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A plethora of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic tests are available, each with different performance specifications, detection methods, and targets. This narrative review aims to summarize the diagnostic technologies available and how they are best selected to tackle SARS-CoV-2 infection as the pandemic evolves. Seven key settings have been identified where diagnostic tests are being deployed: symptomatic individuals presenting for diagnostic testing and/or treatment of COVID-19 symptoms; asymptomatic individuals accessing healthcare for planned non-COVID-19-related reasons; patients needing to access emergency care (symptom status unknown); patients being discharged from healthcare following hospitalization for COVID-19; healthy individuals in both single event settings (e.g. airports, restaurants, hotels, concerts, and sporting events) and repeat access settings (e.g. workplaces, schools, and universities); and vaccinated individuals. While molecular diagnostics remain central to SARS-CoV-2 testing strategies, we have offered some discussion on the considerations for when other tools and technologies may be useful, when centralized/point-of-care testing is appropriate, and how the various additional diagnostics can be deployed in differently resourced settings. As the pandemic evolves, molecular testing remains important for definitive diagnosis, but increasingly widespread point-of-care testing is essential to the re-opening of society.

Purpose: An Expert Panel on Breast Cancer and COVID-19 was convened to address the impact of the COVID-19 pandemic for early breast cancer management. Methods: In order to ensure the most clinically relevant information was addressed, essential information was drawn from several of the latest national and international guidelines and another technical document. The Expert Panel met in five virtual closed sessions from November 2020 to May 2021 to consult on the relevant data from evidence-based results. The data gathered were discussed on an online platform (Within3 ®). Results: This paper reports the Expert Panel’s highlights of these meetings’ discussions. In addition, it provides practical recommendations covering topics regarding diagnosis, treatment, and management of breast cancer patients in clinical settings routinely encountered by HCPs amid the COVID-19 pandemic. Conclusions: It was provided guidance on several topics regarding eBC management amid the COVID-19 pandemics to inform safer care practices.

IntroductionSince the outbreak of COVID-19 there has been an unprecedented effort from the scientific community to develop tools to help tackle this crisis. According to the Foundation for Innovative New Diagnostics (FIND; 18 March 2021) there are 1025 commercialized SARS-CoV-2 assays currently available and an additional 98 in development, including 655 immunoassays and 437 molecular assays.1 Early in the pandemic, molecular testing using nucleic acid amplification tests (NAATs) became the pillar of COVID-19 diagnostics. Since then, the development of antigen tests, immunoassays, point-of-care, and centralized options means there are now choices to be made as to how, when, and where to deploy these technologies and many guidelines have been developed, often based on Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO) guidance.2-4 However, with the rapid emergence of new technologies and new scientific data, these guidelines are very fluid and subject to change. Furthermore, while NAATs are the most sensitive diagnostic tool for COVID-19 infection,3-5 the global demand for diagnostic testing is still such that the use of labour-intensive, specialist techniques needs to be carefully considered.The aim of this review is to provide an international evaluation of real-world testing needs and to define: settings where the ‘next best’ alternatives to NAATs are appropriate; settings where NAATs may not be the best option; how to manage antigen test results; and how to manage negative NAAT results where there is still a strong clinical suspicion of COVID-19. We will further aim to set out the key considerations for defining a testing strategy. Table 1 demonstrates that each testing strategy provides different information on infection status and has different performance metrics, so the right option for the right setting needs to be carefully assessed. Here we also discuss the common challenges facing clinicians and laboratorians when interpreting and supplying COVID-19 diagnostics and provide insights into what will be needed next.Table 1. A summary of the diagnostic testing methodologies for COVID-19.

Neste texto, discutimos os resultados do Projeto de Extensão intitulado “Implantação do Grupo de Percussão do IFPB/JP”, entendendo o Grupo como um laboratório de práticas artístico-musicais que atenderá não somente à comunidade interna da Instituição mas também aos membros da comunidade em geral. Como característica do Projeto, destacamos a ênfase no trabalho com materiais alternativos (reciclados e objetos do cotidiano), bem como a prática da composição e da improvisação. Como principais resultados do trabalho, ressaltamos a realização da prática musical em conjunto pelos extensionistas, o trabalho com as ferramentas de gravação de áudio e vídeo, a divulgação do repertório (peças) trabalhado e atividades institucionais, assim como a significativa interação entre os membros do Projeto e a comunidade.

