Abstract
The diagnosis of Zika virus infection is complicated and includes testing for nucleic acids and IgM and IgG antibodies, depending on the stage of infection. Zika IgG is an important marker of infection after the acute stage; however, IgG assays can lack specificity due to the similarities between Zika and other flaviviruses. In this study, the diagnostic sensitivity and specificity of the Elecsys® Zika IgG assay were assessed in 496 samples from Zika endemic regions, and specificity only was assessed in 1685 blood screening and diagnostic samples from Zika non-endemic regions. Cross-reactivity was also assessed against a panel of 202 potentially cross-reacting samples. The performance of the Elecsys® Zika IgG assay was compared with the anti-Zika virus ELISA IgG. In the samples from the Zika endemic regions, the Elecsys® Zika IgG assay had 92.88% (95% confidence interval 89.42–95.48) sensitivity and 100% specificity and in the samples from Europe the Elecsys® Zika IgG assay specificity was ≥99.62%. The Elecsys® Zika IgG assay was highly specific in samples from both prevalent and non-endemic regions.
Highlights
The Zika virus (ZIKV) is a mosquito-borne flavivirus that was first isolated in 1947 from a febrile rhesus macaque in the Zika forest of Uganda through a yellow fever surveillance network in the area [1]
The objective of this study was to evaluate the specificity of the Elecsys® Zika IgG assay, a qualitative one-step double-antigen sandwich (DAGS) immunoassay using recombinant ZIKV antigens, designed for the in vitro detection of anti-Zika IgG antibodies in human serum and plasma, using samples from: ZIKV prevalence areas, blood donors from Europe, pregnant women from Europe, and samples from other viral, bacterial, and parasitic infections
In the samples from Zika endemic regions, there were no false positives using the Elecsys® Zika IgG assay and only two samples yielded false positives with the Elecsys® Zika IgG assay in this study
Summary
The Zika virus (ZIKV) is a mosquito-borne flavivirus that was first isolated in 1947 from a febrile rhesus macaque in the Zika forest of Uganda through a yellow fever surveillance network in the area [1]. The first human case of infection with ZIKV occurred in Uganda in 1962–3 [3]. Transmission of the virus to humans is primarily through the bite of an infected Aedes mosquito species, transmission may occur through several non-vector-borne routes, including pre- and peri-natal transmission, sexual intercourse, and blood transfusions [6,7,8]. The increasing worldwide presence of the Aedes mosquito species may lead to the emergence of new ZIKV epidemics in urban areas [9]
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