The Cr eati ve Approach to Bio sc ie nce

Anti-cyclic Citrullinated Peptide

Antibody Assay Kit
(Anti-CCP)
REF: 550 000 100 T REF: 550 001 200 T
R1 1 x 15 ml R1 1 x 30 ml
R2 1 x 5 ml R2 1 x 10 ml

Intended Use
The Anti-CCP assay is intended for in vitro quantitative detection of
Anti-cyclic citrulline peptide antibody (Anti-CCP) in human serum
samples.
Specimen Collection and Preservation
Background
Fresh Serum. Fasting blood is the extract sample for testing.The
Anti-cyclic citrullinated peptide (CCP) antibody is an autoantibody sample can be stable for 7 days at 2-8 oC and for 12 months at -20
against citrulline antigen that appears in patients with rheumatoid oC.
arthritis and is one of the important indicators for early diagnosis of
rheumatoid arthritis (RA). Anti-CCP helps in the early diagnosis of
rheumatoid arthritis: The antibody can appear before the clinical System Parameter
manifestations of the disease, and can appear several years before
the typical clinical symptoms of RA. The positive appears earlier Wavelength 700 nm
than the RF, and the specificity is higher than that of the RF. Combined Optical path 1 cm
with RF detection, the laboratory detection rate of RA can be improved. Assay type Fixed Rate
In recent years, studies have found that anti- CCP-positive rheumatoid Temperature 37 oC
arthritis patients have more severe bone destruction than negative Incubation time 5 minutes at 37oC
patients. A high concentration often indicates a poor prognosis and
a high risk of joint erosion. It is a reliable indicator for observing the Procedure
condition and the efficacy of drugs.
1. Add into Cuvette:
Test Principle Sample (S) 10 l
Reagent 1 (R1) 150 l
The kit adopts the principle of latex enhanced turbidimetric 2. Mix well and incubate for 5 minutes at 37oC,
immunoassay, the latex particles coated with cyclocitrulline peptide Reagent 2 (R2) 50 l.
is used to react with anti-cyclic citrulline peptide antibody in the 3. Mix well and incubate 30 seconds at 37 oC ,Read
sample to form insoluble immune complex and to give turbidity to absorbance A1.
the reaction solution. The turbidity of the reaction solution can reflect 4. After incubating for another 270 seconds, read the absorbance A2
the concentration of anti-cyclic citrulline peptide antibody in the and calculate
sample, and the concentration can be determined by the A=A2-A1
concentration-absorbance reaction curve obtained by calibrator.
Calibration
Reagents
It is recommended to use spectrum calibrator. 5- point nonlinear
Reagent 1 (R1) calibration, fitting method: spline.

HEPES 50.0 mmol/L 1. According to the requirements of the calibration procedure in the
operation manual of biochemistry analyzer, each laboratory establishes
(4- hydroxyethylpiperazineethanesulfonic acid) buffer its own calibration procedure according to the specific
conditions.
Reagent 2 (R2)
2. Requirements for calibration and frequency: It is recommended to
Latex 0.2% (w/v) calibrate at least every five days. When the following situations occur,
it is recommended to re-calibrate: change the reagent batch number,
Particles coated with cyclic citrullinated peptides the indoor quality control runs out of control, the biochemistry analyzer
carries out major maintenance or replaces the main parts such as
Material Required but not provided light source or cuvette.

Calibrator set 5 x 0.5 ml (Ref. No. 550 001-C) 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
the results deviate from the scope, please find out the reason by
All human blood components used to prepare controls have been following steps:
tested for Hepatitis B surface antigen (HBsAg) and HTLV-III antibodies 1. Check the parameter setting and light source.
by FDA approved procedure and found to be non-reactive 2.Check the cleanliness of the cuvette and sampling
No known test method for HBsAg or HTLV-III antibodies offers total needle.
assurance that a human derived product will not transmit hepatitis 3. Check whether water is contaminated or not.
or HTLV-III virus. The user is therefore cautioned to handle reagents Bacterial growth can lead to incorrect results.
as if being capable of transmitting these diseases. 4. Check the reaction temperature.
5. Check the validity of the kit.
Storage and Stability
Calculation results
The reagents are stable up to the expiration date stated on the label
when stored at 2 – 8 oC.Open vials are stable for 28 days at the According to the project-specific calibration mode, after the instrument
specified temperature. 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
550 001 200 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:[email protected]

IFUFIM22 Rev.(2),3/3/2025