Corpus overview


MeSH Disease

Human Phenotype


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    Comparison of sixteen serological SARS-CoV-2 immunoassays SERO in sixteen clinical laboratories

    Authors: Lene Holm Harritshoej; Mikkel Gybel-Brask; Shoaib Afzal; Pia R. Kamstrup; Charlotte Svaerke Joergensen; Marianne K. Thomsen; Linda M. Hilsted; Lennart J. Friis-Hansen; Pal B. Szecsi; Lise Pedersen; Lene Nielsen; Cecilie B. Hansen; Peter Garred; Trine-Line Korsholm; Susan Mikkelsen; Kirstine O. Nielsen; Bjarne K. Moeller; Anne T. Hansen; Kasper K. Iversen; Pernille B. Nielsen; Rasmus B. Hasselbalch; Kamille Fogh; Jakob B. Norsk; Jonas H. Kristensen; Kristian Schoenning; Nikolai S. Kirkby; Alex C.Y. Nielsen; Lone H. Landsy; Mette Loftager; Dorte K. Holm; Anna C. Nilsson; Susanne G. Saekmose; Birgitte Grum-Svendsen; Bitten Aagaard; Thoeger G. Jensen; Dorte M. Nielsen; Henrik Ullum; Ram BC Dessau

    doi:10.1101/2020.07.30.20165373 Date: 2020-08-02 Source: medRxiv

    Serological SARS-CoV-2 assays are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for the large-volume detection of total antibodies SERO (Ab) and immunoglobulin (Ig) G and M against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was organized as a Danish national collaboration and included fifteen commercial and one in-house anti-SARS-CoV-2 assays in sixteen laboratories. Sensitivity SERO was evaluated using 150 serum samples SERO from individuals diagnosed with asymptomatic TRANS, mild or moderate nonhospitalized (n=129) or hospitalized (n=31) COVID-19, confirmed by nucleic acid amplification tests, collected 13-73 days from symptom onset TRANS. Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from > 586 blood SERO donors and patients with autoimmune diseases MESHD or CMV or EBV infections MESHD. Predefined specificity criteria of [≥]99% were met by all total-Ab and IgG assays except one (Diasorin/LiaisonXL-IgG 97.2%). The sensitivities SERO in descending order were: Wantai/ ELISA SERO total-Ab (96.7%), CUH/NOVO in-house ELISA SERO total-Ab (96.0%), Ortho/Vitros total-Ab (95.3%), YHLO/iFlash-IgG (94.0%), Ortho/Vitros-IgG (93.3%), Siemens/Atellica total-Ab (93.2%), Roche-Elecsys total-Ab (92.7%), Abbott-Architect-IgG (90.0%), Abbott/Alinity-IgG (median 88.0%), Diasorin/LiaisonXL-IgG (84.6%), Siemens/Vista total-Ab (81.0%), Euroimmun/ ELISA-IgG SERO (78.0%), and Snibe/Maglumi-IgG (median 78.0%). The IgM results were variable, but one assay (Wantai/ ELISA SERO-IgM) had both high sensitivity SERO (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset TRANS and symptom severity. In conclusion, predefined sensitivity SERO and specificity acceptance criteria of 90%/99%, respectively, for diagnostic use were met in five of six total-Ab and three of seven IgG assays.

    Kinetics of SARS-CoV-2 Antibody SERO Avidity Maturation and Association with Disease MESHD Severity

    Authors: Yiqi Ruben Luo; Indrani Chakraborty; Cassandra Yun; Alan H.B. Wu; Kara Lake Lynch

    doi:10.1101/2020.07.30.20165522 Date: 2020-08-02 Source: medRxiv

    The kinetics of immunoglobulin G (IgG) avidity maturation during severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) infection MESHD was studied. The IgG avidity assay used a novel label-free immunoassay SERO technology to test IgG against the virus spike protein receptor-binding domain (RBD). The technology, thin-film interferometry (TFI), is able to sense the formation of immune complex on a sensing probe without attaching a reporter (enzyme, fluorophore, etc.). It was found that there was a strong correlation between IgG antibody SERO avidity and days since symptom onset TRANS (p < 0.0001). In addition, peak readings were significantly higher for specimens from ICU than non-ICU patients for the first month after symptom onset TRANS (1-4 weeks) and thereafter (p<0.0001). The findings are consistent for what has been reported for SARS-CoV. Given that SARS-CoV-2 specific IgG avidity is strong in ICU patients after 1 month, this suggests that antibody SERO-mediated immune enhancement triggered by suboptimal antibodies SERO may not play a role in COVID-19 disease progression MESHD and severity.

