation ofconcentration※

Absorbance I and II: The difference in absorbance
between 800 nm and 570 nm.
Calibration material: Nanopia CRP Calibrator A

1

(Manufacture's assigned value)
Reagent blank: Purified water or saline2）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
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge beforeuse.

Assessment of Assay Results ＊＊1. Reference standard range3)
0.00–0.14 mg/dL
2. There may be reactions or interfering reactions
with non-target substances. If assay resultsappear to be unreliable, repeat the measurement(if necessary, after dilution) or try anotheranalytical methods.
Performance ＊1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.015
2) Sensitivity: The change of absorbance is 0.02–
0.20 per 1 mg/dL of CRP.
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-house methods.)
4. Measurement Range7): (On a Hitachi 9000 series
automated analyzer)
0.02–42 mg/dL
5. Correlation7)
1) Serum N=50 r=0.999 y=1.02x–0.07
Control method: Approved in vitro diagnostic(Latex turbidimetric assay)
2) Plasma N=50 r=0.999 y=0.99x+0.03
Control method: Comparison with the values
for plasma samples obtained simultaneouslywith the serum samples.
6. Standard Material
ERM-DA470/IFCC (IRMM)

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 ＊NameQUALIGENTCRPPrecautions 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)Proclin 300, which possesses skin-irritative
potential, is added as an antiseptic agent in theCRP Buffer Solution 1 and CRP Latex Reagent
2. Therefore, if the reagent comes in contact
with skin or clothes, rinse immediately withample water, and consult the doctor if skinirritation 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 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.

Package
CRP Buffer
Solution1Set
1×15.0 mL(Cassette forHitachi 9000
CRP Latexseries)
Reagent 2
1×15.0 mL
CRP Buffer
Solution1
L set
1×22 mL(Set for Hitachi
LABOSPECTCRP Latexseries)
Reagent 2
1×22 mLCRP Buffer
Solution 1
LL set1×60 mL(Set for Hitachi
LABOSPECTCRP Latexseries)
Reagent 2
1×60 mL×2×2×1

References ＊＊1) Medical Practice Editorial Board: Laboratory test
guide 2013–2014, 202, Bunkodo, 2013.
2) Comprehensive blood and urine chemical tests
and immunological tests (1): Jpn J Clin Med, 57,
197 (1999 extra edition).
3) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 467,
Kanehara Shuppan, 2015.
4) Ujiie S. et al.: J Clin Lab Inst Reag, 26(6), 491,
2003.
5) Onoda C. et al.: J Jpn Soc Clin Labo Autom,
29(5), 612, 2004.
6) Nihonmatsu H. et al.: J Jpn Soc Clin Labo Autom,
30(3), 268, 2005.
7) In house data, SEKISUI MEDICAL CO., LTD.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com

2Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan3