American Red Cross Blood Donation Screening Assay Performance and Testing Metrics” Updated on: 3/09/2021
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, 2021 (July 2020 – June 2021).
Four additional slides are included:
Slide 21 shows the concordance between two supplemental Chagas tests: Abbott ESA Chagas vs Ortho anti-T. cruzi ELISA.
Slide 22 & 23 shows the current algorithm and the confirmatory rates for anti-T. pallidum.
Slide 24 shows the “False Positive Rate by Marker” and illustrates the effectiveness and the success for each marker test.
Slide 25 provides the assay name, manufacturer and implementation date for the current screening and supplemental/confirmatory assays; this information is updated as needed.
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.