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Subspecialties Histology, Regulation and standards, Technology and innovation

A Stain on the Lab

sponsored by Sakura

Laboratory professionals, let’s address the elephant in the room: the staining status quo is simply not enough. The world of advanced staining is often a complicated, delayed, and inaccurate place. It’s been this way for so long that to many it may not even register as a problem, but it is likely making everyone’s work harder than it needs to be. We’ve been questioning this status quo – and we think it’s time for change.

Pathologists know better than most the importance of a diagnosis. When the diverging roads of treatment lie ahead – one path leading to recovery and the other the opposite – it’s the pathologist who must point the way. But with no standard quality for staining, it has always been difficult for pathologists to give those vital directions with confidence.

For decades, quality has been key in staining and immunohistochemistry (IHC) – but everything from less-successful antibodies to insufficient dilutions has meant that one in three slides aren’t accurate enough for a correct diagnosis (1). That’s every other person you walk by on the street whose diagnosis might be compromised. Add an abundance of variables to the mix and you get the current status quo – a situation where many patients are losing out.

The vast majority of unsuitable slides are the result of weak staining that results in false negatives; the remainder are caused by poor signal-to-noise ratio that generates false positives (1). And yet, policies and procedures for staining are largely decided on a lab-by-lab basis. This failure is a result of delayed standardization, which makes suboptimal lab performance all the more likely.

At Sakura Finetek Europe, we’re questioning the situation in which laboratory medicine finds itself. Better yet, we’re offering a solution – one that could see staining become the fast, accurate, trustworthy process it needs to be. With a growing interest in digital pathology, there is an equally growing need for IHC standardization and optimization, but we have decades’ worth of catching up to do. Likewise, recent IVDR regulation in the EU means that compliance is required now, not at some distant future point.

To help labs catch up, we have been hard at work creating solutions such as our Tissue-Tek Genie® that yield reliable, standardization-powered results through closed-loop technology. These systems use single protocols for over 130 optimal antibodies, offering the convenience of reduced IHC assay calibration and validation. We combine this with third-party quality control and by only offering optimal scoring antibodies – giving reassurance to pathologists and patients who need quick, reliable, and accurate results more than ever.

We know that pathologists love the flexibility in advanced staining, but it's that exact same flexibility that is causing confusion. Our aim is to rid the advanced staining market of its blemishes, to rub away the variables and the subjectivity – but the work has to start now. What we all have to do is provide a standard for optimal stain quality. For us, that’s achieved through offering automated start-to-end solutions with Advanced SMART Automation for tissue diagnostics that set a new standard – enabling you to achieve optimal results.

It’s time to wipe away this stain on the lab. Join us in creating a new staining standard, so that we can improve the lives of patients and lab professionals everywhere. Optimal only – make it simple.

Visit Sakura's website to find out more

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  1. M Vyberg, S Nielsen, “Proficiency testing in immunohistochemistry—experiences from Nordic Immunohistochemical Quality Control (NordiQC),” Virchows Arch, 468, 19 (2016). PMID: 26306713.
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