Tracking of Donation Reactivity

American Red Cross COVID Antibody Follow-up Testing from Healthy, Allogeneic Donors

Testing began on 6/15/2020; Updated on: 11/10/2021

This presentation contains: 

• Two graphs depicting donor follow-up Ortho antibody reactivity and
• Two graphs depicting donor follow-up Roche reactivity.

American Red Cross West Nile Virus Testing

Testing began on 5/23/2003; Updated on: 12/31/2023

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. 

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 “triggering for WNV ID-NAT” 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). 
The “Current Red Cross Triggered Areas” 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.

American Red Cross West Nile Virus (WNV) Confirmed Positive Donors

Testing began on 5/23/2003; Updated through: 12/31/2023

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.

American Red Cross Babesia Screening

Testing began on 5/5/2020; Presentation Updated on: 12/31/2023

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’s nucleic acid). ​​

This presentation contains reactivity data by state of collection (table and 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 state of collection.​

American Red Cross HLA Testing
Testing began on 10/10/2016; Presentation updated on: 2/15/2024
Data through collection date 12/31/2023

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.

American Red Cross Zika Virus Testing

Testing began on 6/21/2016; Completed on: 6/30/2022

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 “triggering for ZIKV ID-NAT” 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. Blood Donors, Saa et al., N Engl J Med. 2018 May 10;378(19):1778-1788 https://www.nejm.org/doi/full/10.1056/nejmoa1714977

American Red Cross HIV, HCV, and HBV Nucleic Acid Testing for those who are Seronegative 

Testing began on 6/22/2009; Updated on: 2/15/2024

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).

American Red Cross Human Immunodeficiency Virus (HIV) Confirmed Positive Donors

Updated through: 11/30/2023

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  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).

American Red Cross Hepatitis C Virus (HCV) Confirmed Positive Donors

Updated through: 11/30/2023

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  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).

American Red Cross Hepatitis B Virus (HBV) Confirmed Positive Donors

Updated through: 11/30/2023

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  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).

American Red Cross Blood Donation Screening Assay Performance and Testing Metrics
Slides Updated 1/25/2024

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 – 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 “False Positive Rate by Marker” and illustrates the effectiveness and the success for each marker test. 
  • 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.

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.