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Journal of Clinical Microbiology, April 2000, p. 1476-1481, Vol. 38, No. 4
Department of Congenital Infectious Disease
Diagnostics1 and Department of Clinical
Research,3 Abbott Laboratories, Abbott Park,
Illinois; Dianalab, Geneva,
Switzerland2; Department of Microbiology
and Molecular Cell Biology, Eastern Virginia Medical School, Norfolk,
Virginia4; and Department of Clinical
and Experimental Medicine, Section of Microbiology, University of
Bologna, Bologna, Italy5
Received 9 June 1999/Returned for modification 26 August
1999/Accepted 24 January 2000
A new microparticle enzyme immunoassay (MEIA), the Cytomegalovirus
(CMV) Immunoglobulin M (IgM) test, was developed on the Abbott AxSYM
analyzer. This test uses recombinant CMV antigens derived from portions
of four structural and nonstructural proteins of CMV: pUL32 (pp150),
pUL44 (pp52), pUL83 (pp65), and pUL80a (pp38). A total of 1,608 specimens from random volunteer blood donors (n = 300), pregnant women (n = 1,118), transplant
recipients (n = 6), and patients with various clinical
conditions and disease states (n = 184) were tested
during development and evaluation of this new assay. In a preliminary
clinical evaluation we tested specimens collected prospectively from
pregnant women (n = 799) and selected CMV IgM-positive
archived specimens from pregnant women (n = 39). The
results from the new CMV IgM immunoassay were compared to the results
of a consensus interpretation of the results obtained with three
commercial CMV IgM immunoassays. The results for specimens with
discordant results were resolved by a CMV IgM immunoblot assay. The
relative sensitivity, specificity, and agreement for the AxSYM CMV IgM
assay were 94.29, 96.28, and 96.19%, respectively, and the resolved
sensitivity, specificity, and agreement were 95.83, 97.47, and 97.37%,
respectively. We also tested serial specimens from women who
experienced seroconversion or a recent CMV infection during gestation
(n = 17) and potentially cross-reactive specimens
negative for CMV IgM antibody by the consensus tests (n = 184). The AxSYM CMV IgM assay was very sensitive
for the detection of CMV IgM during primary CMV infection, as shown by the detection of CMV IgM at the same time as or just prior to the
detection of CMV IgG. Specimens from individuals with lupus (n = 16) or parvovirus B19 infection
(n = 6) or specimens containing hyper IgM
(n = 9), hyper IgG (n = 8), or
rheumatoid factor (n = 55) did not cross-react with
the AxSYM assay. One specimen each from individuals infected with
Epstein-Barr virus (n = 26), measles virus
(n = 10), herpes simplex virus (n = 12), or varicella-zoster virus (n = 13) infection, one
specimen from an influenza vaccinee (n = 14), and one
specimen containing antinuclear antibody cross-reacted with the
assay. The overall rate of cross-reactivity of the specimens with the
assay was 3.3% (6 of 184). The AxSYM CMV IgM assay is a
sensitive and specific assay for the detection of CMV-specific IgM.
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.
Development and Clinical Evaluation of a
Recombinant-Antigen-Based Cytomegalovirus Immunoglobulin M Automated
Immunoassay Using the Abbott AxSYM Analyzer
*
Corresponding author. Mailing address: Abbott
Laboratories, Bldg. AP31, D-9JW, Abbott Park, IL 60064-6199. Phone:
(847) 937-5998. Fax: (847) 938-9219. E-mail:
gregory.maine{at}abbott.com.
Journal of Clinical Microbiology, April 2000, p. 1476-1481, Vol. 38, No. 4
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.
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