1. Estimating Frequency of Travel to Endemic Areas Brian Custer, PhD, MPH Blood Systems Research Institute Blood Products Advisory Committee Meeting August 2, 2011

2. Map of Current Service Area and Focus of this Presentation AR

3. 3 Donor Registration Record (DRR) All centers 1. Prospective donors asked to provide race/ethnicity and country of birth UBS centers (excluding Central Coast) 2. Additional questions a. Have you spent time that adds up to 3 months or more in Mexico, Central America or South America? b. Has your mother spent time that adds up to 3 months or more in Mexico, Central America or South America? c. Since your last donation have you traveled to Mexico, Central America or South America? Response Options: 1. No 2. Mexico 3. Central America and/or South America 4. Both Mexico and Central and/or South America 5. No Answer or Refused 6. Unknown

4. 4 Data Sources and Time Periods Universal Testing for T. cruzi by Ortho EIA (January 2007 – April 2010) – Repeat Reactive (RR) donations are tested using RIPA 1-time selective testing after April 2010 except for UBS Central Coast as part of Chagas Incidence Study Protocol Pre-donation questions of donors at UBS centers February 2007 – May 2011 Overlap of universal testing and pre-donation questions during the period of February 2007 – April 2010 at the UBS Centers

5. Prevalence by Country of Birth All BSI Centers ( 1/2007 – 12/2009) Country or Region of Birth All Donors, N=1,183,076 n (%) ELISA Repeat Reactive N=305 N (%) T. cruzi RIPA positive N=89 n (%) RIPA Positive Proportion USA797,981 (67.5)143 (46.9)25 (28.1)1:31,900 Mexico26,541 (2.2)37 (12.1)32 (36.0)1:800 Central or South America 5,074 (0.4)26 (8.5)23 (25.8)1:200 All other countries31,149 (2.6)10 (3.3)1 (1.1)1:31,100 Refused/Missing322,331 (27.3)89 (29.2)8 (9.0)1:40,300

6. T. cruzi EIA Results by State - Repeat Donors (2/2007 – 4/2010) State of Blood Center Total DonationsT. cruzi EIA Repeat Reactive Donations T. cruzi EIA RR Proportion RIPA Positive Donations RIPA Positive Proportion Arizona448,566281:16,02021:224,282 Arkansas109,913101:10,99111:109,913 Louisiana129,05971:18,4370- Mississippi156,071121:13,00631:52,024 Montana119,352121:9,9460- Nevada302,177271:11,19241:75,544 New Mexico196,83991:21,8710- North Dakota218,386141:15,5990- South Dakota121,561111:11,0510- Texas306,164141:21,86971:43,738 Wyoming21,59311:21,5930- Total2,129,6811451:14,687171:125,275

7. T. cruzi EIA Results by State – First Time Donors (2/2007 – 4/2010) State of Blood Center Total DonationsT. cruzi EIA Repeat Reactive Donations T. cruzi EIA RR Proportion RIPA Positive Donations RIPA Positive Proportion Arizona108,236191:5,69761:18,039 Arkansas32,81771:4,68841:8,204 Louisiana38,33581:4,79231:12,778 Mississippi49,93661:8,32311:49,936 Montana19,94231:6,6470- Nevada73,330251:2,933151:4,889 New Mexico37,62371:5,37531:12,541 North Dakota29,24041:7,3100- South Dakota15,58411:15,5840- Texas105,635181:5,869101:10,564 Wyoming3,9640-0- Total514,642981:5,251421:12,253

8. Repeat Donors 3 Months or More in an Endemic Area (2/2007 – 4/2010) Location Repeat Donations Number (%) EIA RR RIPA Positive RIPA positive Proportion No2,022,35812991:224,706 Mexico26,258541:6,565 Central/South America11,500431:3,833 Mexico and C. or S. America2,55400- No Answer/Missing62,055711:62,055 Total2,124,725145171:124,984

9. First Time Donors 3 Months or More in an Endemic Area (2/2007 – 4/2010) Location First Time Donations Number (%) EIA RRRIPA Positive Proportion RIPA positive No473,23072241:19,718 Mexico18,69219131:1,438 Central/South America4,014651:803 Mexico and C. or S. America64300- No Answer/Missing16,57710- Total513,15698421:12,218

10. Travel Since Last Donation in Repeat Donors Includes All Donations (2/2007 – 4/2010) LocationNumber (%)EIA RRProportion EIA RR RIPA positive No 1,979,733 (92.96)122 1:16,227 0 Mexico 79,434 (3.73)12 1:6,620 0 Central or South America 5,601 (0.26)4 1:1,400 0 Both Mexico and Central or South America 1,248 (0.06)00 Total with travel 86,283 (4.05)16 1:5,393 0 No Answer/Missing 63,665 (2.99)7 1:9,095 0 Total 2,129,681145 1:14,687 0

11. Donations Screened (1/2007 – 4/2010) Number (%)EIA RR RIPA positive Proportion First Donation for Each Donor during study interval 1,036,033 (39)169 59 1:17,559 Subsequent Donations 1,608,290 (61)74 0 - Total Donations Screened 2,644,323243 59 1:44,819

