You no longer need a PhD and years of experience to conduct a nucleic acid amplification test, writes Julie Kirkwood in the December CLN. Automation is transforming the foundations of and pushing the traditional boundaries of laboratory medicine.
“New molecular automation systems are capable of connecting directly to clinical chemistry and immunoassay lines, potentially moving high-volume testing out of molecular diagnostics entirely,” Kirkwood writes.
Roche has a goal to move routine molecular testing to the core laboratory. “It is a concept that is revolutionary, I would say, to consider doing molecular testing outside of an expert molecular lab,” says Bryan Moore, PhD, the company’s director of marketing for molecular diagnostics. But as experts describe in the article, laboratories face a number of challenges in deploying automation systems. Moving nucleic acid tests outside of the expert molecular lab, for example, means that labs would have to control for the risk of contamination.
Frederick S. Nolte, PhD, D(ABMM), F(AAM), director of clinical laboratories at The Medical University of South Carolina in Charleston, whose lab uses Abbott’s m2000 system for molecular testing and Abbott’s automation line, wanted to see if he could take just one sample from HCV serological testing and use it to conduct molecular confirmatory testing. Alternating HCV-positive with negative samples, Nolte found very low cross-contamination levels in a small percentage of these samples. His lab now uses this single sample process. However, the staff asks for new specimens if the RNA result is below a certain level.
Roche’s cobas 6800 also uses the single sample approach to do serology and molecular testing, as well as information technology to help with reflex testing and workflow measures. “It’s a large piece of equipment, but we’ve consolidated multiple rooms of a molecular lab and even a refrigerator onto a single instrument,” Moore says.
While excited about the prospect of automation in smaller labs and in point-of-care testing, Belinda Yen-Lieberman, PhD, director of clinical virology, serology, and cellular immunology at the Cleveland Clinic in Ohio, is more wary of “big box” automation technologies. Larger automation systems can lock you into using tests manufactured by just one company, and are also expensive, she says. Karissa Culbreath, PhD, D(ABMM), scientific director of infectious disease at TriCore Reference Laboratories in Albuquerque, New Mexico, also had reservations about moving to a larger automation system but realized she had to keep up with the times.
“It’s uncharted territory for a lot of us, but we can lean on the experiences from others in the lab to figure out how to make the system work for us … When we break down those silos, that’s actually when I’ve been able to make the best decisions because automation is not new: It’s just new to me,” Culbreath says.
Gregory J. Tsongalis, PhD, HCLD, CC, director of the laboratory for clinical genomics and advanced technology at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, has no concerns about moving molecular testing out of molecular and infectious disease laboratories. “I think that’s one of the things that people need to start thinking about—getting over that it really doesn’t matter where the testing gets done, it matters who is interpreting those results,” Tsongalis says.
Pick up December’s CLN and learn more about the new automation technologies companies are developing to deliver faster test results and improve satisfaction among labs, physicians and patients.