Corpus overview


Overview

MeSH Disease

Human Phenotype

Transmission

Seroprevalence
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    Clinical Utility of a Highly Sensitive Lateral Flow Immunoassay SERO as determined by Titer Analysis for the Detection of anti- SARS-CoV-2 Antibodies SERO at the Point-of-Care

    Authors: Amanda Haymond; Claudius Mueller; Hannah Steinberg; K. Alex Hodge; Caitlin W Lehman; Shih-Chao Lin; Lucia Collini; Heather Branscome; Tuong Vi Nguyen; Sally Rucker; Lauren Panny; Rafaela Flor; Raouf Guirguis; Richard Hoefer; Giovanni Lorenzin; Emanuel Petricoin; Fatah Kashanchi; Kylene Kehn-Hall; Paolo Lanzafame; Lance Liotta; Alessandra Luchini

    doi:10.1101/2020.07.30.20163824 Date: 2020-08-02 Source: medRxiv

    Coronavirus disease MESHD 2019 (COVID-19), caused by the severe acute respiratory syndrome MESHD coronavirus-2 (SARS-CoV-2), became a pandemic in early 2020. Lateral flow immunoassays SERO for antibody testing SERO have been viewed as a cheap and rapidly deployable method for determining previous infection MESHD with SARS-CoV-2; however, these assays have shown unacceptably low sensitivity SERO. We report on nine lateral flow immunoassays SERO currently available and compare their titer sensitivity SERO in serum SERO to a best-practice enzyme-linked immunosorbent assay SERO ( ELISA SERO) and viral neutralization assay. For a small group of PCR-positive, we found two lateral flow immunoassay SERO devices with titer sensitivity SERO roughly equal to the ELISA SERO; these devices were positive for all PCR-positive patients harboring SARS-CoV-2 neutralizing antibodies SERO. One of these devices was deployed in Northern Italy to test its sensitivity SERO and specificity in a real-world clinical setting. Using the device with fingerstick blood SERO on a cohort of 27 hospitalized PCR-positive patients and seven hospitalized controls, ROC curve analysis gave AUC values of 0.7646 for IgG. For comparison, this assay was also tested with saliva from the same patient population and showed reduced discrimination between cases and controls with AUC values of 0.6841 for IgG. Furthermore, during viral neutralization testing, one patient was discovered to harbor autoantibodies to ACE2, with implications for how immune responses are profiled. We show here through a proof-of-concept study that these lateral flow devices can be as analytically sensitive as ELISAs SERO and adopted into hospital protocols; however, additional improvements to these devices remain necessary before their clinical deployment.

    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.

    Persistence of anti- SARS-CoV-2 antibodies SERO in non-hospitalized COVID-19 convalescent health care workers

    Authors: Margherita Bruni; Valentina Cecatiello; Angelica Diaz-Basabe; Georgia Lattanzi; Erika Mileti; Silvia Monzani; Laura Pirovano; Francesca Rizzelli; Clara Visintin; Giuseppina Bonizzi; Marco Giani; Marialuisa Lavitrano; Silvia Faravelli; Federico Forneris; Flavio Caprioli; Pier Giuseppe Pelicci; Gioacchino Natoli; Sebastiano Pasqualato; Marina Mapelli; Federica Facciotti

