Uncoupling Molecular Testing for SARS-CoV-2 From International Supply Chains

Area of Science:

• Molecular Diagnostics
• Epidemiology
• Biotechnology

Background:

• The COVID-19 pandemic highlighted global reliance on limited suppliers for critical RT-qPCR reagents.
• Supply chain disruptions, exacerbated by lockdowns, severely impacted reagent availability, particularly for island nations like New Zealand.
• This prompted an investigation into New Zealand's domestic capacity for producing essential diagnostic reagents.

Purpose of the Study:

• To assess New Zealand's capability to manufacture COVID-19 RT-qPCR reagents domestically.
• To develop a functional COVID-19 diagnostic assay using solely onshore-sourced components.
• To evaluate the performance of this self-sufficient assay against commercial standards.

Main Methods:

• Reviewed New Zealand's specific requirements for COVID-19 RT-qPCR testing.
• Assembled local expertise and resources to synthesize all necessary reagents for RT-qPCR.
• Developed and validated the HomeBrew (HB) RT-qPCR assay using clinical samples.

Main Results:

• Successfully synthesized all required reagents for RT-qPCR from onshore components.
• Developed the HomeBrew (HB) RT-qPCR assay, a one-step diagnostic tool.
• Clinical evaluation demonstrated the HB RT-qPCR assay performance was comparable to a commercial COVID-19 assay.

Conclusions:

• New Zealand possesses the scientific expertise to produce its own COVID-19 diagnostic reagents.
• With adequate planning, the nation has the infrastructure capacity to overcome reagent supply challenges.
• The development of the HB RT-qPCR assay provides a model for self-sufficiency in molecular diagnostics during crises.