Julius Lucks of Northwestern University. Picture courtesy of Chicago Tribune.

As a long-time practicing pathologist certified by the American Board of Pathology in Clinical and Anatomic Pathology and the current Medical Director of a large physician’s office laboratory, I have been intimately involved in introducing a variety of testing to patients throughout Chicagoland for the last 40 years. Usually, it is a slow, meticulous project. Decisions need to be made on proper instrumentation and proper chemical reagents. Adequate lab space needs to be set-up with appropriate temperature and humidity control. For the newest tests we are introducing, even the air pressure needs to be monitored.  Proper training for our technicians and technologists includes verification of competency for each new test we introduce.

And tests must be validated. We must show that test results are reproducible and precise–testing a specimen multiple times must yield the same result. We need to ensure that for the population of patients that we are testing, the test is sensitive–those with the condition we are testing for should have a positive result, and specific–those without the conditions should test negative. Our lab should get the same results as other labs doing the same test on the same specimen with the same instrument. In short, we don’t just flip a switch and hope for the best. And this is all AFTER the FDA has already approved the test.

That’s is what worries me about some of the products that are on the market for COVID-19 testing. We lack a gold standard for the “best” test and we don’t really know what the best specimen type (nasal swab, sputum, saliva) will turn out to be. And because of the (necessary) rush to market, some manufacturers and the FDA are short-cutting approval processes. When there is talk of having the thousands of small commercial labs around the country getting involved in using these unregulated tests, I shudder.

For example, this week I was contacted by the owner of one of those small labs, a businessman who didn’t seem to have any knowledge of good laboratory practice. He needed a Medical Director of his lab so that the lab could run a cheap, non-FDA approved test for COVID-19 antibodies. I made my pitch for good laboratory practice, detailing lots of things he had never heard of or considered. It became clear by the end of our 15-minute conversation that I was not the pathologist for him.

But not all is dire. There are many excellent labs, large and small, around the country. And I have hope that the brilliant minds around the country will be developing the tests we need. I particularly noticed an article about Northwestern (Go Cats!) University professor Julius Lucks at the Center for Synthetic Biology who, with his colleagues and the assistance of a National Science Foundation rapid research grant, is working on a new methodology for identifying the SARS-CoV-2 virus. I wish Lucks and his team success in developing the test, and I hope that it can be properly vetted and utilized.

Our testing needs to be better than flipping a coin. I’ve made a career out of that belief.

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