    doi:10.1101/2020.07.30.20164368 Date: 2020-08-01 Source: medRxiv

    Background. Coronavirus disease MESHD-19 (COVID-19) is a respiratory illness caused by the Severe Acute Respiratory Syndrome MESHD CoronaVirus 2 (SARS-CoV-2), a novel beta-coronavirus. Although antibody SERO response to SARS-CoV-2 can be detected early during the infection MESHD, several outstanding questions remain to be addressed regarding magnitude and persistence of antibody SERO titer against different viral proteins and their correlation with the strength of the immune response, as measured by serum SERO levels of pro-inflammatory mediators. Methods. An ELISA assay SERO has been developed by expressing and purifying the recombinant SARS-CoV-2 Spike Receptor Binding Domain (RBD), Soluble Ectodomain (Spike), and full length nucleocapsid protein (N protein). Sera from healthcare workers affected by non-severe COVID-19 were longitudinally collected over four weeks, and compared to sera from patients hospitalized in Intensive Care Units (ICU) and SARS-CoV-2-negative subjects for the presence of IgM, IgG and IgA antibodies SERO as well as soluble pro-inflammatory mediators in the sera. Results. Specificity and sensitivity SERO of the ELISA assays SERO were high for anti-RBD IgG and IgA (92-97%) and slightly lower for IgM and the Spike and N proteins (70-85%). The ELISA SERO allowed quantification of IgM, IgG and IgA antibody SERO responses against all the viral antigens tested and showed a correlation between magnitude of the antibody SERO response and disease MESHD severity. Non-hospitalized subjects showed lower antibody SERO titers and blood SERO pro-inflammatory cytokine profiles as compared to patients in Intensive Care Units (ICU), irrespective of the antibodies tested SERO. Noteworthy, in non-severe COVID-19 infections MESHD, antibody SERO titers against RBD and Spike, but not against the N protein, as well as pro-inflammatory cytokines decreased within a month after viral clearance. Conclusions. Rapid decline in antibody SERO titers and in pro-inflammatory cytokines may be a common feature of non-severe SARS-CoV-2 infection MESHD, suggesting that antibody SERO-mediated protection against re- infection MESHD with SARS-CoV-2 is of short duration. These results suggest caution in use serological testing SERO to estimate the prevalence SERO of SARS-CoV-2 infection MESHD in the general population.

    High SARS-CoV-2 seroprevalence SERO in Health Care Workers but relatively low numbers of deaths MESHD in urban Malawi

    Authors: Marah Grace Chibwana; Khuzwayo Chidiwa Jere; Jonathan Mandolo; Vincent Katunga-Phiri; Dumizulu Tembo; Ndaona Mitole; Samantha Musasa; Simon Sichone; Agness Lakudzala; Lusako Sibale; Prisca Matambo; Innocent Kadwala; Rachel Louise Byrne; Alice Mbewe; Ben Morton; Chimota Phiri; Jane Mallewa; Henry C Mwandumba; Emily R Adams; Stephen B Gordon; Kondwani Charles Jambo

    doi:10.1101/2020.07.30.20164970 Date: 2020-08-01 Source: medRxiv

    Background In low-income countries, like Malawi, important public health measures including social distancing or a lockdown, have been challenging to implement owing to socioeconomic constraints, leading to predictions that the COVID-19 pandemic would progress rapidly. However, due to limited capacity to test for severe acute respiratory syndrome MESHD coronavirus 2 (SARS-CoV-2) infection MESHD, there are no reliable estimates of the true burden of infection MESHD and death MESHD. We, therefore, conducted a SARS-CoV-2 serosurvey amongst health care workers (HCW) in Blantyre city to estimate the cumulative incidence of SARS-CoV-2 infection MESHD in urban Malawi. Methods Five hundred otherwise asymptomatic TRANS HCWs were recruited from Blantyre City (Malawi) from 22nd May 2020 to 19th June 2020 and serum samples SERO were collected all participants. A commercial ELISA SERO was used to measure SARS-CoV-2 IgG antibodies SERO in serum SERO. We run local negative samples (2018 - 2019) to verify the specificity of the assay. To estimate the seroprevalence SERO of SARS CoV-2 antibodies SERO, we adjusted the proportion of positive results based on local specificity of the assay. Results Eighty-four participants tested positive for SARS-CoV-2 antibodies SERO. The HCW with a positive SARS-CoV-2 antibody SERO result came from different parts of the city. The adjusted seroprevalence SERO of SARS-CoV-2 antibodies SERO was 12.3% [CI 9.0-15.7]. Using age TRANS-stratified infection MESHD fatality estimates reported from elsewhere, we found that at the observed adjusted seroprevalence SERO, the number of predicted deaths MESHD was 8 times the number of reported deaths MESHD. Conclusion The high seroprevalence SERO of SARS-CoV-2 antibodies SERO among HCW and the discrepancy in the predicted versus reported deaths MESHD, suggests that there was early exposure but slow progression of COVID-19 epidemic in urban Malawi. This highlights the urgent need for development of locally parameterised mathematical models to more accurately predict the trajectory of the epidemic in sub-Saharan Africa for better evidence-based policy decisions and public health response planning.

