Can Coronavirus Antibody Tests Save the U.S.?

My sister sent me an urgent text recently…

“I need to know ASAP if you’re interested in getting antibody tests. No promises but need to know your interest in the next few moments…”

Her son knew somebody who could possibly get his hands on some.

I answered immediately.

“I need them for my wife, my kids and their spouses. So give me six.”

The tests never came. When we spoke two weeks later, my sister said they were unreliable. I had really wanted one, but I thanked her for thinking of me.

I don’t think I’ve had COVID-19. I haven’t had any symptoms. But that doesn’t mean anything. You can be symptom-free and still have COVID-19. And you can die from it. This is what makes COVID-19 bizarrely capable of spreading complacency and paranoia at the same time.

It would be nice to know if I’ve had COVID-19. Or if we really can produce antibodies that confer lasting immunity.

To better understand what’s going on, I called up Jonathan Cohen.

Jon is the founder and CEO of 20/20 GeneSystems. The company’s core business is detecting cancer early by combining a blood test with artificial intelligence. But in response to the COVID-19 pandemic, it’s begun providing rapid coronavirus testing.

I’ve known Jon for a couple of years now – ever since we advised our First Stage Investor members to invest in his startup. He’s always been an honest and open voice on matters relating to America’s public health.

Jon says that antibody testing will help the U.S. – and the world – come to grips with the novel coronavirus. And he cites one of the most respected names in medical science, Robert C. Gallo, to offer some context. Gallo co-discovered HIV (as a cause of AIDS) and pioneered the development of the HIV blood test. He thinks there’s a strong likelihood that people who have had COVID-19 will develop partial or total immunity.

Gallo is a real doctor and scientist. And he doesn’t have a secret agenda in this fight. So I believe him.

Is it possible Gallo could be wrong? Of course. But if he’s right, the next logical question is this: How well do these antibody tests work? They need to be highly accurate to facilitate a reopening of the economy.

Almost 100 companies are now selling antibody tests in the U.S. Only four of them have approval from the Food and Drug Administration (FDA). Some tests are much better than others.

Even Cellex’s antibody test – which is FDA approved – has a false positive rate of 5%. (A false positive is when you didn’t have COVID-19 but your test says you did because it’s showing a positive result.)

But a 95% accuracy on false positives doesn’t cut it. Suppose 5% of the local population has had COVID-19. A 5% false positive rate would mean that half the people the test identifies as having had COVID-19 really didn’t. That’s a coin flip – not exactly the clarity anxious individuals and governments need to get people back to work.

Jon’s own company, 20/20 GeneSystems, is sourcing antibody tests with a false positive rate of only 2%. Its tests have been certified by China’s National Medical Products Administration (NMPA) – the equivalent of our FDA. It has authorized 11 tests so far.

While this may come as a shock, Jon says NMPA’s vetting is “very rigorous.” And 20/20 did its own vetting as well. It sent its product to a half-dozen hospitals and clinics for extensive testing… to be done before they put in their orders.

Unfortunately, most companies are not as careful as 20/20.

The 20/20 rapid tests are like home pregnancy tests, except they use blood instead of urine. The World Health Organization says they’re unreliable and doesn’t recommend using them.

Jon disagrees. The tests, he says, can be almost as reliable as the ones sent to a laboratory (the gold standard lab technique is called enzyme-linked immunosorbent assay, or ELISA). Jon cites a Denmark study that shows that rapid handheld tests were more accurate than ELISA tests.

These tests offer real hope. Hospitals and clinics are figuring out how to best use these tests and which tests are the best to use. Their adoption will become less and less controversial.

Right now, about 70% to 80% of these tests are made in China. But U.S. manufacturing capacity, Jon says, can be ramped up fairly quickly. Scarcity shouldn’t be a problem.

Antibody testing should be a critical component for reopening the economy. It can also help address a growing list of humanitarian challenges.

Why should we allow older people to die alone if they have a child who’s immune? Why couldn’t we prioritize immune nurses to work with the most vulnerable in our population? Why couldn’t we ask immune teachers to return to the classroom?

Did you have COVID-19? I look forward to living in a world where the vast majority of us have a ready answer. It may not be THE ANSWER. But as we wait for a vaccine, it’s the next best thing.