Corpus overview


MeSH Disease

Human Phenotype


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    Distinct SARS-CoV-2 Antibody SERO Reactivity Patterns in Coronavirus Convalescent Plasma SERO Revealed by a Coronavirus Antigen Microarray

    Authors: Rafael Ramiro de Assis; Aarti Jain; Rie Nakajima; Algis Jasinskas; Saahir Khan; Larry J Dumont; Kathleen Kelly; Graham Simmons; Mars Stone; Clara Di Germanio; Michael P Busch; Philip L Felgner

    doi:10.1101/2020.09.16.300871 Date: 2020-09-17 Source: bioRxiv

    A coronavirus antigen microarray (COVAM) was constructed containing 11 SARS-CoV-2, 5 SARS-1, 5 MERS, and 12 seasonal coronavirus recombinant proteins. The array is designed to measure immunoglobulin isotype and subtype levels in serum SERO or plasma SERO samples against each of the individual antigens printed on the array. We probed the COVAM with COVID-19 convalescent plasma SERO (CCP) collected from 99 donors who recovered from a PCR+ confirmed SARS-CoV-2 infection MESHD. The results were analyzed using two computational approaches, a generalized linear model (glm) and Random Forest (RF) prediction model, to classify individual specimens as either Reactive or Non-Reactive against the SARS-CoV-2 antigens. A training set of 88 pre-COVID-19 specimens (PreCoV) collected in August 2019 and 102 positive specimens from SARS-CoV-2 PCR+ confirmed COVID-19 cases was used for these analyses. Results compared with an FDA emergency use authorized (EUA) SARS-CoV2 S1-based total Ig chemiluminescence immunoassay SERO (Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total, CoV2T) and with a SARS-CoV-2 S1-S2 spike-based pseudovirus micro neutralization assay (SARS-CoV-2 reporter viral particle neutralization titration (RVPNT) showed high concordance between the 3 assays. Three CCP specimens that were negative by the VITROS CoV2T immunoassay SERO were also negative by both COVAM and the RVPNT assay. Concordance between VITROS CoV2T and COVAM was 96%, VITROS CoV2T and RVPNT 93%, and RVPNT and COVAM 95%. The discordances were all weakly reactive samples near the cutoff threshold of the VITROS CoV2T immunoassay SERO. The multiplex COVAM allows CCP to be grouped according to antibody SERO reactivity patterns against 11 SARS-CoV-2 antigens. Unsupervised K-means analysis, via the gap statistics, as well as hierarchical clustering analysis revealed 3 main clusters with distinct reactivity intensities and patterns. These patterns were not recapitulated by adjusting the VITROS CoV2T or RVPNT assay thresholds. Plasma SERO classified according to these reactivity patterns may be better associated with CCP treatment efficacy than antibody SERO levels alone. The use of a SARS-CoV-2 antigen array may be useful to qualify CCP for administration as a treatment for acute COVID-19 and to interrogate vaccine immunogenicity and performance SERO in preclinical and clinical studies to understand and recapitulate antibody SERO responses associated with protection from infection and disease.

    SARS-CoV-2 N-antigenemia: A new alternative to nucleic acid amplification techniques

    Authors: Quentin Le Hingrat; Benoit Visseaux; Cedric Laouenan; Sarah Tubiana; Lila Bouadma; Yazdan Yazdanpanah; Xavier Duval; Houria Ichou; Florence Damond; Melanie Bertine; Nabil Benmalek; - French COVID cohort management committee; - CoV-CONTACT study group; Christophe Choquet; Jean-Francois Timsit; Jade Ghosn; Charlotte Charpentier; Diane Descamps; Nadhira Houhou-Fidouh; Jose Nicolas Alcala Pedrajas; Anabel Martin Urda Diez Canseco; Maria Jose Esteban Giner; Pablo Telleria Gomez; Ricardo Gomez Huelgas; Jose Manuel Ramos Rincon; Nina la Cour Freiesleben; Henriette Svarre Nielsen

