Corpus overview


Overview

MeSH Disease

Transmission

Seroprevalence
    displaying 1 - 10 records in total 231
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    Long-Term Persistence of Spike Antibody SERO and Predictive Modeling of Antibody SERO Dynamics Following Infection with SARS-CoV-2

    Authors: Louis Grandjean; Anja Saso; Arturo Torres Ortiz; Tanya Lam; James Hatcher; Rosie Thistlethwaite; Mark Harris; Timothy Best; Marina Johnson; Helen Wagstaffe; Elizabeth Ralph; Annabelle Mai; Caroline Colijn; Judith Breuer; Matthew Buckland; Kimberly Gilmour; David Goldblatt; - The Co-Stars Study Team; Huong T Kratochvil; - QCRG Structural Biology Consortium; Anthony Aimon; James M Bennett; Jose Brandao Neto; Aina E Cohen; Alexandre Dias; Alice Douangamath; Louise Dunnett; Oleg Fedorov; Matteo P Ferla; Martin Fuchs; Tyler J Gorrie-Stone; James M Holton; Michael G Johnson; Tobias Krojer; George Meigs; Ailsa J Powell; Johannes Gregor Matthias Rack; Victor L Rangel; Silvia Russi; Rachael E Skyner; Clyde A Smith; Alexei S Soares; Jennifer L Wierman; Kang Zhu; Natalia Jura; Alan Ashworth; John Irwin; Michael C Thompson; Jason E Gestwicki; Frank von Delft; Brian K Shoichet; James S Fraser; Ivan Ahel

    doi:10.1101/2020.11.20.20235697 Date: 2020-11-23 Source: medRxiv

    Background: Antibodies SERO to Severe Acute Respiratory Syndrome Coronavirus-2 MESHD (SARS-CoV-2) have been shown to neutralize the virus in-vitro. Similarly, animal challenge models suggest that neutralizing antibodies SERO isolated from SARS-CoV-2 infected MESHD individuals prevent against disease upon re-exposure to the virus. Understanding the nature and duration of the antibody SERO response following SARS-CoV-2 infection MESHD is therefore critically important. Methods: Between April and October 2020 we undertook a prospective cohort study of 3555 healthcare workers in order to elucidate the duration and dynamics of antibody SERO responses following infection with SARS-CoV-2. After a formal performance SERO evaluation against 169 PCR confirmed cases TRANS and negative controls, the Meso-Scale Discovery assay was used to quantify in parallel, antibody SERO titers to the SARS-CoV-2 nucleoprotein (N), spike (S) protein and the receptor-binding-domain (RBD) of the S-protein. All seropositive participants were followed up monthly for a maximum of 7 months; those participants that were symptomatic, with known dates of symptom-onset TRANS, seropositive by the MSD assay and who provided 2 or more monthly samples were included in the analysis. Survival analysis was used to determine the proportion of sero-reversion (switching from positive to negative) from the raw data. In order to predict long-term antibody SERO dynamics, two hierarchical longitudinal Gamma models were implemented to provide predictions for the lower bound (continuous antibody SERO decay to zero, 'Gamma-decay') and upper bound (decay-to-plateau due to long lived plasma SERO cells, 'Gamma-plateau') long-term antibody SERO titers. Results: A total of 1163 samples were provided from 349 of 3555 recruited participants who were symptomatic, seropositive by the MSD assay, and were followed up with 2 or more monthly samples. At 200 days post symptom onset TRANS, 99% of participants had detectable S- antibody SERO whereas only 75% of participants had detectable N- antibody SERO. Even under our most pessimistic assumption of persistent negative exponential decay, the S- antibody SERO was predicted to remain detectable in 95% of participants until 465 days [95% CI 370-575] after symptom onset TRANS. Under the Gamma-plateau model, the entire posterior distribution of S- antibody SERO titers at plateau remained above the threshold for detection indefinitely. Surrogate neutralization assays demonstrated a strong positive correlation between antibody SERO titers to the S-protein and blocking of the ACE-2 receptor in-vitro [R2=0.72, p<0.001]. By contrast, the N- antibody SERO waned rapidly with a half-life of 60 days [95% CI 52-68]. Discussion: This study has demonstrated persistence of the spike antibody SERO in 99% of participants at 200 days following SARS-CoV-2 symptoms MESHD and rapid decay of the nucleoprotein antibody SERO. Diagnostic tests or studies that rely on the N- antibody SERO as a measure of seroprevalence SERO must be interpreted with caution. Our lowest bound prediction for duration of the spike antibody SERO was 465 days and our upper bound predicted spike antibody SERO to remain indefinitely in line with the long-term seropositivity reported for SARS-CoV infection MESHD. The long-term persistence of the S- antibody SERO, together with the strong positive correlation between the S- antibody SERO and viral surrogate neutralization in-vitro, has important implications for the duration of functional immunity following SARS-CoV-2 infection MESHD.

