Intended Use
ASCA IgG/IgA ELISA is a test system for the quantitative measurement of IgG and IgA class antiSaccharomyces cerevisiae antibodies (ASCA) in human serum or plasma. Accurate diagnosis of inflammatory bowel disease (IBD), in particular the differentiation between the ulcerative colitis and Crohn's disease, is important for treatment and prognosis. ASCA are strongly associated to Crohn's disease. IgG as well as IgA ASCA show a high specificity for Crohn's disease, and support the differential dignosis of IBD, when combined with other serological markers and clinical tests
Contents of Kit
1. SORB MT 1x 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, 6.3, 12.5, 25, 50, 100 U/ml), containing serum/buffer matrix (PBS, BSA, detergent, NaN3 0.09%), yellow. Ready to use.
3. CONTROL 1 & 2 2x 1.5 ml Control positive (1) and negative (2), containing ASCA 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, containing PBS, BSA, detergent, preservative NaN3 0.09%, yellow, 5x conc.
5. ENZ CONJ IgG 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. ENZ CONJ IgA 15 ml Enzyme Conjugate; containing anti-human IgA antibodies, HRP labelled; PBS, BSA, detergent, preservative ProClin 300 0.05%, light red. Ready to use.
7. SUB TMB 15 ml TMB Substrate; containing 3,3', 5,5'- Tetramethylbenzidin, colorless. Ready to use.
8. STOP SOLN 15 ml Stop solution; contains acid. Ready to use.
9. WASH SOLN 50x 20 ml Wash Buffer, containing Tris, detergent, preservative NaN3 0.09%; 50x conc.
10. 1 Instruction for Use
11. 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, since no international reference preparation is available for this assay.
Measuring range
The calculation range of this ELISA assay is
IgG: 0 - 100 U/ml IgA: 0 - 100 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: IgG-IgA, 10 U/ml-10 U/ml
Interpretation of results - IgG/IgA
Negative: < 10 U/ml
Positive: ≥ 10 U/ml
IgG
Sensitivity: 75.0 %
Specificity: 96.9 %
Overall agreement: 89.1 %
IgA
Sensitivity: 62.5 %
Specificity: 97.7 %
Overall agreement: 85.1 %
General Notes
ASCA IgG/IgA ELISA is a test system for the quantitative measurement of IgG and IgA class antiSaccharomyces cerevisiae antibodies (ASCA) in human serum or plasma. Accurate diagnosis of inflammatory bowel disease (IBD), in particular the differentiation between the ulcerative colitis and Crohn's disease, is important for treatment and prognosis. ASCA are strongly associated to Crohn's disease. IgG as well as IgA ASCA show a high specificity for Crohn's disease, and support the differential dignosis of IBD, when combined with other serological markers and clinical tests
COA
Publication 
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