Corpus overview


MeSH Disease

Human Phenotype


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    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.

    Seroprevalence SERO of Antibodies to SARS-CoV-2 SERO in US Blood SERO Donors

    Authors: Ralph R Vassallo; Marjorie D Bravo; Larry J Dumont; Kelsey Hazegh; Hany Kamel; Ehab F Abdo; Benjamin S Abella; Javed Akram; Ravi K Amaravadi; Derek C Angus; Yaseen M Arabi; Shehnoor Azhar; Lindsey R Baden; Arthur W Baker; Leila Belkhir; Thomas Benfield; Marvin A H Berrevoets; Cheng-Pin Chen; Tsung-Chia Chen; Shu-Hsing Cheng; Chien-Yu Cheng; Wei-Sheng Chung; Yehuda Z Cohen; Lisa N Cowan; Olav Dalgard; Fernando F de Almeida e Val; Marcus V G de Lacerda; Gisely C de Melo; Lennie Derde; Vincent Dubee; Anissa Elfakir; Anthony C Gordon; Carmen M Hernandez-Cardenas; Thomas Hills; Andy I M Hoepelman; Yi-Wen Huang; Bruno Igau; Ronghua Jin; Felipe Jurado-Camacho; Khalid S Khan; Peter G Kremsner; Benno Kreuels; Cheng-Yu Kuo; Thuy Le; Yi-Chun Lin; Wu-Pu Lin; Tse-Hung Lin; Magnus Nakrem Lyngbakken; Colin McArthur; Bryan McVerry; Patricia Meza-Meneses; Wuelton M Monteiro; Susan C Morpeth; Ahmad Mourad; Mark J Mulligan; Srinivas Murthy; Susanna Naggie; Shanti Narayanasamy; Alistair Nichol; Lewis A Novack; Sean M O'Brien; Nwora Lance Okeke; Lena Perez; Rogelio Perez-Padilla; Laurent Perrin; Arantxa Remigio-Luna; Norma E Rivera-Martinez; Frank W Rockhold; Sebastian Rodriguez-Llamazares; Robert Rolfe; Rossana Rosa; Helge Rosjo; Vanderson S Sampaio; Todd B Seto; Muhammad Shehzad; Shaimaa Soliman; Jason E Stout; Ireri Thirion-Romero; Andrea B Troxel; Ting-Yu Tseng; Nicholas A Turner; Robert J Ulrich; Stephen R Walsh; Steve A Webb; Jesper M Weehuizen; Maria Velinova; Hon-Lai Wong; Rebekah Wrenn; Fernando G Zampieri; Wu Zhong; David Moher; Steven N Goodman; John P A Ioannidis; Lars G Hemkens

    doi:10.1101/2020.09.17.20195131 Date: 2020-09-18 Source: medRxiv

    Background To identify blood SERO donors eligible to donate Coronavirus Disease-2019 (COVID-19) Convalescent Plasma SERO (CCP), a large blood SERO center began testing for antibodies SERO to SARS-CoV-2, the etiologic agent of COVID-19. We report the seroprevalence SERO of total immunoglobulin directed against the S1 spike protein of SARS-CoV-2 in US blood SERO donors. Methods Unique non-CCP donor sera from June 1-July 31, 2020 were tested with the Ortho VITROS Anti-SARS-CoV-2 total immunoglobulin assay (positive: signal-to-cutoff (S/C) =>1). Donor age TRANS, sex, race/ethnicity, ABO/RhD, education, and experience were compared to June and July 2019. Multivariate regressions were conducted to identify demographics associated with the presence of antibodies SERO and with S/C values. Results Unique donors (n=252,882) showed an overall seroprevalence SERO of 1.83% in June (1.37%) and July (2.26%), with the highest prevalence SERO in northern New Jersey (7.3%). In a subset of donors with demographic information (n=189,565), higher odds of antibody SERO reactivity were associated with non-Hispanic Native American/Alaskan (NH-NAA/A) and Black (NH-B), and Hispanic (H) race/ethnicity, age TRANS 18-64, middle school or lesser education, blood SERO Group A, and never or non-recent donor status. In positive donors (n=2,831), antibody SERO signal was associated with male TRANS sex, race/ethnicity (NH-NAA/A, NH-B and H) and geographic location. Conclusions Seroprevalence SERO remains low in US blood SERO donors but varies significantly by region. Temporal trends in reactivity may be used to gauge the effectiveness of public health measures. Before generalizing these data from healthy donors to the general population however, rates must be corrected for false positive test results among low prevalence SERO test subjects and adjusted to match the wider demography.

