Tracking of Blood Donation Screening Results
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Babesia blood donation screening began on May 5th in 14 states on the East Coast (Northern and Mid-Atlantic) and Upper Midwest, plus Washington DC. The screening is performed using the Grifols nucleic acid assay in pools of 16 whole blood samples (note that babesia is a red cell parasite, and thus red cells are needed for lysis to release the parasite鈥檚 nucleic acid).
This presentation contains reactivity data by state of collection (table) and by donor state of residence (map).
The table summarizes the number of nonreactive (negative) and reactive donations collected in each state, including the percentage of reactive donations and reactive rates.
The map provides a visual distribution of reactive donations by residential zip codes.
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The map represents the geographic distribution of ARC Babesia positive donations by donor state of residence; the data represent collections tested for Babesia between May 2020 and December 2024. Maryland, Delaware, and Washington DC had between 1 and 9 positive donors; Minnesota, Vermont, New Hampshire, and Minnesota had between 10 and 99 positive donors; Wisconsin, Maine, and New Jersey had between 100 and 199 positive donors; Pennsylvania, New York, Connecticut, and Massachusetts had between 200 and 387 positive donors.
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A vertical bar chart illustrating the number of positive donations identified monthly for each year since test implementation
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This presentation contains information for Red Cross human leukocyte antigen (HLA) Testing.
HLA testing is performed in order to reduce the possibility of Transfusion-Related Acute Lung Injury (TRALI). TRALI is a rare but serious complication of blood transfusions most commonly thought to be caused by a reaction to HLA antibodies present in the donor鈥檚 plasma. Female donors who have been pregnant are more likely than others to have these HLA antibodies in their plasma. Once the antibodies develop, they are present forever.
HLA testing is performed on donations for female donors who indicate they have ever been pregnant (first-time donors) or donors who have had a pregnancy since their prior HLA-negative donation (repeat donors). Donors who test HLA reactive by the FDA licensed screening test for HLA class I and II antibodies are deferred from donating platelet pheresis and further tested to determine their ongoing suitability via Luminex using a validated cutoff for donor screening. Donors testing negative can be reinstated.
Though HLA testing is intended to only be done on female donors, male donors may be inadvertently tested.
All slides represent the testing date range of 10/10/2016 through 11/30/2024
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Graph: Line graph depicting HLA screening reactive rates for HLA I , HLA II , HLA I and II and total over time, by month, with a total of 204,078 tests conducted.Mean screening reactive rates for HLA I = 8%, HLA II = 13%, HLA I & II =9% and overall = 30%.Inset: Table of minimum, maximum and mean monthly reactive rates from screening for HLA I Positive, HLA II Positive, HLA I and II Positive and the overall minimum (17%), maximum (44%) and mean (30%) reactive rates.
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Graph: Line graph depicting Luminex negative rates for donations that screened positive for HLA I , HLA II , HLA I and II and total over time, by month, with a total of 204,078 donations screened and 59,248 donations tested by Luminex.
Mean Luminex negative rates for HLA I = 8%, HLA II = 21%, HLA I & II = 6% and overall = 36%.
Inset: Table of minimum, maximum and mean monthly Luminex negative rates for donations that screened positive for HLA I , HLA II , HLA I and II and the overall minimum (18%), maximum (77%) and mean (36%) reactive rates.
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Graph: Line graph depicting Luminex positive rates for donations that screened positive for HLA I , HLA II , HLA I and II and total over time, by month, with a total of 204,078 donations screened and 59,248 donations tested by Luminex.
Mean Luminex positive rates for HLA I = 20%, HLA II = 21%, HLA I & II = 23% and overall = 64%.
Inset: Table of minimum, maximum and mean monthly Luminex positive rates for donations that screened positive for HLA I , HLA II , HLA I and II and the overall minimum (23%), maximum (82%) and mean (64%) reactive rates.
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Table 1: Table of all Luminex testing, broken out into gender, Luminex Interpretation and original screening results.
Table 2: Table of all Luminex testing, showing the number of Negative and Positive results used for the calculation of the Positive Predictive Value (62.87%).
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Table: Table of the number donors reinstated for donating platelet pheresis and the percentages that returned to donate after reinstatement, including donation testing (Index), follow-up sample testing and total.