For cardiovascular disease prevention, statins alone or combined with ezetimibe have been recommended to achieve low-density lipoprotein cholesterol targets, but their effects on other lipids are less reported. This study was designed to examine lipid changes in subjects with ST-segment elevation myocardial infarction (STEMI) after two highly effective lipid-lowering therapies. Twenty patients with STEMI were randomized to be treated with rosuvastatin 20 mg QD or simvastatin 40 mg combined with ezetimibe 10 mg QD for 30 days. Fasting blood samples were collected on the first day (D1) and after 30 days (D30). Lipidomic analysis was performed using the Lipidyzer platform. Similar classic lipid profile was obtained in both groups of lipid-lowering therapies. However, differences with the lipidomic analysis were observed between D30 and D1 for most of the analyzed classes. Differences were noted with lipid-lowering therapies for lipids such as FA, LPC, PC, PE, CE, Cer, and SM, notably in patients treated with rosuvastatin. Correlation studies between classic lipid profiles and lipidomic results showed different information. These findings seem relevant, due to the involvement of these lipid classes in crucial mechanisms of atherosclerosis, and may account for residual cardiovascular risk.Randomized clinical trial: ClinicalTrials.gov, NCT02428374, registered on 28/09/2014.

BACKGROUND To determine whether the busulfan (Bu) present in saliva during hematopoietic cell transplantation (HCT) conditioning correlates with oral mucositis and the changes in salivary antioxidant enzymes. METHODS Bu levels in the plasma and saliva of 19 patients who received HCTs were quantified. Salivary flow and salivary superoxide dismutase and catalase activities were measured during HCT. For the toxicity analysis of salivary Bu, an in vitro assay was conducted by exposing human keratinocytes to artificial saliva containing Bu. RESULTS Plasma and salivary Bu concentrations were very similar (rho = 0.92, P < 0.001). Salivary Bu concentration correlated with the degree of oral mucositis severity (rho = 0.391, P = 0.029) and was inversely proportional to salivary superoxide dismutase and catalase activities (rho = -0.458, P = 0.036; rho = -0.424, P = 0.043, respectively). Cells exposed to Bu-containing saliva had fewer viable cells (P < 0.01) and more apoptotic cells (P = 0.001) than those exposed to non-Bu-containing saliva. CONCLUSIONS Bu found in saliva during HCT conditioning was correlated with severe oral mucositis and the reduction in salivary antioxidative activity. Furthermore, Bu can be toxic to keratinocytes.

Background: Bone metabolism involves many complex pathways that are disturbed by several bone diseases. The literature shows some limitations concerning pediatric reference intervals to bone markers, mainly because of the low number of patients included in the studies, the heterogeneity of methods, beyond the fact that it is time-consuming and expensive. The aim of this study was to determine reference values for β-isomerized carboxy-terminal telopeptides collagen type I (β-CTX), a marker of bone resorption, for children and adolescents. Methods: Blood samples from 246 patients were collected and β-CTX was measured using an electrochemiluminescence immunoassay (ECLI). Results and conclusions: We propose reference ranges for β-CTX concentration from the 2.5 percentile and 97.5 percentile for each age group. The reference values obtained, concerning children and adolescents, might be useful in the evaluation of diseases such as osteosarcoma and anorexia in both childhood as adolescence.

OBJECTIVES: This prospective, randomized, open-label study aimed to compare the effects of antihypertensive treatment based on amlodipine or hydrochlorothiazide on the circulating microparticles and central blood pressure values of hypertensive patients. METHODS: The effects of treatments on circulating microparticles were assessed during monotherapy and after the consecutive addition of valsartan and rosuvastatin followed by the withdrawal of rosuvastatin. Each treatment period lasted for 30 days. Central blood pressure and pulse wave velocity were measured at the end of each period. Endothelial, monocyte, and platelet circulating microparticles were determined by flow cytometry. Central blood pressure values and pulse wave velocity were recorded at the end of each treatment period. RESULTS: No differences in brachial blood pressure were observed between the treatment groups throughout the study. Although similar central blood pressure values were observed during monotherapy, lower systolic and diastolic central blood pressure values and early and late blood pressure peaks were observed in the amlodipine arm after the addition of valsartan alone or combined with rosuvastatin. Hydrochlorothiazide-based therapy was associated with a lower number of endothelial microparticles throughout the study, whereas a higher number of platelet microparticles was observed after rosuvastatin withdrawal in the amlodipine arm. CONCLUSIONS: Despite similar brachial blood pressure values between groups throughout the study, exposure to amlodipine was associated with lower central blood pressure values after combination with valsartan, indicating a beneficial interaction. Differences between circulating microparticles were modest and were mainly influenced by rosuvastatin withdrawal in the amlodipine arm.

