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False-positive infectious screening results among blood donors

Sofie Dolores Holm Müller1, Mie Topholm Bruun1,2, Jørgen Georgsen1,2

  • 1Clinical Immunology Research Unit, Department of Clinical Immunology, Odense University Hospital, Odense, Denmark.

Vox Sanguinis
|February 10, 2026
PubMed
Abstract

Insights

New blood donors with a false-positive test result (FPTR) have a significantly higher risk of experiencing a second FPTR. This finding suggests potential benefits in deferring new donors after an initial FPTR to reduce costs and donor concern.

Area of Science:

  • Transfusion Medicine
  • Clinical Laboratory Science
  • Immunology

Background:

  • High-sensitivity assays for blood donation screening can yield false-positive test results (FPTRs).
  • The causes of FPTRs are multifactorial, including lot-dependent and lot-independent factors.
  • FPTRs incur administrative costs, necessitate confirmatory testing, and can cause anxiety for deferred donors.

Purpose of the Study:

  • To investigate the risk factors associated with repeat false-positive test results (FPTRs) in blood donors.
  • To determine if donor characteristics influence the likelihood of a second FPTR.

Main Methods:

  • A retrospective analysis of blood donor screening data from January 2021 to November 2023.
  • Identification of first-time and second-time FPTRs using Abbott Alinity i and Roche Cobas MPX assays.
  • Logistic regression analysis to assess the impact of donor status (new vs. repeat), sex, age, and interval between donations on the risk of a second FPTR.

Main Results:

  • Out of 223,323 donations from 38,962 donors, 216 FPTRs were recorded.
  • Among 83 donors with a first-time FPTR who donated again, 67.5% had a second FPTR.
  • New donors with an initial FPTR had a significantly higher risk (aOR=6.06) of a second FPTR, occurring in 89.5% of such cases.

Conclusions:

  • New blood donors experiencing an initial FPTR demonstrate a substantially elevated risk of a subsequent FPTR.
  • Deferring new donors after a first FPTR may be advisable from ethical and economic perspectives.
  • Persistent FPTRs in some donors, even over extended periods, suggest the influence of lot-independent factors.
Keywords:
blooddonorsfalse‐positive test resultsplasmascreening

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