Laboratory and Pathology Concerns for SARS-CoV-2

The COVID-19 (or coronavirus) is advancing rapidly and has spread out of China, with many cases in Italy, South Korea and others.  

“For the moment, testing in the U.S. is limited,” said Jeannette Guarner, MD, FASCP, author of an editorial, Three Emerging Coronaviruses in Two Decades: The Story of SARS, MERS, and Now COVID-19, published in the April 2020 issue of AJCP.

Dr. Guarner is a professor at the Emory University School of Medicine, Atlanta, Georgia, and has an extensive background as an infectious disease pathologist in global health. She previously worked at the Centers for Disease Control and Prevention (CDC) at the time the SARS virus was discovered. 

At present, not all state laboratories have testing to identify the COVID-19 virus.

“We want testing in the hospital laboratories to have timely results that can help in patient care, including isolation precautions,” Dr. Guarner said.

Medical laboratory testing in the U.S. of the virus is still evolving. “What most would like to see is testing in our hospitals to see if we can test here,” Dr. Guarner said. “However, I don’t think people have done that.

Some laboratories may have to create laboratory developed tests (LDTs), she surmised. Although LDTs have not been independently verified by the Food and Drug Administration, they are something that laboratories with molecular diagnostic testing capability do perform on a regular basis.

“There are other tests that can still be performed in the regular laboratory, such as the complete blood count, chemistries and testing for other respiratory viruses,” Dr. Guarner said. “It’s a category B agent and as long as we use universal precaution we should be able to do the routine testing in the labs.”

These specimens that are being sent to CDC are essentially in three categories, A, B, and C. Each category has own requirements for shipping, packaging and labeling requirements because labs are sending biohazardous materials.

“Essentially, laboratories need to make sure they are up to speed on those categories. A laboratory in Chicago or St. Louis will be up to speed, whereas a smaller, community hospital in a rural area may not know how to deal with that,” Dr. Guarner said.  

In summary, preparation is key. Laboratories need to start thinking about LDTs now, reviewing procedures and ramping up protocols because concerns about the coronavirus will only get worse before it gets better.

Learn more about this evolving story by reading Dr. Guarner’s AJCP editorial online at https://doi.org/10.1093/ajcp/aqaa029.