Public health authorities are making life-and-death decisions.
To make good decisions, federal and state policymakers must be able to understand the trajectory of the COVID-19 pandemic, and that requires solid data.
The truth: Medical experts have been working in the dark. They do not have an accurate picture of how many people have the virus nor how many have recovered.
At the beginning of the coronavirus outbreak, several missteps and technical problems hindered the ability of Americans to be tested. To their credit, President Donald Trump and members of Congress have taken major corrective steps that give private industry the ability to test millions of Americans.
To see the big picture, American medical experts need both broad diagnostic testing and big data collection.
They must not only focus on rapid testing of those currently sick—as they’ve routinely done with seasonal flu or strep—but must also identify which Americans have been exposed or recovered (from mild to moderate illness) through antibody testing.
The Food and Drug Administration recently outlined four separate avenues for such testing.
FDA officials are providing great flexibility for diagnostic companies to get tests to the market quickly.
The FDA now allows commercial COVID-19 tests such as the so-called rapid test to be sold on the market prior to FDA approval. This can be done if the company notifies the FDA, the test has been validated, and the FDA’s Emergency Use Authorization is submitted within 15 days.
Validation means that the developer provides a high-level of assurance through documentation that the test is doing what was intended and will meet needs.
After validation, commercial or high-complexity labs developing antibody tests can be sold immediately.
Testing will determine America’s endgame.
The ability of ordinary Americans to return to normal, everyday life will rely heavily on the capacity of our diagnostic companies to manufacture and distribute these new tests quickly. That is the only way that federal and state officials will be able to accurately assess the situation.
Government officials should work with manufacturers to ensure they face no barriers so that supply meets demand and tests are readily available. These measures will decrease wait times and improve conditions for the American people.
The good news is that companies are stepping up and developing and delivering rapid COVID-19 tests.
There is the much heralded 5-minute rapid test by Abbott Laboratories that began shipping out this week. There is also Cepheid’s 45-minute test.
With these tests, and others like them, medical professionals will have the information necessary to begin treatment for patients with COVID-19 faster; and that will better enable them to secure proper isolation of individuals who test positive for the virus.
Our ability to screen and treat in a rapid fashion will alleviate pressure on medical professionals’ diagnosis, and it will improve the efficiency of our response to the crisis.
Long wait times for results will be over and Americans with the virus can be monitored more closely at an early stage.
With coordination between federal, state, and local entities and the Centers for Disease Control and Prevention reporting guidelines, a clearer picture of the situation will allow public health officials to fight and defeat this virus.
With rapid and widespread testing, they will be able to determine who is sick and who has some level of immunity, as well as secure protective isolation and enforced quarantine (where ordered) of individuals who test positive.
They will also be able to better track and notify persons who are known contacts of exposure. Federal reporting can identify the hot spots, and thus contain the virus.
Beyond the efforts of public health officers, Americans’ willingness to sacrifice through self-isolation will be crucial in the days ahead.
As more testing comes along, medical experts can collect the data, and give sound advice to federal, state, and local officials to secure public safety.
This will allow us to begin to shift strategies and move beyond current stay-at-home measures.
Rapid testing will, of course, increase the growth in the overall number of cases. The widespread use of antibody testing will, however, also provide the balance needed to improve the nation’s overall outlook by recording a more accurate number of people who have recovered.
While not a cure or treatment, antibody testing will be part of an overall strategy to shift back from current social distancing and mitigation strategies to isolating and quarantining individuals.
COVID-19 may be with us for some time, but sound testing and good data will facilitate targeted interventions based on the individual in many locations.
Antibody testing is underway overseas. The first antibody test was approved this week by the FDA from biotech company Cellex under an Emergency Use Authorization. And American companies like Biomerica, Chembio Diagnostics, and others report that manufacturing and distribution should begin soon in the United States.
While we do not yet know how antibodies will determine immunity or length of immunity, such testing will enable us to identify personal and public risk.
The city of Telluride, Colorado, is the first American city to use this strategy. United Biomedical is currently testing all 8,000 residents for antibodies.
Similar programs throughout the country can help public health officials make decisions about local restrictions and quarantine.
Finding immunity among health professionals through antibody testing could also inform staffing decisions and identify risk for health care workers.
Americans from all walks of life have risen to the challenge and have made sacrifices for the good of their fellow citizens. The steps thus far necessary to save lives and slow the spread need a boost, and widespread COVID-19 anti-body testing would be just the right measure.
It could be part of a national response plan to reopen the country, instill confidence in the administration, and give Americans hope in a dark and difficult time.
Our top priority is decreasing illness and death from the coronavirus.
At the same time, Americans want to reopen their country and get back to work, but they also need peace of mind that comes from knowing they are safe to do so. The same is true for medical professionals, overburdened health care workers, and public officials in Washington and the states.
Diagnostic testing is the key to sound public health policy and the path to revitalizing the nation’s social and economic life.