Corpus overview


MeSH Disease

Human Phenotype

Pneumonia (29)

Fever (12)

Hypertension (11)

Cough (6)

Falls (5)


    displaying 11 - 20 records in total 265
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    A Study to Evaluate the Accuracy, Usability, and Acceptance of a Blood SERO-Based HIV Self-Test Performed by Observed Intended Users in Canada

    Authors: Richard A. Galli; Jason Lo Hog Tian; Michelle Sumner-Williams; Kristin McBain; Emal Stanizai; Wangari Tharao; Muna Aden; Heather Jamieson; Mark Da Silva; Anne-Fanny Vassal; Lorie Guilbault; Laurie Ireland; Kim Witges; Alexandra King; Kehinde Ametepee; Nathan J. Lachowsky; Nitika Pant-Pai; Tony Mazzulli; Sean B. Rourke

    doi:10.21203/ Date: 2020-09-16 Source: ResearchSquare

    Introduction: Self-Testing for HIV (“HIVST”) is an emerging targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed especially in priority populations. The study objectives of this study were to (1) evaluate the INSTI HIV-Self-Test (HIV-ST) performance SERO compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV-ST device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for license purposes.Methods: The study used a cross-sectional design and recruited consenting adults TRANS from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV-ST were compared with results of the Abbott Architect HIV Ag/Ab Combo MESHD test. Results: Primary efficacy analysis on 678 completed HIV-ST revealed a positive percent agreement of 100% and a negative percent agreement of 99.5% with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5%. Of the 708 participants who took part in the usability study, 92.4% of participants successfully performed the steps determined to be “critical” for successful completion of the test, 96.7% of participants found the instructions easy to follow, and 95% of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive) to 99.3% (for negative).Conclusions: The addition of this very first self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. An approved blood SERO-based HIV self-test in Canada can offer an accurate, acceptable and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.

    SARS-CoV-2 N-antigenemia: A new alternative to nucleic acid amplification techniques

    Authors: Quentin Le Hingrat; Benoit Visseaux; Cedric Laouenan; Sarah Tubiana; Lila Bouadma; Yazdan Yazdanpanah; Xavier Duval; Houria Ichou; Florence Damond; Melanie Bertine; Nabil Benmalek; - French COVID cohort management committee; - CoV-CONTACT study group; Christophe Choquet; Jean-Francois Timsit; Jade Ghosn; Charlotte Charpentier; Diane Descamps; Nadhira Houhou-Fidouh; Jose Nicolas Alcala Pedrajas; Anabel Martin Urda Diez Canseco; Maria Jose Esteban Giner; Pablo Telleria Gomez; Ricardo Gomez Huelgas; Jose Manuel Ramos Rincon; Nina la Cour Freiesleben; Henriette Svarre Nielsen

    doi:10.1101/2020.09.14.20191759 Date: 2020-09-15 Source: medRxiv

    Background. Molecular assays on nasopharyngeal swabs remain the cornerstone of COVID-19 diagnostic. Despite massive worldwide efforts, the high technicalities of nasopharyngeal sampling and molecular assays, as well as scarce resources of reagents, limit our testing capabilities. Several strategies failed, to date, to fully alleviate this testing process (e.g. saliva sampling or antigen testing on nasopharyngeal samples). We assessed the performances SERO of a new ELISA SERO microplate assay quantifying SARS-CoV-2 nucleocapsid antigen (N-antigen) in serum SERO or plasma SERO. Methods. The specificity of the assay, determined on 63 non-COVID patients, was 98.4% (95% confidence interval [CI], 85.3 to 100). Performances SERO were determined on 227 serum samples SERO from 165 patients with RT-PCR confirmed SARS-CoV-2 infection MESHD included in the French COVID and CoV-CONTACT cohorts. Findings. Sensitivity SERO was 132/142, 93.0% (95% CI, 84.7 to 100), within the first two weeks after symptoms onset TRANS. A subset of 73 COVID-19 patients had a serum SERO collected within 24 hours following or preceding a positive nasopharyngeal swab. Among patients with high nasopharyngeal viral loads, Ct value below 30 and 33, only 1/50 and 4/67 tested negative for N-antigenemia, respectively. Among patients with a negative nasopharyngeal RT-PCR, 8/12 presented positive N-antigenemia. The lower respiratory tract was explored for 6/8 patients, showing positive PCR in 5 cases. Interpretation. This is the first demonstration of the N-antigen antigenemia during COVID-19. Its detection presented a robust sensitivity SERO, especially within the first 14 days after symptoms onset TRANS and high nasopharyngeal viral loads. These findings have to be confirmed with higher representation of outpatients. This approach could provide a valuable new option for COVID-19 diagnosis, only requiring a blood SERO draw and easily scalable in all clinical laboratories.

