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Health Canada has granted authorisation to in-vitro medical diagnostics provider bioLytical Laboratories for its INSTI multiplex HIV-1/2 Syphilis Antibody Test.
Authorised for professional point-of-care use, the test can identify both HIV-1/2 and syphilis antibodies from one sample, gathered using a simple fingerprick method.
The test is claimed to provide precise results in less than one minute.
bioLytical is also working on a self-test version to help Canadians of all demographics access regular and early testing for both infections.
The INSTI test enables healthcare professionals to test in different environments, offering flexible options for individuals who face barriers to accessing healthcare.
As part of Health Canada’s review and subsequent authorisation, the two-year Point of Care Tests for Syphilis and HIV (PoSH) Study was conducted between August 2020 and February 2022.
Led by researchers at the University of Alberta and St Michael’s hospital, the trial demonstrated the significance of regular and frequent testing to help connect patients to care.
The majority (87.4%) of participants were treated immediately following point-of-care results, while the rest received treatment within a median of four days.
bioLytical CEO Rob Mackie said: “I am proud to lead a team of hardworking and innovative individuals who consistently push the boundaries of what is possible.
“Our continued dedication to excellence allowed us to achieve this remarkable milestone that will help Canadians across all demographics access early testing in various settings.”
With a 166% nationwide increase between 2017 and 2021, Canada is presently experiencing unprecedented syphilis infection rates, noted the company.
Last April, Health Canada authorised the company’s iStatis Covid-19 Antigen Home Test, which can be performed at home with easy-to-understand results.
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- Source: https://www.medicaldevice-network.com/news/health-canada-biolytical-syphilis-test/
