Updated: September 16, 2020
In today’s Recommendations for Industry, we discuss two things: (a) FDA’s publication of comparative performance data for 55 authorized molecular diagnostic COVID-19 tests and (b) The Weekly Risk Matrix. Read more here.
In Monday’s Recommendations for Industry, we reviewed the similarities between COVID-19 and the flu and what businesses should do to limit spread of both. Read more here.
While many symptoms of COVID-19 or Influenza are similar, congestion & runny nose symptoms may be the most ambiguous with common causes including the common cold, allergies, influenza, or COVID-19. To reduce the number of potential illnesses in a person or population, TAG encourages everyone to get the get the flu vaccine as soon as available.
Apple and Google have both released “COVID-19 Exposure Notification” notifications that allow for secure and private coronavirus contract tracing.
The CDC has released new guidance for what to do if your pet tests positive for COVID-19.
Recommendations for Industry
A Comparison of COVID-19 EUAs
FDA has published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The tables show the Limit of Detection (LoD) of more than 55 tests against FDA’s standardized sample (reference) panel. The purpose was to assess developers who are required to measure their test’s performance against this panel (or other FDA-recommended reference materials) as a condition of their Emergency Use Authorization (EUA). This provides FDA with insight into the comparative performance of different authorized molecular diagnostic tests under the same conditions.
FDA started distributing the reference panels in May and has provided it to more than 150 developers. The table is available here
Risk Matrix Update
The average U.S. social index value remains the same as last week. However, the social distancing value did decrease dramatically in six states (Alabama, Georgia, Mississippi, Tennessee, Arkansas, Louisiana).
The same ten (10) states (California, Nevada, Arizona, New Mexico, Colorado, Texas, Louisiana, Florida, Kentucky, and Michigan) as last week continue to have reversed re-opening policies, which vary by state. These states are indicated by an asterisk (*) in the matrix.
Twelve (12) states (Washington, Oregon, Idaho, Illinois, Arkansas, Mississippi, Alabama, South Carolina, North Carolina, Delaware, New Jersey, and Connecticut) have partially reopened to varying levels. These states are indicated by a cross (†) in the matrix.
Nine (9) states, compared to last week’s 13 states, have a test positive rate (TPR) greater than 10% indicating they have inadequate testing and/or increasing case counts. These states are:
South Dakota: 17%
Wisconsin, Idaho: 15%
Kansas, Iowa: 14%
Utah, Missouri: 11%
South Dakota, Wisconsin, Kansas, Iowa, Idaho, Florida, and Missouri continue to have TPRs greater than 10% (compared to last week). Over the last week, Alabama and Utah’s TPRs increased above 10% while North Dakota, Mississippi, Arkansas, Nebraska, and South Carolina’s TPRs dropped under 10%.
As of September 16, 2020 (08:17 ET), there are over 29,600,000 cases (>935,000 deaths) worldwide.
Due to the increasing number of cases in the United States, TAG will move from reporting counts per country to focus on the United States, please see here for the data. For further information regarding worldwide numbers, please refer to John Hopkin University’s aggregate map.
Keep up to date with COVID-19:
Please send us any questions, comments, and/or concerns! We are happy to talk with you.
OR call us at 1-800-401-2239
Get the Insights & Guidance You Need!
Learn how TAG can help your company ensure food safety and brand protection.
Contact us today!