ALLERGY & AUTOIMMUNITY -  - -  - T a b l e o f C Page o n Introduction 5 t e Available assays 6 n t s Overview of instruments and assays 7 Allergy and asthma assays ImmunoCAP® Total IgE 8 ImmunoCAP® Total IgE low range 9 ImmunoCAP® Specific IgE 0 ImmunoCAP® Phadiatop / Phadiatop Infant  ImmunoCAP® Specific IgG  ImmunoCAP® Specific IgG4  ImmunoCAP® Specific IgA 4 ImmunoCAP® ECP 5 ImmunoCAP® Tryptase 6 ImmunoCAP® Allergen components 7 ImmunoCAP® Allergens 9 ImmunoCAP® Antigens  ImmunoCAP® Rapid 4 ImmunoCAP® ISAC 5 Autoimmunity assays EliA™ 8 Varelisa® 4 ImmunoCAP® Thyroglobulin IgG / Thyroid Peroxidase IgG 4 ImmunoCAP® Gliadin IgA/IgG 44 Phadia® Laboratory Systems Phadia® 5000 45 System reagents, Accessories and Software Phadia® 500 46 System reagents, Accessories and Software Phadia® 000 47 System reagents, Accessories and Software Phadia® 50 48 System reagents, Accessories and Software Phadia® 00 49 System reagents, Accessories and Software Quality Club™ 50 Specifications 5 ImmunoCAP®, EliA™ and Varelisa® All Phadia products mentioned herein are produced according to ISO 13485:2003. -  - - 4 - I n t About ImmunoDiagnostics ro d u Phadia, the global leader in allergy and autoimmunity diagnostics, is now the ImmunoDiagnostics c t business of Thermo Fisher Scientific. io n As the ImmunoDiagnostics experts within Thermo Fisher Scientific, we work to dramatically improve the management of allergy, asthma and autoimmune diaseases. We do this by providing healthcare professionals with superior diagnostic technologies and clinical expertise. This results in better healthcare and quality of life for millions of patients and their families. For more information, please visit www.thermoscientific.com/phadia. Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $ billion, we have approximately 7,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications. Visit www.thermofisher.com. - 5 - A v a Immunoglobulin E i l a b Phadiatop® , Phadiatop® Infant Allergy, atopy diagnosis l e Total IgE Allergy diagnosis a s Specific IgE Allergy, allergen-specific diagnosis, Molecular Allergology s a y s Immunoglobulin A Specific IgA Allergy (food-sensitive enteropathies) Gliadin IgA Celiac Disease Immunoglobulin G Specific IgG Allergy, celiac disease, immunotherapy, lung disease, autoimmunity Specific IgG4 Allergy, immunotherapy Gliadin IgG Celiac Disease Thyroid Peroxidase IgG Thyroid autoimmunity Thyroglobulin IgG Thyroid autoimmunity Cellular Markers (Asthma and Inflammation) ECP Asthma, guiding corticosteroid treatment Tryptase Allergy, anaphylaxis, hematological disorders, immunotherapy Autoimmunity EliA CCP Rheumatoid Arthritis ANA / ENA Rheumatology ANCA, GBM Vasculitis Celikey, Gliadin Celiac Disease Calprotectin Inflammatory bowel diseases Varelisa ANA / ENA Rheumatology ACA / βGPI Antiphospholipid Syndrome ANCA, GBM Vasculitis Celikey, Gliadin Celiac disease TG/TPO Thyroid diseases LKM, M etc. Liver diseases etc. ImmunoCAP® Rapid Specific IgE Allergy, allergen-specific diagnosis ImmunoCAP® ISAC Specific IgE Allergy, Molecular