OPINION:
It is not possible to produce an in-vitro diagnostic test for a disease not known to exist. The disease now known as COVID-19 traces to a cluster of pneumonia cases of unknown etiology in Wuhan, China, in late December 2019. Following rapid spread of the disease, the World Health Organization declared a public emergency the following month.
The Centers for Disease Control and Prevention were working on an in-vitro diagnostic test for the virus, and requested emergency clearance from the Food and Drug Administration on Feb. 3, 2020, with clearance granted the next day. Reagent production issues slowed early production, which rapidly increased thereafter. At the same time, the participating government agencies worked with commercial clinical laboratories to expedite testing protocols now available from private providers.
Simply put, it was not possible to have stockpiles of millions of test kits and millions of vaccine doses for a disease not previously known to medical science.
WILLIAM T. FIDURSKI
Clark, N.J.
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