Molecular diagnostics success story

Gemma Vanstone, the lead Clinical Scientist for microbiology and laboratory manager at the Royal Cornwall Hospitals NHS Trust details how she first discovered the Enteric-Bio system, and the positive impact clinicians and patients can expect from working with Serosep.

“Working in the microbiology laboratory at the Royal Free Hospital, London, 10 years ago we faced a huge problem. Enteric testing by conventional culture-based methods was slow and laborious, and our highly skilled and experienced staff were spending many hours reading culture plates, of which over 90% would be negative. It would take between 2 – 5 days to issue results and often positive results would come too late to have a significant impact on patient care. Also, for some enteric pathogens, culture was biased towards only the most common organisms (e.g. E.coli O157 only) and so significant results would sometimes be missed.

“In 2012 my laboratory manager met with Serosep, which had just developed the EntericBio system; a rapid, molecular method for the detection of bacterial pathogens directly from stool samples. As scientists working in the clinical laboratory, we understood the vision Serosep described, and we agreed – screening by culture is crazy for enterics! We trialled the assay and found it gave us an improved service, increased sensitivity for results and improved turnaround time to diagnosis. That was a winner for us, and The Royal Free Hospital became the first NHS laboratory in the UK to implement PCR for the detection of bacterial enteric pathogens.”

Today, hospital laboratories face an additional set of challenges as Vanstone explains, “Most laboratories 10 years ago would have opened their doors at nine o'clock and shut the doors at five o'clock and provided a limited on-call service in the hours between. Since then, most laboratories have moved to extended hours and in response to the huge additional workloads associated with Sars-CoV-2 testing laboratories have extended their working hours further or moved to 24 / 7 working. Our plans to introduce Enteric-Bio for Cornwall have been delayed due to COVID but now we have managed to implement the system we will be able to reduce hands on time for BMS staff in the enterics section, allowing them to be reassigned to other busy areas of the laboratory. There are other management advantages too; we can identify highly transmissible infectious organisms more quickly so our Infection Prevention and Control (IPAC) colleagues can work to prevent transmission and act on outbreaks much faster, hopefully restricting the impact on our Patients and to our Trust. It's really positive for patients and it's reducing the risk for everyone in our communities.”

What difference will the introduction of Enteric-Bio make for the Royal Cornwall Hospitals and the people it serves? Vanstone summarises her expectations, “Our laboratory processes some 12,000 stool specimens a year and when we processed these by culture it could take anything from 48 hours to 5 days to give our clinicians the results they needed, which meant our patients are waiting for their diagnosis and treatments. I expect there will be much improved turnaround times with the Enteric-Bio system, most test results will be ready in hours rather than days which means our clinicians can treat our patients faster, reducing time in hospital for some of them and enabling them to have treatment sooner. Positive results will be issued in a timeframe that is far more likely to allow a positive impact on patient care. Also, we sometimes forget the importance of issuing negative results quickly because that will say to our users, ‘well actually, this patient hasn't got any of these things, so if they are clinically unwell you need to consider something else.’  I don’t expect it to take long for our clinicians to begin to see the benefits.”

Vanstone adds: “Also, we, the laboratory team, will be able to focus our efforts on specimens from patients who are positive for one or more of the pathogens and will have the time to liaise with our users about the results that really matter. With time, I'm hoping that we can really improve some of our diagnosis pathways here in Cornwall; we're in a really rural location, with lots of farming communities in our catchment area so I’m hoping the introduction of this assay will improve the service we offer for the detection of STEC, which previously was limited to detecting E.coli 0157 by culture and referral to the Reference Laboratory for other serotypes if necessary. We are committed to improving and providing a world class STEC service for our patients and our communities locally.”

Vanstone concludes, “The products that Serosep produces and the support that it provides make it easy for clinical labs and microbiologists to be better at what we do. As a laboratory manager, who doesn't want that? We still face the challenge of COVID-19, so anything for the coming months and years that makes working in the laboratory easier and allows us to provide a better service is just a win win really. The modular nature of the assays and the way Serosep designs them to be simple to use and set up by any grade of staff makes implementation into the laboratory as simple as possible; different assays are set up in the same way, so the training is similar and staff quickly become comfortable and experienced with the process. Our BMS staff have quickly become competent with interpreting the results; you don’t have to be an experienced molecular biologist to run or interpret the assays, and if required, technical support is provided by Serosep. Our clinical microbiologists are keen to look at using the C. diffficile assay to improve our C. difficile diagnosis pathway, particularly now that they have seen the benefits obtained from implementing the Gastropanel. The modular nature and adaptability of the systems means I can very much see us going forward with some more assays produced by Serosep.”

For Serosep, this deployment was a major company milestone, as the Royal Cornwall Hospitals Trust became its 50th site to introduce Enteric-Bio.

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