Why the CDC botched its coronavirus testing

From the article:

On February 5 the CDC began to send out coronavirus test kits, but many of the kits were soon found to have faulty negative controls (what shows up when coronavirus is absent), caused by contaminated reagents. This was probably a side effect of a rushed job to put the kits together. Labs with failed negative controls had to ship their samples to the CDC itself for testing.

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The first thing to know is that PCR is a very sensitive test. You need extremely clean reagents, and the smallest contaminants can ruin it completely (as happened in this instance). A negative control that detects the wrong viral genome and raises a false positive is practically a worst-case scenario, because it calls into question all the other results in the run—you don’t know if samples are truly positive or if they are positive because of the contamination. “You basically can’t even judge if anything worked,” says Nigel McMillan, the director of infectious diseases and immunology at Griffith University in Australia.

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There’s no particular technical difficulty in designing a PCR test, so most laboratories should be able to do so with confidence. This week, state and commercial labs began testing on their own. We’re already seeing major steps forward; the University of Washington, for instance, has a new diagnostic that will allow it to test 1,500 samples a day. A group in Japan claims to have a test that can detect the virus in just 10 to 30 minutes.

“The great strength the US has always had, not just in virology, is that we’ve always had a wide variety of people and groups working on any given problem,” says Jerome. “When we decided all coronavirus testing had to be done by a single entity, even one as outstanding as CDC, we basically gave away our greatest strength.”