AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis.30'+30'+30' automation incubation.

AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis. 30'+30'+30' automation incubation.

AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis

AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis.

AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel.

Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.

Captia™ MPO

Captia™ PR-3

Gold Standard Diagnostics Is-Anti-MPO (P-ANCA) IgG ELISA Test Kit

Gold Standard Diagnostics Is-Anti-PR3 (C-ANCA) IgG ELISA Test Kit

1. 1 QUANTA Flash MPO Reagent Cartridge

1. 1 QUANTA Flash PR3 Reagent Cartridge

1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coverslips (20 ea)4. 1 x 0.5mL IFA System Negative Control5. 1 x 0.5mL cANCA Positive6. 1 x 0.5mL pANCA Positive7. 20 x ANCA (Formalin Fixed Human Neutrophil) Slide (12 well)8. 2 x 25mL PBS II Concentrate (40x)

1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coverslips (20 ea)4. 1 x 0.5mL IFA System Negative Control5. 1 x 0.5mL cANCA Positive6. 1 x 0.5mL pANCA Positive7. 20 x ANCA (Ethanol Fixed Human Neutrophil) Slide (12 well)8. 2 x 25mL PBS II Concentrate (40x)

1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. MPO SC Coated Wells: 12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. MPO SC ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. MPO SC 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 MPO SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use.10.TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use.11. HRP 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. MPO SC Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. Type III Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use.5. HRP Wash Concentrate: 10 bottles containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. MPO SC ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7.MPO SC 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 MPO SC IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11.HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use.

"1. Instruction leaflet: 2. QC Certificate3. PR3 SC Coated Wells: 12 breakapart 8 well strips 4. Type III Sample Diluent: 2 bottles containing 50mL 5. HRP Wash Concentrate: 1 bottle containing 25mL6. PR3 SC ELISA Calibrators: 5 bottles each containing 1.2mL 7. PR3 SC Positive Control: 1 bottle containing 1.2mL 8. ELISA Negative Control: 1 bottle containing 1.2mL 9. HRP PR3 SC IgG Conjugate: 1 bottle containing 10mL 10. TMB Chromogen: 1 bottle containing 10mL 11. HRP Stop Solution: 1 bottle containing 10mL

1 .Instruction leaflet: Giving full assay details.2.QC Certificate: Indicating the expected performance of the batch.3. PR3 SC Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with PR3 antigen, colour coded red. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4.Type III Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use.5. HRP Wash Concentrate: 10 bottles containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. PR3 SC ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-PR3 autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. PR3 SC Positive Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use.8.ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use.9. HRP PR3 SC IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use.10.TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use.

1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 1x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 10 Coverslips

1. 10x 6-well ANCA Neutrophil substrate slides (formalin-fixed)2. 1x 1mL pANCA Positive Control (prediluted) 3. 1x 1mL ANA Positive Control (prediluted) 4. 1x 1mL IFA System Negative Control5. 1x7mL anti Human IgG AFF Fluorescein with Evans Blue6. 2x 25mL PBS II Concentrate (40x) 7. 1x 3mL 1% Evans Blue Counterstain8. 1x 3mL Mounting Medium9. 1x 10 Coverslips10. 1x Instruction leaflet

1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 2x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 20 Coverslips

1. 20x12-well ANCA Neutrophil substrate slides (formalin-fixed)2. 1x 1mL pANCA Positive Control (prediluted) 3. 1x 1mL cANCA Positive Control (prediluted) 4. 1x 1mL ANA Positive Control (prediluted) 5. 1x 1mL IFA System Negative Control6. 1x 15mL anti Human IgG AFF Fluorescein with Evans Blue7. 2x 25mL PBS II Concentrate (40x)8. 1x 3mL 1% Evans Blue 9. 1x 10mL Mounting Medium10. 1x 20 Coverslips11. 1x Instruction leaflet

1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 2x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 20 Coverslips

1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 1x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 10 Coverslips

"1 .20x ANCA (Formalin Fixed Human Neutrophil), slides - 12 wells2. 1x 15mL FITC IgG Conjugate with DAPI 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 2x25mL PBS II Concentrate (40x)8. 1x 7mL Mounting Medium9. 1x 20 Coverslips10. 1x Direction Insert"

1. 20x ANCA (Ethanol Fixed Human Neutrophil), slides - 12 wells2. 1x 15mL FITC IgG Conjugate with DAPI 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 2x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 20 Coverslips9. 1x Direction Insert

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

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

Anti-PR3 is an ELISA test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.

Anti-MPO is an ELISA test system for the quantitative measurement of IgG class autoantibodies against myeloperoxidase (MPO) in human serum or plasma. This product is intended for professional in vitro diagnostic use only.

EliA ANCA/GBM Positive Control 2500/5000

EliA PR3S Well

EliA MPOS Well