Abbott ID NOW Point-of-Care Testing

NCT07846423 | Recruiting

• 1 other identifier: CMUH115-REC2-151
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza; Influenza-like Illness

Keywords

Point-of-Care Testing; Long-Term Care Facility; Cluster-Randomized Controlled Trial; Influenza-like illness

Outcome Measures

Primary Outcomes (1)

• Time From Specimen Collection to Availability of Influenza Test Result

  Time elapsed between collection of the respiratory specimen and availability of the influenza test result for clinical decision-making, compared between the ID NOW point-of-care testing strategy and the standard laboratory-based RT-PCR diagnostic pathway.

  During the index influenza-like illness episode, from specimen collection to availability of the test result, up to 48 hours

Study Arms (2)

ID NOW Point-of-Care Testing Strategy

EXPERIMENTAL

Participants in this arm will receive point-of-care molecular testing for suspected influenza using the Abbott ID NOW system at the participating long-term care facility. Nasal or nasopharyngeal swab specimens will be collected on site, and the rapid test result will be used to support subsequent clinical management and infection prevention and control decisions.

Device: Abbott ID NOW Point-of-Care Testing

Standard Diagnostic Pathway

ACTIVE COMPARATOR

Participants in this arm will receive the current standard diagnostic pathway for suspected influenza, including laboratory-based reverse transcription polymerase chain reaction (RT-PCR) testing performed through the usual external laboratory process, together with routine clinical management and infection-control measures.

Diagnostic Test: Standard Laboratory-Based RT-PCR Diagnostic Pathway

Interventions

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.

Standard Diagnostic Pathway

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.

ID NOW Point-of-Care Testing Strategy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Chia-Hui Tan, Ph.D

CONTACT

886-4-2205-3366; elisetan@mail.cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Superintendent

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)