Abbott ID NOW Point-of-Care Testing
Evaluating the Clinical Outcomes of Abbott ID NOW Point-of-Care Testing for Respiratory Illnesses in Long-Term Care Facility Residents in Taiwan: Cluster-Randomized Controlled Trial
- Influenza
- Influenza-like Illness
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- China Medical University Hospital
- Enrolment target
- 1,080
- Started
- 1 October 2026
- Main results due
- 31 December 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Aged 20 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Acute onset of illness with fever (tympanic temperature ≥38°C) persisting for at least 24 hours. * Acute onset of illness accompanied by decreased oxygen saturation (e.g., SpO₂ decreased to 94% or deterioration in oxygenation), or influenza infection highly suspected by the treating physician. * Residents aged 65 years or older with comorbidities (e.g., diabetes mellitus, dialysis, hypertension, heart disease, or use of immunosuppressive agents) who develop acute illness with fever (tympanic temperature ≥37.5°C) persisting for at least 24 hours. * At least one respiratory symptom, such as cough, sore throat, or rhinorrhea, persisting for at least 24 hours. Exclusion Criteria: * A definite alternative diagnosis identified at the initial assessment that explains the influenza-like illness, such as bacterial pneumonia, non-respiratory infection, aspiration pneumonia following choking during feeding, definite urinary tract infection, or known exacerbation of heart failure without evidence of infection. * Refusal by the resident or the resident's legally authorized representative to provide informed consent for data collection. * Expected survival of less than 48 hours, as assessed by a physician. * Participation in this study within the previous 14 days, to avoid duplicate enrollment for the same illness episode. * Residence in a dedicated dementia care unit, because differences in disease characteristics, communication ability, and care practices may affect the internal validity of the study.
What this study is about
In the sponsor’s own words, from the registry.
With the rapid aging of the global population, long-term care facilities (LTCFs) have become an increasingly important component of modern public health systems. However, these settings are also at high risk for outbreaks of respiratory infectious diseases. Influenza virus transmission within LTCFs has distinct epidemiological characteristics, including high transmissibility and high risks of severe illness and mortality. In Taiwan, with the accelerated aging of the population, LTCF residents commonly have multiple chronic comorbidities (multimorbidity) and age-related immune dysfunction (immunosenescence). Influenza infection in this population may not only lead to acute respiratory failure but may also contribute to a "silent burden," including post-infection cardiovascular events, metabolic dysregulation, and long-term functional decline.
Under the current standard of care (SOC), influenza diagnosis relies on reverse transcription polymerase chain reaction (RT-PCR) testing performed by external laboratories, with a turnaround time (TAT) of approximately 24 to 48 hours. This time-to-result gap may delay clinical decision-making, potentially preventing timely initiation of antiviral treatment within the optimal 48-hour treatment window and leading facilities to adopt broad precautionary isolation measures, thereby increasing healthcare resource utilization and staffing burden.
The Abbott ID NOW system uses isothermal nucleic acid amplification technology (INAAT) and can provide molecular diagnostic results within approximately 15 minutes. Through a prospective cluster-randomized controlled design, this study aims to evaluate whether implementation of an ID NOW-based point-of-care testing (POCT) strategy can improve clinical outcomes among LTCF residents and reduce overall healthcare costs compared with the current standard diagnostic pathway.
Study sites(1)
China Medical University Hospital
Taichung, Taiwan
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07846423. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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