Establishment of a comprehensive and high throughput serological algorithm for Zika virus diagnostic testing

Area of Science:

• Virology
• Immunology
• Epidemiology

Background:

• The previous Zika virus (ZIKV) serological algorithm relied on anti-ZIKV IgM capture ELISA (MAC-ELISA) and plaque reduction neutralization test (PRNT).
• PRNT is laborious and time-consuming, posing challenges during outbreaks like the 2015 ZIKV epidemic.
• A need existed for a more efficient screening method for ZIKV diagnostics.

Purpose of the Study:

• To evaluate various ZIKV ELISA kits for anti-ZIKV IgM and anti-IgG detection.
• To establish an optimized combination of ELISAs for efficient ZIKV screening prior to PRNT confirmation.
• To develop a high-throughput ZIKV diagnostic algorithm.

Main Methods:

• Evaluation of MAC-ELISA and InBios-M for anti-ZIKV IgM detection.
• Assessment of Euroimmun-G for anti-ZIKV IgG detection.
• Comparison of ELISA combinations against PRNT for sensitivity, specificity, and cross-reactivity with Dengue virus antibodies.

Main Results:

• The MAC-ELISA/Euroimmun-G and InBios-M/Euroimmun-G combinations showed high sensitivities (99.1% and 97.2%) and specificity (96.0%).
• Cross-reactivity with Dengue virus antibodies was observed (71.4% and 50.0%).
• These combinations demonstrated excellent agreement with PRNT and effective detection of samples collected beyond 3 months postexposure or onset (MPEO).

Conclusions:

• Recommended anti-IgM and anti-IgG ELISA combinations serve as effective screening tools for ZIKV diagnostics.
• The new algorithm offers high-throughput capabilities and improved detection for samples collected later after exposure.
• The findings support a revised ZIKV diagnostic strategy with enhanced efficiency and accuracy.