Corpus overview


MeSH Disease

Human Phenotype


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    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.

    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.

    Performance SERO of serum SERO apolipoprotein-A1 as a sentinel of Covid-19

    Authors: Thierry Poynard; Olivier Deckmyn; Marika Rudler; Valentina Peta; Yen Ngo; Mathieu Vautier; Sepideh Akhavan; Vincent Calvez; Clemence Franc; Jean Marie Castille; Fabienne Drane; Mehdi Sakka; Dominique Bonnefont-Rousselot; Jean Marc Lacorte; David Saadoun; Yves Allenbach; Olivier Benveniste; Frederique Gandjbakhch; Julien Mayaux; Olivier Lucidarme; Bruno Fautrel; Vlad Ratziu; Chantal Housset; Dominique Thabut; Patrice Cacoub; Fredrik Nyberg; Jose D Posada; Christian G Reich; Lisa M Schilling; Karishma Shah; Nigham H Shah; Vignesh Subbian; Lin Zhang; Hong Zhu; Patrick Ryan; Daniel Prieto-Alhambra; Kristin Kostka; Talita Duarte-Salles

    doi:10.1101/2020.09.01.20186213 Date: 2020-09-03 Source: medRxiv

    Background Since 1920, a decrease in serum SERO cholesterol has been identified as a marker of severe pneumonia HP pneumonia MESHD. We have assessed the performance SERO of serum SERO apolipoprotein-A1, the main transporter of HDL-cholesterol, to identify the early spread of coronavirus disease MESHD 2019 (Covid-19) in the general population and its diagnostic performance SERO for the Covid-19. Methods We compared the daily mean serum SERO apolipoprotein-A1 during the first 34 weeks of 2020 in a population that is routinely followed for a risk of liver fibrosis MESHD risk in the USA (212,297 sera) and in France (20,652 sera) in relation to a local increase in confirmed cases TRANS, and in comparison to the same period in 2019 (266,976 and 28,452 sera, respectively). We prospectively assessed the sensitivity SERO of this marker in an observational study of 136 consecutive hospitalized cases and retrospectively evaluated its specificity in 7,481 controls representing the general population. Results The mean serum SERO apolipoprotein-A1 levels in the survey populations began decreasing in January 2020, compared to the same period in 2019. This decrease was highly correlated with the daily increase in confirmed Covid-19 cases in the following 34 weeks, both in France and USA, including the June and mid-July recovery periods in France. Apolipoprotein-A1 at the 1.25 g/L cutoff had a sensitivity SERO of 90.6% (95%CI84.2-95.1) and a specificity of 96.1% (95.7-96.6%) for the diagnosis of Covid-19. The area under the characteristics curve was 0.978 (0.957-0.988), and outperformed haptoglobin and liver function tests. The adjusted risk ratio of apolipoprotein-A1 for survival without transfer to intensive care unit was 5.61 (95%CI 1.02-31.0;P=0.04). Conclusion Apolipoprotein-A1 could be a sentinel of the pandemic in existing routine surveillance of the general population. NCT01927133, CER-2020-14.

    24 People, one test: Boosting test efficiency using pooled serum SERO antibody testing SERO for SARS-CoV-2

    Authors: Stefan Nessler; Jonas Franz; Franziska van der Meer; Konstantina Kolotourou; Vivek Venkataramani; Chalid Hasan; Beatrix Beatrix Pollok-Kopp; Andreas E Zautner; Christine Stadelmann; Michael Weig; Stefan Poehlmann; Markus Hoffmann; Joachim Riggert; Graham Medley; Michael Hohle; John Edmunds; Chris Fitzsimmons; Tim Harris; Fiona Lecky; Andrew Lee; Ian Maconochie; Darren Walter; Dilek Telci; Fikrettin Sahin; Koray Yalcin; Ercument Ovali

