Microbiology labs are sitting at the crossroads of change as technology redefines the field. "The field of microbiology is in its infancy," declares John Thomas, PhD (HCLD,ABB), MS, professor, Department of Pathology, adjunct professor, Department of Microbiology, Cell Biology, and Immunology, West Virginia University School of Medicine.
Consider the idea that "microbes are actually an 'organ system,' an important part of healthcare. We have focused on bad bugs, but not the good bugs that are predominant," says the professor. "The balance of internal flora will not only identify a patient, but will also identify when something is going wrong. Bacteria will act as a sensor to tell us good news or bad news. It is a library of information for every individual."
Dr. Thomas offers a broad view to a bright future that elevates microbiology to a diagnostic position as stellar and new-wave as genomic sequencing. And yet he is quick to assert, "We still have to identify staph, E. coli, C. diff, strep. That is still the here and now." So toward that immediate end, labs are adopting new assays and new instrumentation reflective of growing capabilities.
"Our expectations have changed," says Beverly Orr, MT(ASCP), microbiology technical supervisor at Boston Medical Center. "Once we were used to putting a specimen in a container, adding a couple reagents, sticking it into an instrument, then getting results. But now, we are all looking for 'specimen in, results out.' At Boston Medical we are going to nanotechnology - we are trying to do things with less specimen, less reagent, and at a lower cost."
Particularly appealing, says Orr, are closed system tests that cut down on contamination. "You can put a specimen in, close it, place it in an instrument, then all of the PCR reaction, all of the amplification happens inside the closed system. You toss that, and no contamination. And to get the results faster, that's even better. Getting rid of the old antigen tests is where we're heading."
Steve Miller, MD, PhD, director of the University of California Clinical Microbiology Laboratory, says laboratorians will be practicing differently, as new assays and technology is adopted. "I think we are already seeing that laboratorians need to update their practice, particularly in virology and parasitology where there is rapid movement to molecular," says Dr Miller.
But no need to sign up for additional coursework, says Dr. Miller; most training will be on-the-job as technologies are introduced.
"It is still most important to get classically trained and learn that morphology; people with that background will become more valuable as experienced laboratorians start to retire. Focus on the biology, not the technology," advises Dr. Miller. "The technology is going to change anyway."
New to the Market
So what is liable to make its way into the lab in the next year? Orr offers a look at the assays and instrumentation that were causing a stir at the recent Clinical Virology Symposium in Daytona, FL, this spring. "These are the items everyone was talking about, the 'everybody's doing it' stuff," says Orr, while adding some personal commentary about each one.
Cepheid, "the company that started the test in a box revolution with GeneXpert," is close to perfecting a direct-from-specimen test for TB.
Luminex Technology offers a multiplex that tests for influenza, RSV, parainfluenza among 12 test targets. "If you have an extremely immuno-suppressed patient population this might make sense; otherwise it might provide excess information."
Iquum's high-sensitivity (upper 90s) influenza test can be performed in a "little, itty-bitty box that could go POC."
GenturaDX's IDbox is fully automated, from sample preparation through amplification and detection to reporting out results. "It's pretty small--about 22 inches square. You stick the sample in a little tube, screw on the cap and put it in the machine. That's it."
FilmArray from Idaho Technology offers a 15-target panel of respiratory viruses on one multiplex PCR test, featuring sample in/results out from a closed box system in about 60 minutes. It's fully automated, so no need for precise measuring or pipetting. "Of course, whether we need to report 15 targets on one specimen is still in question."
Simplexa by Focus Diagnostics offers both a "good amount of FDA-approved assays as well as laboratory-developed test-type reagents that you can buy to run your own. You can run 96 samples in less than 75 minutes."
BD Max offers moderate throughput in a closed system with a TAT of 1 -1 ½ hours. "It's slick, can do all sorts of tests at the same time, and has laboratory interface that may put them ahead."
Sofia Quidel uses immunofluorescent technology that is "a huge improvement over rapid antigen tests, and still much less expensive than a molecular test. This one drew a huge amount of interest at the symposium."
"We've been talking to all of the manufacturers about bringing in a HSV PCR test for spinal fluid. Everyone would love to bring that in, but no one has it FDA-approved . yet," says Orr. "Yet the forward progress is mind-boggling. It feels like 'Around the World in 80 Days' or 'The Amazing Race.' The manufacturers who stand at the finish line with the biggest menu will win."
Valerie Neff Newitt is a managing editor.