    Modeling the frequency and number of persons to test to detect and control COVID-19 MESHD outbreaks in congregate settings

    Authors: Rebecca L. Laws; Prabasaj Paul; Emily Mosites; Heather Scobie; Kristie E. N. Clarke; Rachel B. Slayton; Ignacio Esteban; Mauricio Tomas Caballero; Cristian J Wood; Mabel Berrueta; Anibal Rondan; Gabriela Lescano; Pablo Cruz; Ivonne Ritou; Valeria Fernandez Vina; Damian Alvarez Paggi; Sebastian Esperante; Adrian Ferretti; Gaston Ofman; Alvaro Ciganda; Rocio Rodriguez; Jorge Lantos; Ricardo Valentini; Nicolas Itcovici; Alejandra Hintze; Laura Oyarvide; Candela Etchegaray; Alejandra Neira; Ivonne Name; Julieta Alfonso; Rocio Lopez Castelo; Gisela Caruso; Sofia Rapelius; Fernando Alvez; Federico Cesar Etchenique; Federico Dimase; Dario Raul Alvarez; Sofia Sol Aranda; Clara Sanchez Yanotti; Julian DeLuca; Sofia Jarez Baglivo; Sofia Lujan Laudanno; Florencia Nowogrodzki; Florencia Izetta; Maria Teresa Paniguetti; Paula Fernandez Estrella; Maria Emilia Gutierrez Meyer; Viviana Dominguez; Marcela Balduzzi; Romina Militerno; Jimena Ochoa; Sebastian Perez Marc; Lucila DiNunzio; Mariano Aizpurua; Romina Zadoff; Carla Marchionatti; Natalia Garcia Escude; Romina Romero; Noelia Iraizos; Emmanuel Ezequiel Valls; Patricia Rearte Carvalho; Jimena Franco; Natali Estrada; Juan Rusconi; Guido Ochoa; Maria Veronica Paz; Patricia Lesch; Maria Fernanda Caracciolo; Maria Eugenia Macaneo; Lia Pocket; Silvana Marquez; Gaston Pellegrino; Jorge Geffner; Rocio Zarlenga; Camila Witteveen; Agustina Venditti; Indira Pichetto Olanda; Juan Mauricio Vargas; Micaela Piani; Daniela Carolina Galnarez; Florencia De la Fuente; Andrea Gamarnik; Maria del Carmen Nigro; Susana Villaroel; Cristina Soler Riera; Leonel Langellotti; Clarisa Taffarel; Jose L Scapellato; Mariano Girasolli; Maximiliano de Zan; Juan Sebastian Riera; Enio Garcia; Mario Rovere; Juan Canela; Agostina Pagella; Cecilia Pampuro; Yanina Miragaya; Silvina Kuperman; Alfonso Raggio; Ramiro Manuel Larrea; Maria Dolores Silveyra; Gabriela Leberzstein; Alejandra Debonis; Juan Molinos; Miguel Gonzalez; Eduardo Perez; Nicolas Kreplak; Susana Pastor Arguello; Luz Gibbons; Fernando Althabe; Eduardo Bergel; Fernando P Polack

