Prevalence of SARS-CoV-2 in Spain (ENE-COVID): a nationwide, population-based seroepidemiological study.

In Italy, 128,948 confirmed cases and 15,887 deaths of people who tested positive for SARS-CoV-2 were registered as of 5 April 2020. Ending the global SARS-CoV-2 pandemic requires implementation of multiple population-wide strategies, including social distancing, testing and contact tracing. We propose a new model that predicts the course of the epidemic to help plan an effective control strategy. The model considers eight stages of infection: susceptible (S), infected (I), diagnosed (D), ailing (A), recognized (R), threatened (T), healed (H) and extinct (E), collectively termed SIDARTHE. Our SIDARTHE model discriminates between infected individuals depending on whether they have been diagnosed and on the severity of their symptoms. The distinction between diagnosed and non-diagnosed individuals is important because the former are typically isolated and hence less likely to spread the infection. This delineation also helps to explain misperceptions of the case fatality rate and of the epidemic spread. We compare simulation results with real data on the COVID-19 epidemic in Italy, and we model possible scenarios of implementation of countermeasures. Our results demonstrate that restrictive social-distancing measures will need to be combined with widespread testing and contact tracing to end the ongoing COVID-19 pandemic.

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Modelling the COVID-19 epidemic and implementation of population-wide interventions in Italy.

The COVID-19 outbreak has had a major impact on clinical microbiology laboratories in the past several months. This commentary covers current issues and challenges for the laboratory diagnosis of infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In the preanalytical stage, collecting the proper respiratory tract specimen at the right time from the right anatomic site is essential for a prompt and accurate molecular diagnosis of COVID-19. Appropriate measures are required to keep laboratory staff safe while producing reliable test results. In the analytic stage, real-time reverse transcription-PCR (RT-PCR) assays remain the molecular test of choice for the etiologic diagnosis of SARS-CoV-2 infection while antibody-based techniques are being introduced as supplemental tools. In the postanalytical stage, testing results should be carefully interpreted using both molecular and serological findings. Finally, random-access, integrated devices available at the point of care with scalable capacities will facilitate the rapid and accurate diagnosis and monitoring of SARS-CoV-2 infections and greatly assist in the control of this outbreak.

Laboratory Diagnosis of COVID-19: Current Issues and Challenges.

In late December 2019, a novel strand of Coronavirus (SARS-CoV-2) causing a severe, potentially fatal respiratory syndrome (COVID-19) was identified in Wuhan, Hubei Province, China and is causing outbreaks in multiple world countries, soon becoming a pandemic. Italy has now become the most hit country outside of Asia: on March 16, 2020, the Italian Civil Protection documented a total of 27980 confirmed cases and 2158 deaths of people tested positive for SARS-CoV-2. In the context of an emerging infectious disease outbreak, it is of paramount importance to predict the trend of the epidemic in order to plan an effective control strategy and to determine its impact. This paper proposes a new epidemic model that discriminates between infected individuals depending on whether they have been diagnosed and on the severity of their symptoms. The distinction between diagnosed and non-diagnosed is important because non-diagnosed individuals are more likely to spread the infection than diagnosed ones, since the latter are typically isolated, and can explain misperceptions of the case fatality rate and of the seriousness of the epidemic phenomenon. Being able to predict the amount of patients that will develop life-threatening symptoms is important since the disease frequently requires hospitalisation (and even Intensive Care Unit admission) and challenges the healthcare system capacity. We show how the basic reproduction number can be redefined in the new framework, thus capturing the potential for epidemic containment. Simulation results are compared with real data on the COVID-19 epidemic in Italy, to show the validity of the model and compare different possible predicted scenarios depending on the adopted countermeasures.

/pdf/a-sidarthe-model-of-covid-19-epidemic-in-italy-3w3iqdiejm.pdf

A SIDARTHE Model of COVID-19 Epidemic in Italy

Prevalence of SARS-CoV-2 in Spain (ENE-COVID): a nationwide, population-based seroepidemiological study

The outbreak of the novel coronavirus disease (COVID-19) quickly spread all over China and to more than 20 other countries. Although the virus (severe acute respiratory syndrome coronavirus [SARS-Cov-2]) nucleic acid real-time polymerase chain reaction (PCR) test has become the standard method for diagnosis of SARS-CoV-2 infection, these real-time PCR test kits have many limitations. In addition, high false-negative rates were reported. There is an urgent need for an accurate and rapid test method to quickly identify a large number of infected patients and asymptomatic carriers to prevent virus transmission and assure timely treatment of patients. We have developed a rapid and simple point-of-care lateral flow immunoassay that can detect immunoglobulin M (IgM) and IgG antibodies simultaneously against SARS-CoV-2 virus in human blood within 15 minutes which can detect patients at different infection stages. With this test kit, we carried out clinical studies to validate its clinical efficacy uses. The clinical detection sensitivity and specificity of this test were measured using blood samples collected from 397 PCR confirmed COVID-19 patients and 128 negative patients at eight different clinical sites. The overall testing sensitivity was 88.66% and specificity was 90.63%. In addition, we evaluated clinical diagnosis results obtained from different types of venous and fingerstick blood samples. The results indicated great detection consistency among samples from fingerstick blood, serum and plasma of venous blood. The IgM-IgG combined assay has better utility and sensitivity compared with a single IgM or IgG test. It can be used for the rapid screening of SARS-CoV-2 carriers, symptomatic or asymptomatic, in hospitals, clinics, and test laboratories.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jmv.25727

Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis

The invention provides a time resolution fluorescence immunoassay method based on magnetic separation; the method mainly comprises the following steps of firstly, coupling magnetic beads with an antibody to form immunomagnetic beads; meanwhile, enabling time resolution fluorescent microsphere to be coupled with antibody to form immunofluorescent microspheres; then enabling the immunomagnetic beadsand the immunofluorescent microspheres and the antigen in a sample to be oscillated and incubated in a reaction tube to form an immunomagnetic bead-antigen-immunofluorescent microsphere compound; andfinally, testing the fluorescence intensity, emitted by excitation of the compound at 360 nm excitation, by a time resolution instrument, wherein a standard curve is used as reference for determiningthe amount of the antigen in the sample. According to the analysis method, the reaction time is greatly shortened, and the detection efficiency and sensitivity are improved.

Time resolution fluorescence immunoassay method based on magnetic separation

The invention provides an immunomagnetic bead-based time-resolved fluorescence immunoassay kit of cardiac myosin binding protein C (cMyBP-C). The kit includes a calibrator, immunomagnetic beads, immunofluorescence microspheres, analysis buffering liquid and wash liquid. The magnetic beads are coupled with antibodies, and the time-resolved fluorescence microspheres are coupled with the antibodies;thus the two parts form immunomagnetic beads-cMyBP-C antigen-immunofluorescence microsphere complexes with cMyBP-C antigens in a sample in a reaction tube after shaking incubation; a time-resolved instrument is used to determine intensity of fluorescence emitted thereby under excitation of ultraviolet light; and comparison of a standard curve is carried out to determine the amount of the cMyBP-C antigens in the sample. The kit of the invention greatly shortens reaction time, and improves efficiency and sensitivity of detection.

Pan Weimin

Papers

Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis

Time resolution fluorescence immunoassay method based on magnetic separation

Immunomagnetic bead-based time-resolved fluorescence immunoassay kit of cardiac myosin binding protein C (cMyBP-C)