Rapid, point of care (POC) testing has been increasingly deployed as an aid in the diagnosis of infectious
disease, due to its ability to deliver rapid, actionable results. In the case of HIV, a number of rapid test
devices have been FDA approved and CLIA-waived in order to enable diagnosis of HIV infection outside
of traditional laboratory settings. These settings include STD clinics, community outreach centers and
mobile testing units, as well as identifying HIV infection among pregnant women and managing
occupational exposure to infection. The OraQuick® rapid test platform has been widely used to identify
HIV in POC settings, due to its simplicity, ease of use and the ability to utilize oral fluid as an alternative
specimen to blood. More recently, a rapid test for antibodies to hepatitis C virus (HCV) has been
developed on the same test platform which uses serum, plasma, finger-stick blood, venous blood and oral
fluid. Clinical testing using this POC test device has shown that performance is equivalent to state of the
art, laboratory based tests. These devices may be suitable for rapid field testing of blood and other body
fluids for the presence of infectious agents.
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