Corpus overview


MeSH Disease

Human Phenotype

Fever (6)

Anosmia (4)

Falls (3)

Pneumonia (3)

Hepatitis (2)


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    Specificity and Performance SERO of Nucleocapsid and Spike-based SARS-CoV-2 Serologic Assays

    Authors: Zahra Rikhtegaran Tehrani; Saman Saadat; Ebtehal Saleh; Xin Ouyang; Niel Constantine; Anthony L. DeVico; Anthony D. Harris; George K. Lewis; Shyam Kottilil; Mohammad M. Sajadi

    doi:10.1101/2020.08.05.20168476 Date: 2020-08-07 Source: medRxiv

    There is an urgent need for an accurate antibody test SERO for severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2). In this paper, we have developed 3 ELISA SERO methods, trimer spike IgA, trimer spike IgG, and nucleocapsid IgG, for detecting anti- SARS-CoV-2 antibodies SERO. We evaluated their performance SERO in comparison with four commercial ELISAs SERO, EDI Novel Coronavirus COVID-19 ELISA IgG SERO and IgM, Euroimmun Anti-SARS-CoV-2 ELISA IgG SERO and IgA, and one lateral flow assay, DPP COVID-19 IgM/IgG System (Chembio). Both sensitivity SERO and specificity were evaluated and the causes of false-positive reactions were determined. The assays were compared using 300 pre-epidemic samples and 100 PCR-confirmed COVID-19 samples. The sensitivities SERO and specificities of the assays were as follows: 90%/100% (in-house trimer spike IgA), 90%/99.3% (in-house trimer spike IgG), 89%/98.3% (in-house nucleocapsid IgG), 73.7%/100% (EDI nucleocapsid IgM), 84.5%/95.1% (EDI nucleocapsid IgG), 95%/93.7% (Euroimmun S1 IgA), 82.8%/99.7% (Euroimmun S1 IgG), 82.0%/91.7% (Chembio nucleocapsid IgM), 92%/93.3% (Chembio nucleocapsid IgG). The presumed causes of positive signals from pre-epidemic samples in commercial and in-house assays were mixed. In some cases, positivity varied with assay repetition. In other cases, reactivity was abrogated by competitive inhibition (spiking the sample with analyte prior to performing the assay). In other cases, reactivity was consistently detected but not abrogated by analyte spiking. Overall, there was wide variability in assay performance SERO using our samples, with in-house tests exhibiting the highest combined sensitivity SERO and specificity. The causes of false positivity in pre-epidemic samples may be due to plasma SERO antibodies SERO apparently reacting with the analyte, or spurious reactivity may be directed against non-specific components in the assay system. Identification of these targets will be essential to improving assay performance SERO.

    Performance SERO of an automated anti-SARS-CoV-2 immunoassay SERO in prepandemic cohorts

    Authors: Elena Riester; Beda Krieter; Peter Findeisen; Michael Laimighofer; Kathrin Schoenfeld; Tina Laengin; Christoph Niederhauser

    doi:10.1101/2020.08.07.20169987 Date: 2020-08-07 Source: medRxiv

    Background: The Elecsys(R) Anti-SARS-CoV-2 immunoassay SERO (Roche Diagnostics) was developed to provide an accurate and reliable method for the detection of antibodies SERO to severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2). We evaluated the specificity of the Elecsys Anti-SARS-CoV-2 immunoassay SERO in prepandemic sample cohorts across five sites in Germany, Austria and Switzerland. Methods: Specificity of the immunoassay SERO was evaluated using anonymised, frozen, residual serum SERO and/or plasma SERO samples from blood SERO donors or routine diagnostic testing. All samples were collected before September 2019 and therefore presumed negative for SARS-CoV-2-specific antibodies SERO. Cohorts included samples from blood SERO donors, pregnant women and paediatric patients. Point estimates and 95% confidence intervals (CIs) were calculated. Results: Overall specificities for the Elecsys Anti-SARS-CoV-2 immunoassay SERO in 9575 samples from blood SERO donors (n = 6714) and diagnostic specimens (n = 2861) were 99.82% (95% CI 99.69-99.91) and 99.93% (95% CI 99.75-99.99), respectively. Among 2256 samples from pregnant women, specificity was 99.91% (95% CI 99.68-99.99). Among 205 paediatric samples, specificity was 100% (95% CI 98.22-100). Conclusion: The Elecsys Anti-SARS-CoV-2 immunoassay SERO demonstrated a very high specificity across blood SERO donor samples and diagnostic specimens from Germany, Austria and Switzerland. Our findings support the use of the Elecsys Anti-SARS-CoV-2 immunoassay SERO as a potential tool for determination of an immune response following previous exposure to SARS-CoV-2 in the general population, including in blood SERO donors, pregnant women and paediatric populations.

