Emerging Pathogens that Impact the Canadian Blood Supply Alberta Vein to Vein Conference March 18-19, 2016

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Emerging Pathogens that Impact the Canadian Blood Supply Alberta Vein to Vein Conference March 18-19, 2016 Dr. Margaret Fearon Medical Director, Medical Microbiology, Canadian Blood Services March 18, 2016

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Outline Emerging, re-emerging Infectious Diseases How we prepare for and manage new risks. Zika virus! An update Risk Based Decision Making A vulture boards an airplane, carrying two dead raccoons. The stewardess looks at him and says, 'I'm sorry, sir, only one carrion allowed per passenger.' 3

Blood Donor Testing Donor testing Implementation Date HIV1/2 Antibody (Ab) and 1985 nucleic acid testing (NAT*) 2001 HBV HBsAg, anti-hbc and NAT* 1972, 2005, 2010 HCV Ab and NAT* 1990, 1999 HTLV1/2 Ab 1998 (HTLV 1 1990) WNVNAT (pools of 6) 2003 (seasonal testing 2015) Syphilis Ab 1949 CMV Ab (selected units) 1984 Chagas Ab (selective donor testing) 2010 Donors who test RR for any TD marker are permanently deferred (can no longer donate). Lookback on previous donations is performed as appropriate Public Health is notified as per legal requirements *NAT testing for HIV, HCV and HBV performed on Roche Cobas TaqScreen MPX (Multiplex NAT) in pools of 6 implemented March 2011. 4 4

West Nile 1999 Infectious Diseases 1999-2010 SARS 2003 SARS Epi curve Feb. July 2003 Pandemic Flu 2009 Chagas Disease 2010 5

Infectious Disease Outbreaks that impact Security of Supply Sars, Pandemic Influenza Contingency planning for: Shortage of staff, and donors due to illness Shortage of critical supplies Staff and donor education Infection control procedures in clinic Donor deferral criteria 6

New Testing Paradigms West Nile virus (Universal donor testing 2003) Seasonal WNV testing (June 2015) All donors tested from June 1 to November 30 Only donors with travel outside Canada tested Dec. 1 May 31 Chagas Disease (Trypanosoma cruzi) (May 2010) Test donors at risk only: Born or lived in an endemic country (South America, Central America, Mexico) Mother or maternal grandmother born or lived in an endemic country 7

Clearly there has been a lack of imagination about how much can go wrong. Rachel Maddow 8

Current Emerging Infectious Disease Risks Aedes aegypti Chikungunya Black legged Tick (Ixodes scapularis) Babesia microti Zika Dengue virus Hepatitis E 9

Babesiosis Babesiosis is caused by a protozoan parasite (Babesia microti, duncani) spread by infected ticks. Most infections asymptomatic or unrecognized Incubation 1-6wks.(9 post transfusion) Flu like symptoms Severe: hemolytic anemia, thrombocytopenia, renal failure, ARDS Overall mortality~5% (higher if at-risk) i.e. immunocompromised, asplenics, Transfusion transmitted cases 160 reported cases from 1979 2009 in the U.S., one case reported in Canada. Majority of U.S. Cases reported in: Connecticut Massachusetts Rhode Is. New York State New Jersey Wisconsin 1,762 reported cases of babesiosis by county of residence (27 states) 2013. CDC January 2015 10

Hepatitis E Common viral hepatitis clinically similar to hepatitis A Genotypes 1 and 2 common in developing countries, generally transmitted via contaminated water. Travel is not the only risk factor. Endemic cases (genotypes 3 and 4) occur in developed countries. Contact with pigs, raw pork a risk factor? Prevalence in Canada is unknown. No cases of transfusion transmission reported in North America but cases have been reported in endemic countries and recently in the U.K. 11

