The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgA antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. 30'+30'+30' automation incubation.

The AESKULISA tTg-G New Generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgG antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum.30'+30'+30' automation incubation.

The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgA antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum.

The AESKULISA tTg-G New Generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgG antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum.

The Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. Each device contains the following: microplate strips with breakaway microwells coated with recombinant human tTG and Gliadin-specific peptide antigen, six levels of calibrators (0, 3, 10, 30, 100, 300 U/mL); positive, negative and cut-off controls (human serum, diluted); wash buffer concentrate; sample buffer; goat anti-human immunoglobulin (IgG) horseradish peroxidase conjugate; 3,3’,5,5’ tetramethylbenzidine (TMB)/H2O2 substrate; and 1M hydrochloric acid stop solution.

The Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. Each device contains the following: microplate strips with breakaway microwells coated with recombinant human tTG and Gliadin-specific peptide antigen, six levels of calibrators (0, 3, 10, 30, 100, 300 U/mL); positive, negative and cut-off controls (human serum, diluted); wash buffer concentrate; sample buffer; goat anti-human immunoglobulin (IgG) horseradish peroxidase conjugate; 3,3’,5,5’ tetramethylbenzidine (TMB)/H2O2 substrate; and 1M hydrochloric acid stop solution.

1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgA):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (0, 10, 20, 50 and 100 AU/ml).4. Control 1: 1x1.5 mL vial.5. Control 2: 1x1.5 mL vial.6. Sample Diluent (10x): 1 x20mL vial.7. Substrate: 1 x15 ml vial.8. Wash solution (20x): 1x50 mL vial.9. Stop Solution: 1 x15 ml vial.

1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgG):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (2, 10, 20, 50 and 100 AU/ml).4. Control 1: 1x1.5 mL vial.5. Control 2: 1x1.5 mL vial.6. Sample Diluent (10x): 1 x20mL vial.7. Substrate: 1 x15 ml vial.8. Wash solution (20x): 1x50 mL vial.9. Stop Solution: 1 x15 ml vial.

1. 1 QUANTA Flash h-tTG IgA reagent cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet

1. 1 QUANTA Flash h-tTG IgA reagent cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet

1. 1 QUANTA Flash h-tTG IgG reagent cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet

1. 10 x Monkey Oesophagus – 5-well slide2. 1 x 1mL Pemphigus Positive Control (prediluted)3. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted)4. 1 x 1mL IFA System Negative Control (prediluted)5. 1 x 7mL FITC IgG (H&L), monkey adsorbed Conjugate6. 1 x 7mL Anti-Human IgA (α) AFF FITC7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25mL PBS II concentrate (x40)9. 1 x 3mL Mounting Medium10. 10 x Coverslips 11. 1 x instruction leaflet

1. 25 x Monkey Oesophagus – 10-well slide 2. 1 x 1mL Pemphigus Positive Control (prediluted)3. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted)4. 1 x 1mL IFA System Negative Control (prediluted)5. 1 x 15mL FITC IgG (H&L), monkey adsorbed Conjugate6. 1 x 15mL Anti-Human IgA (α) AFF FITC7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25mL PBS II concentrate (x40)9. 1 x 10mL Mounting Medium10. 25 x Coverslips11. 1 x instruction leaflet

1. 25 x Monkey Oesophagus – 10-well slide2. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted)3. 1 x 1mL IFA System Negative Control (prediluted)4. 2 x 15mL Anti-Human IgA AFF FITC5. 1 x 3mL 1% Evans Blue Counterstain6. 2 x 25mL PBS II concentrate (x40)7. 1 x 10mL Mounting Medium8. 25 x Coverslips 9. 1 x instruction leaflet

1. 1x F-Actin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted F-Actin IgA ELISA Low Positive4. 1 x1.2mL prediluted F-Actin IgA ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti -human IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

1. 1x h-tTG Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted h-tTG Screen ELISA Low Positive4. 1x 1.2mL prediluted h-tTG Screen ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP h-tTG IgG/IgA Conjugate, (goat), anti-human IgG and IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

1. 1x h-tTG/DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA Low Positive4. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP h-tTG/DGP IgG/IgA, (goat), anti-human IgG and IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

1. Instruction leaflet: Giving full assay details.2.QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgA Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7.R h-tTG IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.8.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP R h-tTG IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. Ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11.Stop Solution HRP: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.

1. Instruction leaflet: Giving full assay details.2.QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 10 bottles containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgA Calibrators: 25 bottles (5 bottles each), containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. R h-tTG IgA Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP R h-tTG IgA Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. Ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB chromogen. Ready to use.11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric Acid. Ready to use.

1. Instruction leaflet: Giving full assay details.2.QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgA Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7.R h-tTG IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate..9. HRP R h-tTG IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen.11.Stop Solution HRP: 1 bottle containing 10mL of 0.344M Sulfuric Acid.

1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgG Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. R h-tTG IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP R h-tTG IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.

1. Instruction leaflet: Giving full assay details. 2. QC Certificate: Indicating the expected performance of the batch. 3. Human Transglutaminase Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 10 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgG Calibrators: 25 bottles (5 bottles each), containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. R h-tTG IgG Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP R h-tTG IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB chromogen. Ready to use.11. Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric Acid. Ready to use.

1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgG Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7. R h-tTG IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 9. HRP R h-tTG IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. 11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid.

1. 1x tTG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. x1 1.2mL prediluted tTG ELISA Low Positive4. 1x 1.2mL prediluted tTG ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

(Human Tissue Transglutaminase)1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ANA ELISA Low Positive4. 1x 1.2mL prediluted ANA ELISA High Positive5. 1x 50mL ANA Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

1. 10x h-tTG IgG ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted h-tTG IgG ELISA Low Positive4. 5x 1.2mL prediluted h-tTG IgG ELISA High Positive5. 9x 50mL HRP Sample Diluent6. 10x 25mL HRP Wash Concentrate, 40x concentrate7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 10x 10mL TMB Chromogen9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

(Human Tissue Transglutaminase) 1. 1x h-tTG IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted h-tTG IgA ELISA Low Positive4. 1x 1.2mL prediluted h-tTG IgA ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

1. 10x h-tTG IgA ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted h-tTG IgA ELISA Low Positive4. 5x 1.2mL prediluted h-tTG IgA ELISA High Positive5. 9x 50mL HRP Sample Diluent6. 10x 25mL HRP Wash Concentrate, 40x concentrate7. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 10x 10mL TMB Chromogen9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples.a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.d. Rehydration Buffer - containing protein stabilizers and preservatives

1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples.a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative.d. Rehydration Buffer - containing protein stabilizers and preservatives

EliA IgA Curve Control

EliA IgA Conjugate

EliA IgA Calibrator Strip

EliA IgA Curve Control Strip

EliA IgA Conjugate 50

EliA IgA Conjugate 200

EliA Celiac Positive Control 2500/5000

Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method.

EliA IgA Calibrator Well

EliA Celikey IgA Well

EliA Celikey IgG Well