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This PowerPoint presentation contains performance metrics for infectious disease blood donation screening and confirmatory tests. The information is presented in slides grouped by marker: anti-HIV, anti-HCV, HBsAg, anti-HBc, anti-HTLV and anti-T. cruzi. The slide groupings contain the current screening and confirmatory algorithm, graphs displaying the Initial Reactive (IR) and Repeat Reactive (RR) rates, and graphs displaying results of supplemental/confirmatory testing for donations that tested RR for the respective screening assay since 2021.
Slide legends display data from the current fiscal year, 2025 (July 2024 - June 2025).
Screening slide legends contain the total number of donations tested, and the mean IR and RR rates. Confirmatory slide legends show the total number of reactive units tested with the numbers for the respective final test results.
The last 2 slides show the current algorithm and the confirmatory rates for anti-T. pallidum
Note: The Conversion of (anti-HIV, anti-HCV, HBsAg, anti-HBc, HTLVI/II, and T. cruzi) testing from Ortho to Abbott Alinitys at CTS Labs is implemented on a different schedule between August - November 2024.
Slides updated on 1/31/2025
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The following HIV screening and confirmatory assays are currently in use:Abbott -Alinity s HIV Ag/Ab Combo AssayGrifols - Procleix Ultrio ELITE (HIV/HBV/HCV NAT)Grifols - Procleix Ultrio ELITE Discriminatory HIV (dHIV) NATBio-Rad - Geenius HIV 1/2听These assays are used per the current testing algorithm.Procleix Ultrio Elite nucleic acid testing (NAT) is performed in mini-pools of 16 (MP) with reactive MP resolved by individual donation testing (IDT).).
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American Red Cross-Reactive Rates for anti-HIV Blood Donations Screening Tests. The legend displays the total number of donations tested between July 鈥 December 2024 with the initial Reactive and Repeat Reactive rates.
The graph displays HIV screening data in two lines starting from January 2021; the Y-axis = (0.00-0.25)% of Reactive Rates and the X-axis = month and year (January 2021 鈥 December 2024).
Green line- Represents Initial Reactive anti-HIV rates from January 2021 to December 2024. Data from November 2024 to December 2024 shows a decrease in Initial Reactive rates.
Red line 鈥揜epresents Repeat Reactive anti-HIV rates from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in Repeat Reactive rates.
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American Red Cross - Anti-HIV repeat reactive confirmatory testing. The legend displays the total number and rates of anti-HIV repeat reactive donations between July 鈥 December 2024 with the total numbers and rates of the confirmed negative, indeterminate, positive, and not tested donations.The graphs display HIV confirmatory data in 4 lines starting from January 2021; the Y-axis = (0 - 600) % number of samples and the X-axis = month and year (January 2021 鈥 December 2024).Blue Line- Represents the total number of reactive samples starting from January 2021 to December 2024.听 Data from November 2024 to December 2024 displays a decrease in total numbersGreen line - Represents the # of confirmed negatives starting from January 2021 to December 2024.听 Data from November 2024 to December 2024 displays a decrease in confirmed negative.Yellow line - Represents the # of indeterminate starting from January 2021 to December 2024.听 Data from November 2024 to December 2024 displays a decrease in indeterminate.Red line - Represents the # of confirmed positives starting from January 2021 to December 2024.听 Data from November 2024 to December 2024 displays a slight increase in confirmed positives.
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The following HCV screening and confirmatory assays are currently in use:
Abbott 鈥 Alinity s anti-HCV
Grifols - Procleix Ultrio ELITE (HIV/HBV/HCV NAT)
Grifols - Procleix Ultrio ELITE HCV (dHCV) NAT
Ortho 鈥 VIP anti-HCV
These assays are used per the current algorithm
Procleix Ultrio Elite nucleic acid testing (NAT) is performed in mini pools of 16 (MP) with reactive MP resolved by individual donation testing (IDT).
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American Red Cross-Reactive Rates for anti-HCV Blood Donations Screening Tests. The legend displays the total number of donations tested between July 鈥 December 2024 with the Initial Reactive and Repeat Reactive rates.
The graph displays HCV screening data in two lines starting from January 2021; Y-axis = (0.00-0.40) % of Reactive Rates and X-axis = month and year (January 2021 鈥 December 2024).
Green line- Represents Initial Reactive anti-HCV rates from January 2021 to December 2024. Data from November 2024 to December 2024 shows a slight increase in Initial Reactive rates.
