Version: A/5

Instruction for C-Reactive Protein (CRP) Detection Kit

(Nephelometry)
【Product Name】 Put the corresponding magcard onto the magnetic induction area,
Generic name: C-Reactive Protein (CRP) Detection Kit (Nephelometry) when a “di” sound heard, the magcard was successfully swiped, and
Trade name: CRP the interface returns to the main measurement interface. For the
English name: C-Reactive Protein (CRP) Detection Kit (Nephelometry) same batch of reagents, no need to swipe the card again.
【Package】 3) The instrument interface prompts “Input Cup!”.
Specification 1: 25T/kit REF: 32026009 4) Take out one cuvette, put one stirrer into it, then use the pipettor to
Specification 2: 2×25T/kit REF: 32080009 accurately add in 600μl buffer solution, then add in 2μl sample.
Specification 3: 50T/kit REF: 32027009 5) Put the cuvette into the test channel, the instrument automatically
Specification 4: 100T/kit REF: 32028009 stir for one time.
Specification 5: 150T/kit REF: 32029009 6) The instrument prompts “Please Add Antiserum”, then use the
Specification 6: 200T/kit REF: 32030009 pipettor to accurately add in 60μl antiserum.
Specification 7: 250T/kit REF: 32031009 7) Immediately press the corresponding channel’s start button, the
Specification 8: 300T/kit REF: 32032009 instrument will stir automatically. When the test finished, the
【Intended Use】 instrument will automatically display and print the test result.
For in vitro quantitative determination of C-reactive protein (CRP) content in 8) After the test, take out the cuvette, the instrument prompts “Input
human serum or whole blood. Cup!”, do the next test.
【Test Principle】 2. Fully-auto specific protein analyzer (PA120, PA200) detection
Couple the specific CRP antibody onto the latex particles to make a specific methods are as follows
combination with the CRP in the sample and form an immune complex with 1) Login fully-auto specific protein analyzer PA120, PA200 PC software,
latex – antibody - CRP antigen. The complex’s production is in positive put the magcard onto the magnetic induction area, the instrument will
correlation with the CRP concentration of the sample. This immune complex prompt the card is successfully swiped, for the same batch of
can be detected by the specific protein analyzer. The reagents are reagents, only swipe the card once.
pre-calibrated, each specific calibration curve has been recorded into the 2) Login the main measurement interface, apply for testing according
magcard, and each detection kit is allocated with one magcard. to the items and sample types to be tested.
【Main Compositions】 3) Put the test sample in place, then put the corresponding reagents
1. Buffer solution: phosphate buffer 20mmol/L, sodium chloride 15.8g/L at the specified locations and start the test, the instrument will
2. Antiserum: 3-hydroxymethyl aminomethane - hydrochloric acid (Tris - HCl) automatically aspirate all the test samples and complete the
20mmol/L, rabbit anti human CRP antibody coupled latex particles 2g/L measurement process. After the test is completed, you can view the
3. Magcard: polyvinyl chloride (PVC) plastic measurement results and print the test results.
4. Stirrer: stainless steel 4) Please refer to PA120, PA200 manual for detailed description of
【Accessories Required But Not Provided】 instrument operation method.
1. Pipettor 【Reference Value】
2. Pipettor tips Reference range: ≤ 10mg/L
3. Reaction cup 【Explanation for the Test Results】
【Storage and Validity Period】 If the sample’s test result is beyond the linearity range, please use distilled
The sealed detection kit can be stored at 2-8℃ for 12 months. Do not freeze. water to dilute the sample with integral multiples and re-test. The result
Once opened, the antiserum stored at 2-8℃ is stable for 30 days, the buffer should multiply the dilution times.
stored at room temperature (18-25℃) is stable for 90 days. Calculation method: Fitting the standard multi-point calibration curve by
【Applicable Instruments】 appropriate mathematical model (nonlinear) such as Logit / Log. Sample
Applicable for PA50&PA54 Specific Protein Analyzer and PA120& PA200 concentration value is obtained by calibration curve.
Fully-auto Specific Protein Analyzer manufactured by Genrui Biotech Inc. to 【Calibration and QC】
quantitatively test the C-reactive protein in the serum and whole blood. 1. Calibration
【Sample Requirements】 It is recommended to use Randox or an internationally recognized CRP
The optimal sample is non-hemolyzed fresh serum or whole blood. The fresh calibrator. The calibration period is 30 days. Recalibration is needed when
serum will be released from the condensation of blood clots, The C-reactive replacing the batch number of reagents.
protein in the sample stored at 2-8℃ is stable for 7 days. 2. QC
【Test Methods】 It is recommended to use QC with normal and pathological values to do
Bring all reagents to room temperature (18-25℃) before the use. the indoor quality control, the tested control value should be within the
1. Test methods for PA50&PA54 Specific Protein Analyzer definite limits, if the value is out of control, the laboratory should take
1) After startup, the instrument displays the main measurement interface, appropriate corrective measures.
select the test item and sample type at the item column (After the 3. QC Solution (optional)
confirmation, it will default to this item and sample type in the future.). 3.1 Product Name: CRP QC
2) Click “LOT” at the batch No. column to enter the card-swiping interface. 3.2 Package Specification