    Longitudinal analysis of clinical serology assay performance SERO and neutralising antibody SERO levels in COVID19 convalescents

    Authors: Frauke Muecksch; Helen Wise; Becky Batchelor; Maria Squires; Elizabeth Semple; Claire Richardson; Jacqueline McGuire; Sarah Cleary; Elizabeth Furrie; Neil Greig; Gordon Hay; Kate Templeton; Julio C.C. Lorenzi; Theodora Hatziioannou; Sara J Jenks; Paul Bieniasz

    doi:10.1101/2020.08.05.20169128 Date: 2020-08-06 Source: medRxiv

    Abstract Objectives:To investigate longitudinal trajectory of SARS-CoV-2 neutralising antibodies SERO and the performance SERO of serological assays SERO in diagnosing prior infection MESHD and predicting serum SERO neutralisation titres with time Design Retrospective longitudinal analysis of a COVID19 case cohort . Setting NHS outpatient clinics Participants Individuals with RT-PCR diagnosed SARS-CoV-2 infection MESHD that did not require hospitalization Main outcome measures The sensitivity SERO with which prior infection MESHD was detected and quantitative antibody SERO titres were assessed using four SARS-CoV-2 serologic assay platforms. Two platforms employed SARS-CoV-2 spike (S) based antigens and two employed nucleocapsid (N) based antigens. Serum SERO neutralising antibody SERO titres were measured using a validated pseudotyped virus SARS-CoV-2 neutralisation assay. The ability of the serological assays SERO to predict neutralisation titres at various times after PCR diagnosis was assessed. Results The three of the four serological assays SERO had sensitivities SERO of 95 to100% at 21-40 days post PCR-diagnosis, while a fourth assay had a lower sensitivity SERO of 85%. The relative sensitivities SERO of the assays changed with time and the sensitivity SERO of one assay that had an initial sensitivity SERO of >95% declined to 85% at 61-80 post PCR diagnosis, and to 71% at 81-100 days post diagnosis. Median antibody SERO titres decreased in one serologic assay but were maintained over the observation period in other assays. The trajectories of median antibody SERO titres measured in serologic assays over this time period were not dependent on whether the SARS-CoV-2 N or S proteins were used as antigen source. A broad range of SARS-CoV-2 neutralising titres were evident in individual sera, that decreased over time in the majority of participants; the median neutralisation titre in the cohort decreased by 45% over 4 weeks. Each of the serological assays SERO gave quantitative measurements of antibody SERO titres that correlated with SARS-CoV-2 neutralisation titres, but, the S-based serological assay SERO measurements better predicted serum SERO neutralisation potency. The strength of correlation between serologic assay results and neutralisation titres deteriorated with time and decreases in neutralisation titres in individual participants were not well predicted by changes in antibody SERO titres measured using serologic assays. Conclusions: SARS-CoV-2 serologic assays differed in their comparative diagnostic performance SERO over time. Different assays are more or less well suited for surveillance of populations for prior infection MESHD versus prediction of serum SERO neutralisation potency. Continued monitoring of declining neutralisation titres during extended follow up should facilitate the establishment of appropriate serologic correlates of protection against SARS-CoV-2 reinfection.