Redline - Represents Repeat Reactive anti-HCV rates from January 2021 to December 2024. Data from November 2024 to December 2024 displays no change in Repeat Reactive rates.
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American Red Cross - HCV repeat reactive confirmatory testing. The legend displays the total number and rates of HCV repeat reactive donations between July 鈥 December 2024 with the total numbers and rates of the confirmed negative, positive, and not-tested donations.
The graphs display HCV confirmatory data in 3 lines starting from January 2021; the Y-axis = (0 - 600) number of samples and the X-axis = month and year (January 2021 鈥 December 2024).
Blue Line- Represents the total number of reactive samples starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight increase in total numbers
Green line - Represents the # of confirmed negatives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight decrease in confirmed negatives.
Redline - Represents the # of confirmed positives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight increase in confirmed positives.
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The following HBsAg screening and confirmatory assays are currently in use:
Bio-Rad - Genetic System (GS) HBsAg EIA
Grifols - Procleix Ultrio ELITE (HIV/HBV/HCV NAT)
Grifols - Procleix Ultrio ELITE HBV (dHBV) NAT
Bio-Rad - GS HBsAg Confirmatory (Neutralization)
These assays are used per the current algorithm
Procleix Ultrio Elite nucleic acid testing (NAT) is performed in mini pools of 16 (MP) with reactive MP resolved by individual donation testing (IDT).
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American Red Cross-Reactive Rates for HBsAg Blood Donations Screening Tests. The legend displays the total number of donations tested between July - December 2024 with the Initial Reactive and Repeat Reactive rates.
The graphs display HBsAg screening data in two lines starting from January 2021; Y-axis = (0.00-0.20) % of Reactive Rates and X-axis = month and year (January 2021 鈥 December 2024).
Green line- Represents Initial Reactive HBsAg rates from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in Initial Reactive rates.
Redline - Represents Repeat Reactive HBsAg rates from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in Repeat Reactive rates.
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American Red Cross - HBsAg repeat reactive confirmatory testing. The legend displays the total number and rates of HBsAg repeat reactive donations between July - December 2024 with the total numbers and rates of the confirmed negative, positive, and not-tested donations.
The graphs display HBsAg confirmatory data in 3 lines starting from January 2021; the Y-axis = (0 - 400) number of samples and the X-axis = month and year (January 2021 鈥 December 2024).
Blue Line- Represents the total number of reactive samples starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in total numbers.
Green line - Represents the # of confirmed negatives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in confirmed negatives.
Redline - Represents the # of confirmed positives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in confirmed positives.
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The following anti-HBc screening and confirmatory assays are currently in use:
- Abbott 鈥 Alinity s anti-HBc
- Grifols - Procleix Ultrio ELITE (HIV/HBV/HCV NAT)
- Grifols - Procleix Ultrio ELITE HBV (dHBV) NAT
These assays are used per the current algorithm.
Procleix Ultrio Elite is performed in mini pools of 16 (MP) with reactive MP resolved by individual donation testing (IDT).
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American Red Cross-Reactive Rates for anti-HBc Blood Donations Screening Tests. The legend displays the total number of donations tested between July 鈥 December 2024 with the Initial Reactive and Repeat Reactive rates.
The graphs display anti-HBc screening data in two lines starting from January 2021; Y-axis = (0.00-0.60) % of Reactive Rates and X-axis = month and year (January 2021 鈥 December 2024).
Green line- Represents Initial Reactive anti-HBc rates starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight increase in Initial Reactive rates.
Redline - Represents Repeat Reactive anti-HBc rates starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight increase in Repeat Reactive rates.
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American Red Cross 鈥 anti-HBc repeat reactive confirmatory testing. The legend displays the total number and rates of anti-HBc repeat reactive donations between July 鈥 December 2024 with the total numbers and rates of the confirmed negative, positive, and not tested donations.
The graphs display anti-HBc confirmatory data in 3 lines starting from January 2021; the Y-axis = (0 - 2000) number of samples and the X-axis = month and year (January 2021 鈥 December 2024).
Blue Line- Represents the total number of reactive samples starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays an increase in total numbers
Green line - Represents the # of confirmed negatives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays an increase in confirmed negatives.
Red line - Represents the # of confirmed positives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in confirmed positives.
