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February 12, 2026Vox Sanguinis0 citations

False‐positive infectious screening results among blood donors

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SMSofie Dolores Holm MüllerMBMie Topholm BruunJGJørgen Georgsen

Key Points

  • The study aims to explore the causes and implications of false-positive test results in blood donors.
  • Identified first-time and second-time FPTRs among blood donors using blood bank computer system data.
  • Utilized Abbott Alinity i and Roche Cobas MPX assays for screening infectious diseases.
  • Employed logistic regression analysis to assess risk factors for second-time FPTRs.
  • 216 false-positive test results identified during the study period.
  • Among donors with a first-time FPTR, 67.5% experienced a second-time FPTR.
  • New donors with a first-time FPTR had a significantly higher risk of recurrence (aOR = 6.06).

Abstract

Abstract Background and Objectives High‐sensitivity assays for infectious screening of blood donations still occasionally result in false‐positive test results (FPTRs). The cause of FPTRs is not always clear and may stem from both lot‐dependent and lot‐independent factors. FPTRs generate additional administration and extra costs for confirmatory testing and may cause concern among deferred donors. Materials and Methods First‐time and second‐time FPTRs among blood donors screened from January 2021 to November 2023 were identified in the blood bank computer system. Abbott Alinity i hepatitis B surface antigen, hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) antibody/antigen assays and Roche Cobas MPX assay were used for screening. Using logistic regression, we examined whether the risk of second‐time FPTR was affected by being a new donor, sex, age and time between two donations. Results During the study period, 38,962 donors gave 223,323 donations. The total number of FPTRs was 216. Among the donors with a first‐time FPTR, 83 had a second donation within the observation period, and 56 (67.5%) of these had a second‐time FPTR. In total, 0.2% of donors were deferred because of second‐time FPTR. New donors with a first‐time FPTR had a significantly higher risk (adjusted odds ratio aOR = 6.06, 95% confidence interval CI 1.17–31.55) of a second‐time FPTR, which occurred in 89.5% of cases. Conclusion An increased risk of second‐time FPTR was found among new donors, and hence it may be beneficial considering the donors′ ethical and economical aspects, to defer this group of donors after the initial FPTR. Lot‐independent factors might explain why some donors keep getting FPTR even after years.

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Cite This Study

Müller et al. (2026) studied this question.

synapsesocial.com/papers/698d6e7b5be6419ac0d543aahttps://doi.org/10.1111/vox.70191
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