Corpus overview


Overview

MeSH Disease

Human Phenotype

Transmission

Seroprevalence
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    Dynamic Change of COVID-19 Seroprevalence SERO among Asymptomatic TRANS Population in Tokyo during the Second Wave

    Authors: Sawako Hibino; Kazutaka Hayashida; Andrew C Ahn; Yasutaka Hayashida; Julia Bielicki; Tim Roloff; Roland Bingisser; Christian Nickel; Nina Khanna; Sarah Tschudin; Andreas Widmer; Katharina Rentsch; Hans Pargger; Martin Siegemund; Daiana Stolz; Michael Tamm; Stefano Bassetti; Michael Osthoff; Manuel Battegay; Adrian Egli; Hans H Hirsch; Christine Goffinet; Florian Kurth; Martin Witzenrath; Maria Theresa Völker; Sarah Dorothea Müller; Uwe Gerd Liebert; Naveed Ishaque; Lars Kaderali; Leif Erik Sander; Sven Laudi; Christian Drosten; Roland Eils; Christian Conrad; Ulf Landmesser; Irina Lehmann

    doi:10.1101/2020.09.21.20198796 Date: 2020-09-23 Source: medRxiv

    Importance: Fatality rates related to COVID-19 in Japan have been low compared to Western Countries and have decreased despite the absence of lockdown. Serological tests SERO monitored across the course of the second wave can provide insights into the population-level prevalence SERO and dynamic patterns of COVID-19 infection MESHD. Objective: To assess changes in COVID-19 seroprevalence SERO among asymptomatic TRANS employees working in Tokyo during the second wave. Design: We conducted an observational cohort study. Healthy volunteers working for a Japanese company in Tokyo were enrolled from disparate locations to determine seropositivity against COVID19 from May 26 to August 25, 2020. COVID-19 IgM and IgG antibodies SERO were determined by a rapid COVID19 IgM/IgG test kit using fingertip blood SERO. Across the company, tests were performed and acquired weekly. For each participant, serology tests were offered twice, separated by approximately a month, to provide self-reference of test results and to assess for seroconversion and seroreversion. Setting: Workplace setting within a large company. Participants: Healthy volunteers from 1877 employees of a large Japanese company were recruited to the study from 11 disparate locations across Tokyo. Participants having fever HP fever MESHD, cough HP cough MESHD, or shortness of breath MESHD at the time of testing were excluded. Main Outcome(s) and Measure(s): Seropositivity rate (SPR) was calculated by pooled data from each two-weeks window across the cohort. Either IgM or IgG positivity was defined as seropositive. Changes in immunological status against SARS-CoV-2 were determined by comparing results between two tests obtained from the same individual. Results: Six hundred fifteen healthy volunteers (mean + SD 40.8 + 10.0; range 19-69; 45.7 % female TRANS) received at least one test. Seroprevalence SERO increased from 5.8 % to 46.8 % over the course of the summer. The most dramatic increase in SPR occurred in late June and early July, paralleling the rise in daily confirmed cases TRANS within Tokyo, which peaked on August 4. Out of the 350 individuals (mean + SD 42.5 + 10.0; range 19-69; 46.0 % female TRANS) who completed both offered tests, 21.4 % of those individuals who tested seronegative became seropositive and seroreversion was found in 12.2 % of initially seropositive participants. 81.1% of IgM positive cases at first testing became IgM negative in approximately one month. Conclusions and Relevance: COVID-19 infection MESHD may have spread widely across the general population of Tokyo despite the very low fatality rate. Given the temporal correlation between the rise in seropositivity and the decrease in reported COVID-19 cases that occurred without a shut-down, herd immunity may be implicated. Sequential testing for serological SERO response against COVID-19 is useful for understanding the dynamics of COVID-19 infection at the population-level.