    doi:10.1101/2020.09.14.20191759 Date: 2020-09-15 Source: medRxiv

    Background. Molecular assays on nasopharyngeal swabs remain the cornerstone of COVID-19 diagnostic. Despite massive worldwide efforts, the high technicalities of nasopharyngeal sampling and molecular assays, as well as scarce resources of reagents, limit our testing capabilities. Several strategies failed, to date, to fully alleviate this testing process (e.g. saliva sampling or antigen testing on nasopharyngeal samples). We assessed the performances SERO of a new ELISA SERO microplate assay quantifying SARS-CoV-2 nucleocapsid antigen (N-antigen) in serum SERO or plasma SERO. Methods. The specificity of the assay, determined on 63 non-COVID patients, was 98.4% (95% confidence interval [CI], 85.3 to 100). Performances SERO were determined on 227 serum samples SERO from 165 patients with RT-PCR confirmed SARS-CoV-2 infection MESHD included in the French COVID and CoV-CONTACT cohorts. Findings. Sensitivity SERO was 132/142, 93.0% (95% CI, 84.7 to 100), within the first two weeks after symptoms onset TRANS. A subset of 73 COVID-19 patients had a serum SERO collected within 24 hours following or preceding a positive nasopharyngeal swab. Among patients with high nasopharyngeal viral loads, Ct value below 30 and 33, only 1/50 and 4/67 tested negative for N-antigenemia, respectively. Among patients with a negative nasopharyngeal RT-PCR, 8/12 presented positive N-antigenemia. The lower respiratory tract was explored for 6/8 patients, showing positive PCR in 5 cases. Interpretation. This is the first demonstration of the N-antigen antigenemia during COVID-19. Its detection presented a robust sensitivity SERO, especially within the first 14 days after symptoms onset TRANS and high nasopharyngeal viral loads. These findings have to be confirmed with higher representation of outpatients. This approach could provide a valuable new option for COVID-19 diagnosis, only requiring a blood SERO draw and easily scalable in all clinical laboratories.

    Comparative evaluation of six immunoassays SERO for the detection of antibodies SERO against SARS-CoV-2

    Authors: Felipe Perez-Garcia; Ramon Perez-Tanoira; Maria Esther Iglesias; Juan Romanyk; Teresa Arroyo; Pena Gomez-Herruz; Rosa Gonzalez; Juan Cuadros-Gonzalez; Richard Croker; Alex J Walker; Elizabeth J Williamson; Chris Bates; Seb Bacon; Amir Mehrkar; Helen J Curtis; David Evans; Kevin Wing; Peter Inglesby; Rohini Mathur; Henry Drysdale; Angel YS Wong; Helen I McDonald; Jonathan Cockburn; Harriet Forbes; John Parry; Frank Hester; Sam Harper; Liam Smeeth; Ian J Douglas; William G Dixon; Stephen JW Evans; Laurie Tomlinson; Ben Goldacre; Sacha Gnjatic; Noam Harpaz; Silvio Danese; Adeeb Rahman; Nikhil A Kumta; Alessio Aghemo; Francesca Petralia; Harm van Bakel; Adolfo Garcia-Sastre; Saurabh Mehandru

    doi:10.1101/2020.09.08.20190488 Date: 2020-09-09 Source: medRxiv

    Objectives: Serologic techniques can serve as a complement to diagnose SARS-CoV-2 infection MESHD. The objective of our study was to compare the diagnostic performance SERO of six immunoassays SERO to detect antibodies SERO against SARS-CoV-2: three lateral flow immunoassays SERO (LFAs), one ELISA SERO and two chemiluminescence assays (CLIAs). Methods: We evaluated three LFAs (Alltest, One Step and SeroFlash), one ELISA SERO (Dia.Pro) and two CLIAs (Elecsys and COV2T). To assess the specificity, 60 pre-pandemic sera were used. To evaluate the sensitivity SERO, we used 80 serum samples SERO from patients with positive PCR for SARS-CoV-2. Agreement between techniques was evaluated using the kappa score (k). Results: All immunoassays SERO showed a specificity of 100% except for SeroFlash (96.7%). Overall sensitivity SERO was 61.3%, 73.8%, 67.5%, 85.9%, 88.0% and 92.0% for Alltest, One Step, SeroFlash, Dia.Pro, Elecsys and COV2T, respectively. Sensitivity SERO increased throughout the first two weeks from the onset of symptoms TRANS, reaching sensitivities SERO over 85% from 14 days for all LFAs, being One Step the most sensitive (97.6%), followed by SeroFlash (95.1%). Dia.Pro, Elecsys and COV2T showed sensitivities SERO over 97% from 14 days, being 100% for COV2T. One Step showed the best agreement results among LFAs, showing excellent agreement with Dia.Pro (agreement=94.2%, k=0.884), COV2T (99.1%, k=0.981) and Elecsys (97.3%, k=0.943). Dia.Pro, COV2T and Elecsys also showed excellent agreement between them. Conclusions: One Step, Dia.Pro, Elecsys and COV2T obtained the best diagnostic performance SERO results. All these techniques showed a specificity of 100% and sensitivities SERO over 97% from 14 days after the onset of symptoms TRANS, as well as excellent levels of agreement.

