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What is the INSTI Multiplex Test?

Health Canada has authorized bioLytical’s INSTI Multiplex HIV-1/HIV-2/Syphilis Antibody Test (INSTI multiplex test) for clinical use. In Canada, this is the first approved rapid point-of-care (POC) test for both HIV and syphilis and the first approved rapid POC syphilis test of any kind. The INSTI multiplex test is a single screening test that detects both HIV and syphilis antibodies using a single blood sample. The test requires a few drops of blood from a finger prick and produces accurate results within minutes.

Results show as either reactive or non-reactive for HIV and/or syphilis. In the case of a reactive result a vial of blood then needs to be drawn and sent to a laboratory for confirmatory testing.

What is new about this test and why does it matter?

The INSTI multiplex test builds on the advantages of the INSTI’s rapid HIV test, which has been in use in Canada for years. Like its predecessor, the multiplex test is fast, convenient, portable and easy to interpret, making it suitable for use in diverse healthcare settings. This in turn makes it useful for reaching underserved and/or remote communities and individuals who otherwise may not get tested. This can serve as a critical first contact with care, facilitating early diagnosis and treatment.

The INSTI multiplex test can help fill the current gap in rapid POC syphilis screening at a time when syphilis rates in Canada have been rapidly increasing. Combining HIV and syphilis screening in a single rapid test also reduces the burden on individuals and care providers of doing multiple screening tests for these two conditions.

What does this mean for access to HIV and syphilis testing in Canada?

Approval of the INSTI multiplex test is an important first step. However, the tool is currently only approved for use by healthcare professionals. An important step will be extending approval to perform testing to a wider variety of people — like outreach workers and peers — who are well positioned to reach people who may not otherwise get tested. Another challenge is that the INSTI multiplex test is not currently funded by any province or territory. Comprehensive funding will be essential for this potentially game-changing tool to reach all the communities and individuals who need it.

Related resources

Rapid tests for the diagnosis of syphilis and HIV: A potential game changer for Canada

Rapid combined syphilis-HIV testing found accurate and useful in an Alberta study

Rapid HIV test now approved for use by lay providers

Rapid point-of-care HIV testing: A review of the evidence

 

About the author(s)

Dan Miller is CATIE’s knowledge Specialist, HIV care and STI. He has a master’s degree in public health from the University of Toronto and previously worked in health services research in Toronto’s academic health sciences system.