- Health Canada has approved two new hepatitis C point-of-care tests for professional use
- These tests can simplify testing, deliver faster results and expand community access to testing
- Funding, distribution and implementation plans will be required to support uptake
Health Canada has authorized two new hepatitis C point-of-care tests for professional use in Canada: bioLytical’s INSTI HCV Antibody Test and Cepheid’s Xpert HCV VL Fingerstick. Approval of these point-of-care tests provides additional testing options that aim to reduce barriers to hepatitis C diagnosis.
What are the tests and how are these tests transforming hepatitis C care?
INSTI HCV Antibody Test
The INSTI HCV Antibody Test (INSTI antibody test) is a point-of-care test that detects hepatitis C antibodies in just one minute. It is the second antibody point-of-care test approved for clinical use in Canada. Its key advantage is the reduced time to obtain a result.
The INSTI antibody test can be used to improve access to hepatitis C antibody testing. The rapid turnaround can help determine, on the spot, in a wide variety of settings, whether confirmatory RNA testing is needed. As a result, it might be possible for confirmatory testing to be done during the same visit, or the person can be referred elsewhere for this testing right away.
Xpert HCV VL Fingerstick
In Canada, the Xpert HCV VL Fingerstick (Xpert RNA test) is the first approved point-of-care test that detects hepatitis C RNA. This type of test is needed to confirm an active hepatitis C infection following a positive antibody test. Previously, confirming an active hepatitis C infection required a blood draw and laboratory-based testing. With the Xpert RNA test, a diagnosis can be made in about 60 minutes using a small blood sample from a finger prick.
The approval of the Xpert RNA test simplifies the testing process, which may enable confirmatory testing to be done in a wider range of community settings. When individuals are required to come for multiple visits for testing and results, they can be lost to follow-up before they are linked to care. Using the Xpert RNA test allows someone to get diagnosed (within an hour) and be linked to care and treatment during the same visit.
This test may be well suited for people who have difficulties with blood draws (e.g., people who use drugs who have poor venous access). It may also improve access to confirmatory testing in settings where laboratory-based testing is challenging such as corrections facilities, shelters, harm reduction sites and rural and remote communities.
What are the next steps for implementation?
The Health Canada approvals allow both parts of the hepatitis C testing process to be completed at the point of care, bringing testing to settings where people may already be accessing care. Rolling out these point-of-care tests in community settings will take time, but these approvals are an important first step to make them available.
As neither the INSTI antibody test nor the Xpert RNA test is currently funded by any province or territory for hepatitis C testing, it will be essential to secure funding to realize their potential. However, many GeneXpert machines were distributed during the COVID-19 response, potentially improving accessibility of this point-of-care test. The Xpert RNA test may have additional implementation requirements, as individuals require training to operate the GeneXpert system. Effective integration of the Xpert RNA test into existing laboratory and surveillance systems will be an important consideration moving forward. Alignment with current systems will help support broader uptake and ensure individuals can access appropriate pathways for care and follow-up.
Related resources
Health Canada authorization of biolytical INSTI HCV Antibody Test
Health Canada authorization of Cepheid Xpert HCV VL Fingerstick
— Madison Kennedy