Development and Clinical Performance of InteliSwab® COVID-19 Rapid Test: Evaluation of Antigen Test for the Diagnosis of SARS-CoV-2 and Analytical Sensitivity to Detect Variants of Concern Including Omicron and Subvariants.

BACKGROUND AND OBJECTIVES: Timely detection of SARS-CoV-2 infection with subsequent contact tracing and rapid isolation are considered critical to containing the pandemic, which continues with the emergence of new variants. Hence, there is an ongoing need for reliable point-of-care antigen rapid diagnostic tests (Ag-RDT). This report describes the development, evaluation, and analytical sensitivity of the diagnostic performance of the InteliSwab® COVID-19 Rapid Test. Methods: Samples from 165 symptomatic subjects were tested with InteliSwab® and the results were compared to RT-PCR to determine the antigen test performance. The analytical sensitivity of InteliSwab® for the detection of different variants was assessed by limit of detection (LOD) determination using recombinant nucleocapsid proteins (NPs) and testing with virus isolates. Western immunoblot independently confirmed that each monoclonal Ab is capable of binding to all variants tested thus far. RESULTS: The overall positivity rate by RT-PCR was 37% for the 165 symptomatic subjects. Based on RT-PCR results as the reference standard, InteliSwab® showed clinical sensitivity and specificity of 85.2% (95% CI, 74.3-92.0%) and 98.1% (95% CI, 93.3-99.7%), respectively. The overall agreement was 93.3% (Kappa index value 0.85; 95% CI, 0.77-0.74) between RT-PCR and InteliSwab® test results. Furthermore, the evaluation of analytical sensitivity for different SARS-CoV-2 variants by InteliSwab® was comparable in the detection of all the variants tested, including Omicron subvariants, BA.4, BA.5, and BQ.1. CONCLUSIONS: Due to the surge of infections caused by different variants from time to time, there is a critical need to evaluate the sensitivity of rapid antigen-detecting tests for new variants. The study findings showed the robust diagnostic performance of InteliSwab® and analytical sensitivity in detecting different SARS-CoV-2 variants, including the Omicron subvariants. With the integrated swab and excellent sensitivity and variant detection, this test has high potential as a point-of-care Ag-RDT in various settings when molecular assays are in limited supply and rapid diagnosis of SARS-CoV-2 is necessary.

Predicting the progressive resistance and balance training response of community-dwelling older adults accessing aged care support services: A stepped-wedge randomised controlled trial.

OBJECTIVE: To quantify the variation in body composition, physical function and cognitive health changes resulting from the Muscling Up Against Disability (MUAD) resistance and balance training program and the potential for baseline characteristics to predict the magnitude of training-related response. METHODS: The study represented a secondary analysis of a stepped-wedge randomised controlled trial involving 245 community-dwelling adults receiving Australian Government-funded aged care services who performed 26 weeks of supervised progressive resistance and balance training (PRBT). The primary outcome was the proportion of response that described the number of individuals expected to make any positive change due to the intervention and not external factors. RESULTS: For all outcomes, the observed average change in the PRBT group was more favourable than the control. Analyses identified that most participants completing the PRBT program would be expected to respond positively to the intervention (86%-99%) with respect to their physical performance (SPPB summary, grip strength, chair stand and isometric knee strength). A smaller proportion completing the PRBT program group would be expected to respond positively in aspects of body composition (45%-60%) or cognitive function (44%-84%). The strongest predictors of positive change were baseline physical function, whereby those with the poorest baseline function experienced the greatest benefits. CONCLUSIONS: This study strongly supports the promotion of PRBT as a standard component of any care plan for community-dwelling older adults, especially those with low levels of physical function.

Progressive Resistance Plus Balance Training for Older Australians Receiving In-Home Care Services: Cost-Effectiveness Analyses Alongside the Muscling Up Against Disability Stepped-Wedge Randomized Control Trial.

In this article, the authors assessed the cost-effectiveness of center-based exercise training for older Australians. The participants were recipients of in-home care services, and they completed 24 weeks of progressive resistance plus balance training. Transport was offered to all participants. A stepped-wedge randomized control trial produced pre-, post-, and follow-up outcomes and cost data, which were used to calculate incremental cost-effectiveness ratios per quality-adjusted life year gained. Analyses were conducted from a health provider perspective and from a government perspective. From a health-service provider perspective, the direct cost of program provision was $303 per person, with transport adding an additional $1,920 per person. The incremental cost-utility ratio of the program relative to usual care was $70,540 per quality-adjusted life year over 6 months, decreasing to $37,816 per quality-adjusted life year over 12 months. The findings suggest that Muscling Up Against Disability offers good value for the money within commonly accepted threshold values.

Sarc-F and muscle function in community dwelling adults with aged care service needs: baseline and post-training relationship.

