Point-of-Care Testing for Epidemics

(PROMPT-LTC Trial)

Recruiting at 1 trial location

Overseen By Christopher Kandel, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Michael Garron Hospital

Disqualifiers: No agreement, Existing point-of-care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether quick test results for respiratory viruses can help prevent outbreaks in long-term care homes. Researchers compare a new point-of-care respiratory test platform, which provides fast on-site results, with the usual lab tests that take longer. The goal is to determine if faster results can reduce the size and number of outbreaks for viruses like the flu, COVID-19, and RSV. Long-term care facilities that do not already use point-of-care tests and are connected to certain hospitals in Ontario are suitable for this study. As an unphased trial, this study offers an opportunity to contribute to important research that could enhance outbreak management in care homes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this point-of-care testing platform is safe for long-term care residents?

Research has shown that quick testing tools for respiratory viruses are generally safe and well-tolerated. These tools deliver fast results, aiding in more effective virus outbreak control. Studies have found that these tests can reduce unnecessary antibiotic use and may lead to shorter hospital stays. This indicates that the testing tool is both effective and safe for use in settings like long-term care homes. Although specific phase information for this trial is unavailable, the widespread use of rapid testing tools suggests a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Point-of-Care Polymerase Chain Reaction (PCR) Testing Platform because it offers a fast and convenient way to diagnose respiratory infections right at the point of care, such as in a doctor's office or clinic. Unlike traditional lab-based tests that can take days to deliver results, this platform aims to provide accurate results within minutes, helping to quickly identify and manage infectious diseases during outbreaks. This rapid testing capability can significantly improve the speed of diagnosis and treatment, potentially reducing the spread of infections and easing the burden on healthcare systems during epidemics.

What evidence suggests that the point-of-care respiratory test platform is effective for reducing respiratory virus outbreaks in long-term care homes?

This trial will compare a Point-of-Care Polymerase Chain Reaction Testing Platform with an Existing Testing Platform for Respiratory Viruses. Studies have shown that quick tests conducted at the point of care for respiratory viruses, such as the flu and COVID-19, can be highly effective. Research indicates that these tests enable doctors to identify these viruses more quickly and accurately. Some studies suggest that using these tests can reduce the cost of isolation procedures by up to 50% and, in certain cases, completely prevent the virus from spreading. By obtaining results rapidly, healthcare providers can also administer antiviral treatments more effectively. Overall, these quick tests can better manage outbreaks by providing timely and accurate results, which is crucial in settings like long-term care homes. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for long-term care facilities in Ontario that are part of a health team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital, or Humber River Health. Facilities must not already be using a point-of-care testing platform and need to sign an agreement to participate.

Inclusion Criteria

Long-term care facility engaged with an Ontario Health Team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital or Humber River Health

Exclusion Criteria

No signed statement of agreement for study participation

Pre-existing use of a point-of-care testing platform

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of point-of-care testing for rapid diagnosis of respiratory viruses in long-term care homes

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

What Are the Treatments Tested in This Trial?

Interventions

• Point-of-care respiratory test platform

Trial Overview The study is comparing the effectiveness of existing respiratory virus tests with a new point-of-care test platform in providing rapid results for Influenza, COVID-19, and RSV. The goal is to see if quicker diagnostics can reduce the number and size of outbreaks in long-term care homes.

How Is the Trial Designed?

Group I: Point-of-Care Polymerase Chain Reaction Testing Platform Experimental Treatment 1 Intervention

Group II: Existing Testing Platform for Respiratory Viruses Active Control 1 Intervention

Point-of-care respiratory test platform is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Point-of-care respiratory test platform for:

• Detection of Influenza
• Detection of COVID-19
• Detection of Respiratory Syncytial Virus

Approved in Canada as POC molecular testing platform for:

• Detection of Influenza
• Detection of COVID-19
• Detection of Respiratory Syncytial Virus

Approved in European Union as Rapid respiratory test platform for:

• Detection of Influenza
• Detection of COVID-19
• Detection of Respiratory Syncytial Virus

Who Is Running the Clinical Trial?

Michael Garron Hospital

Lead Sponsor

Trials

16

Recruited

7,200+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Humber River Health

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

The implementation of a point-of-care testing (POCT) platform significantly increased lactate testing compliance from 61% to 91%, which is linked to improved adherence to sepsis protocols and potentially lower mortality rates.

The POCT platform not only reduced the average cost per test ($6.21 compared to $10.02 for the benchtop system) but also saved the hospital approximately $88,476 annually in labor costs, while enhancing efficiency and employee engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of point-of-care blood gas testing at a large community hospital: Cost analysis, sepsis bundle compliance, and employee engagement. Chase, RA., DeJuilio, PA., Huml, JP., et al.[2022]

Point-of-care (POC) testing for infectious diseases is becoming more advanced, allowing for quicker and more effective diagnosis closer to the patient.