    A High-throughput Anti-SARS-CoV-2 IgG Testing Platform for COVID-19

    Authors: Jinwei Du; Eric Chu; Dayu Zhang; Chuanyi M Lu; Aiguo Zhang; Michael Y. Sha

    doi:10.1101/2020.07.23.20160804 Date: 2020-07-27 Source: medRxiv

    Background: Serology tests for detecting the antibodies SERO to severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) can identify previous infection MESHD and help to confirm the presence of current infection MESHD. Objective: The aim of this study was to evaluate the performances SERO of a newly developed high throughput immunoassay SERO for anti-SARS-CoV-2 IgG antibody SERO detection. Results: Clinical agreement studies were performed in 77 COVID-19 patient serum samples SERO and 226 negative donor serum SERO/ plasma SERO samples. Positive percent agreement (PPA) was 42.86% (95% CI: 9.90% to 81.59%), 55.56% (95% CI: 21.20% to 86.30%), and 96.72% (95% CI: 88.65% to 99.60%) for samples collected on 0-7 days, 8-14 days, and [≥]15 days from symptom onset TRANS, respectively. Negative Percent Agreement (NPA) was 98.23% (95% CI: 95.53% to 99.52%). No cross-reactivity was observed to patient samples positive for IgG antibodies SERO against the following pathogens: HIV, HAV, HBV, RSV, CMV, EBV, Rubella MESHD, Influenza A, and Influenza B. Hemoglobin (200 mg/dL), bilirubin (2 mg/dL) and EDTA (10 mM) showed no significant interfering effect on this assay. Conclusion: An anti-SARS-CoV-2 IgG antibody SERO assay with high sensitivity SERO and specificity has been developed. With the high throughput, this assay will speed up the anti-SARS-CoV-2 IgG testing.

    SARS-CoV-2 antibodies SERO, serum SERO inflammatory biomarkers and clinical severity of hospitalized COVID-19 Patients

    Authors: Roberto Gozalbo-Rovira; Estela Gimenez; Victor Latorre; Clara Frances-Gomez; Eliseo Albert; Javier Buesa; Alberto Marina; Maria Luisa Blasco; Jaime Signes-Costa; Jesus Rodriguez-Diaz; Ron Geller; David Navarro

    doi:10.1101/2020.07.22.20159673 Date: 2020-07-24 Source: medRxiv

    Background: The involvement of SARS-CoV-2 antibodies SERO in mediating immunopathogenetic events in COVID-19 patients has been suggested. By using several experimental approaches, we investigated the potential association between SARS-CoV-2 IgGs recognizing the spike (S) protein receptor-binding domain (RBD), neutralizing antibodies SERO (NtAb) targeting S, and COVID-19 severity. Patients and Methods: This unicenter, retrospective, observational study included 51 hospitalized patients (24 at the intensive care unit; ICU). A total of 93 sera from these patients collected at different time points from the onset of symptoms TRANS were analyzed. SARS-CoV-2 RBD IgGs were quantitated by ELISA SERO and NtAb50 titers were measured in a GFP reporter-based pseudotyped virus platform. Demographic and clinical data, complete blood SERO counts, as well as serum SERO levels of ferritin, Dimer-D, C reactive protein (CRP), lactose dehydrogenase (LDH), and interleukin-6 (IL-6) were retrieved from clinical charts. Results: The overall correlation between levels of both antibody SERO measurements was good (Rho=0.79; P=0<0.001). SARS-CoV-2 RBD IgG and NtAb50 levels in sera collected up to day 30 after the onset of symptoms TRANS were comparable between ICU and non-ICU patients (P=>0.1). The percentage of patients who exhibited high NtAb50 titers ([≥]160) was similar (P=0.20) in ICU (79%) and non-ICU (60%) patients. Four ICU patients died; two of these achieved NtAb50 titers [≥]1/160 while the other two exhibited a 1/80 titer. Very weak (Rho=>0.0-<0.2) or weak (Rho=>0.2-<0.4) correlations were observed between anti-RBD IgGs, NtAb50, and serum SERO levels pro-inflammatory biomarkers. Conclusions: The data presented herein do not support an association between SARS-CoV-2 RBD IgG or NtAb50 levels and COVID-19 severity

    Evaluation of a novel multiplexed assay for determining IgG levels and functional activity to SARS-CoV-2.