Advanced chronic kidney disease is associated with high rates of cardiovascular disease. Considering the crucial role of capillaries in renal function, our study aimed to evaluate microparticles related to vascular physiology examining the link between stages of chronic kidney disease with circulating endothelial (EMP), platelet (PMP) and monocytic (MMP) microparticles. Cross-sectional study with blinded endpoints included subjects of both sexes, aged 40-75 years (n = 247), with established cardiovascular disease (coronary heart disease, ischemic stroke, or peripheral artery disease). They were stratified 1:1 by the presence or absence of decreased glomerular filtration rate (GFR 60 mL/min/1.73 m

Background We evaluated the clinical correlation between the CardioChek PA analyzer and a clinical laboratory reference method to use for screening program purposes. Methods Fasting blood samples were collected on 516 patients (age 20–85 y). One venous sample was collected using a serum tube for the evaluation on a COBAS reference analyzer. A second venous sample was collected in a lithium heparin tube and was evaluated on the CardioChek PA analyzer (CCPA venous). A fingerstick sample (CCPA fingerstick) was evaluated only on the CardioChek PA analyzer. Linear regression analyses were performed for each measured analyte, total cholesterol, HDL-cholesterol and triglycerides. Results The correlation between the CCPA fingerstick and CCPA venous was extremely high for HDL-C and triglycerides, and good for total cholesterol. Our results demonstrated a good clinical agreement for total cholesterol, HDL-C and triglycerides between 97.7% and 94.6% in the comparison of the CCPA to the reference analyzer. Conclusions We identified the pre-analytic phase as an important step to guarantee the quality of results and indicate that the CardioChek PA is a reliable lipid point-of-care testing system that can be used for the application of clinical screening anywhere.

The stability of samples is crucial for getting reliable concentrations of many analytes, including lipid profile. Thus, the goal of this study was to analyze lipid profile under different storage and temperature conditions. This was a prospective study with 809 patients of both genders. Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low density lipoprotein cholesterol and non-high-density lipoprotein were measured within 1 h from collection at room temperature, after 2-3 h of refrigeration (8°C) and after 4-5 h at room temperature. The processing time and storage conditions did not affect the analytes measured. These findings are important for multicenter studies, because of the difficulties related to centrifugation and freezing of samples immediately after collection.

Introduction: Vitamin D is considered a pre-hormone and plays a crucial role in calcium homeostasis and, consequently, in bone health. The best source of vitamin D is the skin in response to sunlight. Only small amounts of this vitamin are found in some foods (especially fatty fish), which makes availability of vitamin D in the diet limited. Brazilian population studies show that the prevalence of hypovitaminosis D in our country is high. Objective: To define the reference intervals for vitamin D [25(OH)D]. Discussion: Consensus of specialists - literature review. Conclusion: The standardization of reference intervals is fundamental for the correct diagnosis and treatment of hypovitaminosis D. RESUMO Introdução: A vitamina D é considerada um pré-hormônio e apresenta papel crucial na homeostase do cálcio e, consequentemente, na saúde óssea. A maior fonte de vitamina D é a pele, em resposta à luz solar. Apenas pequenas quantidades dessa vitamina são encontradas em alguns alimentos (especialmente peixes gordurosos), o que faz com que a disponibilidade da vitamina D na dieta seja limitada. Estudos populacionais brasileiros demonstram que a prevalência da hipovitaminose D no nosso país é elevada. Objetivo: Definição dos intervalos de referência para vitamina D [25(OH)D]. Discussão: Consenso de especialistas - revisão da literatura. Conclusão: A padronização dos intervalos de referência é fundamental para o correto diagnóstico e tratamento da hipovitaminose D.

