Anti-CCP

The Creative Approach to Bioscience
Anti-cyclic Citrullinated Peptide

Antibody Assay Kit
(Anti-CCP)
REF: 550 000 100 T
R1 1 x 15 ml
R2 1 x 5 ml
Calibrator set 5 level
Intended Use
The Anti-CCP assay is intended for in vitro quantitative detection of Specimen Collection and Preservation
Anti-cyclic citrulline peptide antibody (Anti-CCP) in human serum
samples. Fresh Serum. Fasting blood is the extract sample for testing.The
sample can be stable for 7 days at 2-8 oC and for 12 months at -20
Background oC.
Anti-cyclic citrullinated peptide (CCP) antibody is an autoantibody System Parameter

against citrulline antigen that appears in patients with rheumatoid
arthritis and is one of the important indicators for early diagnosis of
rheumatoid arthritis (RA). Anti-CCP helps in the early diagnosis of Wavelength 700 nm
rheumatoid arthritis: The antibody can appear before the clinical Optical path 1 cm
manifestations of the disease, and can appear several years before Assay type Fixed Rate
the typical clinical symptoms of RA. The positive appears earlier Temperature 37 oC
than the RF, and the specificity is higher than that of the RF. Combined Incubation time 5 minutes at 37oC
with RF detection, the laboratory detection rate of RA can be improved.
In recent years, studies have found that anti- CCP-positive rheumatoid Procedure
arthritis patients have more severe bone destruction than negative
patients. A high concentration often indicates a poor prognosis and 1. Add into Cuvette:
a high risk of joint erosion. It is a reliable indicator for observing the Sample (S) 10 l
condition and the efficacy of drugs. Reagent 1 (R1) 150 l
2. Mix well and incubate for 5 minutes at 37 oC,
Test Principle Reagent 2 (R2) 50 l.
3. Mix well and incubate 30 seconds at 37 oC ,Read
The kit adopts the principle of latex enhanced turbidimetric absorbance A1.
immunoassay, the latex particles coated with cyclocitrulline peptide 4. After incubating for another 270 seconds, read the absorbance A2
is used to react with anti-cyclic citrulline peptide antibody in the and calculate
sample to form insoluble immune complex and to give turbidity to A=A2-A1
the reaction solution. The turbidity of the reaction solution can reflect
the concentration of anti-cyclic citrulline peptide antibody in the Calibration
sample, and the concentration can be determined by the
concentration-absorbance reaction curve obtained by calibrator. It is recommended to use spectrum calibrator. 5- point nonlinear
calibration, fitting method: spline.
Reagents
1. According to the requirements of the calibration procedure in the
Reagent 1 (R1) operation manual of biochemistry analyzer, each laboratory establishes
its own calibration procedure according to the specific
HEPES 50.0 mmol/L conditions.
(4- hydroxyethylpiperazineethanesulfonic acid) buffer 2. Requirements for calibration and frequency: It is recommended to
calibrate at least every five days. When the following situations occur,
Reagent 2 (R2) it is recommended to re-calibrate: change the reagent batch number,
the indoor quality control runs out of control, the biochemistry analyzer
Latex 0.2% (w/v) carries out major maintenance or replaces the main parts such as
light source or cuvette.
Particles coated with cyclic citrullinated peptides
Quality Control
Precautions and Warnings
It is recommended to use spectrum Anti-CCP control. The
absorbance of control should be within the labeled value range. If
All human blood components used to prepare controls have been the results deviate from the scope, please find out the reason by
tested for Hepatitis B surface antigen (HBsAg) and HTLV-III antibodies following steps:
by FDA approved procedure and found to be non-reactive 1. Check the parameter setting and light source.
No known test method for HBsAg or HTLV-III antibodies offers total 2.Check the cleanliness of the cuvette and sampling
assurance that a human derived product will not transmit hepatitis needle.
or HTLV-III virus. The user is therefore cautioned to handle reagents 3. Check whether water is contaminated or not.
as if being capable of transmitting these diseases. Bacterial growth can lead to incorrect results.
4. Check the reaction temperature.
Storage and Stability 5. Check the validity of the kit.
The reagents are stable up to the expiration date stated on the label Calculation results
when stored at 2 – 8 oC.Open vials are stable for 28 days at the
specified temperature. According to the project-specific calibration mode, after the instrument
automatically generates a calibration curve, the content of the test
substance is calculated from the change in absorbance.
Expected Range
0-35 U/mL
Laboratories are suggested to establish its own reference interval
according to age, sex, diet and region.
Interference
The effect of Bilirubin < 20mg/dL, hemoglobin < 200mg/dL, rheumatoid
factor < 500IU/mL, fat emulsion < 0.2%, is less than 10%.
Linearity
Range 10 - 200 U/mL.
In the range of [10, 200] U/mL, the linearity correlation coefficient

r > 0.990. In the range of [10, 50] U/mL, the absolute deviation should
< 5 U/mL. In the range of (50, 100] U/mL, the relative deviation
should <10%.
Waste Disposal
This product is made to be used in professional laboratories.
Please consult local regulations for a correct waste disposal.
S56: dispose of this material and its container at hazardous or
special waste collection point.
S57: use appropriate container to avoid environmental contamination.
S61: avoid release in environment. refer to special instructions/safety
data sheets.
References
1. Vossenaarr ER, van Venrooij WJ. Anti-CCP antibodies, a highly
specific marker for (ealy)rheumatoid arthritis. Clin APPlied Immunol
Rev, 2004; 4: 239-262.
2. Xu Miaogen The value and application of anti CCP
antibodies in rheumatoid arthritis [J] Journal of Radioimmunology,
2013, 26 (6): 756-758
3. Wang Wei. Significance of detecting anti citrullinated peptide
antibodies peptide antibodies in patients with rheumatoid
arthritis [J]. Journal of Clinical Laboratory, 2004, 22 (3): 213
ORDERING INFORMATION
CATALOG NO. QUANTITY

550 000 100 T
Egyptian Co for Biotechnology - Spectrum Diagnostics (S.A.E)

Obour city industrial area. block 20008 piece 19 A. Cairo. Egypt.
Tel: +202 4489 2248 - Fax: +202 4489 2247
www.spectrum-diagnostics.com
E-mail:info@spectrum-diagnostics.com
IFUFIM22 Rev.(1),28/11/2024

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The Creative Approach to Bioscience

Anti-cyclic Citrullinated Peptide

Anti-cyclic citrullinated peptide (CCP) antibody is an autoantibody System Parameter

In the range of [10, 200] U/mL, the linearity correlation coefficient

CATALOG NO. QUANTITY

Egyptian Co for Biotechnology - Spectrum Diagnostics (S.A.E)

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