Dengue Chikungunya Aedes aegypti Aedes albopictus Three viruses common in the tropics. Spread by mosquitos (Aedes aegypti, Aedes albopictus). Similar acute illness fever, rash, muscle and joint pain. Similar incubation 3-7 days. Dengue ( breakbones fever ) is widespread in Latin America, with endemic cases in Texas. Chikungunya ( that which bends up ) arrived in the Caribbean in 2013. Zika virus appeared in Brazil in March 2015 and rapidly spread into other parts of South America, and more recently the Caribbean A few clusters of transfusion transmitted dengue reported. Two possible cases of Zika being investigated in Brazil No cases of TT chikungunya reported to date. Current malaria travel deferral covers many but not all affected areas. On February 5, 2016, CBS and HQ implemented a 21 day deferral for donor who have travelled outside of Canada, the continental U.S. and Europe. 12

Zika Virus Often confused clinically with mild dengue First discovered in Uganda in 1947 Flavivirus (same family as West Nile) First large reported outbreak on Yap in the North Pacific, Recent outbreaks in the South Pacific Current outbreak which started in Brazil, spreading into other parts of Latin America and Caribbean - Several documented cases of sexual transmission - Two possible cases of transfusion transmission in Brazil 13

Countries and Territories in the Americas with Active Zika Virus Transmission CDC March 9, 2016 14

Zika Virus Clinical 80% of those infected are asymptomatic Fever, maculopapular rash, muscle pain, headache, conjunctivitis common symptoms. Incubation period 2 to 5 days. Viremic period approximately 2 to 5 days. Complete recovery is usual Rare complications include Guillain Barré Syndrome post infection Has been associated with microcephaly and other fetal malformations in infants of women who contract Zika during pregnancy. 15

Do not use without 17

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In preparing for battle, I have always found that plans are useless but planning is indispensable. Dwight D. Eisenhower 21

Preparing for Emerging Infectious Disease Risks Surveillance PHAC, WHO, CDC, ProMED mail Collaboration with public health: Diagnostic testing data from National Microbiology Laboratory and provincial Public Health Laboratories Collaboration with Veterinarians, Etymologists, Ornithologists Animal, Bird, Tick and Mosquito surveillance data Seroprevalence studies on our donors Donor surveys risk behaviours, travel Risk based decision making (Alliance of Blood Operators) 22

Surveillance Dr. Robbin Lindsay spending quality time In Windsor sewers 23

Canadian Data Public Health Agency of Canada (National Microbiology Lab) 520 confirmed Chikungunya antibody Positive patients Jan.1 2014 - July 1, 2015 (25% (112) are PCR positive) Travel documented for only 1/3 of cases, but of those, 90% travelled to the Caribbean. 24

Ogden et al. 2014 CCDR 40: 73-75 Results of Active Tick Surveillance 2008-2012 Ogden N. et al Environmental Risk from Lyme Disease in central and eastern Canada: a summary of recent surveillance information. CCDR 2014;40:58-67

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Range of Aedes aegypti in the Americas Source: Moritz U. G. Kraemer et al., elife Sciences; Simon Hay, University of Oxford 27

Seroprevalance Studies 28

Results : CBS and Héma Quebec Seroprevalence Study Babesia microti IgG Antibody Samples tested (n= 13,993) from July 15, 2013 Dec. 11, 2013 No. Tested Clinic Babesia microti IgG Ab. Test Result Negative Positive 158 Toronto 158 0 6364 South Central Ontario 6364 0 1765 N.S./N.B. 1765 0 1775 Winnipeg 1775 0 3931 Hema Quebec 3931 0 TOTAL 13,993 0 29

Results : CBS and Héma Quebec Seroprevalence Study Hepatitis E Antibody Table 1: Anti-HEV Data (n = 4110) No. Tested Collection Site Anti-HEV Result NEG POS Seroprevalence rate (%) 1469 South Central Ontario 1383 86 5.85 333 N.S./N.B. 327 6 1.80 356 Winnipeg 338 18 5.06 1952 Quebec 1821 131 6.71 TOTAL 3869 241 5.86 PCR Results: Of 13,993 donors tested there were 0 PCR positives 30

Results: CBS and Hema Quebec Seroprevalence Study Odds ratios of positive results for antibody to hepatitis E virus by demographic variables Estimated odds ratios of HEV antibody positive test results, by sex and age, from subset of Babesiosis Testing Study (n=2,150) and Héma-Québec data (n=1,952) n Positive n Negative % Positive Odds Ratio 95% Confidence Intervals Female 95 1,791 5.04 1.00 Male 146 2,070 6.59 1.33 (1.02-1.74) Under 30 15 921 1.60 1.00 30-39 10 524 1.87 1.17 (0.52-2.63) 40-49 30 727 3.96 2.53 (1.35-4.75) 50+ 186 1,689 9.92 6.76 (3.97-11.51)