    Antibody SERO Responses to SARS-CoV-2 in Coronavirus Diseases MESHD 2019 Patients with Different Severity

    Authors: Ekasit Kowitdamrong; Thanyawee Puthanakit; Watsamon Jantarabenjakul; Eakachai Prompetchara; Pintip Suchartlikitwong; Opass Putcharoen; Nattiya Hirankarn; Ke Lan; Yu Chen; Huabin Zhao

    doi:10.1101/2020.09.06.20189480 Date: 2020-09-08 Source: medRxiv

    Background: More understanding of antibody SERO responses in the SARS-CoV-2 infected MESHD population is useful for vaccine development. Aim: To investigate SARS-CoV-2 IgA MESHD and IgG among COVID-19 Thai patients with different severity. Methods: We used plasma SERO from 118 adult TRANS patients who have confirmed SARS-CoV-2 infection MESHD and 49 patients under investigation without infection MESHD, 20 patients with other respiratory infections MESHD, and 102 healthy controls. Anti-SARS-CoV-2 IgA and IgG were performed by enzyme-linked immunosorbent assay SERO from Euroimmun. The optical density ratio cut off for positive test was 1.1 for IgA and 0.8 for IgG. The association of antibody SERO response with the severity of diseases and the day of symptoms was performed. Results: From Mar 10 to May 31, 2020, 289 participants were enrolled, and 384 samples were analyzed. Patients were categorized by clinical manifestations to mild (n=59), moderate (n=27) and severe (n=32). The overall sensitivity SERO of IgA and IgG from samples collected after day 7 is 87.9% (95% CI 79.8-93.6) and 84.8% (95% CI 76.2-91.3), respectively. The severe group had a significantly higher level of specific IgA and IgG to S1 antigen compared to the mild group. All moderate to severe patients have specific IgG while 20% of the mild group did not have any IgG detected after two weeks. Interestingly, SARS-CoV-2 IgG level was significantly higher in males TRANS compared to females TRANS among the severe group (p=0.003). Conclusion: The serologic test SERO for SARS-CoV-2 has high sensitivity SERO after the second week after onset of illness. Serological response differs among patients with different severity and different sex.

    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.

    24 People, one test: Boosting test efficiency using pooled serum SERO antibody testing SERO for SARS-CoV-2

    Authors: Stefan Nessler; Jonas Franz; Franziska van der Meer; Konstantina Kolotourou; Vivek Venkataramani; Chalid Hasan; Beatrix Beatrix Pollok-Kopp; Andreas E Zautner; Christine Stadelmann; Michael Weig; Stefan Poehlmann; Markus Hoffmann; Joachim Riggert; Graham Medley; Michael Hohle; John Edmunds; Chris Fitzsimmons; Tim Harris; Fiona Lecky; Andrew Lee; Ian Maconochie; Darren Walter; Dilek Telci; Fikrettin Sahin; Koray Yalcin; Ercument Ovali