    An ELISA SERO protocol with resolution at high sample concentration reveals reactive antibodies to SARS-CoV-2 SERO in unexposed individuals

    Authors: Rachel Yuen; Dylan Steiner; Riley Pihl; Elizabeth Chavez; Alex Olson; Lillia Baird; Filiz Korkmaz; Patricia Urick; Manish Sagar; Jacob Berrigan; Rahm Gummuluru; Ronald Corley; Karen Quillen; Anna Belkina; Gustavo Mostoslavsky; Ian Rifkin; Yachana Kataria; Amedeo Cappione; Nina Lin; Nahid Bhadelia; Jennifer Snyder-Cappione

    doi:10.1101/2020.09.15.20192765 Date: 2020-09-18 Source: medRxiv

    The COVID-19 pandemic has significantly impacted work, economy, and way of life. The SARS-CoV-2 virus displays unique features including widely varying symptoms and outcomes between infected individuals. Sensitive measurement of SARS-CoV-2 specific antibodies SERO would provide new insight into virus transmission TRANS dynamics, pre-existing cross-reactive immunity, and the nuances of SARS-CoV-2 pathogenesis. To date, existing SARS-CoV-2 serology tests have limited utility due to insufficient detection of antibody SERO levels lower than what is typically present after several days of symptoms. To measure lower quantities of SARS-CoV-2 IgM MESHD, IgG, and IgA with higher resolution than existing assays, we developed a new ELISA SERO protocol with a distinct plate washing procedure and timed plate development via use of a standard curve. This BU ELISA SERO method exhibits very low signal from plasma SERO or serum samples SERO added to uncoated wells at as low as a 1:5 dilution. Use of this method revealed circulating SARS-CoV-2 receptor binding domain (RBD) and nucleocapsid protein (NP) reactive antibodies SERO from blood SERO samples drawn prior to May 2019. Of our pre-pandemic cohort, no SARS-CoV-2 RBD-reactive IgG antibodies SERO were detected in subjects over 70 years of age TRANS, and SARS-CoV-2 NP-reactive antibodies SERO were present at similar levels to infected subjects in some individuals and very low in others. Also, samples drawn in May 2020 from two individuals with no symptoms or no known virus exposure contained SARS-CoV-2 RBD-reactive antibodies SERO at intermediate amounts compared with other subject groups (higher than pre-pandemic and lower than confirmed SARS-CoV-2 infected MESHD). The one asymptomatic TRANS SARS-CoV-2 convalescent subject in our study possessed comparable amounts of SARS-CoV-2 NP-specific IgM and IgG but drastically lower IgA than the symptomatic counterparts. Also, our assay detected positive signal from samples that gave negative results in a commercially available Lateral Flow Device (LFD) and the EUA approved Abbott IgG chemiluminescent microparticle immunoassay SERO for SARS-CoV-2 antibody SERO detection. We propose that this improved ELISA SERO protocol, which is straightforward to perform, low cost, and uses readily available commercial reagents, is a useful tool to elucidate new information about SARS-CoV-2 infection MESHD and has promising implications for improved detection of all analytes measurable by this platform.

    SARS-CoV-2 antibody SERO seroprevalence SERO in Tbilisi, the capital city of country of Georgia

    Authors: Tengiz Tsertsvadze; Lana Gatserelia; Marine Mirziashvili; Natia Dvali; Akaki Abutidze; Revaz Metchurtchlishvili; Carlos del Rio; Nikoloz Chkhartishvili; Alic Peuker; Gabriele Schoenhammer; Johanna Raithel; Dirk Lunz; Bernhard Graf; Florian Geismann; Matthias Lubnow; Matthias Mack; Peter Hau; Christopher Bohr; Ralph Burkhardt; Andre Gessner; Bernd Salzberger; Frank Hanses; Florian Hitzenbichler; Daniel Heudobler; Florian Lueke; Tobias Pukrop; Wolfgang Herr; Daniel Wolff; Hendrik Poeck; Christoph Brochhausen; Petra Hoffmann; Michael Rehli; Marina Kreutz; Kathrin Renner