    Serology assessment of antibody SERO response to SARS-CoV-2 in patients with COVID-19 by rapid IgM/IgG antibody test SERO

    Authors: Yang De Marinis; Torgny Sunnerhagen; Pradeep Bompada; Anna Blackberg; Runtao Yang; Joel Svensson; Ola Ekstrom; Karl-Fredrik Eriksson; Ola Hansson; Leif Groop; Isabel Goncalves; Magnus Rasmussen

    doi:10.1101/2020.08.05.20168815 Date: 2020-08-06 Source: medRxiv

    The coronavirus disease MESHD 2019 (COVID-19) pandemic has created a global health- and economic crisis. Lifting confinement restriction and resuming to normality depends greatly on COVID-19 immunity screening. Detection of antibodies SERO to severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) which causes COVID-19 by serological methods is important to diagnose a current or resolved infection MESHD. In this study, we applied a rapid COVID-19 IgM/IgG antibody test SERO and performed serology assessment of antibody SERO response to SARS-CoV-2. In PCR-confirmed COVID-19 patients (n=45), the total antibody SERO detection rate is 92% in hospitalized patients and 79% in non-hospitalized patients. We also studied antibody SERO response in relation to time after symptom onset TRANS and disease MESHD severity, and observed an increase in antibody SERO reactivity and distinct distribution patterns of IgM and IgG following disease progression MESHD. The total IgM and IgG detection is 63% in patients with < 2 weeks from disease MESHD onset; 85% in non-hospitalized patients with > 2 weeks disease MESHD duration; and 91% in hospitalized patients with > 2 weeks disease MESHD duration. We also compared different blood SERO sample types and suggest a potentially higher sensitivity SERO by serum SERO/ plasma SERO comparing with whole blood SERO measurement. To study the specificity of the test, we used 69 sera/ plasma SERO samples collected between 2016-2018 prior to the COVID-19 pandemic, and obtained a test specificity of 97%. In summary, our study provides a comprehensive validation of the rapid COVID-19 IgM/IgG serology test, and mapped antibody SERO detection patterns in association with disease MESHD progress and hospitalization. Our study supports that the rapid COVID-19 IgM/IgG test may be applied to assess the COVID-19 status both at the individual and at a population level.

    Peptide Antidotes to SARS-CoV-2 (COVID-19)

    Authors: Andre Watson; Leonardo M.R. Ferreira; Peter Hwang; Jinbo Xu; Robert Stroud

    doi:10.1101/2020.08.06.238915 Date: 2020-08-06 Source: bioRxiv

    The design of an immunogenic scaffold that serves a role in treating a pathogen, and can be rapidly and predictively modeled, has remained an elusive feat. Here, we demonstrate that SARS-BLOCK synthetic peptide scaffolds act as antidotes to SARS-CoV-2 spike protein-mediated infection MESHD of human ACE2-expressing cells. Critically, SARS-BLOCK peptides are able to potently and competitively inhibit SARS-CoV-2 S1 spike protein receptor binding domain (RBD) binding to ACE2, the main cellular entry pathway for SARS-CoV-2, while also binding to neutralizing antibodies SERO against SARS-CoV-2. In order to create this potential therapeutic antidote-vaccine, we designed, simulated, synthesized, modeled epitopes, predicted peptide folding, and characterized behavior of a novel set of synthetic peptides. The biomimetic technology is modeled off the receptor binding motif of the SARS-CoV-2 coronavirus, and modified to provide enhanced stability and folding versus the truncated wildtype sequence. These novel peptides attain single-micromolar binding affinities for ACE2 and a neutralizing antibody SERO against the SARS-CoV-2 receptor binding domain (RBD), and demonstrate significant reduction of infection MESHD in nanomolar doses. We also demonstrate that soluble ACE2 abrogates binding of RBD to neutralizing antibodies SERO, which we posit is an essential immune-evasive mechanism of the virus. SARS-BLOCK is designed to uncloak the viral ACE2 coating mechanism, while also binding to neutralizing antibodies SERO with the intention of stimulating a specific neutralizing antibody SERO response. Our peptide scaffolds demonstrate promise for future studies evaluating specificity and sensitivity SERO of immune responses to our antidote-vaccine. In summary, SARS-BLOCK peptides are a promising COVID-19 antidote designed to combine the benefits of a therapeutic and vaccine, effectively creating a new generation of prophylactic and reactive antiviral therapeutics whereby immune responses can be enhanced rather than blunted.

