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Overview

MeSH Disease

Human Phenotype

Transmission

Seroprevalence
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    Performance SERO assessment of 11 commercial serological tests SERO for SARS-CoV-2 on hospitalized COVID-19 patients

    Authors: Claudia Serre-Miranda; Claudia Nobrega; Susana Roque; Joao Canto-Gomes; Carolina S Silva; Neide Vieira; Palmira Barreira-Silva; Pedro Alves-Peixoto; Jorge Cotter; Ana Reis; Mariana Formigo; Helena Sarmento; Olga Pires; Alexandre Carvalho; Dmitri Y Petrovykh; Lorena Dieguez; Joao C Sousa; Nuno Sousa; Carlos Capela; Joana A Palha; Pedro G Cunha; Margarida Correia-Neves

    doi:10.1101/2020.08.06.20168856 Date: 2020-08-07 Source: medRxiv

    Commercial availability of serological tests SERO to evaluate immunoglobulins (Ig) towards severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) has grown exponentially since the onset of COVID-19 outbreak. Their thorough validation is of extreme importance before using them as epidemiological tools to infer population seroprevalence SERO, and as complementary diagnostic tools to molecular approaches (e.g. RT-qPCR). Here we assayed commercial serological tests SERO (semiquantitative and qualitative) from 11 suppliers in 126 samples collected from hospitalized COVID-19 patients, and from 36 healthy and HIV-infected individuals (collected at the pre-COVID-19 pandemic). Specificity was above 95% in 9 tests. Samples from COVID-19 patients were stratified by days since symptoms onset TRANS (<10, 10-15, 16-21 and >21 days). Tests sensitivity SERO increases with time since symptoms onset TRANS, and peaks at 16-21 days for IgM and IgA (maximum: 91.2%); and from 16-21 to >21 days for IgG, depending on the test (maximum: 94.1%). Data from semiquantitative tests show that patients with severe clinical presentation have lower relative levels of IgM, IgA and IgG at <10 days since symptoms onset TRANS in comparison to patients with non-severe presentation. At >21 days since symptoms onset TRANS the relative levels of IgM and IgG (in one test) are significantly higher in patients with severe clinical presentation, suggesting a delay in the upsurge of Ig against SARS-CoV-2 in those patients. This study highlights the high specificity of most of the evaluated tests, and sensitivity SERO heterogeneity. Considering the virus genetic evolution and population immune response to it, continuous monitoring of commercially available serological tests SERO towards SARS-CoV-2 is necessary.

    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.

    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.

    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.

    SARS-CoV-2 serology increases diagnostic accuracy in CT-suspected, PCR-negative COVID-19 patients during pandemic

    Authors: Jochen Schneider; Hrvoje Mijocevic; Kurt Ulm; Bernhardt Ulm; Simon Weidlich; Silvia Wuerstle; Kathrin Rothe; Matthias Treiber; Roman Iakoubov; Ulrich Mayr; Tobias Lahmer; Sebastian Rasch; Alexander Herner; Egon Burian; Fabian Lohöfer; Rickmer Braren; Marcus Makowski; Roland Schmid; Ulrike Protzer; Christoph Spinner; Fabian Geisler

    doi:10.21203/rs.3.rs-51336/v1 Date: 2020-07-30 Source: ResearchSquare

    Background: In the absence of PCR detection of SARS-CoV-2 RNA, accurate diagnosis of COVID-19 is challenging. Low-dose computed tomography (CT) detects pulmonary infiltrates HP with high sensitivity SERO, but findings may be non-specific. This study assesses the diagnostic value of SARS-CoV-2 serology for patients with distinct CT features but negative PCR. Methods: IgM/IgG chemiluminescent immunoassay SERO was performed for 107 patients with confirmed (group A: PCR+; CT±) and 46 patients with suspected (group B: repetitive PCR-; CT+) COVID-19, admitted to a German university hospital during the pandemic’s first wave. A standardized, in-house CT classification of radiological signs of a viral pneumonia MESHD pneumonia HP was used to assess the probability of COVID-19. Results: Seroconversion rates (SR) determined on day 5, 10, 15, 20 and 25 after symptom onset TRANS (SO) were 8%, 25%, 65%, 76% and 91% for group A, and 0%, 10%, 19%, 37% and 46% for group B, respectively; (p<0.01). Compared to hospitalized patients with a non-complicated course, seroconversion tended to occur at lower frequency and delayed in patients on intensive care units. SR of patients with CT findings classified as high certainty for COVID-19 were 9%, 26%, 65%, 77% and 92% in group A, compared with 0%, 10%, 20%, 40% and 50% in group B (p<0.01). SARS-CoV-2 serology established a definite diagnosis in 12/46 group B patients. In 88% (8/9) of patients with negative serology >14 days after symptom onset TRANS (group B), clinico-radiological consensus reassessment revealed probable diagnoses other than COVID-19. Sensitivity SERO of SARS-CoV-2 serology was superior to PCR >17d after symptom onset TRANS. Conclusions: Approximately one-third of patients with distinct COVID-19 CT findings are tested negative for SARS-CoV-2 RNA by PCR rendering correct diagnosis difficult. Implementation of SARS-CoV-2 serology testing alongside current CT/PCR-based diagnostic algorithms improves discrimination between COVID-19-related and non-related pulmonary infiltrates HP in PCR negative patients. However, sensitivity SERO of SARS-CoV-2 serology strongly depends on the time of testing and becomes superior to PCR after the 2 nd week following symptom onset TRANS.