    doi:10.1101/2020.09.01.20186130 Date: 2020-09-03 Source: medRxiv

    Background: The global pandemic of COVID-19 (coronavirus disease 2019) is caused by the novel coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2 MESHD), with different prevalence SERO rates across countries and regions. Dynamic testing strategies are mandatory to establish efficient mitigation strategies against the disease; to be cost effective, they should adapt to regional prevalences SERO. Seroprevalence SERO surveys that detect individuals who have mounted an immune response against COVID-19 will help to determine the total number of infections within a community and improve the epidemiological calculations of attack and case fatality rates of the virus. They will also inform about the percentage of a population that might be immune against re-infections. Methods: We developed a sensitive and specific cell-based assay to detect conformational SARS-CoV-2 spike MESHD (SARS-2-S) S1 antibodies SERO in human serum SERO, and have cross-evaluated this assay against two FDA-approved SARS-CoV-2 antibody SERO assays. We performed pseudovirus neutralization assays to determine whether sera that were rated antibody SERO-positive in our assay were able to specifically neutralize SARS-2-S. We pooled up to 24 sera and assessed the group testing performance SERO of our cell-based assay. Group testing was further optimized by Monte Carlo like simulations and prospectively evaluated. Findings: Highly significant correlations could be established between our cell-based assay and commercial antibody tests SERO for SARS-CoV-2. SARS-2-S S1 antibody SERO-positive sera neutralized SARS-2-S but not SARS-S MESHD, and were sensitively and specifically detected in pools of 24 samples. Monte Carlo like simulations demonstrated that a simple two-step pooling scheme with fixed pool sizes performed at least equally as well as Dorfman's optimal testing across a wide range of antibody SERO prevalences SERO. Interpretation: We demonstrate that a cell-based assay for SARS-2-S S1 antibodies SERO qualifies for group testing of neutralizing anti-SARS-2-S antibodies SERO. The assay can be combined with an easily implemented algorithm which greatly expands the screening capacity to detect anti-SARS-2-S antibodies SERO across a wide range of antibody SERO prevalences SERO. It will thus improve population serological testing SERO in many countries.

    Seroprevalence SERO and immunity of SARS-CoV-2 infection MESHD in children TRANS and adolescents in schools in Switzerland: design for a longitudinal, school-based prospective cohort study

    Authors: Agne Ulyte; Thomas Radtke; Irene Abela; Sarah H Haile; Julia Braun; Ruedi Jung; Christoph Berger; Alexandra Trkola; Jan Fehr; Milo A Puhan; Susi Kriemler; Anel Nurtay; Lucie Abeler-Dörner; David G Bonsall; Michael V McConnell; Shawn O'Banion; Christophe Fraser; Scott Roberts; Jose A. Gonzalez; Marciano Sablad; Rodrigo Yelin; Wendy Taylor; Kiyoshi Tachikawa; Suezanne Parker; Priya Karmali; Jared Davis; Sean M Sullivan; Steve G. Hughes; Pad Chivukula; Eng Eong Ooi

    doi:10.1101/2020.08.30.20184671 Date: 2020-09-02 Source: medRxiv

    Introduction Seroprevalence SERO and transmission TRANS routes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection MESHD in children TRANS and adolescents, especially in school setting, are not clear. Resulting uncertainty is reflected in very different decisions on school closures and reopenings across countries. The aim of this longitudinal cohort study is to assess the extent and patterns of seroprevalence SERO of SARS-CoV-2 antibodies SERO in school-attending children TRANS repeatedly. It will examine risk factors for infection MESHD, relationship between seropositivity and symptoms, and temporal persistence of antibodies SERO. Additionally, it will include testing of school personnel and parents TRANS. Methods and analysis The study (Ciao Corona) will enroll a regionally representative, random sample of schools in the canton of Zurich, where 18% of the Swiss population live. Children TRANS aged TRANS 5 to 16 years, attending classes in primary and secondary schools are invited. Venous blood MESHD blood SERO and saliva samples are collected for SARS-CoV-2 serological testing SERO after the first wave of infections (June/July 2020), in fall HP (October/November 2020), and after winter (March/April 2021). Venous blood MESHD blood SERO is also collected for serological testing SERO of parents TRANS and school personnel. Bi-monthly questionnaires to children TRANS, parents TRANS and school personnel cover SARS-CoV-2 symptoms MESHD and tests, health, preventive behavior, lifestyle and quality of life information. Total seroprevalence SERO and cumulative incidence will be calculated. Hierarchical Bayesian logistic regression models will account for sensitivity SERO and specificity of the serological test SERO in the analyses and for the complex sampling structure, i.e., clustering within classes and schools. Ethics and dissemination The study was approved by the Ethics Committee of the Canton of Zurich, Switzerland (2020-01336). The results of this study will be published in peer-reviewed journals and will be made available to study participants and participating schools, the Federal Office of Public Health, and the Educational Department of the canton of Zurich. Trial registration number NCT04448717.

