Utility of reference materials for Zika Virus nucleic acid testing

Area of Science:

• Virology
• Molecular Diagnostics
• Biotechnology

Background:

• The emergence of Zika virus (ZIKV) in the Americas necessitated increased nucleic acid amplification testing (NAT).
• Development of new molecular diagnostic assays created a demand for ZIKV reference materials.
• Standardization of ZIKV NAT assays is crucial for accurate diagnosis and surveillance.

Purpose of the Study:

• To produce and calibrate African lineage ZIKV reference materials.
• To compare the performance of these materials in ZIKV NAT assays against the First International Standard (IS).
• To ensure the availability of reliable ZIKV reference materials for global use.

Main Methods:

• Production and calibration of two African lineage ZIKV reference materials: a secondary standard (NIBSC: 16/110) and an external quality control (QC) reagent (NIBSC: 16/124).
• Performance evaluation of these materials in three ZIKV NAT assays.
• Comparison with the First International Standard (IS) for Zika Virus NAT assays (PEI: 11468/16).

Main Results:

• Both African lineage ZIKV reference materials were detected by all three NAT assays.
• The ZIKV lineage did not impact the performance of the secondary standard (NIBSC: 16/110).
• The external QC reagent (NIBSC: 16/124) demonstrated suitability as a low positive control for routine assay monitoring.

Conclusions:

• The developed African lineage ZIKV reference materials are suitable for standardizing molecular diagnostic assays.
• Global availability of these materials will enhance consistency in ZIKV testing across laboratories.
• These reference materials support the ongoing efforts to preserve the integrity of the IS for ZIKV NAT assays.