The average age of populations around the globe is increasing; as a result, an increasing number of older individuals become afflicted by CVD [7]. While age is one of the most powerful risk factors for CVD, it is important to understand the LV adaptation mechanisms that function against the altered cardiovascular system during aging in human adult life. The findings of MESA CMR related to aging are summarized in Fig. 1. The MESA serial longitudinal study confirmed that a pattern of LV remodeling across the life course is concentric remodeling with progressively reduced LV volumes resulting in an increased LV mass-to-volume ratio. Specifically, we see a significant age-related longitudinal increase in LV mass in men and a slight longitudinal decrease in women over 9 years follow-up; additionally, longitudinal decreases in LV end-diastolic volume and stroke volume were seen in both men and women, leading to significant increases in adverse LV concentric remodeling (increased mass-to-volume ratio) in both men and women [8]. The LV ejection fraction (LVEF), however, was maintained with age due to a progressive decline in LV end-diastolic volume (Fig. 1) [5].
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Heart failure (HF) is an important contributor to the burden and cost of national healthcare expenditures, and with the aging of worldwide populations, the estimated prevalence and cost of care for HF will increase markedly for all sex and racial/ethnic subgroups [7, 17]. The pattern of hypertrophy is related to pressure overload leading to concentric hypertrophy and volume overload leading to eccentric hypertrophy.
Since no empirical data were identified to inform the value of serial versus single sample testing compared to molecular testing, results of serial testing were estimated using mathematical modeling; results of this analysis suggested that repeat testing would improve sensitivity.[1] Other evidence gaps included the performance of Ag tests in vaccinated individuals or those previously infected with SARS-CoV-2. Very limited data were available on performance of Ag tests in immunocompromised or pediatric patients (although the literature review excluded studies that included only immunocompromised individuals), or in individuals infected with recent SARS-CoV-2 variants. In the literature search conducted through April 2022, the panel identified only one study that included persons tested after November 2021, the time during which Omicron variants emerged and became dominant. All studies compared Ag to molecular test results, with none using a clinical reference standard.
While the IDSA panel suggests a single standard NAAT over two consecutive/serial Ag tests for diagnosis of SARS-CoV-2 infection in symptomatic individuals, studies directly comparing two consecutive rapid Ag tests versus a single standard NAAT in patients were lacking and are needed. Such studies should include vaccinated, boosted, and unvaccinated populations, and those with and without prior COVID-19 infection, as well as those infected with contemporary SARS-CoV-2 variants (e.g., Omicron). Finally, in persons with prior COVID-19 infection, timing between the first and potential subsequent infection bears consideration as a test could remain positive from prior infection if it occurred in the recent past and therefore not represent a new infection; the differential specificity of a standard NAAT versus Ag testing in this situation needs to be defined. The ideal time interval between the repeat Ag tests also needs definition.
A theoretical benefit of testing following an exposure in an asymptomatic individual would be to provide an early diagnosis of infection to enable early treatment; however, the IDSA panel noted that at the current time, no specific treatment would be indicated in such a situation, as there is no FDA-approved or EUA therapy for asymptomatic COVID-19. The other theoretical benefit would be to prevent transmission of SARS-CoV-2, but we were unable to identify studies of serial testing for SARS-CoV-2 infection compared to molecular testing. One study assessed serial testing as compared to isolation and showed non-inferiority of testing for prevention of transmission [113]. Therefore, the analysis presented focuses on diagnostic test accuracy. The justification to perform testing of asymptomatic individuals in the general population after exposure is unclear. In congregate settings, such as nursing homes, incorporation of serial rapid Ag testing into a bundle of control measures during an outbreak may help to identify individuals most likely to be contagious and guide isolation recommendations [81]. The available data did not inform the timing of NAAT or Ag testing following an exposure, or the timing of repeat Ag testing.
