CRP

C-REACTIVE PROTEIN REAGENT KIT （LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） 3. Testing procedure
Sample volume: 2μL Temperature: 37℃
Reagent 1 volume: 320μL Reagent 2 volume: 80μL Main wavelength: 546nm
◆Product Name Absorbance A1
C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） Absorbance A2

◆Intended Use 300s 24s 276s

The reagent is used for the in vitro quantitative determination of c-reactive protein content in human serum.
C-reactive protein is a major human acute phase response protein, acute phase C-reactive protein concentration can be
increased thousands of times. Half-life of CRP in the circling is 19 hours. Human CRP is produced by the liver. It is a cyclic
pentamer formed by five identical subunits rely on non-covalent. This characteristic structure make it belongs to five poly (a
group of immune defense properties of calcium-binding protein) family. 4. Calibration
CRP positive can be found in pneumonia, nephritis, and acute infection, trauma, and tissue necrosis, myocardial infarction, It is suggested to use supplementary calibrator to conduct 5-point calibration. The calibration curve is formed automatically.
heart failure, leukemia, cholelithiasis, hepatitis, dysentery, rheumatic fever, polyarteritis nodosa, tuberculosis, and vaccine When lot number is changed or QC is invalid, calibration shall be conducted again.
vaccinations, etc. But the virus infection is usually negative or weakly positive, it could serve as identification of indicators of 5. QC
bacterial infection and virus infection. It is suggested to use QC products produced by Dirui. The laboratory shall establish its own QC area and limit. If QC value is
◆Principle out of control, correction measures shall be taken.
Adopt the latex particle that is sensitized by anti-human C-reactive protein antibody. The latex particles react with the 6. Calculation
C-reactive protein of the sample in the liquid phase and form insoluble antigen-antibody complex and a certain turbidity In accordance with the concentration of multi-point calibration and the change of absorbanceΔA, confirm the calibration
immediately. The level of turbidity reflect the C-reactive protein level of the sample, compared with the same treatment curve employing the nonlinear function(logit-log5P). The concentration value that corresponds to the change of absorbance of
calibrator, you can calculate the C-reactive protein content in the sample. tested sample on the calibration curve is the tested concentration.
◆Reagent Composition ◆Reference Range
Reagent 1 0～6mg/L
The reference range applied is the expected value for this method, which is only for reference. It is recommended for all
Tris Buffer 20mmol/L
laboratories to do relevant tests to validate such range or establish their own reference ranges.
Reagent 2
◆Explanation of Results
The latex particles coated with anti-human C-reactive protein antibody. Appropriate
The test of C-reactive protein content in serum is only one of the indicators of clinical diagnosis for patients, and clinicians
Component of kits with different lot numbers are not interchangeable.
will conduct a comprehensive diagnosis according to the patient’s body、history diagnosis, as well as other items and
◆Storage Conditions and Shelf Life diagnostic methods.
1. When stored at 2~8℃ and protected from light, the reagent is stable for 12 months.
◆Limit
2. It is stable for 30 days at 2~8℃ after opened. The reagent should not be frozen.
1. The accuracy of results relies on the control of calibration of the instrument, testing temperature and time.
◆Suitable Device 2. When bilirubin is ＞1368μmol/L, hemoglobin is＞10g/L, triglyceride is ＞50mmol/L, VC is ＞5.7mmol/L, the test result
This reagent is suitable for all kinds of semi-auto and full automatic chemistry analyzers. All kinds of application parameter of may be affected.
automatic chemistry analyzers are prepared for reference.
◆Specifications
◆Sample Requirements
1. Linearity: up to 80 mg/L
1. Fresh serum sample should not be hemolytic.
2. Blank absorbance:A≤3.000
2. The fibrinogen in the serum should be eliminated by centrifugation before test.
3. The minimum test limit: test normal saline 20 times repeatedly, and the minimum test limit is determined as 1.128mg/L by
3. High hemolysis and fat samples are not suitable for determination.
average +2 times SD.
◆Method 4. Precision: test two samples with different concentration on the same test system within 20 work days.
1. Reagent preparation：Reagent 1 and reagent 2 are liquid reagent ready to use. Shake reagent 2 gently to avoid bubble. Precision of the same lot number n=20 Precision between days n=20
2. Test condition (parameters) QC serum
Temperature 37℃ Reagent 1 Volume 320 μL X ( mg/L) SD CV% X ( mg/L) SD CV%