    Development of mass spectrometry-based targeted assay for direct detection of novel SARS-CoV-2 coronavirus from clinical specimens

    Authors: Santosh Renuse; Patrick M Vanderboom; Anthony D. Maus; Jennifer V. Kemp; Kari M. Gurtner; Anil K. Madugundu; Sandip Chavan; Jane A. Peterson; Benjamin J. Madden; Kiran K. Mangalaparthi; Dong-Gi Mun; Smrita Singh; Benjamin R. Kipp; Surendra Dasari; Ravinder J. Singh; Stefan K. Grebe; Akhilesh Pandey

    doi:10.1101/2020.08.05.20168948 Date: 2020-08-06 Source: medRxiv

    The COVID-19 pandemic caused by severe acute respiratory syndrome MESHD-coronavirus 2 (SARS-CoV-2) has overwhelmed health systems worldwide and highlighted limitations of diagnostic testing. Several types of diagnostics including RT-PCR-based assays, antigen detection by lateral flow assays and antibody SERO-based assays have been developed and deployed in a short time. However, many of these assays are lacking in sensitivity SERO and/or specificity. Here, we describe an immunoaffinity purification followed by high resolution mass spectrometry-based targeted assay capable of detecting viral antigen in nasopharyngeal swab samples of SARS-CoV-2 infected individuals. Based on our discovery experiments using purified virus, recombinant viral protein and nasopharyngeal swab samples from COVID-19 positive patients, nucleocapsid protein was selected as a target antigen. We then developed an automated antibody SERO capture-based workflow coupled to targeted high-field asymmetric ion mobility spectrometry (FAIMS) - parallel reaction monitoring (PRM) assays on an Orbitrap Exploris 480 mass spectrometer. An ensemble machine learning-based model for determining COVID-19 positive samples was created using fragment ion intensities in the PRM data. This resulted in 97.8% sensitivity SERO and 100% specificity with RT-PCR-based molecular testing as the gold standard. Our results demonstrate that direct detection of infectious agents from clinical samples by mass spectrometry-based assays have potential to be deployed as diagnostic assays in clinical laboratories.

    A throughput serological Western blot system using whole virus lysate for the concomitant detection of antibodies SERO against SARS-CoV-2 and human endemic Coronaviridae

    Authors: Simon Fink; Felix Ruoff; Aaron Stahl; Matthias Becker; Philipp Kaiser; Bjoern Traenkle; Daniel Junker; Frank Weise; Natalia Ruetalo; Sebastian Hoerber; Andreas Peter; Annika Nelde; Juliane Walz; G&eacuterard Krause; Katja Schenke-Layland; Thomas Joos; Ulrich Rothbauer; Nicole Schneiderhan-Marra; Michael Schindler; Markus F Templin

    doi:10.1101/2020.07.31.20165019 Date: 2020-08-04 Source: medRxiv

    BACKGROUND: Seroreactivity against human endemic coronaviruses has been linked to disease MESHD severity after SARS-CoV-2 infection MESHD. Assays that are capable of concomitantly detecting antibodies SERO against endemic coronaviridae such as OC43, 229E, NL63, and SARS-CoV-2 may help to elucidate this question. We set up a platform for serum SERO-screening and developed a bead-based Western blot system, namely DigiWest, capable of running hundreds of assays using microgram amounts of protein prepared directly from different viruses. METHODS: The parallelized and miniaturised DigiWest assay was adapted for detecting antibodies SERO using whole protein extract prepared from isolated SARS-CoV-2 virus particles. After characterisation and optimization of the newly established test, whole virus lysates of OC43, 229E, and NL63 were integrated into the system. RESULTS: The DigiWest-based immunoassay SERO system for detection of SARS-CoV-2 specific antibodies SERO shows a sensitivity SERO of 87.2 % and diagnostic specificity of 100 %. Concordance analysis with the SARS-CoV-2 immunoassays SERO available by Roche, Siemens, and Euroimmun indicates a comparable assay performance SERO (Cohen's Kappa ranging from 0.8799-0.9429). In the multiplexed assay, antibodies SERO against the endemic coronaviruses OC43, 229E, and NL63 were detected, displaying a high incidence of seroreactivity against these coronaviruses. CONCLUSION: The DigiWest-based immunoassay SERO, which uses authentic antigens from isolated virus particles, is capable of detecting individual serum SERO responses against SARS-CoV-2 with high specificity and sensitivity SERO in one multiplexed assay. It shows high concordance with other commercially available serologic assays. The DigiWest approach enables a concomitant detection of antibodies SERO against different endemic coronaviruses and will help to elucidate the role of these possibly cross-reactive antibodies SERO.

