ABSTRACT
Considering sex as a biological variable in modern digital health solutions, we investigated sex-specific differences in the trajectory of four physiological parameters across a COVID-19 infection. A wearable medical device measured breathing rate, heart rate, heart rate variability, and wrist skin temperature in 1163 participants (mean age = 44.1 years, standard deviation [SD]=5.6; 667 [57%] females). Participants reported daily symptoms and confounders in a complementary app. A machine learning algorithm retrospectively ingested daily biophysical parameters to detect COVID-19 infections. COVID-19 serology samples were collected from all participants at baseline and follow-up. We analysed potential sex-specific differences in physiology and antibody titres using multilevel modelling and t-tests. Over 1.5 million hours of physiological data were recorded. During the symptomatic period of infection, men demonstrated larger increases in skin temperature, breathing rate and heart rate as well as larger decreases in heart rate variability than women. The COVID-19 infection detection algorithm performed similarly well for men and women. Our study belongs to the first research to provide evidence for differential physiological responses to COVID-19 between females and males, highlighting the potential of wearable technology to inform future precision medicine approaches. This work has received support from the Princely House of the Principality of Liechtenstein, the government of the Principality of Liechtenstein, the Hanela Foundation in Switzerland, and the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement No 101005177. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.
Subject(s)
COVID-19 , Learning Disabilities , Severe Acute Respiratory SyndromeABSTRACT
With the COVID-19 pandemic causing a global health crisis, accurate diagnosis is critical. Diagnosing acute disease relies on RT-PCR tests measuring the presence of SARS-CoV-2 in the sampled material but in patients with suspected COVID-19 with a negative RT-PCR result, measuring anti-viral antibodies can help clinicians identify infected individuals. Antibody testing can also determine if someone was previously infected and help to measure the prevalence of the virus in a community. A new study characterizes an assay measuring total antibodies – combined IgA, IgM, and IgG isotypes – against SARS-CoV-2. The assay, ECLIA, specifically measures antibodies against the S1 subunit of the viral spike, which carries the virus’s receptor binding domain. Researchers in Liechtenstein evaluated ECLIA in a population with 125 cases of confirmed SARS-CoV-2 infection and 1159 individuals without evidence of COVID-19. The results showed a test sensitivity of 97.6%, while the specificity was 99.8%. Antibody levels were highest in hospitalized patients and lower in symptomatic patients outside the hospital and those with asymptomatic infection. Following COVID-19, smokers developed lower antibody titers than non-smokers, whereas patients without fever had lower antibody titers than patients with fever. Following COVID-19, smokers developed lower antibody titers than non-smokers, whereas patients without fever had lower antibody titers than patients with fever suggesting that the assay may be able to test the association between clinical characteristics and antibody levels and help identify individuals with potential cross-reactivity to SARS-CoV-2.
Subject(s)
Acute Disease , Fever , COVID-19ABSTRACT
Several tests based on chemiluminescence immunoassay techniques have become available to test for SARS-CoV-2 antibodies. There is currently insufficient data on serology assay performance beyond 35 days after symptoms onset. We aimed to evaluate SARS-CoV-2 antibody tests on three widely used platforms. A chemiluminescent microparticle immunoassay (CMIA; Abbott Diagnostics, USA), a luminescence immunoassay (LIA; Diasorin, Italy), and an electrochemiluminescence immunoassay (ECLIA; Roche Diagnostics, Switzerland) were investigated. In a multi-group study, sensitivity was assessed in a group of participants with confirmed SARS-CoV-2 (n=145), whereas specificity was determined in two groups of participants without evidence of COVID-19 (i.e. healthy blood donors, n=191, and healthcare workers, n=1002). Receiver operating characteristic (ROC) curves, multilevel likelihood ratios (LR), and positive (PPV) and negative (NPV) predictive values were characterized. Finally, analytical specificity was characterized in samples with evidence of Epstein-Barr virus (EBV) (n=9), cytomegalovirus (CMV) (n=7) and endemic common cold coronavirus infections (n=12) taken prior to the current SARS-CoV-2 pandemic. The diagnostic accuracy was comparable in all three assays (AUC 0.98). Using the manufacturers cut-offs, the sensitivities were 90%, 95% confidence interval,[84,94] (LIA), 93% [88,96] (CMIA), and 96% [91,98] (ECLIA). The specificities were 99.5% [98.9,99.8](CMIA) 99.7% [99.3,99,9] (LIA) and 99.9% [99.5,99.98] (ECLIA). The LR at half of the manufacturers cut-offs were 60 (CMIA), 82 (LIA), and 575 (ECLIA) for positive and 0.043 (CMIA) and 0.035 (LIA, ECLIA) for negative results. ECLIA had higher PPV at low pretest probabilities than CMIA and LIA. No interference with EBV or CMV infection was observed, whereas endemic coronavirus in some cases provided signals in LIA and/or CMIA. Although the diagnostic accuracy of the three investigated assays is comparable, their performance in low-prevalence settings is different. Introducing gray zones at half of the manufacturers cut-offs is suggested, especially for orthogonal testing approaches that use a second assay for confirmation.
Subject(s)
COVID-19ABSTRACT
Background Non-communicable diseases (NCDs) have been declared a crisis in the Pacific Islands, and poor diets are a major contributor to this. The COVID-19 pandemic and resulting economic crisis will likely increase the burden on food systems, exacerbating this situation. Pacific Island leaders have been proactive in adopting a range of food policies and regulations to improve diets. This includes taxes and regulations on compositional standards for salt and sugar in foods or school food policies. Whilst there is increasing evidence for the effectiveness of such policies globally, there is a lack of local context-specific evidence about how to implement them effectively in the Pacific. Methods Our 5-year collaborative research project will advance knowledge of how to scale up food policy interventions in the Pacific Islands. The overall aim of this implementation science research project is to test the feasibility and effectiveness of policy interventions to reduce salt and sugar consumption in Fiji and Samoa, and to examine factors that will support sustained implementation. We will engage, as partners, government agencies and civil society in Fiji and Samoa, and support the design, implementation and monitoring of a range of evidence-informed interventions aiming to reduce salt and sugar consumption, in the context of on-going health and environmental challenges, such as COVID-19 and climate change. Specific objectives are to: (1) conduct a policy landscape analysis to understand the potential opportunities and challenges to strengthen policies for prevention of diet-related NCDs in Fiji and Samoa; (2) conduct repeat cross sectional surveys to measure dietary intake, food sources and diet-related biomarkers; (3) use Systems Thinking in Community Knowledge Exchange (STICKE) to strengthen implementation of policies to reduce salt and sugar consumption; (4) evaluate the impact, process and cost effectiveness of implementing these policies. Discussion The project will provide new evidence to support policy making, as well as developing a low-cost, high-tech, sustainable, scalable system for monitoring food consumption, the food supply and health-related outcomes.Contributions to the literature· Poor diets are one of the main contributors to non-communicable diseases. There is increasing evidence to show that food policy interventions (fiscal or regulatory) are an effective way of improving diets, globally. · This project will produce local context-specific evidence for the impact and cost-effectiveness of food policy interventions to improve diets in the Pacific Islands (Fiji and Samoa). It will also produce new insights into what is feasible and which factors contribute most to effective implementation in different contexts.· The findings will provide important insights into gaps in the implementation science literature on food policy implementation, particularly in Small Island Developing States. The project will also make an important contribution globally since the innovative methods of engaging policy makers and monitoring food and health developed through the project may be replicated elsewhere.