Coronavirus symptoms take 5 days | VALID Act gets revived | FDA defends coronavirus response

Dear LabPulse Member,

As the world struggles to cope with the outbreak of the novel coronavirus (SARS-CoV-2), a new study in the Annals of Internal Medicine offers important information on the spread of the virus.

Researchers from Johns Hopkins University found it took an average of five days for people infected with SARS-CoV-2 to show symptoms, and most who did exhibit symptoms did so by 12 days postinfection. The researchers believe the findings support recommendations that individuals be monitored for two weeks after exposure to SARS-CoV-2.

Last week saw the coronavirus story grow beyond being a public health emergency and into a political issue. Criticism of the government's response to the outbreak has emerged from some quarters, while others believe the spread of COVID-19 in the U.S. was exacerbated by what they say is federal overregulation of clinical labs.

Indeed, new legislation introduced in Congress at the end of the week hopes to clear up confusion over lab regulation and make it easier for diagnostic tests to get to market faster during public health emergencies. But this new iteration of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act has drawn a mixed response from the industry. Will the coronavirus emergency give the VALID Act the momentum it needs to pass, or will it suffer the same fate as previous efforts to overhaul clinical lab regulation?

The criticism of the government response to the coronavirus was enough to prompt the U.S. Food and Drug Administration (FDA) to address the issue in a weekend briefing. FDA Commissioner Dr. Stephen Hahn addressed some of the problems behind the initial rollout of a coronavirus diagnostic test from the U.S. Centers for Disease Control and Prevention (CDC), and he also provided an update on the number of coronavirus tests being manufactured and shipped this week.

For its part, the CDC last week broadened the criteria under which individuals could be administered the agency's coronavirus test. The new criteria include those with flu-like symptoms; the CDC had been criticized for rules that resulted in the denial of tests to patients who later turned out to have COVID-19. Stay current on all of the coronavirus news in our Microbiology Community.

Finally, does mobile point-of-care (mPOC) IVD testing offer a possible solution to the need to test large numbers of individuals in a short period of time? Bruce Carlson, publisher of our sister company Kalorama Information, surveys the market for mPOC systems and offers his thoughts.

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