Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid Sequences of Human Immunodeficiency Viruses Types 1 and 2.'' The guidance document addresses general and specific concerns for gene based detection techniques for human immunodeficiency virus (HIV). The document provides guidance on manufacturing and clinical trial design issues pertaining to the validation of tests based on nucleic acid detection either in the presence or absence of an amplification step.