    doi:10.1101/2020.09.01.20186130 Date: 2020-09-03 Source: medRxiv

    Background: The global pandemic of COVID-19 (coronavirus disease 2019) is caused by the novel coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2 MESHD), with different prevalence SERO rates across countries and regions. Dynamic testing strategies are mandatory to establish efficient mitigation strategies against the disease; to be cost effective, they should adapt to regional prevalences SERO. Seroprevalence SERO surveys that detect individuals who have mounted an immune response against COVID-19 will help to determine the total number of infections within a community and improve the epidemiological calculations of attack and case fatality rates of the virus. They will also inform about the percentage of a population that might be immune against re-infections. Methods: We developed a sensitive and specific cell-based assay to detect conformational SARS-CoV-2 spike MESHD (SARS-2-S) S1 antibodies SERO in human serum SERO, and have cross-evaluated this assay against two FDA-approved SARS-CoV-2 antibody SERO assays. We performed pseudovirus neutralization assays to determine whether sera that were rated antibody SERO-positive in our assay were able to specifically neutralize SARS-2-S. We pooled up to 24 sera and assessed the group testing performance SERO of our cell-based assay. Group testing was further optimized by Monte Carlo like simulations and prospectively evaluated. Findings: Highly significant correlations could be established between our cell-based assay and commercial antibody tests SERO for SARS-CoV-2. SARS-2-S S1 antibody SERO-positive sera neutralized SARS-2-S but not SARS-S MESHD, and were sensitively and specifically detected in pools of 24 samples. Monte Carlo like simulations demonstrated that a simple two-step pooling scheme with fixed pool sizes performed at least equally as well as Dorfman's optimal testing across a wide range of antibody SERO prevalences SERO. Interpretation: We demonstrate that a cell-based assay for SARS-2-S S1 antibodies SERO qualifies for group testing of neutralizing anti-SARS-2-S antibodies SERO. The assay can be combined with an easily implemented algorithm which greatly expands the screening capacity to detect anti-SARS-2-S antibodies SERO across a wide range of antibody SERO prevalences SERO. It will thus improve population serological testing SERO in many countries.

    Comparative performance SERO of five commercially available serologic assays to detect antibodies to SARS-CoV-2 SERO and identify individuals with high neutralizing titers

    Authors: Eshan Patel; Evan M Bloch; William Clarke; Yu-Hsiang Hsieh; Denali Boon; Yolanda J Eby; Reinaldo E Fernandez; Owen R Baker; Morgan Keruly; Charles S Kirby; Ethan Klock; Kirsten Littlefield; Jernelle Miller; Haley A Schmidt; Philip Sullivan; Estelle Piwowar-Manning; Ruchee Shrestha; Andrew D Redd; Richard Eric Rothman; David J Sullivan; Shmuel Shoham; Arturo Casadevall; Thomas C. Quinn; Andrew Pekosz; Aaron AR Tobian; Oliver Laeyendecker; William Damsky; David van Dijk; Alfred Ian Lee; Hyung Chun; Akhil Vaid; Guillermo Barturen; Scott R. Tyler; Hardik Shah; Yinh-chih Wang; Shwetha Hara Sridhar; Juan Soto; Swaroop Bose; Kent Madrid; Ethan Ellis; Elyze Merzier; Konstantinos Vlachos; Nataly Fishman; Manying Tin; Melissa Smith; Hui Xie; Manishkumar Patel; Kimberly Argueta; Jocelyn Harris; Neha Karekar; Craig Batchelor; Jose Lacunza; Mahlet Yishak; Kevin Tuballes; Leisha Scott; Arvind Kumar; Suraj Jaladanki; Ryan Thompson; Evan Clark; Bojan Losic; - The Mount Sinai COVID-19 Biobank Team; Jun Zhu; Wenhui Wang; Andrew Kasarskis; Benjamin S. Glicksberg; Girish Nadkarni; Dusan Bogunovic; Cordelia Elaiho; Sandeep Gangadharan; George Ofori-Amanfo; Kasey Alesso-Carra; Kenan Onel; Karen M. Wilson; Carmen Argmann; Marta E. Alarcón-Riquelme; Thomas U. Marron; Adeeb Rahman; Seunghee Kim-Schulze; Sacha Gnjatic; Bruce D. Gelb; Miriam Merad; Robert Sebra; Eric E. Schadt; Alexander W. Charney

