With all the effort it takes to install and validate a new biomarker, plus train the lab staff to use it properly and help the clinicians order it at the right time, the idea of changing established operations for a new device or instrument can be daunting. But given the necessity of change, lab leaders need to remain open to new biomarkers and have a smart roadmap for implementing them.

Recently, a clinical lab team at Osaka Red Cross Hospital in Japan switched from one PIVKA-II assay to another, a process that involved many of the typical challenges, as well as the specific task of managing a unit change. To learn more about how they coordinated this update, Lab Insights interviewed Mr Nobuhiro Sato, Chief Laboratory Technologist at the hospital. His experience highlights some basic principles in assay change management that can apply to any lab.

The process of adopting PIVKA-II

Testing for PIVKA-II, a biomarker used to aid the diagnosis of hepatocellular carcinoma, can deliver higher sensitivity for earlier detection of this cancer when paired with testing of the AFP protein compared to AFP testing alone [1]. In labs around the world, PIVKA-II testing is supplementing these older approaches because it enables clinicians to diagnose patients earlier and get them started on treatment while their odds of survival are highest [2].

Mr Sato’s team successfully switched from an older PIVKA-II testing platform to a newer one, choosing a system that offers faster turnaround time and reduced overall running costs.

“The reason why we chose these tumour markers was that they were widely used at the Core Hospital for Cancer Genomic Medicine, and also employed by the affiliated Kyoto University Hospital.”

“It is important to explain to clinicians why a change has occurred in the clinical laboratory department and have them agree with the items used for follow-up observation,” says Mr Sato, who had educational materials prepared to help clinical colleagues understand the reasons for the platform shift and understand the different measurement values used by the new system.

Training of his staff to reinforce these points is also crucial. “We want to ensure our people can explain with confidence and pride how we came to our conclusions,” he explains. “We don’t want to become just test providers. ”

He also presented data at meetings to raise awareness about the new assay and its value to the hospital, physicians and patients as an aid in the diagnosis of hepatocellular carcinoma. “I think that it is possible to switch smoothly if a proposal is made based on the whole test, such as improvement of test efficiency and reduction of running costs and turnaround times,” he notes. “It’s even better to put this in terms of the hospital goals and functions, rather than focusing only on a single item.

Dealing with assay unit changes

One particular change the team had to manage was a shift in measurement units reported by the new system. This platform reports values in ng/mL, with a cut-off of 28.4, compared to older systems that report values in mAU/mL with a cut-off of 40. To avoid confusion, the clinical lab staff stopped displaying prior test values and provided clear explanations and educational materials to the gastroenterology department about the updated approach.

For clinicians who needed to compare new results to old ones, a paper was made available that included a comparison of diagnostic performance showing that the new platform provides equally accurate results.

Because tumour marker values are rarely used at a single point — their value most often lies in being evaluated and compared over time to assess increases or decreases in activity — Mr Sato’s team understands that as they produce more and more results over time, the shift to different measurement units will enable monitoring just as easily as the previous approach. After a short transition period, the change in units is not expected to be disruptive to clinicians or patients.

Lessons for change management

Mr Sato’s lab, which achieved ISO 15189 certification in 2018, includes 65 medical technologists who run a wide variety of diagnostic platforms for biochemical, haematological, immunological, and microbiological tests, among other capabilities. The lab also recently established cancer genomics operations, a process that involves determining how to manage information.

Sato notes that his lab is part of multiple associations and leverages several quality control systems to ensure they are constantly maintaining the highest standards and adopting the latest techniques. In a lab like his, assay changes are inevitable.

So what does his experience with adopting a new PIVKA-II assay teach us? Here are a few key takeaways:

• Clearly explain your decisions to all stakeholders in your healthcare system
• Train your staff carefully to reinforce those decisions
• Justify the value in terms of the big picture to the hospital and to patient outcomes
• Any short-term inconvenience from changing assay units can be outweighed by significant benefits of a newer system

To learn more about PIVKA-II testing, please read this publication or view this video interview.

References:

[1] Wu, J. et al. (2018) ‘Diagnostic value of serum Pivka-II levels for BCLC early hepatocellular carcinoma and correlation with HBV DNA’, Cancer Biomarkers, 23(2), pp. 235–242. doi:10.3233/cbm-181402.

[2] Chan, H.L. et al. (2022) ‘Performance evaluation of the ELECSYS pivka‐ii and ELECSYS AFP assays for hepatocellular carcinoma diagnosis’, JGH Open, 6(5), pp. 292–300. doi:10.1002/jgh3.12720.