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www.rddiagnostics.com CONTENTS 1) Intended Use 2) Clinical Background (Summary and Explanation of the Test) 3) Principle of the Assay 4) Kit Contents 5) Reagents / Materials required but not provided 6) Precautions - Safety and Operating 7) Sample Collection 8) Reagent Reconstitution 9) Assay Procedures 10) Calculation of Results 11) Quality Assurance 12) Expected Values 13) Comparative Protocol Evaluation 14) Performance Characteristics 15) Limitations of Use 16) Summary of Protocols 17) References 1