As the virus lingers, so do the questions. The one Dr. Nolte says he’s asked most often is astoundingly basic: What is the diagnostic sensitivity and specificity of the SARS coronavirus PCR test that you offer, Dr. Nolte?
“My answer is, ‘I don’t know,’” he says.
He can report the analytical sensitivity and specificity “in excruciating detail,” he says. “I can tell you what looks like a strong positive reaction and a weak positive reaction. I can tell you how we performed in proficiency testing programs. I can tell you to some extent how well we compare with other platforms.” But months into the pandemic, “I honestly cannot tell you what the diagnostic sensitivity and specificity of this test is.”
He unspools more questions in need of answers. “What are the true clinical performance criteria of the test we are offering and will probably continue to offer for some time? The true diagnostic sensitivity and specificity of serology? Are there better markers of disease? Do we need qualitative tests? Do we need to be looking at host response? Do we need to be looking at subgenomic messenger RNA in clinical specimens to figure out, of all these RNA specimens, which ones are actually infectious?”