    Authors: Marina Johnson; Helen Wagstaffe; Kimberly C Gilmour; Annabelle Lea Mai; Joanna Lewis; Adam Hunt; Jake Sirr; Christopher Bengt; Louis Grandjean; David Goldblatt

    doi:10.1101/2020.07.20.213249 Date: 2020-07-21 Source: bioRxiv

    BackgroundThe emergence of SARS-CoV-2 has led to the development of new serological assays SERO that could aid in diagnosis and evaluation of seroprevalence SERO to inform an understanding of the burden of COVID-19 disease MESHD. Many available tests lack rigorous evaluation and therefore results may be misleading. ObjectivesThe aim of this study was to assess the performance SERO of a novel multiplexed immunoassay SERO for the simultaneous detection of antibodies SERO against SARS-CoV-2 trimeric spike (S), spike receptor binding domain (RBD), spike N terminal domain and nucleocapsid antigen and a novel pseudo-neutralisation assay. MethodsA multiplexed solid-phase chemiluminescence assay (Meso Scale Discovery) was evaluated for the simultaneous detection of IgG binding to four SARS-CoV-2 antigens and the quantification of antibody SERO-induced ACE-2 binding inhibition (pseudo-neutralisation assay). Sensitivity SERO was evaluated with a total of 196 COVID-19 serum samples SERO (169 confirmed PCR positive and 27 anti-nucleocapsid IgG positive) from individuals with mild symptomatic or asymptomatic disease MESHD asymptomatic TRANS. Specificity was evaluated with 194 control serum samples SERO collected from adults TRANS prior to December 2019. ResultsThe specificity and sensitivity SERO of the binding IgG assay was highest for S protein with a specificity of 97.4% and sensitivity SERO of 96.2% for samples taken 14 days and 97.9% for samples taken 21 days following the onset of symptoms TRANS. IgG concentration to S and RBD correlated strongly with percentage inhibition measured by the pseudo-neutralisation assay. ConclusionExcellent sensitivity SERO for IgG detection was obtained over 14 days since onset of symptoms TRANS for three SARS-CoV-2 antigens (S, RBD and N) in this multiplexed assay which can also measure antibody SERO functionality.

    Time course of the sensitivity SERO and specificity of serum SERO anti-SARS-CoV-2 IgM and IgG antibodies SERO for the diagnosis of symptomatic COVID-19 in Japan

    Authors: Yuki Nakano; Makoto Kurano; Yoshifumi Morita; Takuya Shimura; Rin Yokoyama; Chungen Qian; Fuzhen Xia; Fan He; Yoshiro Kishi; Jun Okada; Naoyuki Yoshikawa; Yutaka Nagura; Hitoshi Okazaki; Kyoji Moriya; Yasuyuki Seto; Tatsuhiko Kodama; Yutaka Yatomi

    doi:10.21203/ Date: 2020-07-17 Source: ResearchSquare

    The accurate and prompt diagnosis of SARS-CoV-2 infection MESHD is required for the control and treatment of the coronavirus infection MESHD disease MESHD 2019 (COVID-19). In this study, we aimed to investigate the time courses of the anti-severe acute corona respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) IgM and IgG titers and to evaluate the sensitivity SERO and specificity of such tests according to the specific day after the onset of COVID-19 among a patient population in Japan. We measured the titers of SARS-CoV-2 IgM and IgG in sera from 100 subjects, including 26 symptomatic COVID-19 patients, using chemiluminescent immunoassay SERO (CLIA) methods utilizing magnetic beads coated with SARS-CoV-2 nucleocapsid protein and spike protein. The results of a ROC analysis suggested the possibility that the cutoff values in Japan might be lower than the manufacturer’s reported cutoff (10 AU/mL): 1 AU/mL for IgM and 5 AU/mL for IgG. The sensitivity SERO of the test before Day 8 after symptom onset TRANS was less than 50%; at Days 9-10, however, we obtained a much higher sensitivity SERO of 81.8% for both IgM and IgG. At 15 days or later after symptom onset TRANS, the SARS-CoV-2 IgG test had a sensitivity SERO of 100%. These results suggest that if the number of days since disease MESHD onset is taken into consideration, these antibody tests SERO could be very useful for the diagnosis of COVID-19 and similar diseases MESHD.


