Detection of parvovirus B19 IgM by antibody capture enzyme immunoassay: receiver operating characteristic analysis

Parvovirus B19 infection can cause severe effects in high-risk groups inclu ding pregnant women and immunocompromised individuals. Although serological detection of B19 infection is commonplace, minimal information is availabl e on the absolute performance characteristics of various tests for the dete ction of B19 IgM. The performance of the first parvovirus B19 IgM enzyme im munoassay to be cleared by the US Food and Drug Administration (FDA) is des cribed. The immunoassay cut-off has been established using receiver operati ng characteristic (ROC) analysis giving a sensitivity and specificity of de tection of 89.1 and 99.4%, respectively. No cross-reactivity is observed wi th rubella or other viral disease IgM which cause similar symptomologies to parvovirus B19. Multi-site reproducibility studies have shown high immunoa ssay reproducibility with detection rates (observed/expected result) of 100 % for nonreactive specimens (N=324) and strongly reactive (N=403), respecti vely. Immunoassay reproducibility ranged from 11.76 to 17.46% coefficient o f Variation for all reactive specimens tested (N=12) whereby each specimen was assayed a total of 81 times. Parvovirus B19 IgM seroprevalence of 1% wa s observed in a US blood donor population (N=399). In the absence of intern ational performance criteria, this study will be of major benefit to the cl inical virologist in assessing immunoassay reliability for the detection of recent infection with parvovirus B19. (C) 2000 Elsevier Science B.V. All r ights reserved.