Allergology - 6 - O v Overview of instruments and assays e r v i Phadia® 100 Phadia® 250 Phadia® 1000 Phadia® 2500 Phadia® 5000 e w Allergy and Asthma assays o ImmunoCAP Total IgE      f i n ImmunoCAP Total IgE Low Range      s t ImmunoCAP Specific IgE      r u ImmunoCAP Phadiatop/ m Phadiatop Infant      e n ImmunoCAP Specific IgA  – – – – t s ImmunoCAP Specific IgG/IgG4      a n ImmunoCAP ECP    – – d ImmunoCAP Tryptase    – – a s s a y Autoimmunity assays s EliA ANA   –   EliA ANCA/GBM   –   EliA CCP   –   EliA Celikey   –   EliA Gliadin   –   EliA Calprotectin   –   EliA APS   –   ImmunoCAP Thyroglobulin IgG   –   ImmunoCAP Thyroid Peroxidase IgG   –   ImmunoCAP Gliadin IgA/IgG  – – – – - 7 - I m m Total IgE & Total IgE Low Range u n Total IgE measures the quantitative amount of total o IgE in human serum or plasma. IgE antibodies are C produced by the body as a result of repeated allergenic A P stimulation. ® T o t a l I g E Reagents Phadia® 5000 / Phadia® 2500 Product Size Art. No. Total IgE Conjugate 400 6 x 400 10-9480-01 Total IgE Calibrator Strip 5 x 1 curve 10-9387-01 Total IgE Curve Control Strip 5 x 3 pairs 10-9325-01 Total IgE Anti-IgE ImmunoCAP 16 14-4509-01 IgE/ECP/Tryptase Sample Diluent 50 ml 10-9360-01 System reagents, see page 45-46 Control ImmunoCAP Total IgE Control LMH 3 x 2 x 4 10-9447-01 Reagents Phadia® 1000 / Phadia® 250 Product Size Art. No. Total IgE Conjugate 100 6 x 100 10-9319-01 Total IgE Conjugate 400 6 x 400 10-9480-01 Total IgE Calibrator Strip 5 x 1 curve 10-9387-01 Total IgE Curve Control Strip 5 x 3 pairs 10-9325-01 Total IgE Anti-IgE ImmunoCAP 16 14-4509-01 IgE/ECP/Tryptase Sample Diluent 50 ml 10-9360-01 System reagents, see page 47-48 Control ImmunoCAP Total IgE Control LMH 3 x 2 x 4 10-9447-01 Reagents Phadia® 100 Product Size Art. No. Total IgE 96 10-9251-01 Total IgE Calibrators 1 curve 10-9252-01 Total IgE Curve Controls 3 pairs 10-9257-01 IgE/ECP/Tryptase Sample Diluent 6 x 3.0 ml 10-9256-01 System reagents, see page 49 Control ImmunoCAP Total IgE Control LMH 3 x 2 x 4 10-9447-01 Please note that all products are not available in all countries. The article number’s two digit suffix (-01) may vary between countries. - 8 - I m m Reagents Phadia® 5000 / Phadia® 2500 u Product Size Art. No. n o Total IgE Low Range ImmunoCAP 3 x 16 14-4497-35 C Specific IgE Conjugate 100 6 x 100 10-9316-01 A Specific IgE Conjugate 400 6 x 400 10-9310-01 P Specific IgE Calibrator Strip 5 x 1 curve 10-9459-01 ® T Specific IgE Curve Control Strip 5 x 3 pairs 10-9312-01 o IgE/ECP/Tryptase Sample Diluent 50 ml 10-9360-01 t a Specific IgE Anti-IgE ImmunoCAP 16 14-4417-01 l System reagents, see page 45-46 I g E Reagents Phadia® 1000 / Phadia® 250 L o Product Size Art. No. w Total IgE Low Range ImmunoCAP 3 x 16 14-4497-35 R Specific IgE Conjugate 100 6 x 100 10-9316-01 a Specific IgE Conjugate 400 6 x 400 10-9310-01 n g Specific IgE Calibrator Strip 5 x 1 curve 10-9459-01 e Specific IgE Curve Control Strip 5 x 3 pairs 10-9312-01 IgE/ECP/Tryptase Sample Diluent 50 ml 10-9360-01 