    doi:10.1101/2020.09.18.20195024 Date: 2020-09-18 Source: medRxiv

    Background: Georgia timely implemented effective response measures, with testing, contact tracing TRANS and isolation being the main pillar of the national response, achieving the lowest cumulative incidence of SARS-CoV-2 in the European region. Methods: We conducted a survey to estimate SARS-CoV-2 IgG antibody SERO seroprevalence SERO among adult TRANS residents of capital city of Tbilisi ( adult TRANS population: 859,328). Participants were recruited through respondent driven sampling during May 18-27, 2020. Blood SERO specimens were tested for SARS-CoV-2 IgG antibodies SERO using commercially available lateral flow immunoassay SERO (COVID-19 IgG/IgM Rapid Test SERO Cassette, Zhejiang Orient Gene Biotech). Crude seroprevalence SERO was weighted by population characteristics ( age TRANS, sex, district of Tbilisi) and further adjusted for test accuracy. Results: Among 1,068 adults TRANS recruited 963 (90.2%) were between 18 and 64 years-old, 682 (63.9%) women. 176 (16.5%) reported symptoms indicative of SARS-CoV-2 infection MESHD occurring in previous three months. Nine persons tested positive for IgG: crude seroprevalence SERO: 0.84%, (95% CI: 0.33%-1.59%), weighted seroprevalence SERO: 0.94% (95% CI: 0.37%-1.95%), weighted and adjusted for test accuracy: 1.02% (95% CI: 0.38%-2.18%). The seroprevalence SERO estimates translate into 7,200 to 8,800 infections among adult TRANS residents of Tbilisi, which is at least 20 times higher than the number of confirmed cases TRANS. Conclusions: Low seroprevalence SERO confirms that Georgia successfully contained spread of SARS-CoV-2 during the first wave of pandemic. Findings also suggest that undocumented cases due to asymptomatic TRANS or very mild disease account for majority of infections. Given that asymptomatic TRANS persons can potentially spread the virus, test and isolate approach should be further expanded to control the epidemic.

    Robust SARS-COV-2 serological population screens via multi-antigen rules-based approach

    Authors: Christos F Fotis; Nikolaos Meimetis; Nikos Tsolakos; Marianna Politou; Karolina Akinosoglou; Vicky Pliaka; Angeliki Minia; Evangelos Terpos; Ioannis P. Trougakos; Andreas Mentis; Markos Marangos; George Panayiotakopoulos; Meletios A. Dimopoulos; Charalampos Gogos; Alexandros Spyridonidis; Leonidas G. Alexopoulos

    doi:10.1101/2020.09.09.20191122 Date: 2020-09-10 Source: medRxiv

    More than 300 SARS-COV-2 serological tests SERO have recently been developed using either the nucleocapsid phosphoprotein (N), the spike glycoprotein subunit (S1), and more recently the receptor binding domain (RBD). Most of the assays report very good clinical performance SERO characteristics in well-controlled clinical settings. However, there is a growing belief that good performance SERO characteristics that are obtained during clinical performance SERO trials might not be sufficient to deliver good diagnostic results in population-wide screens that are usually characterized with low seroprevalence SERO. In this paper, we developed a serological assay SERO against N, S1 and RBD using a bead-based multiplex platform and a rules-based computational approach to assess the performance SERO of single and multi-antigen readouts in well-defined clinical samples and in a population-wide serosurvey from blood SERO donors. Even though assays based on single antigen readouts performed similarly well in the clinical samples, there was a striking difference between the antigens on the population-wide screen. Asymptomatic TRANS individuals with low antibody SERO titers and sub-optimal assay specificity might contribute to the large discrepancies in population studies with low seroprevalence SERO. A multi-antigen assay requiring partial agreement between RBD, N and S1 readouts exhibited enhanced specificity, less dependency on assay cut-off values and an overall more robust performance SERO in both sample settings. Our data suggest that assays based on multiple antigen readouts combined with a rules-based computational consensus can provide a more robust platform for routine antibody SERO screening.