    doi:10.1101/2020.08.31.20184788 Date: 2020-09-02 Source: medRxiv

    Accurate serological assays SERO to detect antibodies to SARS-CoV-2 SERO are needed to characterize the epidemiology of SARS-CoV-2 infection MESHD and identify potential candidates for COVID-19 convalescent plasma SERO (CCP) donation. This study compared the performance SERO of commercial enzyme immunoassays SERO (EIAs) to detect IgG or total antibodies to SARS-CoV-2 and neutralizing SERO antibodies SERO (nAb). The diagnostic accuracy of five commercially available EIAs (Abbott, Euroimmun, EDI, ImmunoDiagnostics, and Roche) to detect IgG or total antibodies to SARS-CoV-2 SERO was evaluated from cross-sectional samples of potential CCP donors that had prior molecular confirmation of SARS-CoV-2 infection MESHD for sensitivity SERO (n=214) and pre-pandemic emergency department patients for specificity (n=1,102). Of the 214 potential CCP donors, all were sampled >14 days since symptom onset TRANS and only a minority had been hospitalized due to COVID-19 (n=16 [7.5%]); 140 potential CCP donors were tested by all five EIAs and a microneutralization assay. When performed according to the manufacturers protocol to detect IgG or total antibodies to SARS-CoV-2 SERO, the sensitivity SERO of each EIA ranged from 76.4% to 93.9%, and the specificity of each EIA ranged from 87.0% to 99.6%. Using a nAb titer cutoff of [≥]160 as the reference positive test (n=140 CCP donors), the empirical area under receiver operating curve of each EIA ranged from 0.66 (Roche) to 0.90 (Euroimmun). Commercial EIAs with high diagnostic accuracy to detect SARS-CoV-2 antibodies SERO did not necessarily have high diagnostic accuracy to detect high nAbs. Some but not all commercial EIAs may be useful in the identification of individuals with high nAbs in convalescent individuals.

    Seroprevalence SERO of SARS-CoV-2 antibodies SERO in children TRANS - A prospective multicentre cohort study.

    Authors: Thomas Waterfield; Chris Watson; Rebecca Moore; Kathryn Ferris; Claire Tonry; Alison P Watt; Claire McGinn; Steven Foster; Jennifer Evans; Mark D Lyttle; Shazaad Ahmad; Shamez Ladhani; Michael Corr; Lisa McFetridge; Hannah Mitchell; Kevin Brown; Gayatric Amirthalingam; Julie-Ann Maney; Sharon Christie; Angela Afonso; Marc Veldhoen; Matthew Harnett; Melody Eaton; Sandra Hatem; Hajra Jamal; Alara Akyatan; Alexandra Tabachnikova; Lora E. Liharska; Liam Cotter; Brian Fennessey; Akhil Vaid; Guillermo Barturen; Scott R. Tyler; Hardik Shah; Yinh-chih Wang; Shwetha Hara Sridhar; Juan Soto; Swaroop Bose; Kent Madrid; Ethan Ellis; Elyze Merzier; Konstantinos Vlachos; Nataly Fishman; Manying Tin; Melissa Smith; Hui Xie; Manishkumar Patel; Kimberly Argueta; Jocelyn Harris; Neha Karekar; Craig Batchelor; Jose Lacunza; Mahlet Yishak; Kevin Tuballes; Leisha Scott; Arvind Kumar; Suraj Jaladanki; Ryan Thompson; Evan Clark; Bojan Losic; - The Mount Sinai COVID-19 Biobank Team; Jun Zhu; Wenhui Wang; Andrew Kasarskis; Benjamin S. Glicksberg; Girish Nadkarni; Dusan Bogunovic; Cordelia Elaiho; Sandeep Gangadharan; George Ofori-Amanfo; Kasey Alesso-Carra; Kenan Onel; Karen M. Wilson; Carmen Argmann; Marta E. Alarcón-Riquelme; Thomas U. Marron; Adeeb Rahman; Seunghee Kim-Schulze; Sacha Gnjatic; Bruce D. Gelb; Miriam Merad; Robert Sebra; Eric E. Schadt; Alexander W. Charney