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The following HTLV-I/II screening and confirmatory assays are currently in use:
- Abbott 鈥 Alinity s HTLV-I/II
- MP Diagnostics - HTLV Blot 2.4 - Western Blot Assay
These assays are used per the current algorithm.
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American Red Cross-Reactive Rates for anti-HTLV-I/II Blood Donations Screening Tests. The legend displays the total number of donations tested between July 鈥 December 2024 with the Initial Reactive and Repeat Reactive rates.
The graphs display anti-HTLV-I/II screening data in two lines starting from January 2021; Y-axis = (0 - 0.2) % of Reactive Rates and X-axis = month and year (January 2021 鈥 December 2024).
Green line- Represents Initial Reactive anti-HTLV-I/II rates starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight decrease in Initial Reactive rates.
Redline - Represents Repeat Reactive anti-HTLV-I/II rates starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays no change in Repeat Reactive rates.
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American Red Cross - Anti-HTLV-I/II repeat reactive confirmatory testing. The legend displays the total number and rates of anti-HTLV-I/II repeat reactive donations between July 鈥 December 2024 with the total numbers and rates of the confirmed negative, indeterminate, positive, and not tested donations.
The graphs display anti-HTLV-I/II confirmatory data in 4 lines starting from January 2021; the Y-axis = (0 - 350) number of samples and the X-axis = month and year (January 2021 鈥 December 2024).
Blue Line- Represents the total number of reactive samples starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays an increase in total numbers
Green line - Represents the # of confirmed negatives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays an increase in confirmed negative.
Yellow line - Represents the # of indeterminate starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in indeterminate.
Redline - Represents the # of confirmed positives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight decrease in confirmed positives.
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The following anti-T. cruzi screening and confirmatory assays are currently in use:
- Abbott 鈥 Alinity s T. cruzi听
- Abbott - Chagas Enzyme Strip (ESA)
- Ortho - T. cruzi ELISA
These assays are used per the current algorithm.
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American Red Cross-Reactive Rates for anti-T. cruzi Blood Donations Screening Tests. The legend displays the total number of donations tested between July - December 2024 with the Initial Reactive and Repeat Reactive rates.
The graphs display anti-T. cruzi screening data in two lines starting from January 2021; Y-axis = (0.0-0.3) % of Reactive Rates and X-axis = month and year (January 2021 鈥 December 2024).
Green line- Represents Initial Reactive anti-T. cruzi rates starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in Initial Reactive rates.
Redline - Represents Repeat Reactive anti-T. cruzi rates starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in Repeat Reactive rates.
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American Red Cross 鈥 Anti-T. cruzi repeat reactive confirmatory testing. The legend displays the total number and rates of anti-T. cruzi repeated reactive donations between July 鈥 December 2024 with the total numbers and rates of the confirmed negative, indeterminate, positive, and not tested donations.
The graphs display anti-T. cruzi confirmatory data in 4 lines starting from January 2021; the Y-axis = (0 - 60) number of samples and the X-axis = month and year (January 2021 鈥 December 2024).
Blue Line- Represents the total number of reactive samples starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in total numbers
Green line - Represents the # of confirmed negatives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in confirmed negative.
Yellow line - Represents the # of indeterminate starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in indeterminate.
Redline - Represents the # of confirmed positives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in confirmed positives.
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The following T. pallidum screening and confirmatory assays are presently in use:
- Beckman Coulter PK庐 TP System
- Trinity Biotech - Captia 鈩 Syphilis (T. pallidum)-G
- Arlington Scientific, INC. 鈥 RPR Card Test For Syphilis
These assays are used per the current algorithm.
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American Red Cross 鈥 Anti-T. pallidum confirmatory Results- The legend displays the total number and rates of anti-T. pallidum (Syphilis) reactive donations between July 鈥 December 2024 with the total numbers and rates of Captia G negative, equivocal, positive, and not tested donations, also the total # and rate of RPR nonreactive, reactive and not tested. The graphs display anti-T. pallidum confirmatory data in 6 lines starting from January 2021; the Y-axis = (0 - 2000) number of samples and the X-axis = month and year (January 2021 鈥 December 2024).
Blue Line- Represents the total number of reactive T. pallidum samples starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in total numbers
Green line - Represents the # of Captia G negatives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a decrease in Captia G negatives.
