A Zika Reference Panel for Molecular-Based Diagnostic Devices as a US Food and Drug Administration Response Tool to a Public Health Emergency

Publication date: Available online 15 October 2019Source: The Journal of Molecular DiagnosticsAuthor(s): Mayra García, Rafaelle Fares-Gusmao, Kim Sapsford, Caren Chancey, Andriyan Grinev, Stephen Lovell, Uwe Scherf, Maria RiosIn 2015, Zika virus (ZIKV) appeared as an emerging pathogen, generating a global and urgent need for accurate diagnostic devices. During this public health crisis, several nucleic acid testing (NAT)–based Zika assays were submitted to the US Food and Drug Administration (FDA) for Emergency Use Authorization. The FDA’s Center for Devices and Radiological Health, in collaboration with the FDA's Center for Biologics Evaluation and Research, responded to this Zika emergency by developing and producing a reference panel (RP) for Zika RNA (Zika FDA-RP) suitable for performance assessment of ZIKV NAT-based in vitro diagnostic devices. Reference panels are a fundamental tool for performance assessment of molecular tests. The panel is composed of five vials: two different heat-inactivated ZIKV strains (PRVABC59 and FSS13025) in concentrated stocks and three blinded concentrations prepared from those strains. The Zika FDA-RP was shared with developers who had devices in the final stages of validation. In vitro diagnostic developers tested the Zika FDA-RP using the FDA-provided protocol. Depending on sample type, 85% (12/14) of the NAT assays had analytical sensitivities between 500 and 5000 RNA NAT-detectable units/mL (NDUs/mL). One device showed better per...
Source: The Journal of Molecular Diagnostics - Category: Pathology Source Type: research