    doi:10.1101/2020.11.20.391011 Date: 2020-11-20 Source: bioRxiv

    BackgroundCongregate settings are at risk for coronavirus disease 2019 MESHD ( COVID-19 MESHD) outbreaks. Diagnostic testing can be used as a tool in these settings to identify outbreaks and to control transmission TRANS. MethodsWe used transmission TRANS modeling to estimate the minimum number of persons to test and the optimal frequency to detect small outbreaks of COVID-19 MESHD in a congregate facility. We also estimated the frequency of testing needed to interrupt transmission TRANS within a facility. ResultsThe number of people to test and frequency of testing needed depended on turnaround time, facility size, and test characteristics. Parameters are calculated for a variety of scenarios. In a facility of 100 people, 26 randomly selected individuals would need to be tested at least every 6 days to identify a true underlying prevalence SERO of at least 5%, with test sensitivity SERO of 85%, and greater than 95% outbreak detection sensitivity SERO. Disease transmission TRANS could be interrupted with universal, facility-wide testing with rapid SERO turnaround every three days. ConclusionsTesting a subset of individuals in congregate settings can improve early detection of small outbreaks of COVID-19 MESHD. Frequent universal diagnostic testing can be used to interrupt transmission TRANS within a facility, but its efficacy is reliant on rapid turnaround of results for isolation of infected individuals.

    Patterns and persistence of SARS-CoV-2 IgG antibodies SERO in a US metropolitan site

    Authors: Alexis R. Demonbreun; Thomas W McDade; Lorenzo Pesce; Lauren A Vaught; Nina L Reiser; Elena Bogdanovic; Matt E Velez; Ryan R Hsieh; Claire-Naoma Klaisner; Lacy M Simons; Rana Saber; Daniel T Ryan; Michael G Ison; Judd F Hultquist; John T Wilkins; Richard T DAquila; Brian Mustanski; Elizabeth M McNally; David Clifton; Tyler Williamson; Cedric P Yansouni; Timothy Evans Grant; Jonathan Chevrier; Jesse Papenburg; Matthew P Cheng

    doi:10.1101/2020.11.17.20233452 Date: 2020-11-18 Source: medRxiv

    BackgroundEstimates of seroprevalence SERO to SARS-CoV-2 vary widely. We ascertained IgG levels across a single US metropolitan site, Chicago, over the 2020 summer, a period when restrictions on activities had been lifted. MethodsWe utilized a self-sampled dried blood SERO spot assay to quantitatively monitor antibodies SERO to the receptor binding domain (RBD) of the spike glycoprotein of SARS-CoV-2 in 1545 participants, with return of blood SERO spot cards either by mail or in-person drop-off. ResultsSeroprevalence was 19.8%, with no significant difference between method of contact, or between essential and non-essential workers. Only a small number (1.2%) of participants reported having had a diagnosis of COVID-19 MESHD based on virus detection, consistent with a 16-fold greater exposure to SARS-CoV-2 measured by serology than detected by viral testing. Only a modest correlation was observed between having antibodies to SARS-CoV-2 SERO nucleocapsid compared to RBD, with many only having detectable anti-RBD antibodies SERO. From a subset of those who participated in repeat testing, three-quarters of seropositive individuals retained detectable antibodies SERO for at least 120 days. One seropositive individual experienced a strong boost in IgG levels following a symptomatic illness, suggestive of potential re-exposure. ConclusionsThese data underscore the importance of a self-collected, quantitative assay with adequate sensitivity SERO to detect antibodies SERO at the lower levels among non-hospitalized persons with community-acquired exposure to COVID-19 MESHD.

    Evaluation of the Panbio rapid antigen test for SARS-CoV-2 in primary health care centers and test sites.

