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

摘要: Parvovirus B19 infection can cause severe effects in high-risk groups including pregnant women and immunocompromised individuals. Although serological detection of is commonplace, minimal information available on the absolute performance characteristics various tests for IgM. The first parvovirus IgM enzyme immunoassay to be cleared by US Food Drug Administration (FDA) described. cut-off has been established using receiver operating characteristic (ROC) analysis giving a sensitivity specificity 89.1 99.4%, respectively. No cross-reactivity observed with rubella or other viral disease which similar symptomologies B19. Multi-site reproducibility studies have shown high rates (observed/expected result) 100% nonreactive specimens (N=324) strongly reactive (N=403), Immunoassay ranged from 11.76 17. 46% coefficient variation all tested (N=12) whereby each specimen was assayed total 81 times. seroprevalence 1% blood donor population (N=399). In absence international criteria, this study will major benefit clinical virologist assessing reliability recent