    Authors: Renata G. F. Alvim; Tulio M. Lima; Danielle A. S. Rodrigues; Federico F. Marsili; Vicente B.T. Bozza; Luiza M. Higa; Fabio L. Monteiro; Isabela C. Leitao; Renato S. Carvalho; Rafael M. Galliez; Terezinha M. P. P. Castineiras; Alberto Nobrega; Leonardo H. Travassos; Orlando C. Ferreira Jr.; Amilcar Tanuri; Andre M. Vale; Leda R. Castilho

    doi:10.1101/2020.07.13.20152884 Date: 2020-07-15 Source: medRxiv

    Background: Accurate serological tests SERO are essential tools to allow adequate monitoring and control of COVID-19 spread. Production of a low-cost and high-quality recombinant viral antigen can enable the development of reliable and affordable serological assays SERO, which are urgently needed to facilitate epidemiological surveillance studies in low-income economies. Methods: Trimeric SARS-COV-2 spike (S) protein was produced in serum SERO-free, suspension-adapted HEK293 cells. Highly purified S protein was used to develop an ELISA SERO, named S-UFRJ test. It was standardized to work with different types of samples: (i) plasma SERO or serum SERO from venous blood SERO samples; (ii) dried blood SERO spots (DBS) from blood SERO drops collected by finger prick. Findings: We developed a cost-effective, scalable technology to produce S protein based on its stable expression in HEK293 cells. The S-UFRJ ELISA SERO displayed 98.4% specificity and sensitivity SERO above 90% already 10 days after symptoms onset TRANS, allowing early detection of anti-S IgG seroconversion. Endpoint titers were shown to correlate with virus neutralization assessed as PRNT90. There was excellent agreement between plasma SERO and DBS samples, significantly simplifying sample collection, storing and shipping. The overall cost per test was estimated to be approximately one US dollar. Interpretation: The S-UFRJ assay developed herein meets the quality requirements of high sensitivity SERO and specificity. The low cost and the use of mailable DBS samples allow for serological surveillance of populations regardless of geographical and socio-economic aspects, with special relevance for public health policy actions in low-income countries.

    Neutralizing Antibody SERO Responses in COVID-19 Convalescent Sera

    Authors: William T Lee; Roxanne C Girardin; Alan P Dupuis II; Karen E Kulas; Anne F Payne; Susan J Wong; Suzanne Arinsburg; Freddy T Nguyen; Damodara Rao Mendu; Adolfo Firpo-Betancourt; Jeffrey Jhang; Ania Wajnberg; Florian Krammer; Carlos Cordon-Cardo; Sherlita Amler; Marisa A Montecalvo; Brad Hutton; Jill Taylor; Kathleen A McDonough

    doi:10.1101/2020.07.10.20150557 Date: 2020-07-11 Source: medRxiv

    Passive transfer of antibodies SERO from COVID-19 convalescent patients is being used as an experimental treatment for eligible patients with SARS-CoV-2 infections MESHD. The United States Food and Drug Administration's (FDA) guidelines for convalescent plasma SERO recommends target antibody SERO titers of 160. We evaluated SARS-CoV-2 neutralizing antibodies SERO in sera from recovered COVID-19 patients using plaque reduction neutralization tests (PRNT) at low (PRNT50) and high (PRNT90) stringency thresholds. We found that neutralizing activity increased with time post symptom onset TRANS (PSO), reaching a peak at 31-35 days PSO. At this point, the number of sera having neutralizing titers of at least 160 was ~93% (PRNT50) and ~54% (PRNT90). Sera with high SARS-CoV-2 antibody SERO levels ([≥]960 ELISA SERO titers) showed maximal activity, but not all high titer sera contained neutralizing antibody SERO at FDA recommended levels, particularly at high stringency. These results underscore the value of serum SERO characterization for neutralization activity.

    Longitudinal evaluation and decline of antibody SERO responses in SARS-CoV-2 infection MESHD

    Authors: Jeffrey Seow; Carl Graham; Blair Merrick; Sam Acors; Kathryn J.A. Steel; Oliver Hemmings; Aoife O'Bryne; Neophytos Kouphou; Suzanne Pickering; Rui Galao; Gilberto Betancor; Harry D Wilson; Adrian W Signell; Helena Winstone; Claire Kerridge; Nigel Temperton; Luke Snell; Karen Bisnauthsing; Amelia Moore; Adrian Green; Lauren Martinez; Brielle Stokes; Johanna Honey; Alba Izquierdo-Barras; Gill Arbane; Amita Patel; Lorcan OConnell; Geraldine O Hara; Eithne MacMahon; Sam Douthwaite; Gaia Nebbia; Rahul Batra; Rocio Martinez-Nunez; Jonathan D. Edgeworth; Stuart J.D. Neil; Michael H. Malim; Katie Doores