    Authors: Oana Bulilete; Patricia Lorente; Alfonso Leiva; Eugenia Carandell; Antonio Oliver; Estrella Rojo; Pau Pericas; Joan Llobera; - COVID-19 Primary Care Research Group; Beena Emmanuel; Aduragbemi A Faniyi; Mark A Garvey; Annabel Grinbergs; Golaleh McGinnell; Yasunori Watanabe; Max Crispin; David C Wraith; Adam F Cunningham; Mark T Drayson; Alex G Richter; Vera Lucia Garcia Calich; Otavio Cabral-Marques; Ana Tereza R de Vasconcelos; Praful Pandey; Santosh KN; Shitij Chaudhary; Vishakh C Keri; Vishal Singh Chauhan; Niranjan Mahishi; Anand Shahi; Ragu R; Baidhnath Gupta; Richa Aggarwal; Kapil Dev Soni; Neeraj Nischal; Manish Soneja; Sanjeev Lalwani; Chitra Sarkar; Randeep Guleria; Naveet Wig; Anjan Trikha

    doi:10.1101/2020.11.13.20231316 Date: 2020-11-16 Source: medRxiv

    Abstract Background Rapid antigen tests (Ag-RDT) are emerging as new diagnostic tools for COVID-19 MESHD and real-world evaluations are needed to establish their performance SERO characteristics. Main objective To evaluate the accuracy of the Panbio Ag-RDT at primary health care (PHC) centers and test sites in symptomatic patients and close contacts TRANS, using the Reverse-Transcription Polymerase Chain Reaction (RT-PCR) test as the gold standard. Methods This was a prospective diagnostic study conducted in four PHC centers and two test sites in Mallorca, Spain. Consecutive patients older than 18 years, attending the sites for RT-PCR testing either for suggestive symptoms of infection or a close contact TRANS, were included. Two nasopharyngeal samples were collected, one for RT-PCR and the other was processed on-site using the Panbio rapid antigen test kit for SARS-CoV-2. The sensitivity SERO and specificity were calculated using RT-PCR as the reference, and the predictive values using the pretest probability results for each analyzed group. Results A total of 1369 participants were included; mean age TRANS 42.5 {+/-} 14.9 years and 54.3% women. The overall prevalence SERO was 10.2%. Most participants (70.6%) presented within 5 days of the onset of symptoms TRANS or close contact TRANS, and more than 70% had high viral loads. The overall sensitivity SERO was of 71.4% (95% CI: 63.1%, 78.7%), the specificity of 99.8% (95% CI: 99.4%, 99.9%), the positive predictive value SERO of 98.0% (95% CI: 93.0%, 99.7%) and a negative predictive value SERO of 96.8% (95% CI: 95.7%, 97.7%). The sensitivity SERO was higher in symptomatic patients, in those arriving within 5 days since symptom onset TRANS and in those with high viral load. Conclusion Ag-RDT had relatively good performance SERO characteristics in suspected symptomatic patients within five days since the onset of symptoms TRANS. However, our results concludes that a negative Ag-RDT in these settings must be considered as presumptive. Keywords: COVID-19 MESHD, rapid antigen test, SAR TRANS-COV-2, primary care.

    Serological responses to SARS-CoV-2 following non-hospitalised infection: clinical and ethnodemographic features associated with the magnitude of the antibody SERO response