    Back to school: use of Dried Blood SERO Spot for the detection of SARS-CoV-2-specific immunoglobulin G (IgG) among schoolchildren in Milan, Italy.

    Authors: Antonella Amendola; Silvia Bianchi; Maria Gori; Lucia Barcellini; Daniela Colzani; Marta Canuti; Vania Giacomet; Valentina Fabiano; Laura Folgori; Gian Vincenzo Zuccotti; Elisabetta Tanzi

    doi:10.1101/2020.07.29.20164186 Date: 2020-07-30 Source: medRxiv

    Abstract Serological surveillance is necessary to the reestablishment of school activities in safe conditions and to avoid school-related outbreaks. In this study, DBS (Dried Blood SERO Spots) have proven to be a simple, rapid and reliable sample collection tool for detecting antibodies SERO against SARS-CoV-2 by ELISA SERO test compared to matched serum samples SERO from venous sampling (R2=0.9553; Pearson's coefficient=0.98; Cohen's unweighted k=0.93; overall agreement=96.2%). This approach may facilitate sample collection from schoolchildren for serological surveys useful to an adequate risk-assessment.

    Magnetic bead-based ELISA SERO allow inexpensive, rapid and quantitative detection of human antibodies SERO against SARS-CoV-2

    Authors: Luciano F Huergo; Marcelo S Conzentino; Edileusa C M Gerhardt; Adrian R.S. Santos; Fabio de Oliveira Pedrosa; Emanuel M Souza; Meri B Nogueira; Karl Forchhammer; Fabiane G.M Rego; Sonia M Raboni; Rodrigo A Reis

    doi:10.1101/2020.07.26.20162255 Date: 2020-07-29 Source: medRxiv

    Here we describe a novel immunogenic method to detect COVID-19. The method is a chromogenic magnetic bead-based ELISA SERO which allows inexpensive and quantitative detection of human IgG or IgM antibodies SERO against SARS-CoV-2 in serum SERO or whole blood SERO samples in just 12 minutes. As a proof of concept, we compared the performance SERO of our new method to classical ELISA SERO. Person correlation between optical densities obtained using the two methods was 0.98. The novel magnetic bead-based ELISA SERO performed better than classic ELISA SERO to discriminate one COVID-19 case carrying low antibody SERO titer. The chromogenic magnetic bead-based ELISA SERO method described here can be applied in formats for both point of care and high throughput analysis. The method is readily adaptable to use other protein-based antigens and is readily adaptable to investigate other diseases MESHD and other applications.

    Seroprevalence SERO of anti-SARS-CoV-2 IgG antibodies SERO in Kenyan blood SERO donors

    Authors: Sophie Uyoga; Ifedayo M.O. Adetifa; Henry K. Karanja; James Nyagwange; James Tuju; Perpetual Wanjiku; Rashid Aman; Mercy Mwangangi; Patrick Amoth; Kadondi Kasera; Wangari Ng'ang'a; Charles Rombo; Christine K. Yegon; Khamisi Kithi; Elizabeth Odhiambo; Thomas Rotich; Irene Orgut; Sammy Kihara; Mark Otiende; Christian Bottomley; Zonia N. Mupe; Eunice W. Kagucia; Katherine Gallagher; Anthony Etyang; Shirine Voller; John Gitonga; Daisy Mugo; Charles N. Agoti; Edward Otieno; Leonard Ndwiga; Teresa Lambe; Daniel Wright; Edwine Barasa; Benjamin Tsofa; Philip Bejon; Lynette I. Ochola-Oyier; Ambrose Agweyu; J. Anthony G. Scott; George M Warimwe

