HISTOPATHOLOGY
process in the laboratory, because in the past we’ve been making up a lot of the stains ourselves using powders and stock solutions, so that’s where the ready- made stain kits have come in. “Some of the stains we found ourselves making up on an almost weekly basis where we have a high throughput of slides – like a van Gieson stain. And for certain tissue types we do sets of stains; liver tissue for example we do a panel of six different stains, of which two are hand stains. As well as the kits that Atom Scientific do, they also have individual bottles of reagents and in the laboratory we’re trying to balance the two and always find what works best for us.
Atom Scientific’s IVDR-compliant histopathology range delivers consistency and reliability while also ensuring full traceability for all components.
time and provides consistent and reliable results within proven protocols.
Atom Scientific’s stain kits, independently assessed and scored by UK NEQAS CPT, and tested in the company’s QC laboratory before supply, gives the external, pre-validated quality assurance that any pathology laboratory can rely on.
The range of kits on offer all provide complete traceability of all batches and raw materials, so laboratories can be sure there is a robust audit trail if needed. Atom also offers full technical support to ensure users in the laboratory get the best out of the kits.
Some of Atom Scientific’s stain kits contain 20-plus separate raw materials in one, which removes the requirement for laboratories to source – and store – the multiple raw materials used in some stains.
The years of investment the company has made in developing stain kits has resulted in Atom Scientific achieving several quality standards. It is the only UK manufacturer of diagnostic stain kits to comply with the recent EU regulation 2017/746 covering In Vitro Diagnostic Medical Devices for diagnostic use (IVDR) as well as research. This sits alongside the IVDD registration that
Atom Scientific obtained several years ago. Atom’s stain kits and biological stains,
while retaining their CE mark outside of the UK, have also this year attained the new UKCA mark for general In Vitro Diagnostic (IVD) devices, which complies with various ISO standards and replaces the former CE mark for the UK markets, since the UK exited the EU. Reaching these standards for stain quality means Atom Scientific can play a part in its laboratory customers’ own compliance with quality management systems, such as ISO15189 for quality and competence in medical laboratories.
In the laboratory
Craig Mullarkey is a trainee biomedical scientist working for Leeds Teaching Hospitals NHS Trust at St. James’ University Hospital in Leeds. He explains how Atom Scientific’s ready-made stain kits have been introduced in his laboratory recently.
“In our laboratory we have an array of stains which we use. When sectioning tissue for slides the standard is obviously the haematoxylin and eosin (H&E) stain, then we have requests for more specialist stains.
“For the stains which we do by hand, we’ve been trying to simplify that
WWW.PATHOLOGYINPRACTICE.COM APRIL 2025
“If we can reduce our time mixing stains and buying ready-made reagents from Atom directly, then obviously it saves us time. When we’re mixing our own stains, each batch has to be documented: numbered and dated. It also helps when we’re also assessed for quality, obviously the laboratory is subject to external quality assessment – we have a scheme with UK NEQAS and we’re also assessed by UKAS too. “Some of the work I’ve been doing has been in validating the processes when we switch to ready-made stain kits. That’s meant staining two sets of slides side by side, using the old and the new method, and those slides are then assessed by a pathologist for comparison and they decide whether it’s worse, the same or better. We then need five sets signed off to be able to switch to the new method.
“Overall, in the laboratory we’ve changed 12 specific stains over the last six months or so. Previously, for each stain that needed mixing, the process would take up to half an hour or so for the more complex ones. While the time aspect isn’t something we’ve been able to track, it has certainly saved time in the laboratory. As well as the time mixing using the ready-made kits has also cut down on the paperwork and there’s a lot less to worry about with the EQA too. So far the kits we’ve been using have been substantially beneficial. “We’ve had no problems with quality
so far, the validation process for each new stain has gone very smoothly. If there were any issues we’d hear about it pretty quickly but so far any comments we’ve received from the pathologists have been very positive.”
Atom Scientific 0161 366 5123
enquiries@atomscientific.com
www.atomscientific.com
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