Intended Use
For the determination of anti-human tissue transglutaminase sIgA antibodies in stool.
Contents of Kit
1. PLATE: Microtiter plate, pre-coated 12×8 wells
2. WASHBUF: Wash buffer concentrate, 10×, 2×100 ml
3. CONJ: Conjugate, peroxidase-labelled, ready-to-use 1×15ml
4. CTRL NEG: Control negative, lyophilised (see specification for range) 4×1 vial
5. CTRL POS: Control positive, lyophilised (see specification for range) 4×1 vial
6. CTRL CUT OFF: Cut off control, lyophilised (see specification for concentration) 4×1 vial
7. SUB Substrate (tetramethylbenzidine), ready-to-use 1×15 ml
8. STOP Stop solution, ready-to-use 1×15 ml
9. Extract Extraction buffer concentrate 2.5×, 1×100 ml
Precision
Repeatability (Intra-Assay); n = 40
The repeatability was assessed with 2 stool samples under constant parameters (same operator, instrument, day and kit lot).

Reproducibility (Inter-Assay); n = 18
The reproducibility was assessed with 2 stool samples under varying parameters(different operators, instruments, days and kit lots).

Detection Range
We recommend each laboratory to establish its own reference range
Detection Limit
The lower limit of the measurement range can be calculated as: LoB × sample dilution factor to be used Samples with concentrations lower than the measurement range cannot be clearly quantified.
The following value has been estimated based on the concentration of the calibrator without considering possibly used sample dilution factors.
Limit of blank, LoB: 33.01 U/l
General Description
Human tissue transglutaminase (abbreviated as htTG or TG2) is a 78-kDa, calcium-dependent enzyme of the protein-glutamine γ-glutamyltransferases family. It crosslinks proteins between an ε-amino group of a lysine residue and a γ-carboxamide group of glutamine residue, creating an inter- or intramolecular bond that is highly resistant to proteolysis.
Citations
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