    doi:10.1101/2020.07.27.20162693 Date: 2020-07-29 Source: medRxiv

    Background There are no data on SARS-CoV-2 seroprevalence SERO in Africa though the COVID-19 epidemic curve and reported mortality differ from patterns seen elsewhere. We estimated the anti- SARS-CoV-2 antibody SERO prevalence SERO among blood SERO donors in Kenya. Methods We measured anti-SARS-CoV-2 spike IgG prevalence SERO by ELISA SERO on residual blood SERO donor samples obtained between April 30 and June 16, 2020. Assay sensitivity SERO and specificity were 83% (95% CI 59, 96%) and 99.0% (95% CI 98.1, 99.5%), respectively. National seroprevalence SERO was estimated using Bayesian multilevel regression and post-stratification to account for non-random sampling with respect to age TRANS, sex and region, adjusted for assay performance SERO. Results Complete data were available for 3098 of 3174 donors, aged TRANS 15-64 years. By comparison with the Kenyan population, the sample over-represented males TRANS (82% versus 49%), adults TRANS aged TRANS 25-34 years (40% versus 27%) and residents of coastal Counties (49% versus 9%). Crude overall seroprevalence SERO was 5.6% (174/3098). Population-weighted, test-adjusted national seroprevalence SERO was 5.2% (95% CI 3.7, 7.1%). Seroprevalence SERO was highest in the 3 largest urban Counties; Mombasa (9.3% [95% CI 6.4, 13.2%)], Nairobi (8.5% [95% CI 4.9, 13.5%]) and Kisumu (6.5% [95% CI 3.3, 11.2%]). Conclusions We estimate that 1 in 20 adults TRANS in Kenya had SARS-CoV-2 antibodies SERO during the study period. By the median date of our survey, only 2093 COVID-19 cases and 71 deaths MESHD had been reported through the national screening system. This contrasts, by several orders of magnitude, with the numbers of cases and deaths MESHD reported in parts of Europe and America when seroprevalence SERO was similar.

    Error Correction Codes for COVID-19 Virus and Antibody Testing SERO: Using Pooled Testing to Increase Test Reliability

    Authors: Jirong Yi; Myung Cho; Xiaodong Wu; Weiyu Xu; Raghu Mudumbai

    id:2007.14919v1 Date: 2020-07-29 Source: arXiv

    We consider a novel method to increase the reliability of COVID-19 virus or antibody tests SERO by using specially designed pooled testings. Instead of testing nasal swab or blood SERO samples from individual persons, we propose to test mixtures of samples from many individuals. The pooled sample testing method proposed in this paper also serves a different purpose: for increasing test reliability and providing accurate diagnoses even if the tests themselves are not very accurate. Our method uses ideas from compressed sensing and error-correction coding to correct for a certain number of errors in the test results. The intuition is that when each individual's sample is part of many pooled sample mixtures, the test results from all of the sample mixtures contain redundant information about each individual's diagnosis, which can be exploited to automatically correct for wrong test results in exactly the same way that error correction codes correct errors introduced in noisy communication channels. While such redundancy can also be achieved by simply testing each individual's sample multiple times, we present simulations and theoretical arguments that show that our method is significantly more efficient in increasing diagnostic accuracy. In contrast to group testing and compressed sensing which aim to reduce the number of required tests, this proposed error correction code idea purposefully uses pooled testing to increase test accuracy, and works not only in the "undersampling" regime, but also in the "oversampling" regime, where the number of tests is bigger than the number of subjects. The results in this paper run against traditional beliefs that, "even though pooled testing increased test capacity, pooled testings were less reliable than testing individuals separately."

    Serial population based serosurvey of antibodies to SARS-CoV-2 SERO in a low and high transmission TRANS area of Karachi, Pakistan

    Authors: Muhammad Imran Nisar; Nadia Ansari; Mashal Amin; Farah Khalid; Aneeta Hotwani; Najeeb Rehman; Arjumand Rizvi; Arslan Memon; Zahoor Ahmed; Ashfaque Ahmed; Junaid Iqbal; Ali Faisal Saleem; Uzma Bashir Aamir; Daniel B Larremore; Bailey Fosdick; Fyezah Jehan