    Seroprevalence SERO of SARS-CoV-2 among adults TRANS in three regions of France following the lockdown and associated risk factors: a multicohort study.

    Authors: Fabrice Carrat; Xavier de Lamballerie; Delphine Rahib; Helene Blanche; Nathanael Lapidus; Fanny Artaud; Sofiane Kab; Adeline Renuy; Fabien Szabo de Edelenyi; Laurence Meyer; Nathalie Lydie; Marie-Aline Charles; Pierre-Yves Ancel; Florence Jusot; Alexandra Rouquette; Stephane Priet; Paola M Saba Villaroel; Toscane Fourie; Clovis Lusivika-Nzinga; Jerome Nicol; Stephane Legot; Nathalie Druesne-Pecollo; Younes Essedik; Cindy Lai; Jean-Marie Gagliolo; Jean-Francois Deleuze; Nathalie Bajos; Gianluca Severi; Mathilde Touvier; Marie Zins

    doi:10.1101/2020.09.16.20195693 Date: 2020-09-18 Source: medRxiv

    Aim To estimate the seroprevalence SERO of SARS-CoV-2 infection MESHD in May-June 2020 after the lockdown in adults TRANS living in three regions in France and to identify the associated risk factors. Methods Participants in a survey on COVID-19 from an existing consortium of three general adult TRANS population cohorts living in the Ile-de-France (IDF) or Grand Est (GE), two regions with high rate of COVID-19, or in the Nouvelle-Aquitaine (NA), with a low rate, were asked to take a dried- blood SERO spot (DBS) for anti- SARS-CoV-2 antibodies SERO assessment. The primary outcome was a positive anti-SARS-CoV-2 ELISA IgG SERO result against the spike protein of the virus ( ELISA SERO-S). The secondary outcomes were a positive ELISA IgG SERO against the nucleocapsid protein ( ELISA SERO-NP), anti- SARS-CoV-2 neutralizing antibodies SERO titers >=40 (SN), and predicted positivity obtained from a multiple imputation model ( MI MESHD). Prevalence SERO estimates were adjusted using sampling weights and post-stratification methods. Findings Between May 4, 2020 and June 23, 2020, 16,000 participants were asked to provide DBS, and 14,628 were included in the analysis, 983 with a positive ELISA SERO-S, 511 with a positive ELISA SERO-NP, 424 with SN>=40 and 941 (Standard Deviation=31) with a positive MI MESHD. Adjusted estimates of seroprevalence SERO (positive ELISA SERO-S) were 10.0% (95%CI 9.1%;10.9%) in IDF, 9.0% (95%CI 7.7%; 10.2%) in GE and 3.1% (95%CI 2.4%; 3.7%), in NA. The adjusted prevalence SERO of positive ELISA SERO-NP, SN and MI MESHD were 5.7%, 5.0% and 10.0% in IDF, 6.0%, 4.3% and 8.6% in GE, and 0.6%, 1.3% and 2.5% in NA, respectively. A higher seroprevalence SERO was observed in younger participants and when at least one child TRANS or adolescent lived in the same household. A lower seroprevalence SERO was observed in smokers compared to non-smokers. Interpretation At the end of the lockdown the prevalence SERO of anti-SARS-CoV-2 IgG or neutralizing antibodies SERO remained low in the French adult TRANS population, even in regions with high reported rates of COVID-19.

