Experts discuss high-sensitivity troponin immunoassays in laboratory medicine

The potential of high-sensitivity troponin immunoassays to transform clinical practice, particularly in cardiac care, was the focal point of the recent SelectScience^® Advancing Healthcare Forum. Sponsored by Beckman Coulter Clinical Diagnostics, the Forum brought together industry leaders to examine the benefits, challenges, and regulatory landscape of implementing high-sensitivity immunoassay testing, using troponin as the working example.

The event featured three expert panelists: Dr. Frank Peacock, Professor of Emergency Medicine at Baylor College of Medicine, Tracy Mangunlay, Laboratory Services Executive at Adventist Health, and Sten Westgard, Director of Client Services and Technology at Westgard QC. Each speaker provided a unique perspective — clinical, managerial, and regulatory — enriching the dialogue on this cutting-edge diagnostic innovation.

Saving lives in the ER

Dr. Frank Peacock opened the discussion by underlining the urgency of timely diagnoses in emergency care. "The longer you stay in the ER, the more likely you are to die," he stated bluntly, driving home the life-or-death stakes of overcrowded hospitals. High-sensitivity troponin immunoassay testing, he explained, can significantly expedite the evaluation of patients presenting with chest pain — one of the most common complaints seen in emergency departments.

Unlike traditional 'contemporary' troponin tests, which often require multiple measurements over six hours, high-sensitivity assays can detect troponin at much lower levels, allowing for a reliable diagnosis within one to two hours. This rapid turnaround not only helps physicians rule out myocardial infarction (MI) but also facilitates safe discharges, reducing ER congestion.

Peacock emphasized the widespread need for this technology, estimating that only half of U.S. emergency departments currently use high-sensitivity troponin testing. For the other half, the barriers are often logistical and educational rather than clinical. "The value is unquestionable," he asserted, "but implementation is where the challenges lie."

Laboratory management perspective

Providing the laboratory management perspective, Tracy Mangunlay highlighted the complexity of implementing high-sensitivity troponin testing across a healthcare network as diverse as Adventist Health. With 28 hospitals and over 300 clinics ranging from urban centers to rural outposts, achieving uniform adoption required meticulous planning and strong stakeholder engagement.

Mangunlay stressed the importance of involving medical directors, emergency physicians, cardiologists, and nursing staff early in the implementation process. “This is not just a lab transition – it’s a significant clinical shift,” she explained. Educational efforts were key to overcoming resistance, particularly among clinicians who were accustomed to interpreting contemporary troponin results.

Adventist Health also leaned heavily on its vendor partnership, which provided vital support during the rollout. Vendor representatives, including physicians and nurse practitioners, were physically present in emergency departments during the initial go-live phase, helping clinicians interpret the new test results. “Their presence built trust and ensured smoother transitions,” Mangunlay noted.

Despite these efforts, not all facilities transitioned immediately. Mangunlay admitted that two hospitals in the network have yet to adopt high-sensitivity troponin testing, underscoring the variability in readiness and engagement across sites.

Regulatory realities and the CLIA 2024 shift

Sten Westgard offered insights into the regulatory landscape, particularly the new CLIA (Clinical Laboratory Improvement Amendments) requirements that took effect in 2024. For the first time, CLIA will establish specific quality goals for troponin assays, addressing a longstanding gap in U.S. proficiency testing standards.

“Up until now, the regulation of troponin quality has been inconsistent,” Westgard explained. Labs were largely governed by voluntary standards set by organizations like the College of American Pathologists (CAP), which often varied widely in their stringency. With CLIA’s new goals, laboratories will face stricter benchmarks, particularly for high-sensitivity troponin assays.

Westgard also highlighted international discrepancies in troponin quality standards, attributing them to competition among regulatory bodies and proficiency testing providers. While some countries impose rigorous penalties for failing quality standards, others take a more lenient approach, issuing warnings rather than sanctions. “The international regulatory climate is a nightmare,” Westgard quipped, voicing the frustrations of many clinicians navigating these complexities.

Overcoming implementation challenges

Both Peacock and Mangunlay agreed that education and collaboration are critical to successful implementation. Peacock recounted the process of developing an algorithm for interpreting high-sensitivity troponin results at his hospital. This involved extensive meetings with laboratory staff, emergency physicians, and cardiologists to establish clear protocols for handling test results. These algorithms were then posted prominently in emergency departments, providing clinicians with quick reference points.

Mangunlay echoed the importance of clear guidance, noting that her team relied on validation studies, vendor data, and best practices from other hospitals to inform their protocols. She also acknowledged the logistical hurdles of integrating high-sensitivity testing into existing workflows, particularly in rural hospitals with limited resources.

One recurring theme was the trade-off between speed and accuracy. While high-sensitivity troponin tests enable faster diagnoses, they also yield more positive results, many of which are unrelated to myocardial infarction. Peacock pointed out that elevated troponin levels can indicate a range of conditions, from renal failure to marathon running. “All myocardial injury is bad,” he emphasized, “but not all of it is due to a myocardial infarction.” Educating clinicians to interpret these nuances is a crucial part of the transition.

The case for point-of-care testing

The Forum also touched on the potential of point-of-care (POC) testing, particularly for emergency departments. While high-sensitivity POC troponin assays are available internationally, the U.S. Food and Drug Administration (FDA) has yet to approve a comparable product. This regulatory lag has limited the adoption of POC testing in American hospitals, where lab-based high-sensitivity assays remain the standard.

Peacock was unequivocal about the benefits of POC testing in countries where it is available, calling it a “game-changer” for emergency care. However, he acknowledged the FDA’s stringent standards, which require POC tests to match the precision of laboratory assays. Westgard defended this rigor, noting that errors in troponin testing could have life-threatening consequences.

Key takeaways

• The forum underscored the transformative potential of high-sensitivity immunoassays while also highlighting the challenges of adoption. From reducing ER overcrowding to improving diagnostic accuracy, the benefits are clear. However, successful implementation requires careful planning, robust education, and close collaboration among stakeholders.
• As the CLIA 2024 regulations take effect, laboratories face additional pressure to meet stricter quality standards. Yet with the right tools and strategies, high-sensitivity troponin testing can become a cornerstone of modern cardiac care, ensuring better outcomes for patients and more efficient workflows for healthcare providers.
• Through candid discussions and diverse perspectives, the SelectScience Forum provided a valuable roadmap for navigating these challenges, reaffirming the importance of innovation and collaboration in advancing healthcare.

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