Yellow line - Represents the # of Captia G equivocal starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight increase in Captia G equivocal.
Redline - Represents the # of Captia G positives starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays an increase in Captia G positives.
Dark Green line - Represents the # of RPR non-reactive starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays an increase in RPR non-reactive.
Brown line- Represents the # of RPR reactive starting from January 2021 to December 2024. Data from November 2024 to December 2024 displays a slight increase in RPR reactive.
Table: Table of the success rates of reentry testing of donors, by the marker for which they were reactive and therefore deferred from donating blood.

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Table: Table of testing criteria used to classify a donation as a potential yield.

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Graph: Bar chart depicting the number of confirmed NAT yield donations by marker (HCV, HIV and HBV), by year from 6/22/2009 through 11/30/2024

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Table: Table of the rates of confirmed and non-confirmed NAT yield cases from 20,337,919 donations tested during the use of the current screening assay from 7/13/2020 to 11/30/2024.

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This presentation contains information for West Nile Virus (WNV) nucleic acid testing (NAT). It includes only American Red Cross (ARC) information updated through 10/11/2024
The NAT assay is a qualitative tests听 used to screen for WNV.
NAT is performed using minipools comprised of 16 donations. If a pool is reactive, then each of the individual donations is tested using the same WNV NAT assay.
Donations that test reactive for WNV are classified as either a Presumed Viremic Donation (PVD) or non-PVD. A Presumed Viremic Donation (PVD) is defined as: 1) a WNV-initially reactive donation with a signal-to-cutoff (S/CO) ratio of greater than or equal to 17 using the WNV Transcription-Mediated Amplification (TMA) Assay or 2) a WNV-initially reactive donation with an S/CO ratio of less than 17 if upon repeat testing the sample is repeatedly reactive.
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Additional testing is performed to further classify WNV reactives as confirmed or non-confirmed. PVDs have a 95% or greater chance of being confirmed by additional testing.

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Graph: Horizontal bar chart depicting the number of West Nile Virus (WNV) confirmed cases identified through Red Cross testing by year.
Number of confirmed cases varies by season with the maximum of 275 cases in 2012 and a minimum of 35 cases in 2019.
There were 161 WNV confirmed cases identified for 2024.

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Graph: Line graph depicting the average West Nile Virus (WNV) cases from 2004 to 2023 and cases for 2024 WNV cases, by the calendar week.
The WNV seasonal peak occurs between calendar weeks 33 to 39.
There were 167 WNV cases identified for 2024.

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Map: Map showing the categorization of West Nile Virus cases for Red Cross donations as they appear in each state.
States included in each category include:
Confirmed only: CA, CO, DC, IA, IL, IN, KS, KY, MN, MO, MS, MT, NJ, NV, NY, OH, OK, PA, SC, UT, VA, WI, WV
Confirmed and False Positive: GA, MD, MI, NC, NE, TX
Confirmed and Unconfirmed: None
Confirmed, False Positive and Unconfirmed: None
False Positive only: None
False Positive and Unconfirmed: None
Unconfirmed only: None

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Table: Table of West Nile Virus (WNV) Test Results for confirmed cases by years 2004 to 2018, 2019, 2020, 2021, 2022, 2023 and 2024.
Data is broken out to Presumed Viremic Donations (PVDs), confirmed positive identified by individual testing, PVD sensitivity, PVD positive predictive value and confirmed non-PVDs.
For 2004-2024:
Total number of PVDs is 2,706
PVD鈥檚 identified by individual testing that confirmed averages to 46%,
PVD Sensitivity ranges from 94-98 %,
PVD positive predictive value ranges from 91-100%, and
Total number of Confirmed Positives that were not PVDs is 122.
American Red Cross COVID Antibody Follow-up Testing from Healthy, Allogeneic Donors
Testing began on 6/15/2020; Updated on: 11/10/2021
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This presentation contains:听
- Two graphs depicting donor follow-up Ortho antibody reactivity and
- Two graphs depicting donor follow-up Roche reactivity.
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American Red Cross West Nile Virus Testing
Testing began on 5/23/2003; Updated on: 12/31/2023
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This presentation contains information for West Nile Virus (WNV) Testing. It includes not only American Red Cross (ARC) information, but also information from the AABB West Nile Virus Biovigilance Network and the Centers for Disease Control and Prevention (CDC), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Vector-Borne Diseases (DVBD).
