Clinical Investigation Protocol: A Controlled, Observationl Trial of the OraQuick Rapid HIV Self-Test Performance in Untrained Users

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Clinical Investigation Protocol: A Controlled, Observationl Trial of the OraQuick Rapid HIV Self-Test Performance in Untrained Users

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Title: Clinical Investigation Protocol: A Controlled, Observationl Trial of the OraQuick Rapid HIV Self-Test Performance in Untrained Users
Author: OraSure Technologies Inc
Abstract: Acquired Immune Deficiency Syndrome (AIDS), AIDS related complex and pre-AIDS are thought to be caused by the Human Immunodeficiency Virus (HIV). The first AIDS-related virus, HIV-1 9also known as HTLV -III, LAV-1 and ARV)has been isolated from patients with AIDS and from healthy persons at high risk for AIDS. Genetic analysis of HIV-1 isolates has documented the existence of subtypes. To date, eight HIV-1 subtypes (A through H) designated as Group M, have been identified world-wide in addition to the highly divergent HIV-1 isolated from AIDS patients in Cameroon, designated as Group O. A closely related but distinct second type of pathogenic human immunodeficiency retrovirus, designated HIV-2 (formerly LAV-2), has been isolated from West African patients with AIDS. HIV-2 has been shown to share a number conserved sequences with HIV-1, but serological cross-reactivity between HIV-1 and HIV-1 has been shown to be highly variable fro sample to sample.
URI: http://hdl.handle.net/123456789/1259
Date: 2015-08-18


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Final De ville A2_OQHIV-OF-ST1_V1_15-0818.pdf 11.43Mb PDF View/Open Trial Study Report

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