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

Abstract

Parvovirus B19 infection can cause severe effects in high-risk groups including pregnant women and immunocompromised individuals. Although serological detection of B19 infection is commonplace, minimal information is available on the absolute performance characteristics of various tests for the detection of B19 IgM. The performance of the first parvovirus B19 IgM enzyme immunoassay to be cleared by the US Food and Drug Administration (FDA) is described. The immunoassay cut-off has been established using receiver operating characteristic (ROC) analysis giving a sensitivity and specificity of detection of 89.1 and 99.4%, respectively. No cross-reactivity is observed with rubella or other viral disease IgM which cause similar symptomologies to parvovirus B19. Multi-site reproducibility studies have shown high immunoassay reproducibility with detection rates (observed/expected result) of 100% for nonreactive specimens (N=324) and strongly reactive (N=403), respectively. Immunoassay reproducibility ranged from 11.76 to 17.46% coefficient of variation for all reactive specimens tested (N= 12) whereby each specimen was assayed a total of 81 times. Parvovirus B19 IgM seroprevalence of 1% was observed in a US blood donor population (N= 399). In the absence of international performance criteria, this study will be of major benefit to the clinical virologist in assessing immunoassay reliability for the detection of recent infection with parvovirus B19.

Risk of fetal hydrops and non-hydropic late intrauterine fetal death after gestational parvovirus B19 infection

“…22 According to the manufacturer (Biotrin International), an index value <0.9 or >1.1 indicates sample negativity or positivity, respectively. For the present study we arbitrarily categorized specimens showing a B19 IgM index of ≥4.0 as high positive and specimens showing a B19 IgM index of 1.2-3.9 as low positive.…”

Comparison of Three Commercially Available Serologic Assays Used To Detect Human Parvovirus B19-Specific Immunoglobulin M (IgM) and IgG Antibodies in Sera of Pregnant Women

“…Capture enzyme immunoassays (capture EIAs) employing native or recombinant antigens are excellent choices for measuring B19V Ig (5,15,19). Systems utilizing either Escherichia coli-expressed or baculovirus-expressed B19V antigens or both in combination have been described.…”

High-Sensitivity PCR Detection of Parvovirus B19 in Plasma

“…While serological diagnosis of viral infection is now well standardized and widely available (6,12), only a limited number of methods for the extraction and detection of B19 nucleic acid in single or pooled blood products have, as yet, been described (1,3,11,19,24). These assays primarily utilize either digoxigenin (DIG)-labeled UTP incorporation into newly synthesized amplicons during PCR to facilitate detection or quantitative PCR technology such as Taqman chemistry (1,24).…”