Whether it's the back-to-school bug or seasonal flu, respiratory season brings with it a seemingly endless cycle of coughs, fevers, and fatigue. But overlapping symptoms make it difficult to know exactly what’s going around.
Here, Alesia McKeown, scientific partner for infectious disease in medical and scientific affairs at Roche Diagnostics, discusses where we stand with respiratory diagnostics – and what’s yet to come.
What are the major unmet needs in respiratory diagnostics?
The field of respiratory diagnostics has seen significant progress over recent years, but several unmet needs persist – and time is of the essence. Decreasing turnaround times from sample to result is critical to enable timely clinical decisions and infection control initiatives. Healthcare facilities can improve turnaround times by using more rapid solutions and evolving institutional workflows.
Equally crucial is expanding the use of less invasive sample types, such as nasal swabs and self-collected samples, which can enhance accessibility and patient compliance, especially during peak seasons.
Additionally, healthcare facilities must focus on diagnostic stewardship to ensure appropriate test use and effective result integration into patient care. Empirical data highlighting the public health benefits of diagnostics has great potential – both to improve reimbursement models and increase patient access.
How are recent technological advancements helping in terms of turnaround time and accuracy of results?
The development and adoption of rapid multiplex PCR technologies has been a game changer for diagnosing respiratory infections. These technologies deliver highly sensitive and specific results for multiple pathogens in under 30 minutes – all from a single patient sample.
Many of these platforms are Clinical Laboratory Improvement Amendments (CLIA)-waived and specifically designed for use by a more diverse operator base at the point of care, which allows clinicians to make timely, informed decisions during the initial patient visit – improving efficiency and reducing the spread of infectious diseases. These advancements are especially critical during peak respiratory seasons when rapid, accurate differentiation between pathogens can streamline patient management and resource allocation.
In addition, integrated connectivity in these molecular point-of-care (POC) platforms has revolutionized data sharing, enabling real-time transmission of results to electronic health records, healthcare providers, and even directly to patients. This connectivity facilitates seamless communication across care teams, supports remote monitoring, and enhances public health surveillance efforts by aggregating data for timely interventions. Together, these innovations are shaping a future where diagnostics are not only faster and more accurate, but also better integrated into the broader healthcare ecosystem.
What are the main advantages of point-of-care testing (POCT)?
Fast results enable timely clinical decisions, allowing treatments or interventions to begin during the same visit. This speed enhances patient care, supports antimicrobial stewardship by reducing antibiotic misuse, and helps combat antimicrobial resistance.
POCT also aids infection control by quickly identifying contagious patients for rapid isolation, preventing further spread. When integrated with real-time surveillance, it can monitor outbreaks and guide public health responses.
CLIA-waived POCT devices are user-friendly, allowing testing in diverse settings, from urgent care clinics to remote areas. Combined with central lab testing, POCT addresses immediate needs while labs manage non-urgent cases, especially during peak respiratory seasons. These benefits make POCT a vital tool for efficient and effective respiratory disease management.
And what about the limitations of POCT in respiratory diagnostics?
POCT offers significant benefits for workflow efficiency and patient care, but challenges remain in making molecular POCT accessible in all settings. We need to address staff shortages in resource-limited areas, which hinders effective use. Expanding training programs and promoting peer-to-peer sharing of successful strategies can equip non-laboratory staff to operate POCT devices confidently without reducing patient interaction time.
Additionally, reimbursement policies need to better reflect POCT's value in improving outcomes, streamlining workflows, and supporting public health. Generating real-world evidence across various settings and populations is key to driving these changes. Addressing these challenges is essential to fully realize the potential of POCT for all providers and patients.
What regulatory or logistical challenges currently affect the implementation of POCT in respiratory diagnostics?
Implementing POCT for respiratory diagnostics requires collaboration between manufacturers and clinical institutions to meet regulatory and operational standards. Manufacturers must secure regulatory approvals, such as FDA clearance and CLIA-waiver status, by ensuring tests are accurate, reliable, and easy to use with minimal training. They should design devices with safeguards, clear instructions, and secure data connectivity for seamless integration into healthcare systems.
Institutions are responsible for complying with CLIA regulations, maintaining quality assurance, calibrating devices, and training staff to ensure proper use. They must also integrate POCT devices into workflows while protecting data privacy.
Close collaboration between manufacturers and institutions is essential. Manufacturers should provide tailored training, troubleshooting, and workflow integration support, while institutions offer feedback on real-world challenges to improve device usability. Peer-to-peer sharing among institutions further helps optimize test utilization, address training gaps, and integrate results into decision-making. This cooperative approach ensures POCT devices meet standards and deliver meaningful clinical benefits in various care settings.
Can you tell us a little about multiplex testing?
Multiplex testing improves respiratory infection diagnosis by detecting multiple pathogens from a single sample. This is especially useful during peak seasons when illnesses like influenza, RSV, SARS-CoV-2, and Mycoplasma pneumoniae cause similar symptoms such as fever, cough, and fatigue.
By identifying multiple potential causes in one test, multiplex assays save time, reduce the need for multiple tests, and minimize patient discomfort with fewer samples. They also detect co-infections, which are common in pediatric patients and can worsen illness. Early detection of co-infections enables more accurate and comprehensive treatment plans, improving patient outcomes.
Looking ahead, what role will multiplex testing play in respiratory diagnostics?
Multiplex testing is becoming standard in many institutions, thanks to its ability to improve diagnostic accuracy and speed during respiratory seasons. Guidelines like the ADLM Guidance Document on Laboratory Diagnosis of Respiratory Viruses (1) highlight its value for various patient populations.
Different multiplex panels serve specific patient needs. Small panels detecting between two and five pathogens are ideal for initial testing in immunocompetent outpatients, while larger panels identifying over 20 pathogens are better suited for high-risk, immunocompromised inpatients.
To ensure appropriate test use, providers must practice diagnostic stewardship by collaborating with laboratory teams and using decision support tools. This approach helps optimize test selection, enabling more accurate diagnoses and improved patient care.
How do you see POC technologies evolving over the next decade?
I expect molecular POC technologies will expand beyond respiratory diagnostics to address a wider range of infectious diseases, including sexually transmitted infections. Enhanced connectivity features will enable seamless data sharing with electronic health records, improving clinical decision-making and care coordination. These advancements will make molecular POC testing central to streamlining diagnosis and treatment, particularly in settings with limited access to centralized labs.
To fully leverage their potential, clinicians and laboratorians must stay informed about new tests and their impact on patient care. Clear communication between healthcare teams and institutional stakeholders will be essential for integrating these technologies into clinical workflows. This includes developing decision support tools and monitoring test usage and patient outcomes to ensure their effective adoption and success in daily healthcare practice.
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References
- GJ Berry et al., J Appl Lab Med, 9, 3 (2024). PMID: 38695489.