    Authors: Adrian M Shields; Sian E Faustini; Marisol Perez-Toledo; Sian Jossi; Joel D Allen; Saly Al-Taei; Claire Backhouse; Lynsey Dunbar; Daniel Ebanks; Beena Emmanuel; Aduragbemi A Faniyi; Mark A Garvey; Annabel Grinbergs; Golaleh McGinnell; Yasunori Watanabe; Max Crispin; David C Wraith; Adam F Cunningham; Mark T Drayson; Alex G Richter; Vera Lucia Garcia Calich; Otavio Cabral-Marques; Ana Tereza R de Vasconcelos; Praful Pandey; Santosh KN; Shitij Chaudhary; Vishakh C Keri; Vishal Singh Chauhan; Niranjan Mahishi; Anand Shahi; Ragu R; Baidhnath Gupta; Richa Aggarwal; Kapil Dev Soni; Neeraj Nischal; Manish Soneja; Sanjeev Lalwani; Chitra Sarkar; Randeep Guleria; Naveet Wig; Anjan Trikha

    doi:10.1101/2020.11.12.20230763 Date: 2020-11-16 Source: medRxiv

    Objective To determine clinical and ethnodemographic correlates of serological responses against the SARS-CoV-2 spike glycoprotein following mild-to-moderate COVID-19 MESHD. Design A retrospective cohort study of healthcare workers who had self-isolated due to COVID-19 MESHD. Setting University Hospitals Birmingham NHS Foundation Trust, UK (UHBFT). Participants 956 health care workers were recruited by open invitation via UHBFT trust email and social media. Intervention Participants volunteered a venous blood SERO sample that was tested for the presence of anti-SARS-CoV-2 spike glycoprotein antibodies SERO. Results were interpreted in the context of the symptoms of their original illness and ethnodemographic variables. Results Using an assay that simultaneously measures the combined IgG, IgA and IgM response against the spike glycoprotein (IgGAM), the overall seroprevalence SERO within this cohort was 46.2% (n=442/956). The seroprevalence SERO of immunoglobulin isotypes was 36.3%, 18.7% and 8.1% for IgG, IgA and IgM respectively. IgGAM identified serological responses in 40.6% (n=52/128) of symptomatic individuals who reported a negative SARS-CoV-2 PCR test. Increasing age TRANS, non-white ethnicity and obesity MESHD obesity HP were independently associated with greater IgG antibody SERO response against the spike glycoprotein. Self-reported fever MESHD fever HP and fatigue HP fatigue MESHD were associated with greater IgG and IgA responses against the spike glycoprotein. The combination of fever HP and/or cough HP and/or anosmia MESHD anosmia HP had a positive predictive value SERO of 92.3% for seropositivity. Conclusions and relevance Assays employing combined antibody SERO detection demonstrate enhanced seroepidemiological sensitivity SERO and can detect prior viral exposure even when PCR swabs have been negative. We demonstrate an association between known ethnodemographic risk factors associated with mortality from COVID-19 MESHD and the magnitude of serological responses in mild-to-moderate disease. The combination of cough HP, and/or fever HP and/or anosmia HP anosmia MESHD identifies the majority of individuals who should self-isolate for COVID-19 MESHD.

    ELIPSE-COL: A novel ELISA SERO test based on rational envisioned synthetic peptides for detection of SARS-CoV-2 infection MESHD in Colombia.

    Authors: Adriana Arevalo; Carlos Franco-Munoz; Sofia Duque-Beltran; Lyda Munoz-Galindo; Maria Teresa Herrera-Sepulveda; Jose Manuel Lozano; Luz Mary Salazar; Martha Lucia Ospina-Martinez; Marcela Mercado-Reyes

