As molecular diagnostics expand what laboratories can detect, laboratories are placing greater emphasis on matching the breadth of testing to the patient and how the results will be used.
By Kaisha Gonzalez, PhD
(Editor’s note: This article is part of an ongoing series sponsored by Diasorin examining the changing respiratory testing landscape and the range of options available to laboratories.)
As laboratories move toward more differentiated respiratory testing strategies, deciding how much to test is only one part of the stewardship question. Laboratories must also consider why they are testing, what they will do with the result, and whether the information generated will meaningfully support patient management.
That broader view of stewardship is becoming increasingly important as laboratories gain access to highly multiplexed syndromic testing, expanded pathogen menus, and increasingly sensitive molecular technologies. These capabilities have shifted the primary challenge from detecting pathogens to determining which findings are clinically meaningful and actionable.
Laboratories now routinely navigate interpretive complexity, incidental findings, low-probability detections, and questions surrounding clinical actionability.
Molecular diagnostics have created an era of diagnostic abundance. As diagnostic capability expands, so does the responsibility to ensure that the generated information remains clinically relevant, interpretable, and actionable. As a result, diagnostic stewardship is evolving beyond traditional utilization management and becoming a framework for ensuring that diagnostic information supports meaningful clinical decisions.
Laboratory Stewardship and Diagnostic Stewardship Are Not the Same Thing
One source of confusion is that laboratory stewardship and diagnostic stewardship are often used interchangeably. They overlap, but they address different problems.
Laboratory stewardship traditionally focuses on operational efficiency. Common objectives include reducing duplicate testing, minimizing unnecessary utilization, improving workflow efficiency, managing laboratory resources, and controlling costs. These remain important goals.
Diagnostic stewardship addresses a broader clinical challenge. Its purpose is to ensure that testing strategies generate information that meaningfully supports clinical decision-making. The central questions become:
- What clinical question are we trying to answer?
- Is the diagnostic breadth appropriate for this patient?
- Will the result influence management?
- How should the result be interpreted?
- What downstream actions are likely to occur because of that result?
Initiatives designed to improve laboratory stewardship do not automatically translate into improved diagnostic stewardship. For example, a utilization dashboard or ordering intervention may successfully reduce duplicate testing, unnecessary utilization, or operational inefficiencies. These are important laboratory stewardship outcomes. However, diagnostic stewardship asks a broader question: Does the testing strategy generate clinically meaningful information that improves patient care and supports clinical decision-making?
Importantly, diagnostic stewardship is rarely driven by a single individual or intervention. Effective stewardship programs typically require collaboration among laboratories, clinicians, antimicrobial stewardship teams, infection prevention programs, and institutional leadership. Governance, education, clinical feedback, and ongoing reassessment often play equally important roles in ensuring that testing strategies continue to provide meaningful clinical value. Ultimately, diagnostic stewardship seeks to optimize diagnostic value, not simply reduce utilization.
Diagnostic Intent Starts With the Clinical Question
Every testing strategy should begin with a clinical question. Historically, testing decisions were often driven by what technology made possible. Increasingly, laboratories are shifting toward a more fundamental consideration: What are we trying to learn, and how will the answer inform patient care?
Diagnostic intent moves testing from a technology-driven model to a purpose-driven one by aligning diagnostic breadth with the clinical scenario, patient risk factors, epidemiology, and anticipated clinical actionability. Technology defines what we can detect. Diagnostic intent determines what we should test and why.
Diagnostic Accountability Extends Beyond Ordering the Test
Every diagnostic result has consequences. Results may influence treatment decisions, isolation precautions, additional testing, patient management decisions, and healthcare resource utilization. As molecular capability expands, so does the responsibility to ensure that generated information remains clinically relevant and appropriately interpreted.
Diagnostic accountability recognizes that stewardship extends beyond ordering the test. Not every detectable target is equally actionable. Increasingly, laboratories are evaluating diagnostic strategies not only by analytical performance, but also by whether results are likely to influence clinical decisions and patient management.
This shift reflects a broader recognition that the value of a diagnostic result depends not only on what can be detected but also on how that information informs clinical care. Greater analytical power inevitably creates greater interpretive responsibility.
Flexibility Aligns Testing With Clinical Need
One of the most common misconceptions is that flexibility exists primarily to reduce costs or limit testing. Increasingly, however, flexibility is being viewed as a clinical strategy that aligns diagnostic breadth with the clinical question being asked.
Not every patient, syndrome, or clinical scenario carries the same level of risk. As a result, the most appropriate testing strategy may vary based on patient characteristics, epidemiology, seasonality, clinical presentation, and pretest probability. Flexibility allows diagnostic pathways to adapt to these differences while preserving access to broader diagnostic capability when clinically justified.
