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Residual risk of HIV, HCV and HBV in Canada
Sheila F O'Brien1, Qi-Long Yi1, Wenli Fan2
1Canadian Blood Services, Canada; Dept. of Epidemiology & Community Medicine, University of Ottawa, Canada.
Background:
Residual risk is estimated as the product of the incidence and the infectious window period, the time during which a blood donation could be infectious but the assay may not detect it. In 2011 nucleic acid multiplex testing (MPX) was implemented in 6 unit minipools (previously 24 unit minipools). MPX also included hepatitis B (HBV) NAT for the first time (complementing HBsAg screening) in addition to HIV-1 and hepatitis C (HCV) as before. We aimed to estimate window period risk-day equivalents for MPX, and the residual risk of viral infections in blood donations updated to reflect current incidence and testing.
Methods:
Transmissible disease conversions of repeat donations to Canadian Blood Services within the three-year period 2012-2014 divided by person-years estimated incidence for HIV, HCV and HBV (adjusted for transient viremia). Window period risk-day equivalents for MPX were estimated using a published method. Residual risk was the product of incidence and window period risk-day equivalents. 95% confidence intervals were estimated using Monte Carlo simulation of the window period risk-day equivalents and the incidence density 95% confidence intervals.
Results:
The incidence rate per 100,000 person years for HIV was 0.28, HCV 1.0 and HBV 0.26. The residual risk of HIV was 1 per 21.4 million donations, HCV 1 per 12.6 million donations and HBV 1 per 7.5 million donations.
Conclusion:
The residual risk of infection is very low, similar to 2006-2009. The safety benefit of further shortening of the infectious window period is below the threshold to quantify.
Insights
The residual risk of blood donation infections from HIV, HCV, and HBV remains very low, with updated testing methods ensuring continued blood safety. Further reductions in the infectious window period offer minimal quantifiable safety benefits.
Area of Science:
- Blood Transfusion Safety
- Infectious Disease Epidemiology
- Virology
Background:
- Residual risk in blood donations is calculated by incidence and infectious window period.
- Nucleic acid multiplex testing (MPX) was implemented in 2011, including hepatitis B (HBV) NAT alongside HIV-1 and hepatitis C (HCV).
Purpose of the Study:
- To estimate window period risk-day equivalents for MPX.
- To update residual risk estimates for viral infections in blood donations.
Main Methods:
- Incidence of HIV, HCV, and HBV was estimated from repeat donations (2012-2014).
- Window period risk-day equivalents for MPX were calculated using a published method.
- Residual risk was determined by multiplying incidence and window period risk-day equivalents.
Main Results:
- Incidence rates per 100,000 person-years: HIV 0.28, HCV 1.0, HBV 0.26.
- Residual risk: HIV 1 in 21.4 million, HCV 1 in 12.6 million, HBV 1 in 7.5 million donations.
Conclusions:
- The residual risk of viral infection in blood donations is very low.
- Current safety levels are comparable to those observed between 2006-2009.
- The safety benefit of further reducing the infectious window period is below quantifiable thresholds.
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