On the production line: automation in medical diagnostics

9 December 2013

How can medical microbiologists confronted with mounting pressure for faster, more accurate results cope with the workload? Dr Eric Claas of Leiden University Medical Centre shares his vision for automation in medical diagnostics and talks about his work with multiplex assays.

For a medical molecular microbiologist, increasing demand for faster and yet more accurate diagnostics tests within a tight budget can be a problem when much of the work is still performed manually.

"We do about 100,000 assays a year," says Dr Eric Claas of Leiden University Medical Centre in the Netherlands. "At any one time, we have 75 different assays running."

Claas works in the medical diagnostics section of the university hospital and his job spans many different microbiological disciplines, from parasitology to virology. About 90% of his work involves polymerase chain reaction (PCR), a time-consuming technique that involves multiple steps, conditions and reagents.

But he foresees working processes in his laboratory to be very different as automation comes to the fore. With test demands ever-increasing, he thinks it's high time for a more efficient approach.

"The number of requests for diagnosis has been increasing for the last 15 years. What we're seeing now is the whole logistics of the process with increased numbers," he says.

"I think automation is becoming really necessary for us. We still do manual work here. On the processing side of things, we can handle it, but the data management requires further automation. A lot of controls and systems I think can be automated now and that's something we're currently working on."

In a laboratory like Claas's - where a multitude of in-house and commercial assays are being run simultaneously, with samples arriving throughout the day from many different sources - moving towards automated sample preparation and tracking can only be beneficial to the patient waiting for accurate diagnosis results.

"As with every automated step, human failures are being eliminated," he explains. "Even now, in the way we work, it is possible with our manual input of results that mistakes will be made. Once you start automating everything, including the communication between different machines, mistakes will be eliminated and that's the most important thing."

The process would also enable the most clinically relevant samples to be tested as soon as they come in, which means peace of mind for the patient and their healthcare provider.

"If you do your bulk in this fully automated platform, then you can have an additional system for the very acute requests you will get in - for example patients with neurological abnormalities - and you'd be able to set up the assay immediately as soon as it comes in," he says.

"Everything that comes in today will be tested tomorrow, enabling a one day turnaround time. Once we are fully automated, the results will be available tomorrow morning, rather than later in the day."

A move towards complete automation won't just benefit the patient, however. Claas believes more streamlined laboratory processes may result in improved working conditions and less unsociable working hours for scientists and technicians. And by freeing up preparation times, the focus of the scientist will be on the analysis of results rather than performing the tests themselves.

"If we do automation in the way that I think we're going to do it; so a complete platform from sample received to result out, then we can stop working overnight. If you have a fully automated system, you can load it in the evening, and in the morning all your results are available, which will increase the whole diagnostic process," he says.

Ease of use

Claas has been lending his expertise and enthusiasm for automation to foundation studies with Luminex XTAG technology. The company's multiplex equipment allows microbiologists to detect multiple pathogens in a single tube. Luminex is currently developing a new version of its xTAG PCR chemistry to improve the ease of use of its technology while maintaining high-multiplex and high-throughput capabilities.

"Multiplex technology can speed up PCR by automating nucleic acid extraction, plate preparation and pipetting of bead hybridisation," says Claas.

The application of this technology will be an updated version of the company's FDA-approved respiratory virus panel assay. The new technique will apply the product's primers, enzymes and fluorescent reporters in a single mix in the wells of a sealed 96-well plate. This means customers will only need to pipette their nucleic acid samples into the plate's wells once, reseal it and run it in a thermal cycler.

The new technology will significantly reduce manual workload, reportedly from approximately two hours to just a few minutes. There is also far less risk of contamination because the plate is never unsealed after sample application.

In Claas's opinion, it is viral assays like these in his laboratory that will benefit the most from a shift towards automation, and he welcomes the updated technology.

"We do a lot of viral testing, which involves quantitative assays for reactivating viruses in transplant patients," he says. "Right now we've got a lot of manual work going on, but I think all this will change. This won't just affect the preparation work but also the IT side of things."

Information technology is particularly key to Claas's vision for automation in molecular diagnostics and it's something he thinks dedicated IT companies and manufacturers of laboratory hardware and software should get involved with. He emphasises the importance of compatibility between the different computers and robots involved in the complete assay, from sample to result.

"Once you start automating everything, including the communication between different machines, mistakes will be eliminated and that’s the most important thing."

"I think the main part of the IT solution is that all different machines are communicating properly with each other," he says.

"In our lab, we have a laboratory information management system (LIMS). We get clinical samples in, clinical requests for different assays and it all has to be organised in a way that samples will be extracted simultaneously, and then transferred to a platform where all the different assays will be set up and subsequently everything will be transferred to the amplification platforms."

When the results of the assays come out, they are sent directly to the LIMS again. As all the hardware in Claas's laboratory can communicate with each other, technicians are saved from a tedious job.

By providing benefits to scientists and patients alike, it cannot be denied that a shift towards automation will be favourable for microbiology laboratories. But it is clear that establishing Claas' vision for a fully automated diagnostic approach relies on laboratories adopting not only advanced assay kits, but also the accompanying IT hardware. However, he is confident that operational change is near and necessary for his lab.

"I believe the whole logistics in our laboratory will change dramatically over the next two to three years. Once the whole procedure is automated, we will increase the service level that we can provide."

Leiden University Medical Centre in the Netherlands is automating increasing numbers of controls and systems.

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