Performance evaluation of the Diasorin LIAISON® XL Zika capture IgM CLIA test

Because Zika virus (ZIKV) can cause serious birth defects and is involved in cases of Guillain-Barré syndrome, the ZIKV outbreak in the American continent in 2015 resulted in an enormous need for ZIKV diagnostic tools. We evaluated the LIAISON® XL Zika Capture IgM test on 106 samples from patients, mainly travelers, with a confirmed or probable ZIKV infection. Sensitivity between 0 and 84 days after onset of symptoms was 92.5%. Specificity was evaluated on a panel of 56 samples known to cause possible cross-reactions. Cross-reaction with DENV antibodies was limited (10.5%) but false-positive results occurred in samples from patients with malaria, CMV and EBV infections.