Qualification of the Geenius HIV 1/2 supplemental assay for use in the HIV blood donation screening algorithm

BACKGROUND A single, simplified approach for human immunodeficiency virus (HIV)‐1/HIV‐2 antibody confirmation/differentiation is needed for the HIV blood donation supplemental algorithm used in the United States. A clinical evaluation of the Geenius assay was performed—the same assay used for HIV diagnostic confirmation/differentiation in the United States since 2014. STUDY DESIGN AND METHODS Well‐characterized unlinked donation samples classified as HIV negative, false positive, or confirmed positive were included in the study: 200 antibody‐nonreactive, 200 HIV‐1 immunofluorescence assay (IFA) confirmed‐positive, and 100 antibody‐screen false‐positive donations, equally divided between serum and plasma. Samples were retrieved from a repository, relabeled, and tested by an immunochromatographic test (Geenius HIV 1/2 Supplemental Assay, Bio‐Rad). Comparator testing involved parallel US Food and Drug Administration (FDA)‐licensed HIV‐1 IFA or HIV‐2 enzyme immunoassay (EIA) supplemental testing for any sample missing those results as part of routine testing (otherwise test‐of‐record results were used). Samples with discordant results were further tested with a rapid test (Multispot HIV‐1/HIV‐2 Rapid Test, Bio‐Rad) to provide final sample interpretations. Testing volume reductions with the Geenius were estimated from screening performed by the American Red Cross from September 2016 to April 2019. RESULTS Clinical results were 100% sensitivity and specificity with an indeterminate rate of 4.0% to 5.0%. From 2016 to 2019, sole use of the Geenius would reduce testing complexity for 5265 antibody repeat‐reactive donations including 95.7% (5028) false positives, eliminating approximately 5000 unnecessary tests. CONCLUSION Geenius FDA licensure (August 26, 2019) adding the HIV‐1/HIV‐2 differentiation/confirmation donation supplemental claim will enable replacement of previously used FDA‐licensed supplemental assays while maintaining comparable sensitivity, avoiding thousands of unnecessary HIV‐1‐IFA, western blot, and HIV‐2‐EIA tests.