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RECRUITING
NCT07846423
NA

Abbott ID NOW Point-of-Care Testing

Sponsor: China Medical University Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1080

Start Date

2026-10-01

Completion Date

2027-12-31

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DEVICE

Abbott ID NOW Point-of-Care Testing

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.

DIAGNOSTIC_TEST

Standard Laboratory-Based RT-PCR Diagnostic Pathway

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.

Locations (1)

China Medical University Hospital

Taichung, Taiwan