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Updated: May 2, 2026
qPCR Is a Sensitive and Rapid Method for Detection of Cytomegaloviral DNA in Formalin-fixed, Paraffin-embedded Biopsy Tissue
Published on: July 9, 2014
Prevalence of CMV DNA in plasma from United States blood donors
Kacie Grimm1, Laura Tonnetti1, Paula Saá1
1American Red Cross Biomedical Services, Medical and Scientific Office, Washington, DC, USA.
Background:
Current interventions for CMV at-risk recipients include leukoreduction and CMV-antibody screening. We evaluated the CMV-DNA prevalence in United States (US) blood donors to estimate the residual risk from cell-free virus.
Methods:
A highly sensitive, automated quantitative nucleic acid testing (NAT) assay assessed plasma samples in pools of 24 from CMV-seropositive or CMV-antibody not-tested donations. CMV-NAT-initial reactive (IR) samples were tested for CMV-IgG and IgM. CMV-NAT-reactive donors were invited to participate in follow-up (F/U) to confirm CMV seroconversion and DNA resolution.
Results:
Of 240,115 CMV-DNA-tested samples, 23 were IR; titers ranged from 34.5 to 4020 IU/mL. Of 23 IR, 20 (87%) were CMV-NAT repeatedly reactive (RR); 3 (13%) were seroreactive only (repeat NAT-nonreactive/IgG-only positive). Of 20 CMV-NAT-RRs, 4 (20%) were CMV-IgG-only positive, 15 (75%) were IgM/IgG positive, and 1 (5%) was antibody-negative (i.e., window-period). F/U samples from 9 RR and 2 IR-only donors were collected at an 18-day mean after their IR donation. All F/U samples were NAT RR except those from the 2 IR-only donors, both NAT nonreactive. F/U IgG testing confirmed positivity in all 11 donors, with 8 of 11 also IgM positive. The mean age of CMV-NAT-reactive donors was 47 years; 16 (70%) were male, with 6 first-time donors. Previous donations (1999-2024) for 6 CMV-reactive donors were anti-CMV positive. A commercial infectivity assay yielded negative results for the 8 highest titer samples.
Conclusions:
Sensitive NAT determined a CMV-NAT-IR prevalence of 1:10,440 in plasma samples from CMV-screened seropositive/serology-unscreened US blood donors. One identified window-period donor highlights the limitation of current CMV interventions.