12. Travel Since Last Donation in Repeat Donors Analyzed as Donations (2/2007 – 4/2010) LocationNumber (%)EIA RRProportion EIA RR RIPA positive No 1,569,087 (97.5)70 1:22,416 0 Mexico 41,253 (2.57)4 1:10,313 0 Central or South America 2,512 (0.16)0 _ 0 Both Mexico and Central or South America 462 (0.03)0 _ 0 Total with travel 44,227 (2.7)4 1:11,057 0 No Answer/Missing 9,424 (0.59)0 - 0 Total 1,608,29074 1:21,204 0

13. Person-Time in Intervals with Travel Interdonation intervals with travel to Mexico, Central, or South America Mean Person-Years (95% CI) Median) Person- Years Median Person- Years (IQR) Total Person- Years 44,2571.30 (0.23 – 2.70) 1.17 (0.59 – 1.97) 400,481

14. Travel Since Last Donation - Repeat Donors (2/2007 – 4/2010) State of Blood Center NoMexicoCentral or South America Mexico and Central or South America No Answer / Missing Arizona 331,242 (95.05)14,489 (4.16)725 (0.21)159 (0.05)1,862 (0.53) Arkansas 79,203 (98.39)908 (1.13)123 (0.15)13 (0.02)253 (0.31) Louisiana 90,047 (98.63)672 (0.74)71 (0.08)16 (0.02)489 (0.54) Mississippi 98,471 (98.02)511 (0.51)59 (0.06)15 (0.01)1,402 (1.40) Montana 100,184 (98.42)1,113 (1.09)171 (0.17)34 (0.03)292 (0.29) Nevada 227,414 (97.29)4,284 (1.83)410 (0.18)71 (0.04)1,576 (0.67) New Mexico 149,252 (97.57)2,645 (1.73)343 (0.22)56 (0.02)666 (0.58) North Dakota 167,181 (97.86)2,386 (1.40)226 (0.13)41 (0.02)998 (0.44) South Dakota 95,657 (98.42)953 (0.98)143 (0.15)15 (0.02)429 (0.56) Texas 203,521 (93.27)13,187 (6.04)228 (0.10)41 (0.01)1,223 (1.83) Wyoming 12,467 (97.25)105 (0.82)13 (0.10)1 (0.03)234 (0.59 Total 1,608,290 (96.66)41,253 (2.57)2,512 (0.16)462 (0.03)9,424 (0.59)

15. T. cruzi EIA Results by State - Repeat Donors with Travel (2/2007 – 4/2010) State of Blood Center Total Donors with Travel T. cruzi EIA Repeat Reactive Donations T. cruzi EIA RR Proportion RIPA Positive Donations Person-Years of Observation Arizona15,3730-084,208 Arkansas1,0440-020,480 Louisiana7590-023,854 Mississippi5850-024,121 Montana1,31821:659024,082 Nevada4,7650-057,288 New Mexico3,0440-040,091 North Dakota2,65311:2,653047,861 South Dakota1,1110-026,737 Texas13,45611:13,456050,285 Wyoming1190-01,474 Total44,22741:11,0570400,481

16. Unconfirmed EIA (False Positive?) by Area of Travel – Repeat Donors (2/2007 – 4/2010) Donations from Donors with Travel Donations Number EIA RR, RIPA Negative Proportion EIA RR, RIPA Negative No1,554,639701:22,209 Mexico41,25341:10,313 Central/South Amer.2,5120- Mexico and C. or S. Amer.4620- No Answer/Missing9,4240- Total1,608,290741:21,734

17. Example Donor with High Travel to Mexico EIA s/co Results and Donation/Sample Dates RIPA Negative at both time points Interval with travel

18. Travel by State of Residence Overall, 97% of repeat donors report no travel to endemic areas for T. cruzi Proportion of donors traveling by state is variable – ~ 6% of repeat donors in Texas report travel since last donation 98% of which is to Mexico – Under 1% of repeat donors from Mississippi report travel since last donation 84% of which is to Mexico

19. Summary Period of January 2007 – April 2010 at UBS Centers: 1)243 EIA positive donations 145 repeat donations 98 first time donations 2)59 RIPA positive donations 17 repeat donors (first time screened) – No previously tested repeat donors reporting travel were RIPA positive – No previously tested repeat donors were newly RIPA positive 42 first time donations 3) Proportion of apparent False Positives (~1:15,000) is the similar for donors who do and do not report travel to endemic areas since last donation

20. Summary Over 400,000 interdonation interval person-years accumulated included travel to endemic areas. 4 Donors with travel to Mexico were newly EIA RR – All four were RIPA negative – 3 were RIPA negative on an additional follow-up sample We do not see evidence of incident infection in donors with travel and the proportion of apparent false positive EIA results is similar to that observed for donors who did not report travel

21. Acknowledgements Roberta Bruhn Mike Busch Hany Kamel Marj Bravo Karen Ofafa Peter Tomasulo