Pretest probability is particularly important. The clinical value of a result is influenced not only by assay performance, but also by disease prevalence, patient risk factors, and the likelihood of disease before testing occurs. Aligning diagnostic breadth with pretest probability helps maximize clinical relevance while reducing unnecessary ambiguity and interpretive burden.
A Flexible Framework for Intentional Testing
One approach is to organize testing into progressive tiers based on clinical need.
- At the foundation are core targets—high-prevalence pathogens that provide immediate value for routine clinical decision-making and initial patient management.
- Beyond that are extended targets, which may be appropriate when the clinical picture becomes more complex, such as persistent symptoms, immunocompromised patients, treatment failure, or specific epidemiologic exposures.
- Finally, specialized targets may be reserved for lower-probability scenarios, rare pathogens, unique exposures, or highly complex clinical situations where broader diagnostic investigation is warranted.
In this framework, diagnostic breadth expands when clinical context supports additional testing rather than applying the broadest possible testing strategy to every patient by default. Progression through these tiers is guided by predefined clinical criteria rather than arbitrary escalation, allowing testing to become dynamic and responsive to patient context.
The underlying principle is straightforward: Every target should earn its place through demonstrated clinical value, not simply technological availability.
From Flexibility to Panel Stewardship
Historically, stewardship focused on how tests were ordered. As syndromic testing becomes more flexible and laboratories gain greater ability to determine which targets are included in a testing strategy, a framework is also needed to support those decisions and their ongoing reassessment. Panel stewardship extends stewardship to selecting and reassessing individual targets, considering target utility, positivity rates, epidemiologic relevance, clinical actionability, interpretive burden, and evolving patient needs.
Evaluating What Belongs on a Panel
As diagnostic capability expands, stewardship increasingly involves evaluating which targets should be included in diagnostic panels. Several questions are becoming increasingly important:
- Is the target epidemiologically relevant to the population being tested?
- Does detection influence clinical management?
- Does the result improve diagnostic clarity or introduce interpretive ambiguity?
- Does inclusion support institutional priorities, stewardship objectives, and clinical workflows?
Importantly, panel stewardship does not necessarily require eliminating targets that do not currently meet these criteria. A target may have low prevalence yet still provide significant value in specific patient populations, clinical scenarios, or epidemiologic settings. In many cases, these targets may remain available through reflex, tiered, or specialized testing pathways. The focus shifts from maximizing the number of targets on a panel to ensuring that each target contributes meaningful clinical value.
Panels are increasingly being viewed as evolving clinical tools rather than static diagnostic products. Stewardship does not end at implementation. Diagnostic panels, testing pathways, and reporting strategies require continuous reassessment as epidemiology, clinical practice, patient populations, and stewardship priorities evolve.
Why This Matters
A recurring observation across laboratory discussions is that additional detection breadth does not automatically create additional clinical value. Most laboratories already have access to highly capable molecular testing platforms. The emerging challenge is determining how to use those capabilities effectively. Expanding detection capability and expanding clinical value are not always the same thing. The ability to detect additional organisms does not automatically improve patient management. Clinical value is ultimately determined by how effectively diagnostic information supports interpretation, decision-making, and action.
This is particularly evident in highly multiplexed environments where broader testing may generate findings that are technically correct but clinically difficult to interpret. Incidental findings, colonization, co-detections, and findings of uncertain clinical significance can all increase interpretive complexity without necessarily improving patient management. As diagnostic breadth expands, interpretive burden often expands as well.
The goal of stewardship is not to limit information but to improve diagnostic confidence by ensuring that the information generated remains clinically relevant, interpretable, and actionable. The value of molecular diagnostics is not determined solely by analytical performance. It is also determined by how effectively results support clinical decisions, influence management, and provide clarity for clinicians.
The Next Phase Is Intentional Testing
The future of diagnostic stewardship is unlikely to be defined by limiting testing. It is more likely to be defined by intentional testing. The goal is not to limit access to diagnostic information, but to ensure that diagnostic breadth remains aligned with clinical context, diagnostic intent, and patient management.
Historically, innovation was often measured by expanding analytical capability through broader menus, larger panels, and faster detection. Those advances remain important. However, as broad molecular capability becomes increasingly common across the industry, the next phase of innovation may be defined by how intelligently that capability is applied. Differentiation may increasingly depend on how effectively diagnostic information supports clinical decision-making rather than simply how many targets can be detected.
In that environment, flexibility becomes more than a menu feature. Panel stewardship becomes more than utilization management. Diagnostic intent becomes more than an ordering consideration. Together, they form a framework for applying molecular diagnostics in a way that remains clinically meaningful, operationally sustainable, and responsive to patient needs. The defining question of the next molecular era may not be how much we can detect. It may be how effectively we apply what we detect.
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