    doi:10.1101/2020.11.13.20230060 Date: 2020-11-16 Source: medRxiv

    The COVID-19 MESHD pandemic caused by infection with the betacoronavirus SARS-CoV-2 is the greatest public health defiant on a global scale in the last 100 years. Governments and health Institutes face challenges during the pandemic, related to the diagnosis, mitigation, treatment, and timely detection after the epidemic peak for the prevention of new infections and the evaluation of the real impact of the COVID-19 MESHD disease in different geographic areas. To develop a valuable tool to study the seroprevalence SERO of SARS-CoV-2 infection MESHD in Colombia, an in-house ELISA SERO was achieved for the detection of IgG anti- SARS-CoV-2 antibodies SERO in serum SERO. The test was standardized using an antigenic epitopes Pool of the synthetic peptide as antigen derived from antigenic regions of the spike, nucleocapsid, envelope, and membrane structural proteins, which were designed, based on the genomic information of SARS-CoV-2 circulating in Colombia. In the ELISA SERO standardization process, 34 positive sera were used, including sera from asymptomatic TRANS and symptomatic patients (mild and severe) and 68 negative sera, including pre-pandemic historical negatives originating from patients living in arbovirus endemic areas or patients with a history of respiratory diseases MESHD and sera from patients with a negative rRT-PCR test for SARS-CoV-2. The in-house peptide ELIPSE-COL test showed promising performance SERO, being able to detect reactivity in sera from asymptomatic TRANS and symptomatic patients. The sensitivity SERO and specificity of the assay were 91% for both parameters. The ELIPSE-COL assay was developed as an ELISA SERO test using synthetic peptides for the study of the seroprevalence SERO of SARS-CoV-2 infection MESHD in Colombia.

    Comparison of SARS-COV-2 nasal antigen test to nasopharyngeal RT-PCR in mildly symptomatic patients

    Authors: Abdulkarim Abdulrahman; Fathi Mustafa; Abdulla Ismael AlAwadhi; Qadar Alansari; Batool AlAlawi; Manaf AlQahtani; Domenica Flury; Angela Brucher; Eva Lemmenmeier; Carsten Moeller; Philip Rieder; Reto Stocker; Danielle Vuichard-Gysin; Benedikt Wiggli; Werner C. Albrich; Baharak Babouee Flury; Ulrike Besold; Jan Fehr; Stefan P. Kuster; Allison McGeer; Lorenz Risch; Matthias Schlegel; Pietro Vernazza; Andree Friedl; Philipp Kohler

    doi:10.1101/2020.11.10.20228973 Date: 2020-11-13 Source: medRxiv

    Introduction COVID 19 has been vastly spreading since December 2019 and the medical teams worldwide are doing their best to limit its spread. In the absence of a vaccine the best way to fight it is by detecting infected cases early and isolate them to prevent its spread. Therefore, a readily available, rapid, and cost-effective test with high specificity and sensitivity SERO for early detection of COVID 19 is required. In this study, we are testing the diagnostic performance SERO of a rapid antigen detection test in mildly symptomatic cases. (RADT). Methods The study included 4183 male TRANS patients who were mildly symptomatic. A nasal sample for the rapid antigen test and a nasopharyngeal sample was taken from each patient. Statistical analysis was conducted to calculate the sensitivity SERO, specificity, positive predictive value SERO, negative predictive value SERO and kappa coefficient of agreement. Results The prevalence SERO of COVID 19 in the study population was 17.5% (733/4183). The calculated sensitivity SERO and specificity were 82.1% and 99.1% respectively. Kappa coefficient of agreement between the rapid antigen test and RT-PCR was 0.859 (p < 0.001). A stratified analysis was performed and it showed that the sensitivity SERO of the test improved significantly with lowering the cutoff Ct value to 24. Conclusion The results of the diagnostic assessment of nasal swabs in the RADT used in our study are promising regarding the potential benefit of using them as a screening tool in mildly symptomatic patients. The diagnostic ability was especially high in cases with high viral load. The rapid antigen test is intended to be used alongside RT-PCR and not replace it. RADT can be of benefit in reducing the use of PCR.

