Transcription of Package Insert - T-SPOT.com
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Package Insert - T-SPOT.com
PI-TB-US-V5 Package Insert For In Vitro Diagnostic Use Only This Package Insert covers use of: 8 (Multi-use 8-Well Strip Plate Format. Catalogue number: ) 50 (1200 test 96-Well Plate Format. Catalogue number: ) Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed health care professional Package Insert PI-TB-US-V5 Page 2 of 36 INDEX 1. INTENDED USE .. 3 2. SUMMARY & EXPLANATION .. 3 Principle of Test .. 4 3. REAGENTS & STORAGE .. 5 Materials Provided .. 5 Storage & Stability .. 5 Equipment and Materials Required but Not Provided .. 6 4. WARNINGS & PRECAUTIONS .. 6 5. SPECIMEN COLLECTION & HANDLING .. 7 6. INSTRUCTIONS FOR USE .. 8 Reagent Preparation .. 9 Cell Counting and Dilution .. 9 Plate Set Up and Incubation.
T-SPOT.TB Package Insert PI-TB-US-V5 Page 3 of 36 1. INTENDED USE The T-SPOT®.TB test is an in vitro diagnostic test for the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP 10 by capturing interferon gamma (IFN- ) in the vicinity of T cells in human whole blood collected in sodium citrate or sodium or lithium heparin.
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