Specific IgE Anti-IgE ImmunoCAP 16 14-4417-01 System reagents, see page 47-48 Reagents Phadia® 100 Product Size Art. No. Total IgE Low Range ImmunoCAP 3 x 16 14-4497-35 Specific IgE (Conjugate, Curve Controls) 96, 2 pairs CC 10-9462-01 Specific IgE Conjugate 6 x 96 10-9463-01 Specific IgE Calibrators 1 curve 10-9460-01 Specific IgE Curve Controls 3 pairs 10-9408-01 IgE/ECP/Tryptase Sample Diluent 6 x 3.0 ml 10-9256-01 Specific IgE Anti-IgE ImmunoCAP 16 14-4417-01 System reagents, see page 49 Please note that all products are not available in all countries. The article number’s two digit suffix (-01) may vary between countries. - 9 - I m m Specific IgE u n ImmunoCAP Specific IgE provides an objective measurement of o the circulating IgE antibodies and the sensitization to a specific C allergen. Specific IgE antibodies appear as a result of exposure A P and following sensitization to an allergen. ImmunoCAP Specific ® IgE measure IgE antibodies to specific allergens in human serum S or plasma and allows quantitative measurements of a wide p range of individual allergens and allergen components. Over 600 e c different allergens are available for determinations. i fi c I g E Reagents Phadia® 5000 / Phadia® 2500 Product Size Art. No. Specific IgE Conjugate 400 6 x 400 10-9310-01 Specific IgE Calibrator Strip 5 x 1 curve 10-9459-01 Specific IgE Curve Control Strip 5 x 3 pairs 10-9312-01 IgE/ECP/Tryptase Sample Diluent 50 ml 10-9360-01 Specific IgE Anti-IgE ImmunoCAP 16 14-4417-01 System reagents, see page 45-46 Controls ImmunoCAP Specific IgE Control 6 x 4 10-9449-01 ImmunoCAP Specific IgE f1 Control 4 x 4 10-9450-01 ImmunoCAP Specific IgE Negative Control 6 x 4 10-9445-01 Allergens ImmunoCAP Allergens, see pages 9- Reagents Phadia® 1000 / Phadia® 250 Product Size Art. No. Specific IgE Conjugate 100 6 x 100 10-9316-01 Specific IgE Conjugate 400 6 x 400 10-9310-01 Specific IgE Calibrator Strip 5 x 1 curve 10-9459-01 Specific IgE Curve Control Strip 5 x 3 pairs 10-9312-01 IgE/ECP/Tryptase Sample Diluent 50 ml 10-9360-01 Specific IgE Anti-IgE ImmunoCAP 16 14-4417-01 System reagents, see page 47-48 Controls ImmunoCAP Specific IgE Control 6 x 4 10-9449-01 ImmunoCAP Specific IgE f1 Control 4 x 4 10-9450-01 ImmunoCAP Specific IgE Negative Control 6 x 4 10-9445-01 Allergens ImmunoCAP Allergens, see pages 9- Reagents Phadia® 100 Product Size Art. No. Specific IgE (Conjugate, Curve Controls) 96, 2 pairs CC 10-9462-01 Specific IgE Conjugate 6 x 96 10-9463-01 Specific IgE Calibrators 1 curve 10-9460-01 Specific IgE Curve Controls 3 pairs 10-9408-01 IgE/ECP/Tryptase Sample Diluent 6 x 3.0 ml 10-9256-01 Specific IgE Anti-IgE ImmunoCAP 16 14-4417-01 System reagents, see page 49 Controls ImmunoCAP Specific IgE Control 6 x 4 10-9449-01 ImmunoCAP Specific IgE f1 Control 4 x 4 10-9450-01 ImmunoCAP Specific IgE Negative Control 6 x 4 10-9445-01 Allergens ImmunoCAP Allergens, see pages 9- Please note that all products are not available in all countries. The article number’s two digit suffix (-01) may vary between countries. - 0 -