    Development, clinical translation, and utility of a COVID-19 antibody test SERO with qualitative and quantitative readouts

    Authors: Robert H. Bortz III; Catalina Florez; Ethan Laudermilch; Ariel S Wirchnianski; Gorka Lasso; Ryan J Malonis; George I Georgiev; Olivia Vergnolle; Natalia G Herrera; Nicholas C Morano; Sean T Campbell; Erika P. Orner; Amanda Mengotto; M Eugenia Dieterle; Jens Maximilian Fels; Denise Haslwanter; Rohit Jangra; Alev Celikgil; Duncan Kimmel; James H Lee; Margarette Mariano; Antonio Nakouzi; Jose Quiroz; Johanna Rivera; Wendy A Szymczak; Karen Tong; Jason Barnhill; Mattias NE Forsell; Clas Ahlm; Daniel T. Stein; Liise-anne Pirofski; Doctor Y Goldstein; Scott J. Garforth; Steven C. Almo; Johanna P. Daily; Michael B. Prystowsky; James D. Faix; Amy S. Fox; Louis M. Weiss; Jonathan R. Lai; Kartik Chandran

    doi:10.1101/2020.09.10.20192187 Date: 2020-09-11 Source: medRxiv

    The COVID-19 global pandemic caused by severe acute respiratory syndrome coronavirus-2 MESHD (SARS-CoV-2) continues to place an immense burden on societies and healthcare systems. A key component of COVID-19 control efforts is serologic testing SERO to determine the community prevalence SERO of SARS-CoV-2 exposure and quantify individual immune responses to prior infection MESHD or vaccination. Here, we describe a laboratory-developed antibody test SERO that uses readily available research-grade reagents to detect SARS-CoV-2 exposure in patient blood SERO samples with high sensitivity SERO and specificity. We further show that this test affords the estimation of viral spike-specific IgG titers from a single sample measurement, thereby providing a simple and scalable method to measure the strength of an individual's immune response. The accuracy, adaptability, and cost-effectiveness of this test makes it an excellent option for clinical deployment in the ongoing COVID-19 pandemic.

    Robust SARS-COV-2 serological population screens via multi-antigen rules-based approach

    Authors: Christos F Fotis; Nikolaos Meimetis; Nikos Tsolakos; Marianna Politou; Karolina Akinosoglou; Vicky Pliaka; Angeliki Minia; Evangelos Terpos; Ioannis P. Trougakos; Andreas Mentis; Markos Marangos; George Panayiotakopoulos; Meletios A. Dimopoulos; Charalampos Gogos; Alexandros Spyridonidis; Leonidas G. Alexopoulos

    doi:10.1101/2020.09.09.20191122 Date: 2020-09-10 Source: medRxiv

    More than 300 SARS-COV-2 serological tests SERO have recently been developed using either the nucleocapsid phosphoprotein (N), the spike glycoprotein subunit (S1), and more recently the receptor binding domain (RBD). Most of the assays report very good clinical performance SERO characteristics in well-controlled clinical settings. However, there is a growing belief that good performance SERO characteristics that are obtained during clinical performance SERO trials might not be sufficient to deliver good diagnostic results in population-wide screens that are usually characterized with low seroprevalence SERO. In this paper, we developed a serological assay SERO against N, S1 and RBD using a bead-based multiplex platform and a rules-based computational approach to assess the performance SERO of single and multi-antigen readouts in well-defined clinical samples and in a population-wide serosurvey from blood SERO donors. Even though assays based on single antigen readouts performed similarly well in the clinical samples, there was a striking difference between the antigens on the population-wide screen. Asymptomatic TRANS individuals with low antibody SERO titers and sub-optimal assay specificity might contribute to the large discrepancies in population studies with low seroprevalence SERO. A multi-antigen assay requiring partial agreement between RBD, N and S1 readouts exhibited enhanced specificity, less dependency on assay cut-off values and an overall more robust performance SERO in both sample settings. Our data suggest that assays based on multiple antigen readouts combined with a rules-based computational consensus can provide a more robust platform for routine antibody SERO screening.