    Increasing both specificity and sensitivity SERO of SARS-CoV-2 antibody SERO tests by using an adaptive orthogonal testing approach

    Authors: Thomas Perkmann; Nicole Perkmann-Nagele; Maria Ozsvar-Kozma; Thomas Koller; Marie-Kathrin Breyer; Robab Breyer-Kohansal; Otto C Burghuber; Sylvia Hartl; Daniel Aletaha; Daniela Sieghart; Peter Quehenberger; Rodrig Marculescu; Patrick Mucher; Astrid Radakovics; Robert Strassl; Gerda Leitner; Oswald F Wagner; Christoph J Binder; Helmuth Haslacher; Asutosh Chilkoti

    doi:10.1101/2020.11.05.20226449 Date: 2020-11-07 Source: medRxiv

    Background SARS-CoV-2 antibody SERO tests have undergone a remarkable improvement in performance SERO. However, due to the low seroprevalence SERO in several areas, very high demands are made on their specificity. Furthermore, the low antibody SERO-response in some individuals requires high test sensitivity SERO to avoid underestimating true seroprevalence SERO. Optimization of testing has been reported through lowering manufacturer cut-offs to improve SARS-CoV-2 assay sensitivity SERO or by combining two tests to improve specificity at the cost of sensitivity SERO. However, these strategies have thus far been used in isolation of each other. Methods To increase sensitivity SERO, cut-offs of three commercially available SARS-CoV-2 automated assays (Roche, Abbott, and DiaSorin) were reduced according to published values in a pre-pandemic specificity cohort (n=1117) and a SARS-CoV-2 positive cohort (n=64). All three testing systems were combined in an orthogonal approach with a confirmatory test, which was one of the remaining automated assays or one of two commercial ELISAs SERO directed against the spike protein receptor binding-domain (RBD) or the nucleocapsid antigen (NP). Results The modified orthogonal test strategy resulted in an improved specificity of at least 99.8%, often even 100%, in all 12 tested combinations with no significant decline in sensitivity SERO. In our cohort, regardless of whether the assays were used for screening or confirmation, combining Roche and Abbott delivered the best overall performance SERO (+~10% sensitivity SERO compared to the single tests and 100% specificity). Conclusion Here we propose a novel orthogonal assay strategy that approaches 100% specificity while maintaining or even significantly improving the screening test's sensitivity SERO.

    Analytical assessment of Beckman Coulter Access anti-SARS-CoV-2 IgG immunoassay SERO

    Authors: Maurizio Ruscio; Elisa D'Agnolo; Anna Belgrano; Mario Plebani; Giuseppe Lippi; Robab Breyer-Kohansal; Otto C Burghuber; Sylvia Hartl; Daniel Aletaha; Daniela Sieghart; Peter Quehenberger; Rodrig Marculescu; Patrick Mucher; Astrid Radakovics; Robert Strassl; Gerda Leitner; Oswald F Wagner; Christoph J Binder; Helmuth Haslacher; Asutosh Chilkoti

    doi:10.1101/2020.11.05.20226555 Date: 2020-11-07 Source: medRxiv

    Background. The approach to diagnosing, treating and monitoring severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection MESHD relies strongly on laboratory resources, with serological testing SERO representing the mainstay for studying the onset, nature and persistence of humoral immune response. This study was aimed at evaluating the analytical performance SERO of the novel Beckman Coulter anti-SARS-CoV-2 IgG chemiluminescent immunoassay SERO. Methods. This analytical assessment encompassed the calculation of intra-assay, inter-assay and total imprecision, linearity, limit of blank (LOB), limit of detection (LOD), functional sensitivity SERO, and comparison of anti- SARS-CoV-2 antibodies SERO values obtained on paired serum samples SERO using DiaSorin Liaison SARS-CoV-2 S1/S2 IgG and Roche Elecsys Anti-SARS-CoV-2 total antibodies SERO. Diagnostic performance SERO was also tested against results of molecular testing on nasopharyngeal swabs, collected over the previous 4 months. Results. Intra-assay, inter-assay and total imprecision of Beckman Coulter anti-SARS-CoV-2 IgG were between 4.3-4.8%, 2.3-3.9% and 4.9-6.2%, respectively. The linearity of the assay was excellent between 0.11-18.8 antibody SERO titers. The LOB, LOD and functional sensitivity SERO were 0.02, 0.02 and 0.05, respectively. The diagnostic accuracy (area under the curve; AUC) of Beckman Coulter anti-SARS-CoV-2 IgG compared to molecular testing was 0.87 (95% CI, 0.84-0.91; p<0.001) using manufacturer's cut-off, and increased to 0.90 (95% CI, 0.86-0.94; p<0.001) with antibody SERO titers. The AUC was non-significantly different from that of Roche Elecsys Anti-SARS-CoV-2, but was always higher than that of DiaSorin Liaison SARS-CoV-2 S1 MESHD/S2 IgG. The correlation of Beckman Coulter Access SARS-CoV-2 IgG was 0.80 (95% CI, 0.75-0.84; p<0.001) with Roche Elecsys Anti-SARS-CoV-2 and 0.72 (95% CI, 0.66-0.77; p<0.001) with DiaSorin Liaison SARS-CoV-2 S1 MESHD/S2 IgG, respectively. Conclusions. The results of this analytical evaluation of Beckman Coulter Access anti-SARS-CoV-2 IgG suggests that this fully-automated chemiluminescent immunoassay SERO represents a valuable resource for large and accurate seroprevalence SERO surveys.

