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Covid-19 Antibody Testing -- The Unknown, The Bad, and The Ugly
From:
Joyce L. Gioia, CMC, CSP --  The Herman Group Joyce L. Gioia, CMC, CSP -- The Herman Group
Austin , TX
Wednesday, April 29, 2020

 

The Herman Trend Alert

April 29, 2020

The Unknown, The Bad, and The Ugly

As I promised in last week's Herman Trend Alert, this week's is about the confusing and complex area of antibody testing. You may be aware that the World Health Organization (WHO) has announced that even with a positive antibody test, there is no assurance that the person is protected from reinfection by COVID-19.

The Unknown

Sadly, almost everything about this area of COVID-19 antibody testing is, as yet, undetermined. We do not know the extent of correlations with disease severity; due to the virus mutation and the proliferation of associated proteins, we have no idea which antibodies are protective, if any. We also do not know which of the now 114 tests will actually work---other than the three or four that have actually been "approved" by the United States Food and Drug Administration (FDA)---and there is a critical shortage of these tests.

The Bad

The balance of the 110 tests that were "allowed" by the FDA are unvalidated and have flooded the market, while there is little or no oversight. We currently have almost no evidence that the presence of antibodies means permanent immunity or at least resistance to re-infection within some length of time.

The Ugly

The worst news is that many of the kits being marketed to help employers certify that people are safe to go back to work have not been adequately validated. (The FDA left it up to the test suppliers to have completed the validation.) Some of these point-of-care tests are being misused to diagnose the absence of infection---definitely not what they were intended for. But that's not all: many of the offshore tests have demonstrated high rates of false positives that can lead to an unwarranted sense of security.

So Why Do Antibody Testing At All?

Antibody testing holds promise to help us in two areas: 1) public health surveillance to give us a rough idea of what percentage of people in a large population have had COVID-19 (like they were used recently in New York State) and later 2) to assist in vaccine development---hopefully within the next year. (Though most vaccines take about four years to develop---no kidding, we hope that due to the severity of this outbreak, it won't take that long. As we go to press, there is good news on the vaccine front out of Oxford in the United Kingdom. A small study with six primates appears to have been very successful.)

On the Horizon

There are some reputable quantitative antibody tests on the near-term skyline. Antibody testing will ultimately contribute to knowledge of the occurrence of COVID and to assess the concept of "Herd Immunity" in a particular community. Next week's Herman Trend Alert will be about what leaders should be doing now to ensure that their teams will be there when we are "back to work" in our congregate workspaces. If/when we find a universal treatment that works to fight this infectious disease, it will go a long way towards helping us feel comfortable going back to work.

Hope is Not a Strategy, But. . .

As most of us continue to shelter in place, know that your actions have helped to "flatten the curve" and your continued staying home can make a profound difference for yourself, your family, and your community. I know it's not pleasant, however you will be keeping yourself, your family, and your community safe. . . and don't forget to tell the people close to you that you love them---because none of us knows what will happen, if we become infected or even if we already are.

To read the entire COVID-19 Antibody Testing Primer (Updated: April 22, 2020) from the IDSA (Infectious Diseases Society of America), visit here.

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Read this Herman Trend Alert on the web: http://www.hermangroup.com/alert/archive 4-29-2020.html

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Joyce L. Gioia, CMC, CSP
Austin, TX
336-210-3548
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