Intended Use
CCP Ab is an ELISA test system for the quantitative measurement of IgG class autoantibodies against cyclic citrullinated peptides (CCP) in human serum or plasma.
Measurement of anti-CCP antibodies may aid in the diagnosis of rheumatoid arthritis (RA), where anti-CCP antibody levels represent one parameter of a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
Contents of Kit
1. SORB MT One divisible microplate consisting of 12 modules of 8 wells each. Ready to use.
2. CAL A – F 6x 1.5 ml Calibrator A-F (0, 20, 40, 100, 300, 1000 U/ml), containing CCP antibodies in a serum/buffer matrix (PBS, BSA, detergent, NaN3 0.09%), yellow. Ready to use.
3. CONTROL 1 & 2 2x 1,5 ml Control positive (1) & negative (2), containing CCP antibodies in a serum/buffer matrix (PBS, BSA, detergent, NaN3 0.09%), yellow. Ready to use. The concentration is specified on the certificate of analysis.
4. SAM DIL 5x 20 ml Sample Buffer P, containing PBS, BSA, detergent, preservative NaN3 0.09%, yellow, concentrate (5x).
5. ENZ CONJ 15 ml Enzyme Conjugate containing anti-human IgG antibodies, HRP labelled; PBS, BSA, detergent, preservative ProClin 300 0.05%, light red. Ready to use.
6. SUB TMB 15 ml TMB Substrate; containing 3,3',5,5'- Tetramethylbenzidine, colorless. Ready to use.
7. STOP SOLN 15 ml Stop Solution; contains acid. Ready to use.
8. WASH SOLN 50x 20 ml Wash Buffer, containing Tris, detergent, preservative NaN3 0.09%; 50x conc.
9. 1 Instruction for Use
10. 1 Certificate of Analysis
Storage
1. Store test kit at 2-8°C in the dark.
2. Do not expose reagents to heat, sun, or strong light during storage and usage.
3. Store microplate sealed and desiccated in the clip bag provided.
4. Unopened reagents are stable until expiration of the kit. See labels for individual batch.
5. Diluted Wash Solution and Sample Buffer are stable for at least 30 days when stored at 2-8°C. We recommend consumption on the same day.
Performance Characteristics
Calibration
This assay system is calibrated in relative arbitrary units. It is calibrated against an external anti-CCP Assay, since no international reference sera for RA diagnostic are available so far.
Measuring range
The calculation range of this ELISA assay is 0 - 1000 U/ml
Expected values
In a normal range study with samples from healthy blood donors the following ranges have been established with this ELISA assay: Cut-off 20 U/ml
Interpretation of results
Negative: < 20 U/ml
Positive: ≥ 20 U/ml
Sensitivity 91.5 %
Specificity 95.5 %
Overall agreement 93.1 %
General Notes
CCP Ab is an ELISA test system for the quantitative measurement of IgG class autoantibodies against cyclic citrullinated peptides (CCP) in human serum or plasma.
Measurement of anti-CCP antibodies may aid in the diagnosis of rheumatoid arthritis (RA), where anti-CCP antibody levels represent one parameter of a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
COA
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