The Value of an RTU

Hello, and welcome to this presentation on the value of a ready-to-use antibody. My name is Chris Rhodes, and I'm the Senior Commercial Product Manager at Leica Biosystems.

Agenda

The agenda will be as follows. An introduction to the ready-to-use antibodies, looking at quality, optimization, stability, and a couple of workflow studies. We will then review the true cost of an RTU and the value.

Introduction to RTU

An RTU in a clinical setting is defined as able to dispense with minimal, if any, effort or preparation. It is important to remember this definition. Ready-to-use products offer many advantages, including the removal of variability of quality, which naturally will occur when a user is required to prepare a reagent.

You may not think about it this way, but you already use ready-to-use reagents as part of your IHC process. When was the last time you made your detection from raw materials? How long did it take?

I'm confident when I say that you more than likely use a detection system that comes in a kit format, so you have already experienced the benefits of ready-to-use products, such as workflow improvements, standardization, potential cost savings, and a reduction in waste. Workload pressures are increasing every day. You're expected to do more with less or the same resources. So you need to find efficiency improvements.

The Value of Ready To Use (RTU)

So let me show you how RTU antibodies can help with this. Laboratories are coming under increasing pressure to improve the way they work and gain efficiency improvements. This is one of the reasons that RTU products are becoming accepted by more and more laboratories.

As the name suggests, they are ready to use with the other reagents they have been designed to work with, including the detection system and other ancillary reagents. Ready-to-use antibodies are only to be used with those components that they have been designed to work with. Otherwise, they may not work or may require further optimization and are therefore not ready to use.

If a laboratory uses a ready-to-use antibodies, there is minimal optimization that is required compared to what they would need to do when using a concentrated antibody.

Leica Biosystems has already taken care of identifying the optimal dilution, and therefore, all you need to do is optimize for your pre-analytical variations. There is no need to dilute the markers, thereby reducing the potential risk of introducing errors due to inappropriate dilutions being used.

RTU Quality

As the end user of an RTU, you should not see any difference in staining quality between a ready-to-use antibody and an appropriately diluted concentrate antibody. That is the point. The same quality with additional efficiency improvements.

So looking at the below two images and ignoring the counterstain, can you see a difference in the staining quality?

The right-hand image is the ready-to-use marker.

So if the end result from a quality point of view is the same, why would you use a ready-to-use antibody? Improved standardization, improved reproducibility, labor savings, improved workflow efficiency, improved reagent stability, reduction in the potential for errors.

Optimization

As the manufacturer of the ready-to-use antibody, Leica Biosystems has designed it to require minimal, if any, optimization to produce a clinically-relevant result. You may have to perform some level of optimization due to your lab's specific pre-analytical variability, but this is not essential.

As Leica Biosystems has taken on the burden of optimization, it frees up the lab team to focus on other tasks. Although, of course, validation into your laboratory will still be required.

Manufacturer's Stability Testing

Stability is also an area that needs to be considered.

Some antibodies do not respond well to being diluted, and the reactivity declines before the stated expiry date of the stock concentrate. What does this mean for you? At a minimum, additional work having to continually check the reactivity.

A manufacturer has to ensure that the product still works up to the stated expiry date, providing you with diagnostic confidence and potentially reducing the cost associated with wasted reagents.

Switch Conc. to BOND RTUs - Workflow Studies

An assessment was carried out in a Japanese laboratory to look at the efficiencies that can be gained from switching from concentrates to ready-to-use antibodies. The assessment utilized a beginner technician for the ready-to-use preparation and a veteran technician for the preparation of concentrates, preparing concentrates from frozen stock and then also from liquid stock in the fridge.

So let's have a look at each step. You can see for the six BOND ready-to-use antibodies, it took a total of one minute and 31 seconds with three steps.

For the concentrate antibodies from the fridge, total of 16 minutes, 53 seconds, nine steps. Five of these steps offered potentials for error. For the six frozen concentrate antibodies, it took a total of 28 minutes and 19 seconds, 12 steps, six of which offered potentials for errors. As you can see, a significant time saving was seen in this laboratory.

The Value of RTU - True Cost of an RTU

Customers often say that ready-to-use antibodies are more expensive per test compared to concentrates, and at face value, this appears to be true. However, a study performed in the US suggests otherwise. We worked with this laboratory to measure how long it took them to make up their entire panel of antibodies from concentrates.

So on average, it took 92 seconds to decant a concentrate antibody from a stock solution. On average, it takes 254 seconds to make up a diluted antibody from the concentrated antibody stock. In reality, it takes an average of 20 minutes to make up five vials of diluted antibody.

So how many antibodies are in your panel? Using this calculation, you could work out the physical cost of diluting those antibodies. So for example, if you have 100 antibodies in your panel, it would take 6.67 hours to make them all up to a working concentration from stock.

How many times are mistakes made when diluting antibodies? What's your repeat rate due to incorrect antibody dilution? And what's the cost of the wasted reagents, including the detection system?

So in effect, the true cost of a concentrate antibody is the physical cost of purchasing the concentrate antibody, plus the physical cost of diluting the antibody, plus the cost of the wasted reagents.

Value of an RTU Antibody

So in summary, ready-to-use antibodies offer workflow efficiency improvements, reducing the number of steps required for preparation of these reagents.

Standardization improvements. Ready-to-use antibodies are designed to work with the entire solution through large-scale manufacturing process, thereby offering minimal variability between lots. And finally, the reduction in the potential for errors. By minimizing the steps in preparation, the potential for errors is also reduced.

Thank you for your time.