Donations that test reactive for WNV are classified as either a Presumed Viremic Donation (PVD) or non-PVD. A Presumed Viremic Donation (PVD) is defined as: 1) a WNV-initially reactive donation with a signal-to-cutoff (S/CO) ratio of greater than or equal to 17 using the WNV Transcription-Mediated Amplification (TMA) Assay or 2) a WNV-initially reactive donation with an S/CO ratio of less than 17 if upon repeat testing the sample is repeatedly reactive.听
American Red Cross WNV TMA testing is routinely performed using minipools comprised of 16 samples. When WNV activity is identified in a geographic area from: a WNV-reactive donation, human WNV activity or mosquito WNV activity, testing is converted to Individual Donation Nucleic Acid Testing (ID-NAT). This is termed as 鈥渢riggering for WNV ID-NAT鈥 and the area of trigger is defined as a 50-mile radius surrounding a single zip code.
Additional testing is performed to further classify WNV reactives as confirmed or non-confirmed. PVDs have a 95% or greater chance of being confirmed by additional testing (repeat testing from an independent sample including the same or alternate WNV NAT and/or IgM reactivity at index or follow-up testing).听
The 鈥淐urrent Red Cross Triggered Areas鈥 map can be accessed online by hovering over the link in the header and selecting control & click. The online map is interactive and can be zoomed in/out.
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American Red Cross West Nile Virus (WNV) Confirmed Positive Donors
Testing began on 5/23/2003; Updated through: 12/31/2023
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This presentation contains Maps of WNV Confirmed Positive Donors for each WNV season from 2003 through 2023. It includes only American Red Cross (ARC) Donors.
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American Red Cross Babesia Screening
Testing began on 5/5/2020; Presentation Updated on: 12/31/2023
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Babesia blood donation screening began on May 5th in 14 states on the East Coast (Northern and Mid-Atlantic) and Upper Midwest, plus Washington DC. The screening is performed using the Grifols nucleic acid assay in pools of 16 whole blood samples (note that babesia is a red cell parasite and thus red cells are needed for lysis to release the parasite鈥檚 nucleic acid). 鈥嬧
This presentation contains reactivity data by state of collection (table and map). 鈥嬧
The table summarizes the number of nonreactive (negative) and reactive donations collected in each state, including the percentage of reactive donations and reactive rates. 鈥嬧
The map provides a visual distribution of reactive donations by state of collection.鈥
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American Red Cross HLA Testing
Testing began on 10/10/2016; Presentation updated on: 2/15/2024
Data through collection date 12/31/2023
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This presentation contains information for Red Cross human leukocyte antigen (HLA) Testing.
HLA testing is performed on donations from female donors who indicate they have ever been pregnant (first-time donors) or donors who have had a pregnancy since their prior HLA-negative donation (repeat donors). Donors who test HLA reactive by the FDA licensed screening test for HLA class I and II antibodies are further tested to determine their ongoing suitability via Luminex using a validated cutoff for donor screening. Donors testing negative can be reinstated.
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American Red Cross Zika Virus Testing
Testing began on 6/21/2016; Completed on: 6/30/2022
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This presentation contains information for Zika virus (ZIKV) testing.
Donations that test reactive for ZIKV RNA are classified as either a Presumed Viremic Donation (PVD) or non-PVD. A PVD is defined as a ZIKV RNA-initially reactive donation if upon repeat Nucleic Acid Testing (NAT) is repeatedly reactive. American Red Cross ZIKV NAT testing is routinely performed using minipools comprised of 16 samples but was initially done by Individual Donation NAT(ID-NAT) until January 1, 2019. When ZIKV activity is identified in a geographic area from: a ZIKV-reactive donation, human ZIKV activity or mosquito ZIKV activity, testing is converted to ID-NAT. This is termed as 鈥渢riggering for ZIKV ID-NAT鈥 and the area of trigger is defined as a 50-mile radius surrounding a single zip code.
Additional testing is performed to further classify ZIKV reactives as confirmed or non-confirmed. One of the tests used to confirm cases (Grifols Red Cell TMA) was dropped from the confirmatory algorithm because of inconsistencies in which 4 cases were identified as confirmed positive, but with additional testing were found to be false reactive.
