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Abbott ID NOW Point-of-Care Testing

Sponsor: China Medical University Hospital • ClinicalTrials.gov ID: NCT07846423

Registry updated: 2026-09-29

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Description

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.

Interventions

Abbott ID NOW Point-of-Care Testing (Device)
Abbott ID NOW is a rapid molecular diagnostic platform based on isothermal nucleic acid amplification technology for the detection of influenza. Testing will be performed at the participating long-term care facility using nasal or nasopharyngeal swab specimens collected from eligible residents with suspected influenza-like illness. The system can provide molecular test results within approximately 15 minutes.
Standard Laboratory-Based RT-PCR Diagnostic Pathway (Diagnostic test)
Standard-of-care influenza testing using reverse transcription polymerase chain reaction (RT-PCR) performed through the usual external laboratory workflow. Test results are generally available within approximately 24 to 48 hours and are used together with routine clinical assessment to guide subsequent management and infection-control decisions.

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.

Conditions

Influenza Influenza-like Illness

Locations

China Medical University Hospital — Taichung, Taiwan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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