    Disinfection and sterilization methods to reuse face masks and respirators: A systematic review

    Authors: Kirellos Said Abbas; Ngoc Mai Luu; Dao Ngoc Hien Tam; Abdelrahman Gad; Reham Reda; Basant Lashin; Khadiga Nour; Fatmaelzahraa Yasser Ali; Atef Khairy Sharaf; Ranjit Tiwari; Abdelwahap Salem Khalifa Elghezewi; Vinh Dong; Nguyen Tien Huy

    doi:10.21203/ Date: 2020-09-10 Source: ResearchSquare

    Background: In the context of COVID-19 pandemic, mask, or respirator wearing is considered one of the essential protection measures for healthcare workers to deal with infected MESHD patients. As the demand for face masks strongly increases during the pandemic leading to their shortages, our study aimed to review the current decontamination methods to reuse masks and respirators. Method: On May 18th, 2020, a systematic search for articles reported the methods of disinfection and sterilization for reusing surgical masks or respirators was conducted in eight electronic databases including PubMed, Scopus, Web of Science (ISI), Google Scholar, Cochrane, WHO Global Health Library (GHL), Clinicaltrials and Virtual Health Library (VHL). Manual search was further performed by screening references of included articles and relevant reviews and their related articles in PubMed and Google Scholar. We excluded unreliable extracted data, non-original or secondary research, not available full texts or abstract only. Results: There were 52 articles included in the qualitative synthesis. While hydrogen peroxide gas plasma SERO (HPGP) (59%) degraded the mask filtration performance SERO, vapor hydrogen peroxide (VHP) at varying concentrations and ethylene oxide (EtO) did not affect this. Moist heat incubation (MHI) (at 65 ± 5°C for 20 minutes) and microwave generated steam (MGS) (2 -3 minutes) caused > 4 log reduction of the H5N1 virus and did not degrade the mask filtration performance SERO, while autoclave (at 121°C, 103 kPas) strongly affected this. The mask filtration efficacy was significantly reduced by ethanol 70% but recovered to 86% after the recharge process. Ultraviolet germicidal irradiation (UVGI) (4.32 – 7.2 J/cm2) showed good biocidal efficacy and no degradation of filtration performance SERO but had a poor effect with a dose of 3J/cm2 and degraded the mask with a dose of 18 J/cm2. Conclusion: MHI and UVGI could be highly recommended decontamination methods for reusing masks. VHP could be considered but less effective due to the possible degradation in physical appearances. 

    Comparative evaluation of six immunoassays SERO for the detection of antibodies SERO against SARS-CoV-2

    Authors: Felipe Perez-Garcia; Ramon Perez-Tanoira; Maria Esther Iglesias; Juan Romanyk; Teresa Arroyo; Pena Gomez-Herruz; Rosa Gonzalez; Juan Cuadros-Gonzalez; Richard Croker; Alex J Walker; Elizabeth J Williamson; Chris Bates; Seb Bacon; Amir Mehrkar; Helen J Curtis; David Evans; Kevin Wing; Peter Inglesby; Rohini Mathur; Henry Drysdale; Angel YS Wong; Helen I McDonald; Jonathan Cockburn; Harriet Forbes; John Parry; Frank Hester; Sam Harper; Liam Smeeth; Ian J Douglas; William G Dixon; Stephen JW Evans; Laurie Tomlinson; Ben Goldacre; Sacha Gnjatic; Noam Harpaz; Silvio Danese; Adeeb Rahman; Nikhil A Kumta; Alessio Aghemo; Francesca Petralia; Harm van Bakel; Adolfo Garcia-Sastre; Saurabh Mehandru

