Analysis of voluntary blood donors with biologic false reactivity on chemiluminescent immunoassays and implications for donor management

Philip Kiely · Yvonne Stewart · Luciana Valois Pereira de Castro

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Blood donation and transfusion practices Clinical Laboratory Practices and Quality Control HIV Research and Treatment

Abstract

BACKGROUND: Biologic false-reactive (BFR) results in blood donors are problematic due to both component loss and donor-management issues. This report analyzes the results of a longitudinal study of BFR donors and the implications for donor management. STUDY DESIGN AND METHODS: Donors who gave BFR results on HBsAg, HIV-1/HIV-2, HCV, or HTLV-I/HTLV/II chemiluminescent immunoassays (ChLIAs) (PRISM, Abbott) between May 1997 to March 1999 were analyzed. Donors were followed up for up to three donations after an index BFR episode. In addition, results of any negative donations before the index BFR result but within the study period were included in the analysis. RESULTS: For donors who gave an index BFR result on the HBsAg ChLIA, 14.3 percent remained BFR at subsequent donations, whereas for the anti-HIV-1/HIV-2, anti-HCV, and anti-HTLV-I/HTLV-II ChLIAs, the figures were 66.0, 77.4, and 71.6 percent, respectively. For donors who gave a second BFR result, the percentage who remained BFR at subsequent donations was 75.0, 80.6, 84.6, and 74.5 percent for the four assays, respectively. The rate at which negative repeat donors became BFR during the study period was 0.02, 0.07, 0.12, and 0.02 percent for the HBsAg, anti-HIV-1/HIV-2, anti-HCV, and anti-HTLV-I/HTLV-II assays, respectively. CONCLUSIONS: Our results indicate that donors who give an index BFR result on the ChLIAs (PRISM, Abbott) should be allowed to continue donating because most donors with a HBsAg BFR result were negative at subsequent donations, and between 22.6 and 34.0 percent of those with BFR results on the HIV-1/HIV-2, HCV, or HTLV-I/HTLV-II assays gave subsequent negative donations. However, donors who give a second BFR result should be counseled and deferred because they were very unlikely to give subsequent negative results.

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References

1998False-Positive HIV-1 Test Results in a Low-Risk Screening Setting of Voluntary Blood Donation 2003Improved efficiency of national HIV, HCV, and HTLV antibody testing algorithms based on sequential screening immunoassays 1997Loss of volunteer blood donors because of unconfirmed enzyme immunoassay screening results. Retrovirus Epidemiology Donor Study 1996Frequency of human immunodeficiency virus (HIV) infection among contemporary anti‐HIV‐1 and anti‐HIV‐½ supplemental test‐ indeterminate blood donors 1997To thy (reactive) donors be true!1995Long‐term follow‐up of blood donors with indeterminate human immunodeficiency virus type 1 results on Western blot 2000Indeterminate results in blood donor testing: What you don't know can hurt you

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2014Screening tests for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus in blood donors: Evaluation of two chemiluminescent immunoassay systems 2010The significance of repeat testing in Turkish blood donors screened with HBV, HCV and HIV immunoassays and the importance of S/CO ratios in the interpretation of HCV/HIV screening test results and as a determinant for further confirmatory testing 2005Can We Improve the Management of Blood Donors With Nonspecific Reactivity in Viral Screening and Confirmatory Assays?2014Comparison Between Screening and Confirmatory Serological Assays in Blood Donors in a Region of South Italy

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