BACKGROUND: This study sought to better understand the psychometric properties of the SARC-F, by examining the baseline and training-related relationships between the five SARC-F items and objective measures of muscle function. Each of the five items of the SARC-F are scored from 0 to 2, with total score of four or more indicative of likely sarcopenia. METHODS: This manuscript describes a sub-study of a larger step-wedge, randomised controlled 24-week progressive resistance and balance training (PRBT) program trial for Australian community dwelling older adults accessing government supported aged care. Muscle function was assessed using handgrip strength, isometric knee extension, 5-time repeated chair stand and walking speed over 4 m. Associations within and between SARC-F categories and muscle function were assessed using multiple correspondence analysis (MCA) and multinomial regression, respectively. RESULTS: Significant associations were identified at baseline between SARC-F total score and measures of lower-body muscle function (r =  - 0.62 to 0.57; p ≤ 0.002) in 245 older adults. MCA analysis indicated the first three dimensions of the SARC-F data explained 48.5% of the cumulative variance. The initial dimension represented overall sarcopenia diagnosis, Dimension 2 the ability to displace the body vertically, and Dimension 3 walking ability and falls status. The majority of the 168 older adults who completed the PRBT program reported no change in their SARC-F diagnosis or individual item scores (56.5-79.2%). However, significant associations were obtained between training-related changes in SARC-F total and item scores and changes in walking speed and chair stand test performance (r =  - 0.30 to 0.33; p < 0.001 and relative risk ratio = 0.40-2.24; p < 0.05, respectively). MCA analysis of the change score data indicated that the first two dimensions explained 32.2% of the cumulative variance, with these dimensions representing whether a change occurred and the direction of change, respectively. DISCUSSION: The results advance our comprehension of the psychometric properties on the SARC-F, particularly its potential use in assessing changes in muscle function. Older adults' perception of their baseline and training-related changes in their function, as self-reported by the SARC-F, closely matched objectively measured muscle function tests. This is important as there may be a lack of concordance between self-reported and clinician-measured assessments of older adults' muscle function. However, the SARC-F has a relative lack of sensitivity to detecting training-related changes, even over a period of 24 weeks. CONCLUSIONS: Results of this study may provide clinicians and researchers a greater understanding of how they may use the SARC-F and its potential limitations. Future studies may wish to further examine the SARC-F's sensitivity of change, perhaps by adding a few additional items or an additional category of performance to each item.

active@home: Investigating the Value of a Home Care Worker-Led Exercise Program for Older Adults With Complex Care Needs.

Exercise has proven health benefits for older adults independent of age, disability, and disease. However, barriers to exercise participation exist, including travel to, and access to, appropriate facilities and programs. Evidence shows that in-home exercise delivered by allied health professionals can improve physical health and prolong independence among individuals with government supported aged care packages. A less costly alternative is program delivery by home care workers. However, effective training for workers and resources to guide the consumer is required. This project evaluated an exercise training module for home care workers and a consumer resource to promote in-home exercise participation among older Australians with government supported aged care packages. Outcomes included a significant improvement in functional capacity as measured by the short physical performance battery (mean increase of 1.4 points), a 19% reduction in participants classified as frail and a reduction in healthcare service access of 47% across the intervention.

Engineering Improved Balance Confidence in Older Adults With Complex Health Care Needs: Learning From the Muscling Up Against Disability Study.

OBJECTIVE: To investigate the associations of balance confidence with physical and cognitive markers of well-being in older adults receiving government-funded aged care services and whether progressive resistance plus balance training could positively influence change. DESIGN: Intervention study. SETTING: Community-based older adult-specific exercise clinic. PARTICIPANTS: Older adults (N=245) with complex care needs who were receiving government-funded aged care support. INTERVENTIONS: Twenty-four weeks of twice weekly progressive resistance plus balance training carried out under the supervision of accredited exercise physiologists. MAIN OUTCOME MEASURES: The primary measure was the Activity-specific Balance Confidence Scale. Secondary measures included the Short Physical Performance Battery; fall history gathered as part of the health history questionnaire; hierarchical timed balance tests; Geriatric Anxiety Index; Geriatric Depression Scale; Fatigue, Resistance, Ambulation, Illness, Loss of Weight scale; and EuroQoL-5 dimension 3 level. RESULTS: At baseline, better physical performance (r=.54; P<.01) and quality of life (r=.52; P<.01) predicted better balance confidence. In contrast, at baseline, higher levels of frailty predicted worse balance confidence (r=-.55; P<.01). Change in balance confidence after the exercise intervention was accompanied by improved physical performance (+12%) and reduced frailty (-11%). Baseline balance confidence was identified as the most consistent negative predictor of change scores across the intervention. CONCLUSIONS: This study shows that reduced physical performance and quality of life and increased frailty are predictive of worse balance confidence in older adults with aged care needs. However, when a targeted intervention of resistance and balance exercise is implemented that reduces frailty and improves physical performance, balance confidence will also improve. Given the influence of balance confidence on a raft of well-being determinants, including the capacity for positive physical and cognitive change, this study offers important insight to those looking to reduce falls in older adults.

Examining evidence based resistance plus balance training in community-dwelling older adults with complex health care needs: Trial protocol for the Muscling Up Against Disability project.

Progressive resistance plus balance training (PRBT) has been demonstrated as effective in reducing later life physical disability, falls risk and poor health, even among those with complex health care needs. However, few studies have examined the influence of PRBT on health service utilisation, cognitive wellbeing and training modality acceptance or undertaken a cost benefit analysis. This project will investigate the broad scope benefits of PRBT participation among community-dwelling older Australians receiving Government supported aged care packages for their complex health care needs. Using a modified stepped-wedge design, 248 community-dwelling adults 65 years and older with some level of government support aged care have been randomised into the study. Those randomised to exercise undertake six months of twice weekly machine-based, moderate to high intensity, supervised PRBT, followed by a six month unsupervised, unsupported follow-up. Controls spend six months undertaking usual activities, before entering the PRBT and follow-up phases. Data are collected at baseline and after each of the six month phases. Measures include level of and change in health and care needs, body composition, muscle capacity, falls, sleep, quality of life, nutritional and mental health status. In addition, acceptance and engagement is determined through telephone and focus group interviews complementing a multi-model health cost benefit evaluation. It is hypothesised this study will demonstrate the feasibility and efficacy of PRBT in improving primary and secondary health outcomes for older adults with aged care needs, and will support the value of this modality of exercise as an integral evidence-based service model of care.