    doi:10.1101/2020.09.08.20190488 Date: 2020-09-09 Source: medRxiv

    Objectives: Serologic techniques can serve as a complement to diagnose SARS-CoV-2 infection MESHD. The objective of our study was to compare the diagnostic performance SERO of six immunoassays SERO to detect antibodies SERO against SARS-CoV-2: three lateral flow immunoassays SERO (LFAs), one ELISA SERO and two chemiluminescence assays (CLIAs). Methods: We evaluated three LFAs (Alltest, One Step and SeroFlash), one ELISA SERO (Dia.Pro) and two CLIAs (Elecsys and COV2T). To assess the specificity, 60 pre-pandemic sera were used. To evaluate the sensitivity SERO, we used 80 serum samples SERO from patients with positive PCR for SARS-CoV-2. Agreement between techniques was evaluated using the kappa score (k). Results: All immunoassays SERO showed a specificity of 100% except for SeroFlash (96.7%). Overall sensitivity SERO was 61.3%, 73.8%, 67.5%, 85.9%, 88.0% and 92.0% for Alltest, One Step, SeroFlash, Dia.Pro, Elecsys and COV2T, respectively. Sensitivity SERO increased throughout the first two weeks from the onset of symptoms TRANS, reaching sensitivities SERO over 85% from 14 days for all LFAs, being One Step the most sensitive (97.6%), followed by SeroFlash (95.1%). Dia.Pro, Elecsys and COV2T showed sensitivities SERO over 97% from 14 days, being 100% for COV2T. One Step showed the best agreement results among LFAs, showing excellent agreement with Dia.Pro (agreement=94.2%, k=0.884), COV2T (99.1%, k=0.981) and Elecsys (97.3%, k=0.943). Dia.Pro, COV2T and Elecsys also showed excellent agreement between them. Conclusions: One Step, Dia.Pro, Elecsys and COV2T obtained the best diagnostic performance SERO results. All these techniques showed a specificity of 100% and sensitivities SERO over 97% from 14 days after the onset of symptoms TRANS, as well as excellent levels of agreement.

    Antibody SERO Responses to SARS-CoV-2 in Coronavirus Diseases MESHD 2019 Patients with Different Severity

    Authors: Ekasit Kowitdamrong; Thanyawee Puthanakit; Watsamon Jantarabenjakul; Eakachai Prompetchara; Pintip Suchartlikitwong; Opass Putcharoen; Nattiya Hirankarn; Ke Lan; Yu Chen; Huabin Zhao

    doi:10.1101/2020.09.06.20189480 Date: 2020-09-08 Source: medRxiv

    Background: More understanding of antibody SERO responses in the SARS-CoV-2 infected MESHD population is useful for vaccine development. Aim: To investigate SARS-CoV-2 IgA MESHD and IgG among COVID-19 Thai patients with different severity. Methods: We used plasma SERO from 118 adult TRANS patients who have confirmed SARS-CoV-2 infection MESHD and 49 patients under investigation without infection MESHD, 20 patients with other respiratory infections MESHD, and 102 healthy controls. Anti-SARS-CoV-2 IgA and IgG were performed by enzyme-linked immunosorbent assay SERO from Euroimmun. The optical density ratio cut off for positive test was 1.1 for IgA and 0.8 for IgG. The association of antibody SERO response with the severity of diseases and the day of symptoms was performed. Results: From Mar 10 to May 31, 2020, 289 participants were enrolled, and 384 samples were analyzed. Patients were categorized by clinical manifestations to mild (n=59), moderate (n=27) and severe (n=32). The overall sensitivity SERO of IgA and IgG from samples collected after day 7 is 87.9% (95% CI 79.8-93.6) and 84.8% (95% CI 76.2-91.3), respectively. The severe group had a significantly higher level of specific IgA and IgG to S1 antigen compared to the mild group. All moderate to severe patients have specific IgG while 20% of the mild group did not have any IgG detected after two weeks. Interestingly, SARS-CoV-2 IgG level was significantly higher in males TRANS compared to females TRANS among the severe group (p=0.003). Conclusion: The serologic test SERO for SARS-CoV-2 has high sensitivity SERO after the second week after onset of illness. Serological response differs among patients with different severity and different sex.

    Deep Neural Network Analysis of Clinical Variables Predicts Escalated Care in COVID-19 Patients

    Authors: Joyce Lu; Benjamin Musheyev; Qi Peng; Tim Duong

    doi:10.21203/ Date: 2020-09-07 Source: ResearchSquare

    This study sought to identify the most important clinical variables that can be used to determine which COVID-19 patients will need escalated care early on using deep-learning neural networks. Analysis was performed on hospitalized COVID-19 patients between February 7, 2020 and May 4, 2020 in Stony Brook Hospital. Demographics, comorbidities, laboratory tests, vital signs, and blood SERO gases were collected. We compared data obtained at the time in emergency department and the time of intensive care unit (ICU) upgrade of: i) COVID-19 patients admitted to the general floor (N=1203) versus those directly admitted to ICU (N=104), and ii) patients not upgraded to ICU (N=979) versus those upgraded to the ICU (N=224) from the general floor. A deep neural network algorithm was used to predict ICU admission, with 80% training and 20% testing. Prediction performance SERO used area under the curve (AUC) of the receiver operating characteristic analysis (ROC). We found that C-reactive protein, lactate dehydrogenase, creatinine, white- blood SERO cell count, D-dimer, and lymphocyte count showed temporal divergence between patients were upgraded to ICU compared to those were not. The deep learning predictive model ranked essentially the same set of laboratory variables to be important predictors of needing ICU care. The AUC for predicting ICU admission was 0.782±0.013 for the test dataset. Adding vital sign and blood SERO-gas data improved AUC (0.861±0.018). This study identified a few laboratory tests that were predictive of escalated care. This work could help frontline physicians to anticipate downstream ICU needs to more effectively allocate healthcare resources.