For additional information on the testing algorithm and results, refer to Investigational Testing for Zika Virus among U.S. 糖心原创, Saa et al., N Engl J Med. 2018 May 10;378(19):1778-1788
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American Red Cross听HIV, HCV, and HBV Nucleic Acid Testing for those who are Seronegative听
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Testing began on 6/22/2009; Updated on: 2/15/2024
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This update only includes potential yield and confirmed yield samples for nucleic acids for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV). Yield indicates that these donations were only reactive by nucleic acid testing (NAT) for one of the three viruses.
Ultrio and Ultrio Plus assays are qualitative transcription mediated amplification (TMA) tests used to screen for HIV RNA, HCV RNA and HBV DNA. The Ultrio Elite assay was updated to add HIV-1 group O and HIV-2 RNA in addition to HIV-1. Dates of use of each assay are shown in slide 4.
Ultrio multiplex (HIV/HCV/HBV) NAT is performed using minipools comprised of 16 samples. If a pool is reactive, then each of the individual samples is tested using the multiplex test. Donations that are individually reactive by the multiplex test are then further tested using the 3 discriminatory tests (HIV, HCV and HBV).
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American Red Cross听Human Immunodeficiency Virus (HIV) Confirmed Positive Donors
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Updated through: 11/30/2023
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This presentation contains information for HIV Confirmed Positive Donors starting in 2003 and maps of HIV Confirmed Positive Donors starting in 2010. It includes only听 American Red Cross (ARC) Donors that are concordant positive (seroreactive and dHIV reactive) and Yield positive (non-seroreactive and dHIV reactive, confirmed on alternate sample).
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American Red Cross听Hepatitis C Virus (HCV) Confirmed Positive Donors
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Updated through: 11/30/2023
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This presentation contains information for HCV Confirmed Positive Donors starting in 2003 and maps of HCV Confirmed Positive Donors starting in 2010. It includes only听 American Red Cross (ARC) Donors that are concordant positive (seroreactive and dHCV reactive) and Yield positive (non-seroreactive and dHCV reactive, confirmed on alternate sample).
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American Red Cross听Hepatitis B Virus (HBV) Confirmed Positive Donors
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Updated through: 11/30/2023
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This presentation contains information and maps of HBV Confirmed Positive Donors starting in 2008 and maps of HBV Confirmed Positive Donors starting in 2010. It includes only听 American Red Cross (ARC) Donors that are concordant positive (seroreactive and dHBV reactive) and Yield positive (non-seroreactive and dHBV reactive, confirmed on alternate sample).
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American Red Cross Blood Donation Screening Assay Performance and Testing Metrics
Slides Updated 1/25/2024
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This presentation contains performance metrics for infectious disease blood donation screening and confirmatory tests. The information is presented in slides grouped by marker: anti-HIV-1/HIV-2, anti-HCV, HBsAg, anti-HBc, anti-HTLV and anti-T. cruzi (Chagas). The slide groupings contain the current screening and confirmatory algorithm, graphs displaying the Initial Reactive (IR) and Repeat Reactive (RR) rates, and graphs displaying results of supplemental/ confirmatory testing for donations that tested RR for the respective screening assay since 2017. Select marker groupings (HIV and HBsAg) include graphs with the respective supplemental testing results according to the algorithm in use at the time of donation. Screening slide legends contain the total number of donations tested, the mean IR and RR rates; as well as RR rates and totals by testing laboratory. Confirmatory slide legends show the total number of reactive units tested with the numbers for the respective final test results. All slide legends display data from the current fiscal year, 2024 (July 2023 鈥 June 2024).
Four additional slides are included:
- Slide 21 & 22 shows the current algorithm and the confirmatory rates for anti-T. pallidum.
- Slide 23 shows the 鈥淔alse Positive Rate by Marker鈥 and illustrates the effectiveness and the success for each marker test.听
- This table is updated quarterly, all other slides are updated monthly.
- Slide 24 provides the assay name, manufacturer and implementation date for the current screening and supplemental/confirmatory assays; this information is updated as needed.
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Notes:
In January 2018, Creative Testing Solutions (CTS) began testing for all donations for the American Red Cross (ARC).Beginning January 2019, graphs include results for ARC donations only; data through 2018 included ARC donation and contracted customer samples tested by ARC.There is an approximate six-week delay before testing data are available to update the included slides.
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