Justificativas A revisao da necessidade do jejum para determinacao do perfil lipidico (colesterol total, LDL-C, HDL-C, nao-HDL-C e triglicerides [TG]) baseia-se nas seguintes justificativas: […] Posicionamento sobre a Flexibilizacao do Jejum para o Perfil Lipidico

Biomarkers such as procalcitonin (PCT) have been studied to guide duration of antibiotic therapy. We aimed to assess whether a decrease in PCT levels could be used to reduce the duration of antibiotic therapy in intensive care unit (ICU) patients with a proven infection without risking a worse outcome. We assessed 265 patients with suspected sepsis, severe sepsis, or septic shock in our ICU. Of those, we randomized 81 patients with a proven bacterial infection into 2 groups: an intervention group in which the duration of the antibiotic therapy was guided by a PCT protocol and a control group in which there was no PCT guidance. In the per-protocol analysis, the median antibiotic duration was 9 days in the PCT group (n = 20) versus 13 days in the non-PCT group (n = 31), P = 0.008. This study demonstrates that PCT can be a useful tool for limiting antimicrobial therapy in ICU patients with documented bacterial infection.

Objective To compare the level of vitamin D3 in cutaneous melanoma patients, with or without disease activity, with reference values and with patients from a general hospital.Methods The serum levels of vitamin D3 were measured in cutaneous melanoma patients, aged 20 to 88 years, both genders, from January 2010 to December 2013. The samples from the general group were processed at Hospital Israelita Albert Einstein (control group). Data analysis was performed using the Statistics software.Results A total of 100 patients were studied, 54 of them men, with mean age of 54.67 years, and 95 Caucasian. Out of these 100 patients, 17 had active disease. The average levels of vitamin D3 in the melanoma patients were lower than the level considered sufficient, but above the average of the control group. Both groups (with or without active disease) of patients showed a similar distribution of vitamin D3 deficiency.Conclusion Vitamin D3 levels in melanoma patients were higher than those of general patients and lower than the reference level. If the reference values are appropriate, a large part of the population had insufficient levels of vitamin D, including those with melanoma, or else, this standard needs to be reevaluated. No difference in vitamin D3 levels was found among melanoma patients with or without active disease. More comprehensive research is needed to assess the relation between vitamin D and melanoma. Objetivo Comparar o nível de vitamina D3 em portadores de melanoma, em atividade de doença ou não, com os valores de referência e com pacientes de um hospital geral.Métodos Os níveis séricos de vitamina D3 foram dosados em portadores de melanoma cutâneo entre 22 a 80 anos, de ambos os sexos, de janeiro de 2010 a dezembro de 2013. As amostras do grupo dos pacientes gerais foram processadas no Hospital Israelita Albert Einstein (grupo controle). A análise dos dados foi realizada utilizando o software Statistica.Resultados Foram estudados 100 pacientes, sendo 54 homens, com média de idade 54,67 anos, e 95 brancos. Desses 100 pacientes, 17 apresentavam doença em atividade. A média dos níveis de vitamina D3 nos 100 pacientes foi inferior ao nível considerado suficiente, porém acima da média do grupo controle. A deficiência de vitamina D3 apresentou distribuição semelhante nos dois grupos com melanoma (em atividade de doença ou não).Conclusão Os níveis de vitamina D3 nos pacientes com melanoma foram superiores aos dos pacientes gerais e inferiores aos de referência. Se os valores de referência estão adequados, grande parte da população apresenta níveis insuficientes de vitamina D3, incluindo os portadores de melanoma, ou tal padrão precisa ser reavaliado. Não houve diferença dos níveis de vitamina D3 entre portadores de melanoma com ou sem atividade. Estudos relacionando vitamina D e melanoma devem ser aprofundados.

The paper summarizes the difficulties to study the rare population of endothelial progenitor cells in clinical trials, based on the experience of our group in many publications in this area.

Objective: To correlate the serum levels of B type natriuretic peptide and the N-terminal fraction of the pro-B type natriuretic peptide, as well as to analyze the influence of age, obesity, renal failure, left ventricle ejection fraction, diastolic dysfunction, and anemia on serum levels of both markers. Methods: An observational study in which the agreement was compared between these markers in consecutive samples of 138 patients. For the correlation, Pearson's test was used, and p