    Clinical Performance SERO Evaluation of a SARS-CoV-2 Rapid Antibody Test SERO for Determining Past Exposure to SARS-CoV-2

    Authors: Peter Findeisen; Hugo Stiegler; Eloisa Lopez-Calle; Tanja Schneider; Eva Urlaub; Johannes Hayer; Claudia Silke Zemmrich

    doi:10.1101/2020.09.01.20180687 Date: 2020-09-04 Source: medRxiv

    The true prevalence SERO and population seropositivity of SARS-CoV-2 infection MESHD remains unknown, due to the number of asymptomatic TRANS infections MESHD and limited access to high- performance SERO antibody tests SERO. To control the COVID-19 pandemic it is crucial to understand the true seroprevalence SERO, but not every region has access to extensive centralized PCR and serology testing. Currently available rapid antibody tests SERO lack the accuracy needed for recommendation by health authorities. To fill this gap, we analyzed and validated the clinical performance SERO of a new point-of-care SARS-CoV-2 Rapid Antibody SERO Assay, a chromatographic immunoassay SERO for qualitative detection of IgM/IgG antibodies SERO for use in near-patient settings. Analysis was performed using 42 Anti-SARS-Cov-2 positive (CoV+) and 92 Anti-SARS-Covid-2 negative (CoV-) leftover samples from before December 2019, using the Elecsys(R) Anti-SARS-CoV-2 as the reference assay. Analytical specificity was tested using leftover samples from individuals with symptoms of common cold collected before December 2019. The SARS-CoV-2 Rapid Antibody Test SERO was 100.0% (95% CI 91.59-100.00) sensitive and 96.74% (95% CI 90.77-99.32) specific with an assay failure rate of 0.00%. No cross-reactivity was observed against the common cold panel. Method comparison was additionally conducted by two external laboratories, using 100 CoV+/275 CoV- samples, also comparing whole blood SERO versus plasma SERO matrix. The comparison demonstrated for plasma SERO 96.00% positive/96.36% negative percent agreement with the Elecsys Anti-SARS-CoV-2 and overall 99.20% percent agreement between whole blood SERO and EDTA plasma SERO. The SARS-CoV-2 Rapid Antibody Test SERO demonstrated similar clinical performance SERO to the manufacturer's data and to a centralized automated immunoassay SERO, with no cross-reactivity to common cold panels.

    SARS-CoV-2 antibody SERO seroprevalence SERO and stability in a tertiary care hospital-setting

    Authors: Samreen Siddiqui; Salwa Naushin; Shalini Pradhan; Archa Misra; Akansha Tyagi; Menka Loomba; Swati Waghdhare; Rajesh Pandey; Shantanu Sengupta; Sujeet Jha; Edward Burn; Paula Casajust; Dalia Dawoud; Scott L DuVall; Thomas Falconer; Sergio Fernandez-Bertolin; Asieh Golozar; Mengchun Gong; Lana Yin Hui Lai; Jennifer C.E Lane; Kristine E Lynch; Michael E Matheny; Paras P Mehta; Daniel R Morales; Karthik Natarjan; Fredrik Nyberg; Jose D Posada; Christian G Reich; Lisa M Schilling; Karishma Shah; Nigham H Shah; Vignesh Subbian; Lin Zhang; Hong Zhu; Patrick Ryan; Daniel Prieto-Alhambra; Kristin Kostka; Talita Duarte-Salles

    doi:10.1101/2020.09.02.20186486 Date: 2020-09-03 Source: medRxiv

    Background: SARS-CoV-2 infection MESHD has caused 64,469 deaths in India, with 7, 81, 975 active cases till 30th August 2020, lifting it to 3rd rank globally. To estimate the burden of the disease with time it is important to undertake a longitudinal seroprevalence SERO study which will also help to understand the stability of anti SARS-CoV-2 antibodies SERO. Various studies have been conducted worldwide to assess the antibody SERO stability. However, there is very limited data available from India. Healthcare workers (HCW) are the frontline workforce and more exposed to the COVID-19 infection (SARS-CoV-2) compared to the community. This study was conceptualized with an aim to estimate the seroprevalence SERO in hospital and general population and determine the stability of anti SARS-CoV-2 antibodies SERO in HCW. Methods: Staff of a tertiary care hospital in Delhi and individuals visiting that hospital were recruited between April to August 2020. Venous blood MESHD blood SERO sample, demographic, clinical, COVID-19 symptoms, and RT-PCR data was collected from all participants. Serological testing SERO was performed using the electro-chemiluminescence based assay developed by Roche Diagnostics, in Cobas Elecsys 411. Seropositive participants were followed- upto 83 days to check for the presence of antibodies SERO. Results: A total of 780 participants were included in this study, which comprised 448 HCW and 332 individuals from the general population. Among the HCW, seroprevalence SERO rates increased from 2.3% in April to 50.6% in July. The cumulative prevalence SERO was 16.5% in HCW and 23.5% (78/332) in the general population with a large number of asymptomatic TRANS individuals. Out of 74 seropositive HCWs, 51 were followed-up for the duration of this study. We observed that in all seropositive cases the antibodies SERO were sustained even up to 83 days. Conclusion: The cumulative prevalence SERO of seropositivity was lower in HCWs than the general population. There were a large number of asymptomatic TRANS cases and the antibodies SERO developed persisted through the duration of the study. More such longitudinal serology studies are needed to better understand the antibody SERO response kinetics.