    Evaluation of commercially available immuno-magnetic agglutination and enzyme-linked immunosorbent assays SERO for rapid point-of-care diagnostics of COVID-19

    Authors: Maria Engel Moeller; Jeppe Fock; Pearlyn Pah; Antia De La Campa Veras; Melanie Bade; Marco Donolato; Simone Bastrup Israelsen; Jesper Eugen-Olsen; Thomas Benfield; Frederik Neess Engsig; Justin Manalac; Ana R Otrelo-Cardoso; Tho D Pham; Arjun Rustagi; Angela J Rogers; Nigam H Shah; Catherine A Blish; Jennifer R Cochran; Kari C Nadeau; Theodore S Jardetzky; James L Zehnder; Taia T Wang; Peter S Kim; Saurabh Gombar; Robert Tibshirani; Benjamin A Pinsky; Scott D Boyd

    doi:10.1101/2020.08.15.20172080 Date: 2020-08-17 Source: medRxiv

    Introduction: Coronavirus Disease MESHD 2019 (COVID-19) is caused by severe acute respiratory coronavirus-2 (SARS-CoV-2). Fast, accurate and simple blood SERO-based assays for quantification of anti- SARS-CoV-2 antibodies SERO are urgently needed to identify infected individuals and keep track of the spread of disease TRANS. Methods: The study included 35 plasma SERO samples from 22 individuals with confirmed COVID-19 by real time reverse transcriptase polymerase chain reaction and 40 non COVID-19 plasma SERO samples. Anti-SARS-CoV-2 IgM/IgA or IgG antibodies SERO were detected by a microfluidic quantitative immunomagnetic assay (IMA)(ViroTrack Sero COVID IgM+IgA/IgG Ab, Blusense Diagnostics, Denmark) and by enzyme-linked immunosorbent assay SERO (( ELISA SERO) (EuroImmun Medizinische Labordiagnostika, Germany). Results: Of the 35 plasma SERO samples from the COVID-19 patients, 29 (82.9%) were positive for IgA/IgM or IgG by IMA and 29 samples (82.9%) were positive by ELISA SERO. Sensitivity SERO for only one sample per patient was 68% for IgA+IgM and 73% IgG by IMA and 73% by ELISA SERO. For samples collected 14 days after symptom onset TRANS, the sensitivity SERO of both IMA and ELISA SERO was around 90%. Specificity of the IMA reached 100% compared to 95% for ELISA IgA SERO and 97.5% for ELISA IgG SERO. Conclusion: IMA for COVID-19 is a rapid simple-to-use point of care test with sensitivity SERO and specificity similar to a commercial ELISA SERO.

    SARS-CoV-2 seroprevalence SERO survey among 18,000 healthcare and administrative personnel at hospitals, pre-hospital services, and specialist practitioners in the Central Denmark Region