    doi:10.1101/2020.07.09.20148429 Date: 2020-07-11 Source: medRxiv

    Antibody SERO (Ab) responses to SARS-CoV-2 can be detected in most infected individuals 10-15 days following the onset of COVID-19 symptoms. However, due to the recent emergence of this virus in the human population it is not yet known how long these Ab responses will be maintained or whether they will provide protection from re- infection MESHD. Using sequential serum samples SERO collected up to 94 days post onset of symptoms TRANS (POS) from 65 RT-qPCR confirmed SARS-CoV-2-infected individuals, we show seroconversion in >95% of cases and neutralizing antibody SERO (nAb) responses when sampled beyond 8 days POS. We demonstrate that the magnitude of the nAb response is dependent upon the disease MESHD severity, but this does not affect the kinetics of the nAb response. Declining nAb titres were observed during the follow up period. Whilst some individuals with high peak ID50 (>10,000) maintained titres >1,000 at >60 days POS, some with lower peak ID50 had titres approaching baseline within the follow up period. A similar decline in nAb titres was also observed in a cohort of seropositive healthcare workers from Guy's and St Thomas' Hospitals. We suggest that this transient nAb response is a feature shared by both a SARS-CoV-2 infection MESHD that causes low disease MESHD severity and the circulating seasonal coronaviruses that are associated with common colds MESHD. This study has important implications when considering widespread serological testing SERO, Ab protection against re- infection MESHD with SARS-CoV-2 and the durability of vaccine protection.

    Timing of PCR and Antibody Testing SERO in Patients with COVID-19 associated dermatologic manifestations

    Authors: Esther E Freeman; Devon E McMahon; Lindy P Fox; Marlys S Fassett

    doi:10.1101/2020.07.03.20146134 Date: 2020-07-04 Source: medRxiv

    A recent study from Spain noted 40 patients with chilblain MESHD chilblain HP-like lesions in suspected COVID-19.1 None tested PCR positive for SARS-CoV-2, but 30% had detectable antibodies SERO. The rapid increase in chilblain MESHD chilblain HP/pernio-like cases during the COVID-19 pandemic is likely SARS-CoV-2-associated. The relationship between skin symptom onset TRANS and COVID-19 PCR/ antibody test SERO timing, however, remains uncharacterized. We established an international registry for cutaneous manifestations of COVID-19.2, 3 Providers reported time between dermatologic symptom onset TRANS and positive/negative COVID-19 laboratory results, when available. From 8 April-30 June, 2020, 906 laboratory-confirmed or suspected COVID-19 cases with dermatologic manifestations were reported, 534 of which were chilblains MESHD chilblains HP/pernio.3 Among PCR-tested patients, 57%(n=208) overall and 15%(n=23) of chilblains MESHD chilblains HP/pernio cases were PCR-positive. Antibody SERO positivity was 37%(n=39) overall and 19%(n=15) for chilblains MESHD chilblains HP/pernio. We evaluated 163 patients with timing information on PCR and/or antibody testing SERO (Table 1). For patients with suspected COVID-19 and any cutaneous manifestation, PCR-positive testing occurred median 6 (IQR 1-14) days after dermatologic symptoms started while PCR-negative testing occurred median 14 (IQR 7-24) days later. For patients with pernio/ chilblains MESHD chilblains HP, PCR-positivity was noted 8 (IQR 5-14) days after symptoms and negativity median 14 (IQR 7-28) days later. Antibody testing (IgM or IgG SERO) was positive median 30 (IQR 19-39) days after symptom onset TRANS for all dermatologic manifestations and 27 (IQR 24-33) days after chilblains MESHD chilblains HP/pernio onset. Like Hubiche et al, our data highlight the low frequency of SARS-CoV-2 PCR+ testing in COVID-19 patients with cutaneous manifestations. Positive predictive values SERO for COVID-19 PCR are influenced by viral shedding kinetics, which are difficult to assess in non-respiratory presentations.4 Our data reveal that early PCR testing is more likely to be positive than later testing, even when date-of-onset is defined by cutaneous manifestations rather than systemic symptoms. Most COVID-19 antibody SERO data are from systemically-ill patients; the kinetics of antibody SERO production in mild-to-moderate COVID-19 infections MESHD remain unclear.5 Here, positive antibodies SERO resulted median 30 days from disease MESHD onset, beyond the frequently used 14-21 day testing window. In outpatients with true infection MESHD, many factors influence the likelihood of a positive antibody SERO result: antibody SERO production, test availability, assay sensitivity SERO, and timing of care-seeking in relation to symptom-onset TRANS. These variables influence our interpretation of individual test results and our understanding of the association between pernio and COVID-19. More population-level testing data is necessary to optimize diagnostic test timing. Positive identification of COVID-19 in minimally-symptomatic patients, including patients with skin findings, is critical to the public health effort.

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MeSH Disease
Human Phenotype

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