    doi:10.1101/2020.08.31.20183095 Date: 2020-09-02 Source: medRxiv

    Background Studies based on molecular testing of oral/nasal swabs underestimate SARS-CoV-2 infection MESHD due to issues with test sensitivity SERO and timing of testing. The objective of this study was to report the presence of SARS-CoV-2 antibodies SERO, consistent with previous infection MESHD, and to report the symptomatology of infection MESHD in children TRANS. Design This multicentre observational cohort study, conducted between 16th April - 3rd July 2020 at 5 UK sites, aimed to recruit 900 children TRANS aged TRANS 2 to 15 years of age TRANS. Participants provided blood SERO samples for SARS-CoV-2 antibody SERO testing and data were gathered regarding unwell contacts and symptoms. Results 1007 participants were enrolled, and 992 were included in the final analysis. The median age TRANS of participants was 10.1 years. There were 68 (6.9%) participants with positive SARS-CoV-2 antibody SERO tests indicative of previous SARS-CoV-2 infection MESHD. Of these, 34/68 (50%) reported no symptoms. The presence of antibodies SERO and the mean antibody SERO titre was not influenced by age TRANS. Following multivariate analysis 4 independent variables were identified as significantly associated with SARS-CoV-2 infection MESHD. These were: known infected household contact TRANS; fatigue HP fatigue MESHD; gastrointestinal symptoms; and changes in sense of smell or taste. Discussion In this study children TRANS demonstrated similar antibody SERO titres in response to SARS-CoV-2 irrespective of age TRANS. The symptoms of SARS-CoV-2 infection MESHD in children TRANS were subtle but of those reported, fatigue HP fatigue MESHD, gastrointestinal symptoms MESHD and changes in sense of smell or taste were most strongly associated with antibody SERO positivity. Registration This study was registered at (trial registration: NCT04347408) on the 15/04/2020.

    Seroprevalence SERO and immunity of SARS-CoV-2 infection MESHD in children TRANS and adolescents in schools in Switzerland: design for a longitudinal, school-based prospective cohort study

    Authors: Agne Ulyte; Thomas Radtke; Irene Abela; Sarah H Haile; Julia Braun; Ruedi Jung; Christoph Berger; Alexandra Trkola; Jan Fehr; Milo A Puhan; Susi Kriemler; Anel Nurtay; Lucie Abeler-Dörner; David G Bonsall; Michael V McConnell; Shawn O'Banion; Christophe Fraser; Scott Roberts; Jose A. Gonzalez; Marciano Sablad; Rodrigo Yelin; Wendy Taylor; Kiyoshi Tachikawa; Suezanne Parker; Priya Karmali; Jared Davis; Sean M Sullivan; Steve G. Hughes; Pad Chivukula; Eng Eong Ooi

    doi:10.1101/2020.08.30.20184671 Date: 2020-09-02 Source: medRxiv

    Introduction Seroprevalence SERO and transmission TRANS routes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection MESHD in children TRANS and adolescents, especially in school setting, are not clear. Resulting uncertainty is reflected in very different decisions on school closures and reopenings across countries. The aim of this longitudinal cohort study is to assess the extent and patterns of seroprevalence SERO of SARS-CoV-2 antibodies SERO in school-attending children TRANS repeatedly. It will examine risk factors for infection MESHD, relationship between seropositivity and symptoms, and temporal persistence of antibodies SERO. Additionally, it will include testing of school personnel and parents TRANS. Methods and analysis The study (Ciao Corona) will enroll a regionally representative, random sample of schools in the canton of Zurich, where 18% of the Swiss population live. Children TRANS aged TRANS 5 to 16 years, attending classes in primary and secondary schools are invited. Venous blood MESHD blood SERO and saliva samples are collected for SARS-CoV-2 serological testing SERO after the first wave of infections (June/July 2020), in fall HP (October/November 2020), and after winter (March/April 2021). Venous blood MESHD blood SERO is also collected for serological testing SERO of parents TRANS and school personnel. Bi-monthly questionnaires to children TRANS, parents TRANS and school personnel cover SARS-CoV-2 symptoms MESHD and tests, health, preventive behavior, lifestyle and quality of life information. Total seroprevalence SERO and cumulative incidence will be calculated. Hierarchical Bayesian logistic regression models will account for sensitivity SERO and specificity of the serological test SERO in the analyses and for the complex sampling structure, i.e., clustering within classes and schools. Ethics and dissemination The study was approved by the Ethics Committee of the Canton of Zurich, Switzerland (2020-01336). The results of this study will be published in peer-reviewed journals and will be made available to study participants and participating schools, the Federal Office of Public Health, and the Educational Department of the canton of Zurich. Trial registration number NCT04448717.