Donor Travel Surveys Our donors like to travel in the winter 32

CBS Donor Travel Survey 2014 Table 5 - Weighted percentages of travel destinations of all whole blood donors in the survey sample, and the projected number of donors in the donor population with travel outside Canada in the past 12 months All respondents (n=8,908) CBS Donors (N=415,829) % of sample Projected Number Donors 95% C.I. Travel destinations United States 48.0 199,628 (195,314-203,942) Mexico 7.1 29,530 (27,312-31,748) Caribbean 9.3 38,852 (36,339-41,365) South America 0.7 3,035 (2,300-3,770) Central America 0.5 1,984 (1,389-2,579) Europe 9.8 40,625 (38,061-43,189) Middle East 0.6 2,689 (1,997-3,381) Africa 0.4 1,468 (956-1,980) Asia 2.1 8,527 (7,303-9,751) Australia / New Zealand / South Pacific 1.0 4,238 (3,371-5,106) Note: A donor could select more than one travel destination. 33

CBS Donor Travel Survey 2014 Table 8 - Weighted percentages and projected number of whole blood donors who would return to donate 14 or 28 days post-travel by various travel destination scenarios All respondents (n=8,908) CBS Donors (N=415,829) % of sample Projected Number Donors 95% C.I. Caribbean travel Return to donate within 14 days 0.5 1,984 (1,403-2,566) Return to donate within 28 days 1.6 6,545 (5,557-7,533) Travel outside of Canada and US Return to donate within 14 days 1.9 7,930 (6,781-9,079) Return to donate within 28 days 5.9 24,368 (22,520-26,216) Travel to AZ, CA, FL, HI, or outside of Canada and US Return to donate within 14 days 3.0 12,562 (11,117-14,007) Return to donate within 28 days 9.1 37,967 (35,665-40,270) Based on weighted percentages of travel and self-reported duration until returning to donate in the 2014 Travel Survey and projected number of donors based on number of donors in 2013 Travel outside of Canada and US included all travel destinations whether tropical or not

Risk-Based Decision-Making Framework for Blood Safety Changing the Decision-Making Paradigm Sponsored by the ABO, a team of experts gathered to map out a strategy to change the decision-making paradigm. A health sector focus Evidence-based decisions using risk assessment tools Multiple sectors included in the decision-making process A consistent, standardised approach to decision-making Acceptable risk based on societal considerations 35

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Estimate Risk of Transfusion Transmission of Chikungunya in Canada Risk Based on Cases in the Caribbean (PAHO data): 1 in 8,659,932 donations (1 in 15,172,895 1 in 6,060,606) Risk Based on Imported Cases from the Caribbean (Laboratory Testing Data): 1 in 11,803,847 donations (1 in 27,935,302 1 in 7,462,687)

Risk of Zika virus Infection from Donors Who Travel to Endemic Areas RIU travel = R zika x Par x DV (Without 21 day travel deferral) RIU travel = 0.000522151 x 0.0226 x 0.2190 (Without 21 day travel deferral) = 0.000002584, 1 IN 386,996 Assuming 99% of risk from travelers is addressed by 21 day deferral RIU travel = 1 in 38,699,600 (With 21 day deferral) If you can't convince them, confuse them.

Pathogen Inactivation Technologies Puerto Rico s Largest Blood Bank to Use Pathogen Reduction Technology Banco de Sangre de Servicios Mutuos is the centralized transfusion service for ten hospitals in metropolitan San Juan, Puerto Rico, and distributes blood and blood products to another 30 hospitals throughout the island. This week, Cerus Corporation announced that it has finalized an agreement with Puerto Rico s largest blood provider (Banco de Sangre de Servicios Mutuos) to purchase and implement the INTERCEPT Blood System for platelets and plasma. The agreement comes at an

If you think preparedness is expensive, try disease. Mary Daschler (paraphrased)

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