Antibody Testing: FDA performance data shows reliability for new Roche test

(Roche Diagnostics photo)

INDIANAPOLIS (WTHR) - Hoosiers want antibody testing to see if they've had COVID-19.

But is there a way to ensure lab results are accurate?

Roche Diagnostics is answering questions from 13 Investigates. Based on its science, Roche believes its new test will boost confidence.

Cellex, Abbott, Euroimmun and now Roche Diagnostics are among the dozen labs granted emergency use by the FDA for what's known as serology or antibody testing.

"We recognize the urgency of this pandemic and the need for answers. At the same time, those answers have to be right," said Randy Pritchard, senior vice president of U.S. Marketing at Roche.

Antibody tests help determine if you have had COVID-19 and managed to fight if off. During infection, our bodies can create antibodies or white blood cells to counter attack.

But how do you know if a test is detecting COVID-19 or nothing more than the common cold?

According to data from the FDA, Roche put its science to the test. The results put them near the top.

13 Investigates asked Roche about its approach to ensuring more reliable results.

"We've tested over 5,000 patient samples, more than five times what any of the competitors have done and the data they have released," responded Pritchard.

Based on it's performance testing, Roche has an estimated 100% confidence rating for sensitivity. That's the ability to detect antibodies in blood samples from those confirmed to have COVID-19.

When it comes to specificity, Roche has an estimated 98% confidence interval detecting the right virus from varied samples. In this case, that means detecting COVID-19.

While all labs will see some false positives and negatives, the FDA says these numbers provide a likelihood of the reliability of the testing. And according to Pritchard, it provides an option for those seeking answers.

"So patients and their health care providers that are taking care of them can have confidence in the decisions that they make," he said.

If you have questions about antibody testing, reach out to your doctor.

Roche is shipping out its new tests nationwide to partners already using its systems with a goal of conducting millions of antibody tests each week.