- Health Canada has authorized the iStatis Hepatitis B Surface Antigen Test by bioLytical Laboratories as the first point-of-care hepatitis B surface antigen test approved in Canada and North America
- The portable test delivers results in ~15 minutes and is designed for clinics, outreach programs, mobile units, and community-based healthcare settings where lab access may be limited
- The test detects hepatitis B surface antigen with high sensitivity and specificity, helping frontline providers diagnose active infections and connect patients to care faster
- With >260K Canadians living with chronic hepatitis B and many still undiagnosed, the approval supports Canada’s hepatitis elimination efforts aligned with WHO’s 2030 public health goals
Takeaways:
This authorization makes iStatis the first rapid point‑of‑care HBsAg test cleared in both Canada and North America, giving frontline providers a 15‑minute tool to find active hepatitis B in community settings and link patients to care sooner.
By enabling lab‑free screening in clinics, outreach programs, and mobile units with high sensitivity and specificity, the test can help uncover a substantial share of the more than 260,000 Canadians estimated to be living with chronic hepatitis, many of whom remain undiagnosed, supporting Canada’s hepatitis elimination strategy in line with WHO’s 2030 goals.
Source: Globenewswire