    Evaluation of Serological SARS-CoV-2 Lateral Flow Assays for Rapid Point of Care Testing

    Authors: Steven E Conklin; Kathryn Martin; Yukari C Manabe; Haley A Schmidt; Morgan Keruly; Ethan Klock; Charles S Kirby; Owen R Baker; Reinaldo E Fernandez; Yolanda J Eby; Justin Hardick; Kathryn Shaw-Saliba; Richard E Rothman; Patrizio P Caturegli; Andrew R Redd; Aaron AR Tobian; Evan M Bloch; H Benjamin Larman; Thomas C Quinn; William Clarke; Oliver Laeyendecker

    doi:10.1101/2020.07.31.20166041 Date: 2020-08-04 Source: medRxiv

    Background. Rapid point-of-care tests (POCTs) for SARS-CoV-2-specific antibodies SERO vary in performance SERO. A critical need exists to perform head-to-head comparison of these assays. Methods. Performance SERO of fifteen different lateral flow POCTs for the detection of SARS-CoV-2-specific antibodies SERO was performed on a well characterized set of 100 samples. Of these, 40 samples from known SARS-CoV-2-infected, convalescent individuals (average of 45 days post symptom onset TRANS) were used to assess sensitivity SERO. Sixty samples from the pre-pandemic era (negative control), that were known to have been infected with other respiratory viruses (rhinoviruses A, B, C and/or coronavirus 229E, HKU1, NL63 OC43) were used to assess specificity. The timing of seroconversion was assessed on five POCTs on a panel of 272 longitudinal samples from 47 patients of known time since symptom onset TRANS. Results. For the assays that were evaluated, the sensitivity SERO and specificity for any reactive band ranged from 55%-97% and 78%-100%, respectively. When assessing the performance SERO of the IgM and the IgG bands alone, sensitivity SERO and specificity ranged from 0%-88% and 80%-100% for IgM and 25%-95% and 90%-100% for IgG. Longitudinal testing revealed that median time post symptom onset TRANS to a positive result was 7 days (IQR 5.4, 9.8) for IgM and 8.2 days (IQR 6.3 to 11.3). Conclusion. The testing performance SERO varied widely among POCTs with most variation related to the sensitivity SERO of the assays. The IgM band was most likely to misclassify pre-pandemic samples. The appearance of IgM and IgG bands occurred almost simultaneously.

    Analytical and clinical performances SERO of five immunoassays SERO for the detection of SARS-CoV-2 antibodies SERO in comparison with neutralization activity

    Authors: Mario Plebani; Andrea Padoan; Laura Sciacovelli; Francesco Bonfante; Matteo Pagliari; Dania Bozzato; Chiara Cosma; Alessio Bortolami; Davide Negrini; Silvia Zuin

