Bio-Rad - Preparing for a Stress-free QC Audit

Beckman Coulter at EuroMedLab 2023

The use of immunoassays is widespread in clinical lab testing as these assays have inherent high specificity and high sensitivity, and are very amenable to high-throughput formats. These attributes make them particularly useful for the measurement of low concentrations of low molecular weight drugs, metabolites or biomarkers that indicate disease diagnosis or prognosis. Although there are a number of specific types of immunoassay, the general idea behind the principle is that the analyte in question is specifically bound by labelled antibody and analysis is achieved by measuring the label activity (such as chemiluminescence). Immunoassay analysers are instruments that are used in hospital and clinical laboratories to run these tests in an automated manner to allow large numbers of samples to be assayed as accurately and as fast as possible. CLI News Editor Twan Heesakkers caught up with Heather Read-Harper, Senior European Product Manager for Clinical Diagnostic of Beckman Coulter, in Rome EuroMedLab 2023 at the launch of their new immunoassay analyser to find out more about it.

What new product(s) are you presenting at Euromedlab this year?

One of the many products we have on our booth today is the DxI 9000 Access Immunoassay Analyzer and we are launching it here at the show. We have been building up to this great big event for a long time and it’s been really successful. We have had good engagement with our customers – it’s been very exciting and we’re happy that this instrument hits the mark.

0199 EML 2023 DxI 9000 launch photography 22052023

You mention the immunoassay analyser, the DxI 9000, can you tell us a little more about this product? What sets it apart from similar competitors’ products?

OK, so to answer this question, I think we’ve really got to think about how we designed this instrument. We at Beckman Coulter are all about “Customers talk, we listen”. Beckman Coulter is committed to improve patient care. That’s our ultimate goal. That’s also the laboratory professionals’ goal. What we want to do is take it to another level and to improve the operators’ experience in addition to being able to deliver the best results and the best patient care. So, when we started out with the design of this instrument, we brought a lot of customers together to get their feedback and input that into the design and usability of the analyser. We did this to make sure that we not only deliver excellent analytical performance as an output from our R&D but ensure that we also deliver a good operator experience from those that know what they need. This operator feedback also helped in the design of our brand-new software on the analyser, which we’re really excited about. It provides tools that are easy to navigate and support the user. We also introduced a new substrate which gives excellent results and confidence in those results. Furthermore, we have PrecisionVision technology and that’s where the gamechanger comes because we’ve now got the ability to detect errors in real time.

What reasons are behind you choosing to develop this immunoassay analyser?

We want to keep throughput high – that’s seriously important. With 450 tests an hour and 215 tests per hour per square metre we have the highest productivity, which is important to deliver to our customers because workloads are increasing in every laboratory, and we want users to be able to deliver results on time. Immunoassay technology is always developing and, for us, our one of our innovations is the Lumi-Phos PRO, which is our new chemiluminescent substrate. We have developed all of our assays using this new substrate, which has allowed us to improve the signal-to-noise ratio, to deliver results quicker but also to have the future in mind. So, as we bring new assays out on this instrument – we can deliver greater sensitivity, reduce luminometer read-time and keep the accuracy of the results and that’s the important thing.

You claim the DxI 9000 is the only immunoassay analyser which requires no daily maintenance. Are there other unique features besides the ZeroDaily Maintenance?

When I say ZeroDaily Maintenance I mean no daily hands-on maintenance but also no daily automatic maintenance performed by the analyser, and I think that’s the difference – it’s the way maintenance is described.

It’s the meaning of the term ‘maintenance’. I’m talking about maintenance involving all daily actions, both manual and automated, that are needed to maintain the analyser, with the DxI 9000 analyzer there is no preparation, no automatic washing procedures and no buffers to be loaded every day. The point I want to get across is that this platform has ZeroDaily Maintenance: there is nothing to do except run the quality controls (QC), and the preparation for this take less than one minute.