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Web: www.genrui-bio.com
P04.04.020108-05
 Version: A/5
0.2ml/bottle Batch code
3.3 Intended Use
Temperature limit
Intended for in vitro diagnostic use in the quality control of diagnostic assays.
3.4 Main Composition: CRP antigen Use-by date
3.5 Storage and Validity Period
Authorized representative in the
The QC can be stored for 12 months at 2-8℃. It is stable for 30 days at 2~8℃
European Community
once opened.
3.6 Target and Limitation Volume

Please refer to the label.

Consult instructions for use
3.7 Test Method
The test procedure is same as sample (serum) test, please refer to the sample Do not re-use
test method above.
【Limitations for the Test Results】 Keep away from sunlight
The diagnosis and treatment cannot only depend on this test result, please
consider the clinical history and other laboratory test results at the same time. It
Contains sufficient for <n>tests
is suggested that each laboratory builds up its own reference range based on
its own patient group.
Catalogue number
When the test result is suspicious, need to re-test.
【Product Performance Indicators】
CE Marking
1. Analysis sensitivity: 3mg/L
2. Linearity range: 3-300mg/L 【Reference】
(0-10mg/L absolute deviation ±0.5, Ultrarapid, Ultrasensitive One-Step kinetic Immunoassay for C-Reactive
10.1-30mg/L relative deviation ±8%, Protein (CRP) in Whole Blood Samples: Measurement of the Entire CRP
30.1-150mg/L relative deviation ±7%, Concentration Range With a Single Sample Dilution Clin, Chem, Feb
>150.1mg/L relative deviation ±6%) 2002, 48:269-277.
3. Measurement of precision: 【Manufacturer】
Repeatability: CV ≤ 4%, relative deviation of detection kit’s inter batches (R) ≤ Genrui Biotech Inc.
5% Address: 4-10F, Building 3, Geya Technology Park, Guangming
4. Accuracy: Bias% ≤ ±10% District, 518106, Shenzhen, China
5. Specificity: Web: www.genrui-bio.com
When add in 525IU/ml rheumatoid factors, 540IU/ml antistreptolysin O, 【Medical Devices’ Manufacturing Permit No.】
400μmol/L bilirubin, triglyceride<10mmol/L, the test result Bias% ≤ ±10% Guangdong SFDA (State Food and Drug Administration) authorized
Medical Device Manufacturing Permit No. 20041046
【Precautions】 【Medical Devices’ Product Registration】
— Only used for in vitro diagnostic, please refer to the Operation Manual. Certificate No.
— Do not use the expired reagents. Shake the antiserum reagent well before Guangdong SFDA 2016.2401259 (Approved)
use. 【Product Standard Code】
— Do not use reagents of different batches together. YZB/Guangdong --- 0052-2013
— The waste solution after reaction contains both human and animal derived 【Instruction Approved and Revised Date】
materials, should be treated as a potential source of infection. Approved date: October 10th, 2016
Revised date: September 30th, 2018
【Labels】 【Guarantee and Technical Support】
Label Meaning
If invalid message repeats or need technical support, please contact
Date of manufacture Genrui Customer Service and Support Center.

In vitro diagnostic medical device

Manufacturer

Biological risks

Genrui Biotech Inc. -2-

Web: www.genrui-bio.com
P04.04.020108-05