In principle, many hospital and academic labs around the country have the capability to carry out tests themselves. The PCR reaction uses so-called primers, short stretches of DNA, to find viral sequences. The CDC website posts the primers used in its test, and WHO publicly catalogs other primers and protocols, too. Well-equipped state or local labs can use these—or come up with their own—to produce what are known as a “laboratory-developed tests” for in-house use.
But at the moment, they’re not allowed to do that without FDA approval. When the United States declared the outbreak a public health emergency on 31 January, a bureaucratic process kicked in that requires FDA’s “emergency use approval” for any tests.
“The declaration of a public health emergency did exactly what it shouldn’t have. It limited the diagnostic capacity of this country,” Mina says. “It’s insane.”
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