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Accuracy of the Zika IgM Antibody Capture Enzyme-Linked Immunosorbent Assay from the Centers for Disease Control and Prevention (CDC Zika MAC-ELISA) for Diagnosis of Zika Virus Infection

Sciprofile linkMoyra Machado Portilho, Sciprofile linkLaise De Moraes, Sciprofile linkMariana Kikuti, Sciprofile linkLeile Camila Jacob Nascimento, Sciprofile linkMitermayer Galvão Reis, Sciprofile linkViviane Sampaio Boaventura, Sciprofile linkRicardo Khouri, Sciprofile linkGuilherme Sousa Ribeiro
Published: 18 October 2020
 by  MDPI
Diagnostics , Volume 10; doi:10.3390/diagnostics10100835

Abstract: Serological diagnosis of Zika virus (ZIKV) infection is challenging because of antigenic cross-reactivity with dengue virus (DENV). This study evaluated the accuracy of the Zika IgM antibody capture enzyme-linked immunosorbent assay (CDC Zika IgM MAC-ELISA) in differentiating between ZIKV and DENV infections. To determine sensitivity, we used acute- and convalescent-phase sera from 21 patients with RT-PCR-confirmed ZIKV infection. To determine specificity, we used acute- and convalescent-phase sera from 60 RT-PCR-confirmed dengue cases and sera from 23 blood donors. During the acute-phase of the illness, the assay presented a sensitivity of 12.5% (2/16) for samples collected 0–4 days post symptoms onset (DPSO), and of 75.0% (3/4) for samples collected 5–9 DPSO. During the convalescent-phase of the illness, the test sensitivity was 90.9% (10/11), 100% (2/2), and 0% (0/2) for samples obtained 12–102, 258–260, and 722–727 DPSO, respectively. Specificity for acute- and convalescent-phase samples from RT-PCR-confirmed dengue cases was 100% and 93.2%, respectively. Specificity for blood donor samples was 100%. The assay is an accurate method for Zika serological diagnosis and proved to be reliable for use during surveillance and outbreak investigations in settings where ZIKV and DENV cocirculate.
Keywords: sensitivity and specificity / Enzyme-linked immunosorbent assay / Zika virus / Diagnostic Accuracy / CDC Zika MAC-ELISA

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