The US Virus Problem Is Going From Bad To Worse: But There Is One Bright Ray Of Hope - Testing

Let’s face it. There is a lot about the virus that we do not know. And the politicization of the issues has not helped. But experts I trust (recognizing nevertheless that they might be wrong) fear we are on a bad path that will get much worse before getting better. Dr. Michael Osterholm is director of the Center for Infectious Disease Research/Policy at the University of Minnesota and Mr. Kashkari is president of the Federal Reserve Bank of Minneapolis. They just laid all this out in an article published in the New York Times. I quote from that article:

We believe the choice is clear. We can continue to allow the coronavirus to spread rapidly throughout the country or we can commit to a more restrictive lockdown, state by state, for up to six weeks to crush the spread of the virus to less than one new case per 100,000 people per day –currently, the US is running at approximately 17 new cases per 100,000 people per day.

The imperative for this is clear because as a nation what we have done so far hasn’t worked. Some 160,000 people have died and more than a third of all US cases occurred in July alone.

And the next six months could make what we have experienced so far seem like just a warm-up to a greater catastrophe. With many schools and colleges starting, stores and businesses reopening, and the beginning of the indoor heating season, new case numbers will grow quickly.

The authors say the US opened too soon and suggest the only way to control the virus is through another lockdown: one with real teeth. To successfully drive down the case rate to less than one per 100,000 people per day, we should mandate sheltering in place for everyone but the truly essential workers. By that, we mean people must stay at home and leave only for essential reasons: food shopping and visits to doctors and pharmacies while wearing masks and washing hands frequently.

They point out:

At this level of national cases we simply don’t have the public health tools to bring the pandemic under control. Our testing capacity is overwhelmed in many areas, resulting in delays that make contact tracing and other measures to control the virus virtually impossible.

The Bright Ray of Hope

Right now, the FDA approved test for COVID costs $100+ and takes 2 or 3 days (if you are lucky) to get test results. Waiting a few days is far from optimal, especially when there are much better options available. Why won’t the FDA approve tests that can be self-administered with results in 15 minutes? It is because the FDA makes decisions based on accuracy: is the test definitive on whether or not you have the virus.

The question is whether this should be the approval criterion. A number of experts say no. They argue that while test accuracy is important, it is worth giving up a little accuracy for a cheap test yielding immediate results.

There are now “pretty definitive tests” that identify 60% or 70% of those with the virus versus maybe 90% for the FDA approved test.  Some argue it would be irresponsible to widely use a test that might miss a significant number of positive cases. But test accuracy should not be the only criteria for tests. How about whether you get tested or not and whether those with the virus go unidentified for a few days while waiting for test results.

Further, the FDA approved tests are slowing laboratories to a crawl. If everyone took the new tests —even identifying only 50% percent of the positives—we would still identify 50% percent of all current infections in the country – five times more than the 10 percent of cases we are likely currently identifying because we are testing so few people.

Accuracy could be further increased through repeated testing and through the recognition that quicker test results would identify viral loads during the most infectious period, meaning those cases we care most about identifying – at the peak period of infectiousness—are less likely to be missed. Even better, we would be identifying these cases while they are still infectious, rather than in 10 days when the virus may have already been transmitted repeatedly. Mina and colleagues have shown through modeling that this logic holds up; speed matters much more than test sensitivity in controlling a pandemic.  

On testing, FDA's approved test for COVID costs about $100 and test results come in 2 days or more. There is a new test that you can personally administer with a cotton swab costing $1 and you get the results instantly. The FDA has not approved it because it is not as accurate as the test it has approved.  But it will pick up more than 50% of those with COVID and this is so much better than no test at all: you administer the FDA test to those identified as having COVID by this new test.

In the following YouTube, Dr. Michael Mina Michael Mina, MD/Ph.D., Assistant Professor of Epidemiology at the Harvard T. H. Chan School of Public Health and a physician at Brigham and Women's Hospital and Harvard Medical School makes the argument for the new test.

Regarding the FDA, there is a little good news: Concerns over accuracy bogged down the FDA approval process for simple, speedy tests. But FDA guidelines allow for emergency FDA clearance provided the tests perform nearly as well as those already approved. And the tests of a few companies have been given the green light to move ahead. And in hopes of moving ahead rapidly, the governors of seven states (Maryland, Louisiana, Massachusetts, Michigan, Ohio, and Virginia) just announced a joint bid to purchase a total of 3.5 million antigen tests from Becton, Dickinson and Company (NYSE - BDX) and Quidel Corporation (Nasdaq - QDEL).

Conclusion

In closing, I quote Susan Butler-Wu Ph.D. Associate Professor of Clinical Pathology, Director of Medical Microbiology, at the LAC+USC Medical Center:

There probably isn’t one way to grapple with all these issues — and certainly not an obvious one. Our backs are against the wall, and it’s Hail Mary time. We have to try something different.”