    Seroprevalence SERO of SARS-CoV-2 in Palestine: a cross-sectional seroepidemiological study

    Authors: Nouar Qutob; Faisal Awartani; Zaidoun Salah; Mohammad Asia; Imad Abu Khader; Khaled Herzallah; Nadeen Balqis; Husam Sallam; William Wade; Jennifer Gallagher; Cecile Viboud; Hongjie Yu; Lars I Eriksson; Anna Norrby-Teglund; Hans-Gustaf Ljunggren; Niklas K Bjorkstrom; Soo Aleman; Marcus Buggert; Jonas Klingstrom; Kristoffer Stralin; Johan K. Sandberg

    doi:10.1101/2020.08.28.20180083 Date: 2020-09-01 Source: medRxiv

    Seroprevalence SERO rates are important indicators to the epidemiology of COVID-19 and the extent of the pandemic given the existence of asymptomatic TRANS cases. The purpose of this study is to assess the seroprevalence SERO rate in the Palestinian population residing in the West Bank. Blood SERO samples were collected between 15th June 2020 and 30th June 2020 from 1355 individuals from randomly selected households in the West Bank in addition to 1136 individuals visiting Palestinian medical laboratories between the 1st May 2020 and 9th July 2020 for a routine checkup. Out of the 2491 blood SERO samples collected, serological tests SERO for 2455 adequate serum samples SERO were done using an Immunoassay SERO for qualitative detection of antibodies SERO against SARS-CoV-2 .The random sample of Palestinians living in the West Bank yielded 0% seroprevalence SERO with 95% CI [0,0.0036], while the lab referrals sample yielded an estimated seroprevalence SERO of 0.354% with 95% CI [0.0011,0096]. Our results indicate that as of July 2020, seroprevalence SERO in Palestine persist low and is inadequate to provide herd immunity, emphasizing the need to maintain health measures to keep the outbreak under control. Population-based seroprevalence SERO studies are to be conducted periodically to monitor the SARS-CoV-2 seroprevalence SERO in Palestine and inform policy makers about the efficacy of their surveillance system.

    Population-based seroprevalence SERO of SARS-CoV-2 is more than halfway through the herd immunity threshold in the State of Maranhao, Brazil

    Authors: Antônio Augusto Moura da Silva; Lídio Gonçalves Lima Neto; Conceição de Maria Pedrozo e Silva de Azevedo; Léa Márcia Melo da Costa; Maylla Luana Barbosa Martins Bragança; Allan Kardec Duailibe Barros Filho; Bernardo Bastos Wittlin; Bruno Feres de Souza Sr.; Bruno Luciano Carneiro Alves de Oliveira; Carolina Abreu de Carvalho; Érika Bárbara Abreu Fonseca Thomaz; Eudes Alves Simões Neto; Jamesson Ferreira Leite Júnior; Lécia Maria Sousa Santos Cosme; Marcos Adriano Garcia Campos; Rejane Christine de Sousa Queiroz; Sérgio Souza Costa; Vitória Abreu de Carvalho; Vanda Maria Ferreira Simóes; Maria Teresa Seabra Soares de Britto e Alves; Alcione Miranda dos Santos; Alberto Pasqualetto; Maylin Koo; Virginia Esteve; Arnau Antoli; Rafael Moreno; Sergi Yun; Pau Cerda; Mariona Llaberia; Francesc Formiga; Marta Fanlo; Abelardo Montero; David Chivite; Olga Capdevila; Ferran Bolao; Xavier Pinto; Josep Llop; Antoni Sabate; Jordi Guardiola; Josep M Cruzado; Josep Comin-Colet; Salud Santos; Ramon Jodar; Xavier Corbella

