FDA Warning on Accuracy of Abbott ID NOW Rapid Test
Preliminary data suggest that Abbott Labs’ ID NOW rapid test for COVID-19, reportedly in use to screen White House staff, may give false-negative results, the US Food and Drug Administration (FDA) said in an alert late Thursday.
To date, the FDA has received 15 adverse event reports about the Abbott ID NOW test that suggest some users are receiving inaccurate negative results, the agency said, and some studies have identified accuracy issues with the test. The agency is investigating whether this could be due to the types of swabs or viral transport media used.
“This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” an FDA official said in the alert statement.
Details on ‘Operation Warp Speed’ Vaccine Project
Under an initiative called “Operation Warp Speed,” a group of federal officials, scientists, and drug companies have the challenge of developing a coronavirus vaccine by the end of the year.
The team includes leaders from the Centers for Disease Control and Prevention, the FDA, the National Institutes of Health, the Department of Health and Human Services (HHS), and the Department of Defense. President Donald Trump discussed details of the initiative during a press briefing Friday afternoon.
Public health experts have predicted that a coronavirus vaccine could take 12 to 24 months to produce. Operation Warp Speed’s goal is to reduce that timeline by simultaneously preparing the manufacturing and distribution processes so drug companies can fill vaccine vials once the formula is ready. Under the directive, orders were placed this week for vaccine-related supplies like glass vials, needles, and syringes, said Alex Azar, HHS Secretary.
Stay-at-Home Orders Correlated With Slower Spread
Two studies suggest that government stay-at-home orders have had a significant impact on slowing the spread of COVID-19. One found a significant difference in the growth of COVID-19 cases between border counties in Illinois, which has a stay-at-home order, and Iowa, which does not. Another measured how much shelter-in-place orders have decreased the spread of the virus compared with other social distancing measures.
“A lot of national experts suggest that as social distancing criteria are relaxed, there’s more of a chance that the infection will spread,” said an author of one of the studies. “At the same time, it’s unrealistic to keep these restrictions forever. But reopening has to be a calculated and gradual process. That’s why the evidence from this study and others is useful — because it gives you some idea of what the results are of some of these measures.”
The dermatologic manifestations associated with SARS-CoV-2 are many and varied, with new information coming out frequently. Two dermatologists discuss the issue and how to assess patients.
Modeling the Case for PPE
Bill Hanage, PhD, and colleagues built an epidemiological model of what happens if COVID-19 gets into healthcare environments that are supposed to be for treating patients without COVID-19. Writing in Medscape, Hanage describes the findings: “The upshot is that, unsurprisingly, in the absence of personal protective equipment (PPE) or testing, our model finds that all [healthcare workers] eventually become infected.”
“Our data support the need for adequate and appropriate PPE throughout healthcare, and assuming that everyone might be asymptomatic but infectious unless shown otherwise,” he writes. “This is well understood in some places but not in all. And in some of those places, supplies are short.”
Kawasaki Disease and COVID-19
There are reports of a mysterious syndrome that may be associated with COVID-19 in children, with youngsters exhibiting unusual inflammatory symptoms associated with toxic shock or Kawasaki disease. Medscape’s Reference team rounds up what is known so far.
As front-line healthcare workers care for patients with COVID-19, they commit themselves to difficult, draining work and also put themselves at risk for infection. More than 1000 throughout the world have died.
Medscape has published a memorial list to commemorate them. We will continue updating this list as, sadly, needed. Please help us ensure this list is complete by submitting names with an age, profession or specialty, and location through this form.
Ellie Kincaid is Medscape’s associate managing editor. She has previously written about healthcare for Forbes, the Wall Street Journal, and Nature Medicine.
Medscape Medical News © 2020
Cite this: COVID-19 Daily: FDA Test Warning, ‘Warp Speed’ Vaccine Project – Medscape – May 15, 2020.