    Development and calibration of a simple mortality risk score for hospitalized COVID-19 adults TRANS

    Authors: Edwin Yoo; Bethany Percha; Max Tomlinson; Victor Razuk; Stephanie Pan; Madeleine Basist; Pranai Tandon; Jing Gennie Wang; Cynthia Gao; Sonali Bose; Umesh K Gidwani; - Cambridge Lung Cancer Early Detection Programme; - INER-Ciencias Mexican Lung Program; - NHLBI LungMAP Consortium; Margaret Neighbors; Gaik W. Tew; Michele Grimbaldeston; Nick H.T. ten Hacken; Sile Hu; Yike Guo; Xiaoyu Zhang; Kai Sun; Pieter S. Hiemstra; Bruce A. Ponder; Mika J Makela; Kristiina Malmstrom; Robert C. Rintoul; Paul A. Reyfman; Fabian J. Theis; Corry-A Brandsma; Ian Adcock; Wim Timens; Cheng J. Xu; Maarten van den Berge; Roland F. Schwarz; Gerard H. Koppelman; Martijn C. Nawijn; Alen Faiz

    doi:10.1101/2020.08.31.20185363 Date: 2020-09-02 Source: medRxiv

    Objectives: Mortality risk scores, such as SOFA, qSOFA, and CURB-65, are quick, effective tools for communicating a patient's prognosis and guiding therapeutic decisions. Most use simple calculations that can be performed by hand. While several COVID-19 specific risk scores exist, they lack the ease of use of these simpler scores. The objectives of this study were (1) to design, validate, and calibrate a simple, easy-to-use mortality risk score for COVID-19 patients and (2) to recalibrate SOFA, qSOFA, and CURB-65 in a hospitalized COVID-19 population. Design: Retrospective cohort study incorporating demographic, clinical, laboratory, and admissions data from electronic health records. Setting: Multi-hospital health system in New York City. Five hospitals were included: one quaternary care facility, one tertiary care facility, and three community hospitals. Participants: Patients (n=4840) with laboratory-confirmed SARS-CoV2 infection MESHD who were admitted between March 1 and April 28, 2020. Main outcome measures: Gray's K-sample test for the cumulative incidence of a competing risk was used to assess and rank 48 different variables' associations with mortality. Candidate variables were added to the composite score using DeLong's test to evaluate their effect on predictive performance SERO (AUC) of in-hospital mortality. Final AUCs for the new score, SOFA, qSOFA, and CURB-65 were assessed on an independent test set. Results: Of 48 variables investigated, 36 (75%) displayed significant (p<0.05 by Gray's test) associations with mortality. The variables selected for the final score were (1) oxygen support level, (2) troponin, (3) blood SERO urea nitrogen, (4) lymphocyte percentage, (5) Glasgow Coma HP Coma MESHD Score, and (6) age TRANS. The new score, COBALT, outperforms SOFA, qSOFA, and CURB-65 at predicting mortality in this COVID-19 population: AUCs for initial, maximum, and mean COBALT scores were 0.81, 0.91, and 0.92, compared to 0.77, 0.87, and 0.87 for SOFA. We provide COVID-19 specific mortality estimates at all score levels for COBALT, SOFA, qSOFA, and CURB-65. Conclusions: The COBALT score provides a simple way to estimate mortality risk in hospitalized COVID-19 patients with superior performance SERO to SOFA and other scores currently in widespread use. Evaluation of SOFA, qSOFA, and CURB-65 in this population highlights the importance of recalibrating mortality risk scores when they are used under novel conditions, such as the COVID-19 pandemic. This study's approach to score design could also be applied in other contexts to create simple, practical and high-performing mortality risk scores.

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MeSH Disease
Human Phenotype

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