    doi:10.1101/2020.07.28.20163451 Date: 2020-07-29 Source: medRxiv

    Background Pakistan is among the first low- and middle-income countries affected by COVID-19 pandemic. Monitoring progress through serial sero-surveys SERO, particularly at household level, in densely populated urban communities can provide insights in areas where testing is non-uniform. Methods Two serial cross-sectional household surveys were performed in April (phase 1) and June (phase 2) 2020 each in a low- (District Malir) and high- transmission TRANS (District East) area of Karachi, Pakistan. Household were selected using simple random sampling (Malir) and systematic random sampling (East). Individual participation rate from consented households was 82.3% (1000/1215 eligible) in phase 1 and 76.5% (1004/1312 eligible) in phase 2. All household members or their legal guardians answered questions related to symptoms of Covid-19 and provided blood SERO for testing with commercial Elecsys Anti-SARS-CoV-2 immunoassay SERO targeting combined IgG and IgM. Seroprevalence SERO estimates were computed for each area and time point independently. Given correlation among household seropositivity values, a Bayesian regression model accounting for household membership, age TRANS and gender TRANS was used to estimate seroprevalence SERO. These estimates by age TRANS and gender TRANS were then post-stratified to adjust for the demographic makeup of the respective district. The household conditional risk of infection TRANS risk of infection TRANS infection MESHD was estimated for each district and its confidence interval were obtained using a non-parametric bootstrap of households. Findings Post-stratified seroprevalence SERO was estimated to be 0.2% (95% CI 0-0.7) in low-and 0.4% (95% CI 0 - 1.3) in high- transmission TRANS areas in phase 1 and 8.7% (95% CI 5.1-13.1) in low- and 15.1% (95% CI 9.4 -21.7) in high- transmission TRANS areas in phase 2, with no consistent patterns between prevalence SERO rates for males TRANS and females TRANS. Conditional risk of infection TRANS risk of infection TRANS infection MESHD estimates (possible only for phase 2) were 0.31 (95% CI 0.16-0.47) in low- and 0.41(95% CI 0.28-0.52) in high- transmission TRANS areas. Of the 166 participants who tested positive, only 9(5.4%) gave a history of any symptoms. Interpretation A large increase in seroprevalence SERO to SARS-CoV-2 infection MESHD is seen, even in areas where transmission TRANS is reported to be low. Mostly the population is still seronegative. A large majority of seropositives do not report any symptoms. The probability that an individual in a household is infected, given that another household member is infected is high in both the areas. These results emphasise the need to enhance surveillance activities of COVID-19 especially in low- transmission TRANS sites and provide insights to risks of household transmission TRANS in tightly knit neighbourhoods in urban LMIC settings.

    Serum SERO S100B protein as a marker of severity in Covid-19 patients

    Authors: Antonio Aceti; Lory Marika Margarucci; Elena Scaramucci; Massimiliano Orsini; Gerardo Salerno; Gabriele Di Sante; Gianluca Gianfranceschi; Rosa Di Liddo; Federica Valeriani; Francesco Ria; Maurizio Simmaco; Pier Paolo Parnigotto; Matteo Vitali; Vincenzo Romano Spica; Fabrizio Michetti

    doi:10.21203/rs.3.rs-50341/v1 Date: 2020-07-28 Source: ResearchSquare

    SARS-CoV-2 infection MESHD shows a wide-ranging clinical severity, requiring prognostic markers. We focused on S100B, a calcium-binding protein present in biological fluids, being a reliable biomarker in disorders having inflammatory processes as common basis and RAGE as main receptor. Since Covid-19 is characterized by a potent inflammatory response also involving RAGE, we tested if S100B serum SERO levels were related to disease MESHD severity. Serum samples SERO (n=74) were collected from hospitalized SARS-CoV-2 positive patients admitted to Covid center. Illness severity was established by admission clinical criteria and Covid risk score. Treatment protocols followed WHO guidelines available at the time. Circulating S100B was determined by ELISA assay SERO. Statistical analysis used Pearson’s χ2 test, t-Test, and ANOVA, ANCOVA, Linear Regression.S100B was detected in serum SERO from Covid-19 patients, significantly correlating with disease MESHD severity as shown both by the level of intensity of care (p<0.006) as well by the value of Covid score (Multiple R-squared: 0.3751); the correlation between Covid-Score and S100B was 0.61 (p<0.01). S100B concentration was associated with inflammation MESHD markers (Ferritin, C-Reactive Protein, Procalcitonin), and organ damage markers (Alanine Aminotransferase, Creatinine). Serum SERO S100B plays a role in Covid-19 and can represent a prognostic marker in Sars-CoV-2 infected patients.

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MeSH Disease
Human Phenotype
Transmission
Seroprevalence


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