Stopped: The device manufacturer is no longer seeking licensure for this use-case in Canada.
To help reach the undiagnosed living with HIV and/or syphilis in Canada, point-of-care (POC) tests for HIV and Syphilis may have substantial utility for increased identification of infected individuals through their relative ease of use and portability, as well as their ability to deliver rapid, actionable results while the care provider still has access to the patient. MedMira Inc. (Halifax, NS, Canada), has developed a POC test to detect HIV and Syphilis antibodies in fingerstick blood samples that is seeking approval from Health Canada for use by trained healthcare professionals. The goal of this study is to provide evidence that untrained, non-registered health care providers (ie. peer testers) can perform the test without any increased risk of obtaining erroneous results. This test requires no instrumentation and can be used by non-registered health care professionals including peer testers ("Operators") in multiple near patient settings such as community health centres and point of care testing locations.
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Percent positive and negative agreement of the Multiplo® TP/HIV Test performed by non-healthcare providers to the Participant's HIV and/or syphilis status confirmed by the lab results.
Timeframe: 6 months