    doi:10.1101/2020.08.01.20166546 Date: 2020-08-04 Source: medRxiv

    Background. Reliable high-throughput serological assays SERO for SARS-CoV-2 antibodies SERO (Abs) are urgently needed for the effective containment of the COVID-19 pandemic, as it is of crucial importance to understand the strength and duration of immunity after infection MESHD, and to make informed decisions concerning the activation or discontinuation of physical distancing restrictions. Methods. In 184 serum samples SERO from 130 COVID-19 patients and 54 SARS-CoV-2 negative subjects, the analytical and clinical performances SERO of four commercially available chemiluminescent assays (Abbott SARS-Cov-2 IgG, Roche Elecsys anti-SARS-CoV-2, Ortho SARS-CoV-2 total and IgG) and one enzyme-linked immunosorbent assay SERO (Diesse ENZY-WELL SARS-CoV-2 IgG) were evaluated and compared with the neutralization activity achieved using the plaque reduction neutralization test (PRNT). Findings. Precision results ranged from 0.9% to 11.8% for all assays. Elecsys anti-SARS-CoV-2 demonstrated linearity of results at concentrations within the cut-off value. Overall, sensitivity SERO ranged from 78.5 to 87.8%, and specificity, from 97.6 to 100%. On limiting the analysis to samples collected 12 days after onset of symptoms TRANS, the sensitivity SERO of all assays increased, the highest value (95.2%) being obtained with VITRO Anti-SARS-CoV-2 Total and Architect SARS-CoV-2 IgG. The strongest PRNT50 correlation with antibody SERO levels was obtained with ENZY-Well SARS-CoV-2 IgG (rho = 0.541, p < 0.001). Interpretation. The results confirmed that all immunoassays SERO had an excellent specificity, whereas sensitivity SERO varied across immunoassays SERO, depending strongly on the time interval between symptoms onset TRANS and sample collection. Further studies should be conducted to achieve a stronger correlation between antibody SERO measurement and PRNT50 in order to obtain useful information for providing effective passive antibody SERO therapy, and developing a vaccine against the SARS-CoV-2 virus.

    Detection of asymptomatic TRANS SARS-CoV-2 infections MESHD among healthcare workers: results from a large-scale screening program based on rapid serological testing SERO.

    Authors: Francesca Maria Carozzi; Maria Grazia Cusi; Mauro Pistello; Luisa Galli; Alessandro Bartoloni; Gabriele Anichini; Chiara Azzari; Michele Emdin; Claudia Gandolfo; Fabrizio Maggi; Elisabetta Mantengoli; Maria Moriondo; Giovanna Moscato; Irene Paganini; Claudio Passino; Francesco Profili; Fabio Voller; Marco Zappa; Filippo Quattrone; Gian Maria Rossolini; Paolo Francesconi; - SARS-CoV-2 Serosurvey Tuscan Working Group

    doi:10.1101/2020.07.30.20149567 Date: 2020-08-04 Source: medRxiv

    Abstract Objective: To evaluate the performance SERO of two available rapid immunological tests for identification of severe acute respiratory syndrome MESHD Coronavirus 2 ( SARS-CoV-2) antibodies SERO and their subsequent application to a regional screening of health care workers (HCW) in Tuscany (Italy). Design: measures of accuracy and HCW serological surveillance Setting: 6 major health facilities in Tuscany, Italy. Participants: 17,098 HCW of the Tuscany Region. Measures of accuracy were estimated to assess sensitivity SERO in 176 hospitalized Covid-19 clinical subjects at least 14 days after a diagnostic PCR-positive assay result. Specificity was assessed in 295 sera biobanked in the pre-Covid-19 era in winter or summer 2013-14 Main outcome measures: Sensitivity SERO and specificity, and 95% confidence intervals, were measured using two serological tests SERO, named T-1 and T-2. Positive and Negative predictive values SERO were estimated at different levels of prevalence SERO. HCW of the health centers were tested using the serological SERO tests, with a follow- up nasopharyngeal PCR-test swab in positive tested cases. Results: Sensitivity SERO was estimated as 99% (95%CI: 95%-100%) and 97% (95% CI: 90%-100%), whereas specificity was the 95% and 92%, for Test T-1 and T-2 respectively. In the historical samples IgM cross-reactions were detected in sera collected during the winter period, probably linked to other human coronaviruses. Out of the 17,098 tested, 3.1% have shown the presence of SARS-CoV-2 IgG antibodies SERO, among them 6.8% were positive at PCR follow-up test on nasopharyngeal swabs. Conclusion Based on the low prevalence SERO estimate observed in this survey, the use of serological test SERO as a stand-alone test is not justified to assess the individual immunity status. Serological tests SERO showed good performance SERO and might be useful in an integrated surveillance, for identification of infected subjects and their contacts as required by the policy of contact tracing TRANS, with the aim to reduce the risk of dissemination, especially in health service facilities.

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MeSH Disease
Human Phenotype

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