Molecular Automation Is Changing Clinical Laboratories

Most mid-career laboratory medicine professionals find it hard not to recall the days when DNA had to be extracted manually and polyacrylamide gels were mixed by hand without also reflecting on how fast things have changed.

Automation has come so far, in fact, that it is poised to disrupt the very structure of molecular diagnostics laboratories. 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.

Frederick S. Nolte, PhD, D(ABMM), F(AAM), the director of the clinical laboratories at the Medical University of South Carolina (Charleston, SC, USA) has explored the current situation as regards automation of molecular testing in the clinical laboratory. His laboratory uses the Abbott m2000 system (Abbott Molecular, Des Plaines, IL, USA) for molecular testing and also Abbott’s automation line. He wondered if he could take a single sample from hepatitis C virus (HCV) serological testing and also use it to perform molecular confirmatory testing. He conducted a study alternating HCV-positive samples with negative samples and found a very low level of cross-contamination in about 5% of samples. His laboratory went ahead with the new single-sample routine, but if the RNA result is below a certain threshold the staff asks for a new specimen.

The Cobas 6800 (Roche Molecular Diagnostics, Branchburg Township, NJ, USA) with the right connection modules, already uses a single sample for serology and molecular testing. It also uses information technology to control the testing workflow and incorporates intelligent rules for reflex testing. Molecular testing will inevitably integrate with chemistry testing in the coming years and that automation will continue to improve the ability of the laboratory to do more with fewer people.

The TriCore Reference Laboratories (Albuquerque, NM, USA) performs about 75,000 to 80,000 tests per month, on their recently installed the Roche Cobas 6800. Karissa Culbreath, PhD, D(ABMM), the scientific director of infectious diseases, said, “We can do more because now I’m able to free up my extremely talented molecular scientists and molecular technologists to work on the next wave of clinical infectious disease tests. Automation is not new; it's just new to clinical microbiology.” The study was published on December 1, 2017, in Clinical Laboratory News.