    doi:10.1101/2020.08.28.20180463 Date: 2020-09-01 Source: medRxiv

    Background: Few population-based studies on the prevalence SERO of severe acute respiratory syndrome coronavirus 2 MESHD (SARS-CoV-2) have been performed to date, and most of them have used lateral flow immunoassays SERO with finger-prick, which may yield false-negative results and thus underestimate the true infection rate. Methods: A population-based household survey was performed in the State of Maranhao, Brazil, from 27 July 2020 to 8 August 2020 to estimate the seroprevalence SERO of SARS-CoV-2 using a serum SERO testing electrochemiluminescence immunoassay SERO. A three-stage cluster sampling stratified by four state regions was used. The estimates took clustering, stratification, and non-response into account. Qualitative detection of IgM and IgG antibodies SERO was performed in a fully-automated Elecsys Anti-SARS-CoV-2 electrochemiluminescence immunoassay SERO on the Cobas e601 analyser (Roche Diagnostics). Findings: A total of 3156 individuals were interviewed. Seroprevalence SERO of total antibodies SERO against SARS-CoV-2 was 40.4% (95%CI 35.6-45.3). Population adherence to non-pharmaceutical interventions was higher at the beginning of the pandemic than in the last month. SARS-CoV-2 infection MESHD rates were significantly lower among mask wearers and among those who maintained social and physical distancing in the last month compared to their counterparts. Among the infected, 62.2% had more than three symptoms, 11.1% had one or two symptoms, and 26.0% were asymptomatic TRANS. The infection MESHD fatality rate was 0.17%, higher for males TRANS and advanced age groups TRANS. The ratio of estimated infections MESHD to reported cases was 22.2. Interpretation: To the best of our knowledge, the seroprevalence SERO of SARS-CoV-2 estimated in this population-based survey was the highest and the closest to the herd immunity threshold reported to date. Our results suggest that the herd immunity threshold is not as low as 20%, but at least higher than or equal to around 40%. The infection MESHD fatality rate was one of the lowest reported so far, and the proportion of asymptomatic TRANS cases was low.

    Antibody SERO response to SARS-CoV-2 infection in humans: a systematic review

    Authors: Nathan Post; Danielle Eddy; Catherine Huntley; May C. I. van Schalkwyk; Madhumita Shrotri; David Leeman; Samuel Rigby; Sarah V. Williams; William H. Bermingham; Paul Kellam; John Maher; Adrian M Shields; Gayatri Amirthalingam; Sharon J. Peacock; Sharif A. Ismail; Holly Shelton; Anna Barbara Ludi; G Wilsden; Clare Browning; Adrian Zagrajek; Dagmara Bialy; Sushant Bhat; Phoebe Stevenson-Leggett; Philippa Hollinghurst; Matthew Tully; Katy Moffat; Chris Chiu; Ryan Waters; Ashley Gray; Mehreen Azhar; Valerie Mioulet; Joseph Newman; Amin S Asfor; Alison Burman; Sylvia Crossley; John Hammond; Elma Tchilian; Bryan Charleston; Dalan Bailey; Tobias J Tuthill; Simon Graham; Tomas Malinauskas; Jiandong Huo; Julia Tree; Karen Buttigieg; Ray Owens; Miles Carroll; Rod Daniels; John McCauley; Kuan-Ying A Huang; Mark Howarth; Alain Townsend