Before our launch, we wanted to put the DxI 9000 analyzer into a live environment, so we invited some early adopters to evaluate the analyser in a laboratory environment for us. One laboratory was particularly keen to understand the answer to the question, “If the analyser does not require daily maintenance, how does that affect the performance?” So, the customer ran QC every day for a period of 70 days and the precision was as good on day 70 as it was on day 1! So I think that’s a testimonial we can be proud of. The terminology we’ve heard around the booth today is that the DxI 9000 analyzer is a ‘gamechanger’. Along with the new Lumi-Phos PRO substrate and the PrecisionVision technology, it’s important to also focus on the brand-new software features. Now, what we’ve done is to make sure that the user can easily navigate using simple tiles all on one screen when interacting with the analyser. In addition, we have created SimpleSolve Onboard Guide. We have provided intelligence within the software, to give autonomy to the user. With any analyser, whether it’s ours or a competitor’s, there will be times when problems crop up, so you might need to troubleshoot that instrument if it’s not doing something you want it to do. So, we’ve actually built a system that will match the error to an instruction for the user. This system provides a step-by-step guide that the user can easily navigate to tell them how to overcome the error and give them the confidence to work independently. This is important because in the discussions we had with customers, they said they can have a significant staff turnover. They have experienced staff but also staff who don’t necessarily have the confidence to troubleshoot the instrument themselves. So, we’re now putting that capability into their hands. Should an issue not be resolved, we obviously still have all of our call centres to support our customers, but we have also introduced DxS IntelliServe, our new online remote diagnostic within the analyser. It uses advanced analytical tools for predictive and preventive analytics to communicate critical information, allow virtual issue resolution, and enable technical and application experts to interact with the instrument. We brought users in at each step of development the process. As an example, we had a meeting in France a couple of years ago where we brought together laboratory professionals for a roundtable discussion. During this discussion, we uncovered their pain points, and then we took their feedback to develop something to help them. I think it’s important to involve customers in the design of an instrument.

Your company also mentions the PrecisionVision technology. Can you tell us a little more about this?

I’d love to! It’s a patented machine vision technology where we match imaging software with algorithms so that the analyser has the intelligence to understand all of the principal processes within the system. So how do we do that? We do that with cameras.
We have lots of miniature cameras within the system that we’ve trained with these algorithms to monitor processes, such as the amount of sample aspirated and dispensed. Obviously, with immunoassays you’ve got to have accuracy at all stages. We’re also checking the total reaction volume and residual volume, so we’re looking at every analytical stage of that instrument. And
we use these images along with the software algorithms so that the operator can be confident that the correct amount of sample is delivered; or that the reaction vessel has been cleaned and dried properly. We also have this technology at the pre-analytical level. When I say pre-analytical level, it’s looking at the tube type that is loaded onto the instrument. Obviously, it reads barcodes but it does more than just read barcodes. It looks at cap detection, etc, so the process is being monitored all the way through – in real time – to make sure there is confidence in every result that is reported. Now, if it does detect an error, it will stop analysing that sample, inform the user with an error message, and continue with everything else. This is so that the user doesn’t lose time.

So it’s like a complete scan throughout the whole process?

Yes, it really is. The instrument itself is checking that everything is done correctly. We’ve still got pressure sensors within it, you know, the traditional technology, but we’re creating s the ability to see what the instrument is doing. It’s quite exciting – very exciting actually!

What else is in the pipeline for Beckman Coulter?

We have a very impressive pipeline! We’ve got additional new analysers launching later this year, that we’re excited about. And clearly with the new substrate and features that we’ve introduced on the DxI 9000 analyzer, we have the ability to bring new novel markers to our immunoassay menu. Now, you’re probably aware

“The DxI 9000 has a new modern interface. It’s sleek, you have tiles that lay out your different sections, your consumables, reagents, calibrations, QC and your samples, so it’s very easy to find everything.”

Niamh Omahony, Medical Scientist at Mayo General Hospital

alongside the launch of the analyser today, we are delighted that we’ve brought our Access NT-proBNP assay to market, which allows us to close the gap in our cardiac marker menu. We will continue to bring additional assays, together with new instruments, so we can provide that full solution our customers are looking for. The DxI 9000 analyzer compliments our clinical chemistry, hematology and automation systems allowing us to offer a comprehensive portfolio for the hospital and clinical laboratory.

The new substrate is a big deal: faster assays with more sensitive and precise performance – the detection capabilities give us such confidence in the results”.

Niamh Omahony, Medical Scientist at Mayo General Hospital

The interviewee

Heather Read-Harper,
Senior European Manager for Clinical Diagnostics of Beckman Coulter Beckman Coulter United Kingdom Limited, High Wycombe, Buckinghamshire, UK