Abbott ID NOW Point-of-Care Testing

Long-term care facilities (LTCFs) play an increasingly important role in healthcare systems as populations age. However, LTCFs are also settings with a high risk of respiratory infectious disease transmission. Influenza outbreaks in these facilities are of particular concern because residents often have advanced age, multiple chronic comorbidities, and age-related immune dysfunction, all of which may increase the risks of severe disease, hospitalization, and mortality. In addition to acute respiratory complications, influenza infection in this population may also be associated with subsequent cardiovascular events, metabolic deterioration, and prolonged functional decline.

In current clinical practice, influenza diagnosis in LTCFs commonly relies on reverse transcription polymerase chain reaction (RT-PCR) testing performed by external laboratories. The interval between specimen collection and reporting of results may be approximately 24 to 48 hours. This delay may affect the timing of clinical decision-making, including initiation of antiviral therapy and implementation of infection prevention and control measures. During the period when diagnostic results are unavailable, LTCFs may also need to implement precautionary isolation or cohorting measures for residents with suspected influenza-like illness, which may increase healthcare resource utilization and staff workload.

The Abbott ID NOW system is a rapid molecular diagnostic platform based on isothermal nucleic acid amplification technology (INAAT) and can provide molecular test results within approximately 15 minutes. The availability of rapid molecular testing at the point of care may shorten the time between clinical suspicion, diagnostic testing, and subsequent management decisions.

This study is designed as a prospective, cluster-randomized, open-label, two-arm, active-controlled study to evaluate the impact of two different influenza diagnostic strategies in residents of LTCFs in Taiwan: an ID NOW-based point-of-care testing strategy and the current standard diagnostic pathway. The study aims to determine whether the implementation of rapid point-of-care molecular testing can improve clinical outcomes and healthcare resource utilization compared with the standard diagnostic approach.

The study is planned to be conducted in 8 to 10 legally registered residential LTCFs, including nursing homes and other long-term care institutions, located in northern, central, southern, and eastern Taiwan. Participating facilities are required to have at least 40 approved beds, sufficient healthcare personnel to follow the study procedures, the ability to perform on-site specimen collection and infection-control measures, and an established system of regular physician visits. Institutional management approval is required before a facility enters the randomization process.

Specific participating rooms within the study facilities will be designated for study participation. Residents living in these participating rooms will be considered potential participants during the study period. Enrollment will be event-driven rather than based on routine screening of all residents. Nursing staff at participating LTCFs will monitor residents for acute clinical events suggestive of influenza-like illness. When a resident develops symptoms or signs that meet the study inclusion criteria, the responsible physician will perform a clinical assessment to determine whether the resident is potentially eligible and to exclude alternative diagnoses that clearly explain the clinical presentation. After eligibility assessment and informed consent, the resident will be formally enrolled in the study.

Eligible participants may include residents with acute onset of fever, decreased oxygen saturation, respiratory symptoms, or clinical suspicion of influenza. Specific eligibility criteria include acute illness with tympanic temperature of at least 38°C persisting for at least 24 hours; acute illness associated with decreased oxygen saturation or deterioration in oxygenation; influenza infection highly suspected by the treating physician; residents aged 65 years or older with relevant comorbidities who develop acute illness with tympanic temperature of at least 37.5°C persisting for at least 24 hours; or at least one respiratory symptom, such as cough, sore throat, or rhinorrhea, persisting for at least 24 hours.

Residents will be excluded if an alternative definite diagnosis is identified at the initial assessment that adequately explains the influenza-like illness, including conditions such as bacterial pneumonia, non-respiratory infection, aspiration pneumonia, definite urinary tract infection, or exacerbation of heart failure without evidence of infection. Additional exclusion criteria include refusal to provide informed consent, expected survival of less than 48 hours, previous participation in the study within the preceding 14 days, and residence in a dedicated dementia care unit.

In the intervention group, eligible residents with suspected influenza-like illness will undergo point-of-care molecular testing using the Abbott ID NOW system. Nasal or nasopharyngeal swab specimens will be collected at the LTCF, and the test result will be available rapidly to support subsequent clinical and infection-control decisions. In the control group, residents will be managed according to the current standard diagnostic pathway, which relies on conventional laboratory-based RT-PCR testing and routine clinical management.

The study is open-label because the diagnostic strategy assigned to each group cannot be concealed from healthcare personnel. The study uses a parallel two-group design with active comparison between the ID NOW point-of-care testing strategy and the standard diagnostic pathway.

A total of 1,080 participants are planned for enrollment. The minimum eligible age is 20 years, with no specified upper age limit. Each enrolled participant will be followed for 30 days after the qualifying influenza-like illness event.

Clinical and healthcare utilization data will be collected during the follow-up period to evaluate differences between the two diagnostic strategies. The study is intended to provide evidence on whether rapid point-of-care molecular testing can shorten the diagnostic process, support more timely clinical and infection-control decision-making, improve resident outcomes, and reduce unnecessary healthcare resource utilization and overall healthcare costs in LTCFs.