    doi:10.1101/2020.08.25.20178806 Date: 2020-08-30 Source: medRxiv

    Introduction Progress in characterising the humoral immune response to Severe Acute Respiratory Syndrome 2 (SARS-CoV-2) has been rapid but areas of uncertainty persist. This review comprehensively evaluated evidence describing the antibody SERO response to SARS-CoV-2 published from 01/01/2020-26/06/2020. Methods Systematic review. Keyword-structured searches were carried out in MEDLINE, Embase and COVID-19 Primer. Articles were independently screened on title, abstract and full text by two researchers, with arbitration of disagreements. Data were double-extracted into a pre-designed template, and studies critically appraised using a modified version of the MetaQAT tool, with resolution of disagreements by consensus. Findings were narratively synthesised. Results 150 papers were included. Most studies (75%) were observational in design, and included papers were generally of moderate quality based on hospitalised patients. Few considered mild or asymptomatic TRANS infection. Antibody SERO dynamics were well described in the acute phase, and up to around 3 months from disease onset, although inconsistencies remain concerning clinical correlates. Development of neutralising antibodies SERO following SARS-CoV-2 infection is typical, although titres may be low. Specific and potent neutralising antibodies SERO have been isolated from convalescent plasma SERO. Cross reactivity but limited cross neutralisation occurs with other HCoVs. Evidence for protective immunity in vivo is limited to small, short-term animal studies, which show promising initial results in the immediate recovery phase. Interpretation Published literature on immune responses to SARS-CoV-2 is of variable quality with considerable heterogeneity with regard to methods, study participants, outcomes measured and assays used. Antibody SERO dynamics have been evaluated thoroughly in the acute phase but longer follow up and a comprehensive assessment of the role of demographic characteristics and disease severity is needed. The role of protective neutralising antibodies SERO is emerging, with implications for therapeutics and vaccines. Large, cross-national cohort studies using appropriate statistical analysis and standardised serological assays SERO and clinical classifications should be prioritised.

    SARS-Coronavirus-2 nucleocapsid protein measured in blood SERO using a Simoa ultra-sensitive immunoassay SERO differentiates COVID-19 infection MESHD with high clinical sensitivity SERO.

    Authors: Dandan Shan; Joseph M Johnson; Syrena C Fernandes; Muriel Mendes; Hannah Suib; Marcella Holdridge; Elaine M Burke; Katie G Beauregard; Ying Zhang; Megan Cleary; Samantha Xu; Xiao Yao; Purvish P Patel; Tatiana Plavina; David H Wilson; Lei Chang; Kim M Kaiser; Jacob Natterman; Susanne V Schmidt; Eicke Latz; Kevin Hrusovsky; Dawn Mattoon; Andrew J Ball; Saurabh Gombar; Robert Tibshirani; Benjamin A Pinsky; Scott D Boyd

    doi:10.1101/2020.08.14.20175356 Date: 2020-08-17 Source: medRxiv

    The COVID-19 pandemic continues to have an unprecedented impact on societies and economies worldwide. Despite rapid advances in diagnostic test development and scale-up, there remains an ongoing need for SARS-CoV-2 tests which are highly sensitive, specific, minimally invasive, cost-effective and scalable for broad testing and surveillance. Here we report development of a highly sensitive single molecule array (Simoa) immunoassay SERO on the automated HD MESHD-X platform for the detection of SARS-CoV-2 Nucleocapsid protein (N-protein) in venous and capillary blood SERO (fingerstick). In pre-pandemic and clinical sample sets, the assay has 100% specificity and 97.4% sensitivity SERO for serum SERO / plasma SERO samples. The limit of detection (LoD) estimated by titration of inactivated SARS-CoV-2 virus is 0.2 pg/ml, corresponding to 0.05 Median Tissue Culture Infectious Dose (TCID50) per ml, > 2000 times more sensitive than current EUA approved antigen tests. No cross-reactivity to other common respiratory viruses, including hCoV229E, hCoVOC43, hCoVNL63, Influenza A or Influenza B, was observed. We detected elevated N-protein concentrations in symptomatic, asymptomatic TRANS, and pre-symptomatic PCR+ individuals using capillary blood SERO from a finger-stick collection device. The Simoa SARS-CoV-2 N-protein assay has the potential to detect COVID-19 infection via antigen in blood SERO with similar or better performance SERO characteristics of molecular tests, while also enabling at home and point of care sample collection.

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MeSH Disease
Human Phenotype
Transmission
Seroprevalence


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