Abbott ID NOW Point-of-Care Testing

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Time From Specimen Collection to Availability of Influenza Test Result — During the index influenza-like illness episode, from specimen collection to availability of the test result, up to 48 hours
  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.

Trial sites (1)

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