    Incidence and outcomes of healthcare-associated COVID-19 infections MESHD: significance of delayed diagnosis and correlation with staff absence

    Authors: Kirstin Khonyongwa; Surabhi K Taori; Ana Soares; Nergish Desai; Malur Sudhanva; William Bernal; Silke Schelenz; Lisa A Curran

    doi:10.1101/2020.07.24.20148262 Date: 2020-07-30 Source: medRxiv

    Background: The sudden increase in COVID-19 admissions in hospitals during the SARS-CoV2 pandemic of 2020 has led to onward transmissions TRANS among vulnerable inpatients. Aims: This study was performed to evaluate the prevalence SERO and clinical outcomes of Healthcare-associated COVID-19 infections MESHD (HA-COVID-19) during the 2020 epidemic and study factors which may promote or correlate with its incidence and transmission TRANS in a London Teaching Hospital Trust. Methods: Electronic laboratory, patient and staff self-reported sickness records were interrogated for the period 1st March to 18th April 2020. HA-COVID-19 was defined as symptom onset TRANS >14d of admission. Test performance SERO of a single combined throat and nose swab (CTNS) for patient placement and the effect of delayed RNA positivity (DRP, defined as >48h delay) on patient outcomes was evaluated. The incidence of staff self-reported COVID-19 sickness absence, hospital bed occupancy, community incidence and DRP was compared HA-COVID-19. The incidence of other significant hospital-acquired bacterial infections MESHD (OHAI) was compared to previous years. Results: 58 HA-COVID-19 (7.1%) cases were identified. As compared to community-acquired cases, significant differences were observed in age TRANS (p=0.018), ethnicity (p<0.001) and comorbidity burden (p<0.001) but not in 30d mortality. CTNS negative predictive value SERO was 60.3%. DRP was associated with greater mortality (p=0.034) and 34.5% HA-COVID-19 cases could be traced TRANS to delayed diagnosis in CA-COVID-19. Incidence of HA-COVID-19 correlated positively with DRP (R=0.7108) and staff sickness absence (R=0.7815). OHAI rates were similar to previous 2 years. Conclusion: Early diagnosis and isolation of COVID-19 would help reduce transmission TRANS. A single CTNS has limited value in segregating patients into positive and negative pathways.

    Eleven Routine Clinical Features Predict COVID-19 Severity

    Authors: Kai Zhou; Yaoting Sun; Lu Li; Zelin Zang; Jing Wang; Jun Li; Junbo Liang; Fangfei Zhang; Qiushi Zhang; Weigang Ge; Hao Chen; Xindong Sun; Liang Yue; Xiaomai Wu; Bo Shen; Jiaqin Xu; Hongguo Zhu; Shiyong Chen; Hai Yang; Shigao Huang; Minfei Peng; Dongqing Lv; Chao Zhang; Haihong Zhao; Luxiao Hong; Zhehan Zhou; Haixiao Chen; Xuejun Dong; Chunyu Tu; Minghui Li; Yi Zhu; Baofu Chen; Stan Z. Li; Tiannan Guo

    doi:10.1101/2020.07.28.20163022 Date: 2020-07-29 Source: medRxiv

    Severity prediction of COVID-19 remains one of the major clinical challenges for the ongoing pandemic. Here, we have recruited a 144 COVID-19 patient cohort consisting of training, validation, and internal test sets, longitudinally recorded 124 routine clinical and laboratory parameters, and built a machine learning model to predict the disease progression MESHD based on measurements from the first 12 days since the disease MESHD onset when no patient became severe. A panel of 11 routine clinical factors, including oxygenation index, basophil counts, aspartate aminotransferase, gender TRANS, magnesium, gamma glutamyl transpeptidase, platelet counts, activated partial thromboplastin time, oxygen saturation, body temperature and days after symptom onset TRANS, constructed a classifier for COVID-19 severity prediction, achieving accuracy of over 94%. Validation of the model in an independent cohort containing 25 patients achieved accuracy of 80%. The overall sensitivity SERO, specificity, PPV and NPV were 0.70, 0.99, 0.93 and 0.93, respectively. Our model captured predictive dynamics of LDH and CK while their levels were in the normal range. This study presents a practical model for timely severity prediction and surveillance for COVID-19, which is freely available at webserver https://guomics.shinyapps.io/covidAI/.

    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.

    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.

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MeSH Disease
Human Phenotype
Transmission
Seroprevalence


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