While these tests have improved significantly in performance, their increased complexity necessitates oversight by trained laboratory personnel to ensure accurate results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point-of-Care Testing in Microbiology. Samuel, L.[2021]

The QuickVue rapid influenza diagnostic test demonstrated high specificity (100%) in detecting influenza, making it a reliable tool for ruling in the disease during public health emergencies.

However, its low sensitivity (23%) indicates that negative results should be confirmed with a more accurate RT-PCR test, highlighting the need for follow-up testing in cases of suspected influenza.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of rapid influenza diagnostic tests (QuickVue) for influenza A and B Infection in India. Koul, PA., Mir, H., Bhat, MA., et al.[2018]

Point-of-care testing (POCT) can significantly enhance the identification of antimicrobial resistance (AMR) in patients, particularly those critically ill with COVID-19, by enabling faster decision-making and targeted treatment options.

Implementing POCT can help reduce the risks of coinfections, improve healthcare cost-effectiveness, and potentially prevent millions of deaths due to AMR, highlighting the urgent need for healthcare professionals to adopt rapid diagnostic testing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geospatial Spread of Antimicrobial Resistance, Bacterial and Fungal Threats to Coronavirus Infectious Disease 2019 (COVID-19) Survival, and Point-of-Care Solutions. Kost, GJ.[2021]

Point-of-care testing (POCT) is crucial for quickly detecting and managing outbreaks of infectious diseases like COVID-19, as it provides fast results that can help control the spread and improve emergency responses.

The study emphasizes that governments should support POCT initiatives and that healthcare professionals need to adopt geospatial strategies to enhance community resilience and optimize resource deployment during health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geospatial Hotspots Need Point-of-Care Strategies to Stop Highly Infectious Outbreaks. Kost, GJ.[2020]

In a study involving 720 adults with acute respiratory illness, routine point-of-care testing (POCT) for respiratory viruses did not significantly reduce the overall use of antibiotics compared to standard care, as many patients were already started on antibiotics before test results were available.

However, the POCT group had a shorter hospital stay and a higher rate of appropriate antiviral treatment for influenza, indicating that while it didn't lower antibiotic use, it improved clinical management and safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Brendish, NJ., Malachira, AK., Armstrong, L., et al.[2022]

The ResPOC study is a randomized controlled trial involving adults with acute respiratory illness, aiming to evaluate the effectiveness of rapid molecular point-of-care testing for respiratory viruses using the FilmArray Respiratory Panel, which provides results in 1 hour compared to traditional PCR tests that take at least 24 hours.

This trial seeks to demonstrate that molecular point-of-care testing can reduce unnecessary antibiotic use, improve the detection of respiratory viruses, and enhance the use of antiviral treatments, ultimately aiming to improve patient care in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular point-of-care testing for respiratory viruses versus routine clinical care in adults with acute respiratory illness presenting to secondary care: a pragmatic randomised controlled trial protocol (ResPOC). Brendish, NJ., Malachira, AK., Clark, TW.[2022]

Implementing point-of-care (POC) molecular COVID-19 tests requires careful planning and monitoring of operators to minimize errors from various sources, including samples and reagents.

Establishing clear policies for the preanalytic, analytic, and postanalytic phases of testing is essential for ensuring the accuracy and reliability of test results, as highlighted by guidelines from the CLSI EP23-Ed2 document.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Individualized quality control plans and managing risk at the point-of-care for molecular diagnostics. Laryea, ET., Nichols, JH.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7172689/

Point-of-care testing for respiratory viruses in adults This review focuses on the currently available molecular diagnostic platforms for respiratory virus detection with potential for use as point-of-care tests ( ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260017301200

Routine molecular point-of-care testing for respiratory ... Our study suggests that routine POCT leads to improvements in the rate of respiratory virus detection, improved antiviral use for influenza, rationalisation of ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0307621

Implementation of Point-of-Care PCR-testing for the diagnosis ... Point-of-Care (POC) PCR-testing provides accurate, and timely results in diagnosing respiratory viral infections. Despite these benefits, stakeholder ...

4. openrespiratorymedicinejournal.com openrespiratorymedicinejournal.com/VOLUME/18/ELOCATOR/e18743064319029/FULLTEXT/

Recommendations on Rapid Diagnostic Point-of-care ... POC molecular rapid tests generate savings, with up to 50% reduction in the cost of isolation and a 100% reduction in secondary transmission ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11518670/

Implementation of point-of-care molecular testing for ... Abstract. Objective: To implement and evaluate a point-of-care (POC) molecular testing platform for respiratory viruses in congregate living settings (CLS).

6. globalpointofcare.abbott globalpointofcare.abbott/us/en/product-details/id-now.html

ID NOW™ Instrument The ID NOW™ Platform is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Our unique ID NOW™ isothermal nucleic ...

7. nature.com nature.com/articles/s41467-025-57647-3

Portable molecular diagnostic platform for rapid point-of- ... In response, we developed Dragonfly, a portable molecular diagnostic platform for point-of-care use that integrates power-free nucleic acid ...