Evaluation and optimisation of commercial Zika IgG avidity assay

Abstract

Background: ZIKV infection has potentially severe consequences particularly in fetuses/newborns born to mothers that were infected early in pregnancy. Diagnosis relies on the detection of ZIKV IgM that can also be detected due to cross reactivity or to nonspecific polyclonal activation of the immune system. Therefore, in case of ZIKV IgM detection, identification of a recent infection can be of major importance for the optimal management of pregnant women.

Objective: This study evaluates the performances of a commercially available assay to measure ZIKV-IgG avidity.

Study design: A total of 110 serum or plasma samples collected from symptomatic or asymptomatic patients living or returning from a ZIKV endemic area were classified according to epidemiological and clinical information, and to serology and molecular assays' results. Samples were tested with the IgG ZIKV Avidity Test (DIA.PRO®) according to manufacturer's instruction and with a modified protocol.

Results: By using the manufacturer's Avidity Index cut-off, distinction between recent and past infection was unclear with similar AIs in the two situations (p = 0.8872). Sensitivity and specificity in identifying recent infection were poor, 67.3 % and 4.5 % respectively. By using a modified protocol, a better discrimination was observed with significant differences between mean AIs (p = 0.0318), and with higher sensitivity and specificity, respectively 87.8 % and 100 %.

Conclusion: Our results highlight that IgG ZIKV Avidity Test DIA.PRO® assay is not reliable enough to be used in clinical practice without modifications.

Keywords: IgG avidity; Pregnancy; Zika virus.