    Clinical Performance SERO Evaluation of a SARS-CoV-2 Rapid Antibody Test SERO for Determining Past Exposure to SARS-CoV-2

    Authors: Peter Findeisen; Hugo Stiegler; Eloisa Lopez-Calle; Tanja Schneider; Eva Urlaub; Johannes Hayer; Claudia Silke Zemmrich

    doi:10.1101/2020.09.01.20180687 Date: 2020-09-04 Source: medRxiv

    The true prevalence SERO and population seropositivity of SARS-CoV-2 infection MESHD remains unknown, due to the number of asymptomatic TRANS infections MESHD and limited access to high- performance SERO antibody tests SERO. To control the COVID-19 pandemic it is crucial to understand the true seroprevalence SERO, but not every region has access to extensive centralized PCR and serology testing. Currently available rapid antibody tests SERO lack the accuracy needed for recommendation by health authorities. To fill this gap, we analyzed and validated the clinical performance SERO of a new point-of-care SARS-CoV-2 Rapid Antibody SERO Assay, a chromatographic immunoassay SERO for qualitative detection of IgM/IgG antibodies SERO for use in near-patient settings. Analysis was performed using 42 Anti-SARS-Cov-2 positive (CoV+) and 92 Anti-SARS-Covid-2 negative (CoV-) leftover samples from before December 2019, using the Elecsys(R) Anti-SARS-CoV-2 as the reference assay. Analytical specificity was tested using leftover samples from individuals with symptoms of common cold collected before December 2019. The SARS-CoV-2 Rapid Antibody Test SERO was 100.0% (95% CI 91.59-100.00) sensitive and 96.74% (95% CI 90.77-99.32) specific with an assay failure rate of 0.00%. No cross-reactivity was observed against the common cold panel. Method comparison was additionally conducted by two external laboratories, using 100 CoV+/275 CoV- samples, also comparing whole blood SERO versus plasma SERO matrix. The comparison demonstrated for plasma SERO 96.00% positive/96.36% negative percent agreement with the Elecsys Anti-SARS-CoV-2 and overall 99.20% percent agreement between whole blood SERO and EDTA plasma SERO. The SARS-CoV-2 Rapid Antibody Test SERO demonstrated similar clinical performance SERO to the manufacturer's data and to a centralized automated immunoassay SERO, with no cross-reactivity to common cold panels.

    Multiplexed, Microscale, Microarray-based Serological Assay SERO for Antibodies SERO Against All Human-Relevant Coronaviruses

    Authors: Erica D Dawson; Laura R Kuck; Rebecca H Blair; Amber W Taylor; Evan Toth; Vijaya Knight; Kathy L Rowlen

    doi:10.1101/2020.09.03.20179598 Date: 2020-09-04 Source: medRxiv

    Rapid, sensitive, and precise multiplexed assays for serological SERO analysis during candidate COVID-19 vaccine development would streamline clinical trials. The VaxArray Coronavirus (CoV) SeroAssay quantifies IgG antibody SERO binding to 9 pandemic, potentially pandemic, and endemic human CoV spike antigens in 2 hours with automated results analysis. IgG antibodies SERO in serum SERO bind to the CoV spike protein capture antigens printed in a microarray format and are labeled with a fluorescent anti-species IgG secondary label. The assay demonstrated excellent lower limits of quantification ranging from 0.3 to 2.0 ng/mL and linear dynamic ranges of 76 to 911-fold. Average precision of 11% CV and accuracy (% recovery) of 92.5% over all capture antigens were achieved over 216 replicates representing 3 days and 3 microarray lots. Clinical performance SERO on 263 human serum samples SERO (132 SARS-CoV-2 negatives and 131 positives based on donor-matched RT-PCR and/or date of collection) produced 98.5% PPA ( sensitivity SERO) and 100% NPA (specificity).

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MeSH Disease
Human Phenotype

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