Regulatory body Health Canada has approved MedMira's point-of-care test for HIV and syphilis.
The Multiplo Rapid TP/HIV Test uses blood from a finger-stick sample to simultaneously identify HIV-1, HIV-2, and syphilis antibodies. In a statement, the Halifax, Nova Scotia-based MedMira said that the multiplex test delivers results “immediately,” is easy to use, can be used in any healthcare setting, and does not require refrigeration or special storage conditions.
The firm noted that Health Canada based its approval of the device on findings from a clinical study conducted in Alberta, Canada, between 2020 and 2022, with over 1,500 participants. The results showed the Multiplo TP/HIV test to be 100% accurate in identifying HIV infection and more than 98% accurate in identifying syphilis.
In addition, MiraMed said that it anticipates that its single Reveal TP (syphilis) test will receive approval from Health Canada soon. The Multiplo Rapid TP/HIV Test has not yet been approved for use in the U.S. by the U.S. Food and Drug Administration.