Main Wavelength 546 nm Optical Path 1.0cm Sample 1 13.53 0.66 4.88 15.28 0.29 1.90
Sample Volume 2 μL Reagent 2 Volume 80μL Sample 2 43.62 1.02 2.34 64.87 1.44 2.22
Absorbance Range 0~3.2A Reaction Time 300s 5. Method comparison: Conduct tests upon 200 samples with reagent y of the company and the on the market reagent x, the
Test Mode 2 point end assay Delay Time 24s relevance between our reagent (y) and approved market reagent (x) is: y=0.8336x+1.1386 r=0.9918.
◆Standardization Traceability
The constant value of calibrator can be traced to international reference ERM-DA472/IFCC.
 Positive Positive Positive Positive Positive Positive Positive Positive Positive Positive
◆Matters Need Attention Reaction type
reaction reaction reaction reaction reaction reaction reaction reaction reaction reaction
1. Cautions for operation -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower -3.3 lower
Prozone check
1.1 The product is only for in vitro diagnosis. limit limit limit limit limit limit limit limit limit limit
1.2 Do not add reagent during the test. Calibration method Logit-log5p Logit-log5p Logit-log5p Logit-log5p Logit-log5p Logit-log5p Logit-log5p Logit-log5p Logit-log5p Logit-log5p
1.3 Volume of reagent and sample can be changed proportionally in accordance with the requirements of instrument.
2. Cautions for safety Deflection check 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1

2.1 Consider the product as dangerous materials that may cause HIV, HBV, HCV and other infections. To avoid the risk, use Discreteness check 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1
single-use gloves.
2.2 Avoid contact with skin, clothes, and eyes. Once in contact with skin or clothes, rinse the contact part with plenty of water, Sensitivity check 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05

and go to see a doctor. Blank horizontal

-1~1.5 -1~1.5 -1~1.5 -1~1.5 -1~1.5 -1~1.5 -1~1.5 -1~1.5 -1~1.5 -1~1.5
2.3 The samples and waste liquid have potential infectious risk, and the user should manage them according to the laboratory check

safety operation rule, local laws and regulations. Linearity range 1~80 1~80 1~80 1~80 1~80 1~80 1~80 1~80 1~80 1~80

◆Reference
1. Lars-Olof Hanson et al. Current Opinion in Infect. Diseases 1997; 10:196～201.
2. Chetana Vaishnavi. Immunology and Infetious Diseases 1996; 6:139～144.
3. NCCLS.Interference Testing in Clinical Chemistry;Approved Guideline,2005.
◆Date of Approval and Revision: 11/2018

◆Packaging Specification
No. Specifications Type

232021602025 R1:2×60mL R2:2×15mL Calibration sample: 1mL Dirui CS-400/600/800/1200/1300/1600/6400 package

232021602029 R1:2×60mL R2:2×15mL Calibration sample: 1mL Dirui CS-240/300 package

232021602030 R1:2×60mL R2:2×15mL Calibration sample: 1mL Dirui CS-T series package

232021602031 R1:1×40mL R2:1×10mL Calibration sample: 1mL Dirui CS-T series package

232021602032 R1:1×40mL R2:1×10mL Calibration sample: 1mL Dirui CS-T series package

◆P.S.：CS Series Auto-Chemistry analyzer parameters

Model CS-240 CS-300 CS-400 CS-600 CS-1200 T240 T300 CS-6400 CS-1600 CS-1300

Item CRP CRP CRP CRP CRP CRP CRP CRP CRP CRP

Unit mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L mg/L

Method 2 point end 2 point end 2 point end 2 point end 2 point end 2 point end 2 point end 2 point end 2 point end 2 point end

Time 20 20 10 10 10 13 10 9 12 9

Photometric point 18~31 18~31 18~31 17~41 17~31 22~41 22~47 15~31 15~31 17~33

Main wavelength 546 546 546 546 546 546 546 546 546 546

Sub wavelength 0 0 0 0 0 0 0 0 0 0

Reagent R1/T1 320 320 320 320 320 320 320 280 280 320

R2/T2 80 80 0 80 0 80 80 70 70 0

R3/T3 —— —— 80 —— 80 —— —— —— —— 80

R4/T4 —— —— 0 —— 0 —— —— —— —— 0

Normal volume of
2 2 2 2 2 3 3 1.8 1.8 2
serum sample

Absorbance limit 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3