We identified no studies that compared serial Ag testing versus no testing among students in an educational setting or employees in a workplace with an outcome of SARS-CoV-2 transmission, COVID-19 incidence, or diagnostic test accuracy. Therefore, a modeling analysis was performed using a repeat testing algorithm (2 consecutive Ag tests). Results of each test were considered to be independent, which might not be a valid assumption. For all comparisons, prevalence of 1%, 5%, and 10% SARS-COV-2 infection were considered. The sensitivity and specificity of testing (2 consecutive repeat Ag tests) versus no testing, using standard NAAT as the reference standard, were 86% (95% CI: 80% to 90%) and 100% (95% CI: 99% to 100%), respectively. Comparing two repeated tests versus no testing showed 1 to 14 false negative results per 1,000 patients tested depending on disease prevalence.
Theoretical benefits of serial Ag testing of asymptomatic individuals in schools, colleges, other educational settings and workplaces include preventing transmission of SARS-CoV-2, but the IDSA panel was unable to identify any studies that directly addressed whether serial Ag testing versus no testing reduced SARS-CoV-2 transmission. Some indirect evidence was identified that suggested possible benefit of serial testing. A large, cluster randomized trial of English secondary schools and colleges found that daily Ag testing was non-inferior to self-isolation in preventing secondary cases of COVID-19, with similar numbers of contacts testing positive for SARS-CoV-2 in both study arms [113]. A retrospective cohort study of students at 18 colleges and universities in Connecticut, USA reported that institutions that tested students more frequently detected more COVID-19 cases and prevented further spread [116]; in the fall of 2020, each additional test per student per week was associated with a decrease of 0.0014 cases per student per week (95% CI: -0.0028 to -0.00001).
The IDSA panel recognizes that serial rapid Ag testing of students and employees is common, and that testing cadences vary, with common cadences being daily, twice weekly, or weekly Ag testing. We chose to model two consecutive rapid Ag tests. Performing additional rounds of testing would be expected to alter the performance characteristics of the testing strategy.
Employers may require serial testing of asymptomatic employees who decline SARS-CoV-2 vaccination. The IDSA panel found no evidence that serial testing for COVID-19 provided benefit comparable to the proven benefits of vaccination, nor that serial testing reduced the incidence of occupational transmission of COVID-19.
The IDSA panel found no empirical evidence that serial Ag testing of asymptomatic students in educational settings or employees in workplaces provided benefit compared to no testing. To generate evidence to inform this recommendation, students and/or employees would need to be subjected to no testing, single Ag testing or serial Ag testing at varying cadences. Because actions of one subject could impact others in the same cohort, this might best be performed as a cluster randomized trial. Variables such as prior vaccination and/or prior COVID-19 infection would need to be accounted for, as would circulating variants and underlying risk factors in the students/employees. Outcomes of interest could include illness (including numbers of confirmed SARS-CoV-2 infections, both symptomatic and asymptomatic), time away from school or work, healthcare encounters, hospitalizations, and deaths in study subjects and their contacts.
The panel identified other notable evidence gaps. Despite the common use of single or serial Ag testing as a tool to reduce risk of SARS-CoV-2 transmission in schools, colleges, workplaces, and before large social gatherings, we were unable to identify any empirical evidence in support of these practices. Mathematical modeling has suggested that repeated Ag testing will help to overcome the sensitivity limitations of rapid Ag tests and that the frequency of testing and turn-around-time to results may be just as important as test sensitivity in certain situations. Well-designed studies are needed to measure the effect of repeated testing strategies on analytical test performance and transmission events in a variety of settings. In addition, the cost-effectiveness of repeated Ag testing versus less frequent rapid RT-PCR, or potentially no testing depending on prevalence, needs to be determined. Potential effectiveness measures should include the number of SARS-CoV-2 cases identified, the results of contact tracing around new cases, and ideally, transmission events. In addition to the price of test kits (e.g., reagents and consumables), assessments of cost should also factor in the resources required to scale up testing.
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