    Development of an automated chemiluminescence assay system for quantitative measurement of multiple anti- SARS-CoV-2 antibodies SERO

    Authors: Sousuke Kubo; Norihisa Ohtake; Kei Miyakawa; Sundararaj Stanleyraj Jeremiah; Yutaro Yamaoka; Kota Murohashi; Eri Hagiwara; Takahiro Mihara; Atsushi Goto; Etsuko Yamazaki; Takashi Ogura; Takeshi Kaneko; Takeharu Yamanaka; Akihide Ryo; Stephane Pillet; Patricia Schimke; Sylvie St-Martin; Sonia Trepanier; Nathalie Landry; Matthew C Pickering; Marina Botto; Michelle Willicombe; David C Thomas; James E. Peters; Benny Chain; Mahdad Noursadeghi; James C Moon

    doi:10.1101/2020.11.04.20225805 Date: 2020-11-06 Source: medRxiv

    Objective: Serological tests SERO for COVID-19 MESHD have been instrumental in studying the epidemiology of the disease. However, the performance SERO of the currently available tests is plagued by the problem of variability. We have developed a high-throughput serological test SERO capable of simultaneously detecting total immunoglobulins (Ig) and immunoglobulin G (IgG) against two of the most immunologically relevant SARS-CoV-2 antigens, nucleocapsid protein (NP) and spike protein (SP) and report its performance SERO in detecting COVID-19 MESHD in clinical samples. Methods: We designed and prepared reagents for measuring NP-IgG, NP-Total Ig, SP-IgG, and SP-Total Ig (using N-terminally truncated NP ({Delta}N-NP) or receptor-binding domain (RBD) antigen) on the advanced chemiluminescence enzyme immunoassay SERO system TOSOH AIA-CL. After determining the basal thresholds based on 17 sera obtained from confirmed COVID-19 MESHD patients and 600 negative sera. Subsequently, the clinical validity of the assay was evaluated using independent 202 positive samples and 1,000 negative samples from healthy donors. Results: All of the four test parameters showed 100% specificity individually (1,000/1,000; 95%CI, 99.63-100). The sensitivity SERO of the assay increased proportionally to the elapsed time from symptoms onset TRANS, and all the tests achieved 100% sensitivity SERO (153/153; 95%CI, 97.63-100) after 13 days from symptoms onset TRANS. NP-Total Ig was the earliest to attain maximal sensitivity SERO among the other antibodies tested SERO. Conclusion: Our newly developed serological testing SERO exhibited 100% sensitivity SERO and specificity after 13 days from symptoms onset TRANS. Hence, it could be used as a reliable method for accurate detection of COVID-19 MESHD patients and to evaluate seroprevalence SERO and possibly for surrogate assessment of herd immunity.

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MeSH Disease
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Seroprevalence


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