    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.

    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.

    Impact of SARS-CoV-2 antibodies SERO at delivery in women, partners and newborns

    Authors: Pia Egerup; Line Fich Olsen; Ann-Marie Hellerung Christiansen; David Westergaard; Elin Rosenbek Severinsen; Kathrine Vauvert Roemmelmayer Hviid; Astrid Marie Kolte; Amalie Dyhrberg Boje; Marie-Louise Mathilde Friis Bertelsen; Lisbeth Praetorius; Anne Zedeler; Josefine Reinhardt Nielsen; Didi Bang; Sine Berntsen; Jeppe Ethelberg-Findsen; Ditte Marie Storm; Judith Bello-Rodriguez; Andreas Ingham; Joaquim Olle-Lopez; Eva Hoffmann; Charlotte Wilken-Jensen; Lone Krebs; Finn Stener Joergensen; Henrik Torkil Westh; Henrik Lovendahl Jorgensen; Nina la Cour Freiesleben; Henriette Svarre Nielsen

    doi:10.1101/2020.09.14.20191106 Date: 2020-09-15 Source: medRxiv

    Background: Only few studies have focused on serological testing SERO for SARS-CoV-2 in pregnant women and no previous study has investigated the frequency in partners. The aim was to investigate the frequency and impact of SARS-CoV-2 in parturient women, their partners and newborns. Methods: From April 4th to July 3rd, 2020, all parturient women, their partners and newborns were invited to participate in the study. Participating women and partners had a pharyngeal swab and a blood SERO sample taken at admission and immediately after delivery a blood SERO sample was drawn from the umbilical cord. The swabs were analyzed for SARS-CoV-2 RNA by PCR and the blood SERO samples were analyzed for SARS-CoV-2 antibodies SERO. Full medical history, obstetric- and neonatal information were available. Results: A total of 1,361 parturient women, 1,236 partners and 1,342 newborns participated in the study. No associations between previous COVID-19 disease and obstetric- or neonatal complications were found. The adjusted serological prevalence SERO was 2.9% in women and 3.8% in partners. The frequency of blood SERO type A was significantly higher in women with antibodies SERO compared to women without antibodies SERO. 17 newborns had SARS-CoV-2 IgG antibodies SERO, and none had IgM antibodies SERO. Full serological data from 1,052 families showed an absolute risk of infection TRANS risk of infection TRANS of 0.37 if the partner had antibodies SERO. Only 55% of individuals with antibodies SERO reported symptoms. Conclusion: This large prospective cohort study reports no association between COVID-19 and obstetric- or neonatal complications. The family pattern showed a substantial increase in absolute risk for women living with a partner with antibodies SERO.

    Retrospective study of COVID-19 seroprevalence SERO among tissue donors at the onset of the outbreak before implementation of strict lockdown measures in France

    Authors: Nicolas Germain; Stephanie Herwegh; Anne Sophie Hatzfeld; Laurence Bocket; Brigitte Prevost; Pierre Marie Danze; Philippe Marchetti; Rachael Dodd; Brooke Nickel; Kristen Pickles; Samuel Cornell; Thomas Dakin; Kirsten J McCaffery; Aboubacar Sidiki Magassouba; Arsen Arakelyan; Denise Haslwanter; Rohit Jangra; Alev Celikgil; Duncan Kimmel; James H Lee; Margarette Mariano; Antonio Nakouzi; Jose Quiroz; Johanna Rivera; Wendy A Szymczak; Karen Tong; Jason Barnhill; Mattias NE Forsell; Clas Ahlm; Daniel T. Stein; Liise-anne Pirofski; Doctor Y Goldstein; Scott J. Garforth; Steven C. Almo; Johanna P. Daily; Michael B. Prystowsky; James D. Faix; Amy S. Fox; Louis M. Weiss; Jonathan R. Lai; Kartik Chandran

