Doyle, Sean and Kerr, S. and O'Keeffe, Grainne and O'Carroll, D. and Daly, P. and Kilty, C. (2000) Detection of parvovirus B19 IgM by antibody capture enzyme immunoassay: receiver operating characteristic analysis. Journal of Virological Methods, 90 (2). pp. 143-1522. ISSN 0166-0934

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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.

Item Type:	Article
Keywords:	Serology; Diagnosis; Infection; Fetus; Pregnancy; Immunocompromised;
Academic Unit:	Faculty of Science and Engineering > Biology
Item ID:	7400
Identification Number:	https://doi.org/10.1016/S0166-0934(00)00227-5
Depositing User:	Dr. Sean Doyle
Date Deposited:	29 Aug 2016 15:31
Journal or Publication Title:	Journal of Virological Methods
Publisher:	Elsevier
Refereed:	Yes
URI:	http://www.sciencedirect.com
Use Licence:	This item is available under a Creative Commons Attribution Non Commercial Share Alike Licence (CC BY-NC-SA). Details of this licence are available here

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