Prevalence and quantitation of parvovirus B19 DNA levels in blood donors with a sensitive polymerase chain reaction screening assay.

Pubmed ID: 17880600

Journal: Transfusion

Publication Date: Oct. 1, 2007

Affiliation: Westat, 1650 Research Boulevard, Rockville, MD 20850, USA.

MeSH Terms: Algorithms, Blood Donors, DNA, Viral, Parvoviridae Infections, Parvovirus B19, Human, Polymerase Chain Reaction, Antibodies, Viral, Viral Load, Sensitivity and Specificity, Reproducibility of Results, Erythema Infectiosum, Transfusion Reaction

Grants: N01 HB 97077, N01 HB 47175, N01 HB 57181, N01 HB 97078, N01 HB 97079, N01 HB 97080, N01 HB 97081, N01 HB 97082

Authors: Busch MP, Kleinman SH, Glynn SA, Lee TH, Todd D, Tobler L, Montalvo L, Kiss JE, Shyamala V

Cite As: Kleinman SH, Glynn SA, Lee TH, Tobler L, Montalvo L, Todd D, Kiss JE, Shyamala V, Busch MP, National Heart Lung Blood Institute Retrovirus Epidemiology Donor Study (REDS-II). Prevalence and quantitation of parvovirus B19 DNA levels in blood donors with a sensitive polymerase chain reaction screening assay. Transfusion 2007 Oct;47(10):1756-64.

Studies:

Abstract

BACKGROUND: Blood donor parvovirus B19 DNA prevalence with sensitive nucleic acid test assays has recently been demonstrated to be higher than that found with assays designed to detect high viral titers in the plasma manufacturing sector. STUDY DESIGN AND METHODS: Stored plasma aliquots from 5020 donations collected between 2000 and 2003 at seven US blood centers were tested. Testing was performed with a real-time B19 DNA polymerase chain reaction (PCR; TaqMan, Applied Biosystems) assay with a 50 percent limit of detection (LOD) of 1.6 IU per mL (95% confidence interval [CI], 1.2-2.1 IU/mL) and a 95 percent LOD of 16.5 IU per mL (95% CI, 10.6-33.9 IU/mL). Confirmation and quantitation of B19 DNA was accomplished by retesting of two additional subaliquots. Confirmed-positive specimens were tested for the presence of anti-B19 immunoglobulin M (IgM) and IgG with FDA-licensed assays. RESULTS: B19 DNA prevalence was 0.88 percent (95% CI, 0.64%-1.2%). Among the 23 donations with B19 DNA titers of at least 20 IU per mL, the median DNA concentration was 105 IU per mL with an interquartile range of 42 to 481 IU per mL; the highest value was 1869 IU per mL. All B19 DNA-positive donations were positive for the presence of IgG and 10 (23%) were also positive for the presence of IgM; IgM seropositivity was associated with increasing DNA levels (p = 0.0013). CONCLUSION: Low-level B19 DNA was detected in nearly 1 percent of donations. The 23 percent of DNA-positive donations with both IgM and IgG B19 antibody most likely represent acute resolving infection, whereas those with IgG but no IgM are most consistent with a more chronic and possibly persistent phase of B19 infection.