Intended Use
Anti-Tissue-Transglutaminase IgA is an ELISA test system for the quantitative measurement of IgA class autoantibodies to tissue transglutaminase (tTG) in human serum or plasma. Autoantibodies against tissue transglutaminase (tTG) during a gluten containing diet are the most obvious serologic feature of coeliac disease (CD). Determination of serum levels of IgA against tTG is the first choice in suspected CD. In subjects with either primary or secondary humoral IgA deficiency, at least one additional test measuring IgG class CD-specific antibodies is recommended. The clinical relevance of a positive anti-tTG result should be confirmed by histology of the small intestinal mucosa.
Contents of Kit
1. SORB MT 1 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, 5, 10, 25, 75 and 200 U/ml), containing tTG 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) and negative (2), containing tTG 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, 5xconc.
5. ENZ CONJ 15 ml Enzyme Conjugate; light red, containing anti-human IgA antibodies, HRP labelled; PBS, BSA, detergent, preservative ProClin 300 0.05%. Ready to use.
6. SUB TMB 15 ml TMB Substrate; containing 3,3', 5,5'- Tetramethylbenzidin, 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%; 50 x 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, since no international reference preparation is available for this assay.
Measuring range
The calculation range of this ELISA assay is 0 - 200 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 10 U/ml
Interpretation of results
Negative: < 10 U/ml
Positive: ≥ 10 U/ml
Sensitivity: 100.0 %
Specificity: 97.8 %
Overall agreement: 98.4 %
General Notes
Anti-Tissue-Transglutaminase IgA is an ELISA test system for the quantitative measurement of IgA class autoantibodies to tissue transglutaminase (tTG) in human serum or plasma. Autoantibodies against tissue transglutaminase (tTG) during a gluten containing diet are the most obvious serologic feature of coeliac disease (CD). Determination of serum levels of IgA against tTG is the first choice in suspected CD. In subjects with either primary or secondary humoral IgA deficiency, at least one additional test measuring IgG class CD-specific antibodies is recommended. The clinical relevance of a positive anti-tTG result should be confirmed by histology of the small intestinal mucosa.
COA
Publication 
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