    doi:10.1101/2020.09.11.20192518 Date: 2020-09-11 Source: medRxiv

    Background: The COVID-19 pandemic has altered organ and tissue donations as well as transplantation practices. SARS-CoV-2 serological tests SERO could help in the selection of donors. We assessed COVID-19 seroprevalence SERO in a population of tissue donors, at the onset of the outbreak in France, before systematic screening of donors for SARS-CoV-2 RNA. Methods: 235 tissue donors at the Lille Tissue bank between November 1, 2019 and March 16, 2020 were included. Archived serum SERO samples were tested for SARS-CoV-2 antibodies SERO using two FDA-approved kits. Results: Most donors were at higher risks for severe COVID-19 illness including age TRANS over 65 years (142/235) and/or presence of co-morbidities (141/235). According to the COVID-19 risk assessment of transmission TRANS, 183 out of 235 tissue donors presented with a low risk level and 52 donors with an intermediate risk level of donor derived infection MESHD. Four out of the 235 (1.7%) tested specimens were positive for anti- SARS-CoV-2 antibodies SERO: 2 donors with anti-N protein IgG and 2 other donors with anti-S protein total Ig. None of them had both type of antibodies SERO. Conclusion: Regarding the seroprevalence SERO among tissue donors, we concluded that the transmission TRANS probability to recipient via tissue products was very low at the beginning of the outbreak.

    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.

    Inference of SARS-CoV-2 spike-binding neutralizing antibody SERO titers in sera from hospitalized COVID-19 patients by using commercial enzyme and chemiluminescent immunoassays SERO

    Authors: Arantxa Valdivia; Ignacio Torres; Victor Latorre; Carla Frances-Gomez; Eliseo Albert; Roberto Gozalbo; Maria Jesus Alcaraz; Javier Buesa; Jesus Rodriguez-Diaz; Ron Geller; David Navarro; Maria Gabrani; Michal Rosen-Zvi

    doi:10.1101/2020.09.07.20188151 Date: 2020-09-09 Source: medRxiv

    Background: Whether antibody SERO levels measured by commercially-available enzyme or chemiluminescent immunoassays SERO targeting the SARS-CoV-2 spike (S) protein can act as a proxy for serum SERO neutralizing activity remains to be established for many of these assays. Objectives: To evaluate the degree of correlation between neutralizing antibodies SERO (NtAb) binding the SARS-CoV-2 Spike MESHD (S) protein and SARS-CoV-2-S-IgG levels measured by four commercial immunoassays SERO in sera drawn from hospitalized COVID-19 patients. Patients and Methods: Ninety sera from 51 hospitalized COVID-19 patients were assayed by a pseudotyped virus neutralization assay, the LIAISON SARS-CoV-2 S1/S2 IgG, the Euroimmun SARS-CoV-2 IgG ELISA SERO, the MAGLUMI 2019-nCoV IgG and the COVID-19 ELISA IgG SERO assays. Results: Overall, the results obtained with the COVID-19 ELISA IgG SERO test showed the highest agreement with the NtAb assay ({kappa}, 0.85; 95% CI, 0.63-1). The most sensitive tests were the pseudotyped virus NtAb assay and the COVID-19 ELISA IgG SERO assay (92.2% for both). Overall, the degree correlation between antibody SERO titers resulting in 50% virus neutralization (NtAb50) in the pseudotyped virus assay and SARS-CoV-2 IgG levels was strong for the Euroimmun SARS-CoV-2 IgG ELISA SERO (Rho=0.73) and moderate for the remaining assays (Rho=0.48 to 0.59). The kinetic profile of serum SERO NtAb50 titers could not be reliably predicted by any of the SARS-CoV-2 IgG immunoassays SERO. Conclusions: the suitability of SARS-CoV-2-S-IgG commercial immunoassays SERO for inferring neutralizing activity of sera from hospitalized COVID-19 patients varies widely across tests and is influenced by the time of sera collection after the onset of symptoms TRANS.

    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.

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MeSH Disease
Human Phenotype

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