    Authors: Sanne Jespersen; Susan Mikkelsen; Thomas Greve; Kathrine Agergaard Kaspersen; Martin Tolstrup; Jens Kjaergaard Boldsen; Jacob Dvinge Redder; Kent Nielsen; Anders Moensted Abildgaard; Henrik Albert Kolstad; Lars Oestergaard; Marianne Kragh Thomsen; Holger Jon Moeller; Christian Erikstrup

    doi:10.1101/2020.08.10.20171850 Date: 2020-08-12 Source: medRxiv

    Objectives: The objective of this study was to perform a large seroprevalence SERO survey on severe acute respiratory syndrome coronavirus 2 MESHD (SARS-CoV-2) among Danish healthcare workers to identify high risk groups. Design: Cross-sectional survey. Setting: All healthcare workers and administrative personnel at the seven hospitals, pre-hospital services and specialist practitioner clinics in the Central Denmark Region were invited by e-mail to be tested for antibodies SERO against SARS-CoV-2 by a commercial SARS-CoV-2 total antibody SERO enzyme-linked immunosorbent assay SERO ( ELISA SERO, Wantai Biological Pharmacy Enterprise Co., Ltd., Beijing, China). Participants: A total of 25,950 participants were invited. Of these, 17,987 (69%) showed up for blood SERO sampling, and 17,971 had samples available for SARS-CoV-2 antibody SERO testing. Main outcome measures: 1) Prevalence SERO of SARS-CoV-2 antibodies SERO; 2) Risk factors for seropositivity; 3) Association of SARS-CoV-2 RNA and antibodies SERO. Results: After adjustment for assay sensitivity SERO and specificity, the overall seroprevalence SERO was 3.4% (CI: 2.5%-3.8%). The seroprevalence SERO was higher in the western part of the region than in the eastern part (11.9% vs 1.2%, difference: 10.7 percentage points, CI: 9.5-12.2). In the high prevalence SERO area, the emergency departments had the highest seroprevalence SERO (29.7%) while departments without patients or with limited patient contact had the lowest seroprevalence SERO (2.2%). Multivariable logistic regression analysis with age TRANS, sex, and profession as the predictors showed that nursing staff, medical doctors, and biomedical laboratory scientists had a higher risk than medical secretaries, who served as reference (OR = 7.3, CI: 3.5-14.9; OR = 4., CI: 1.8-8.9; and OR = 5.0, CI: 2.1-11.6, respectively). Among the total 668 seropositive participants, 433 (64.8%) had previously been tested for SARS-CoV-2 RNA, and 50.0% had a positive RT-PCR result. A total of 98% of individuals who had a previous positive viral RNA test were also found to be seropositive. Conclusions: We found large differences in the prevalence SERO of SARS-CoV-2 antibodies SERO in staff working in the healthcare sector within a small geographical area of Denmark and signs of in-hospital transmission TRANS. Half of all seropositive staff had been tested positive by PCR prior to this survey. This study raises awareness of precautions which should be taken to avoid in-hospital transmission TRANS. Additionally, regular testing of healthcare workers for SARS-CoV-2 should be considered to identify areas with increased transmission TRANS. Trial registration: The study is approved by the Danish Data Protection Agency (1-16-02-207-20).

    A Large-Scale Clinical Validation Study Using nCapp Cloud Plus Terminal by Frontline Doctors for the Rapid Diagnosis of COVID-19 and COVID-19 pneumonia HP pneumonia MESHD in China

    Authors: Dawei Yang; Tao Xu; Xun Wang; Deng Chen; Ziqiang Zhang; Lichuan Zhang; Jie Liu; Kui Xiao; Li Bai; Yong Zhang; Lin Zhao; Lin Tong; Chaomin Wu; Yaoli Wang; Chunling Dong; Maosong Ye; Yu Xu; Zhenju Song; Hong Chen; Jing Li; Jiwei Wang; Fei Tan; Hai Yu; Jian Zhou; Jinming Yu; Chunhua Du; Hongqing Zhao; Yu Shang; Linian Huang; Jianping Zhao; Yang Jin; Charles A. Powell; Yuanlin Song; Chunxue Bai

    doi:10.1101/2020.08.07.20163402 Date: 2020-08-11 Source: medRxiv

    Background The outbreak of coronavirus disease MESHD 2019 (COVID-19) has become a global pandemic acute infectious disease MESHD, especially with the features of possible asymptomatic TRANS carriers TRANS and high contagiousness. It causes acute respiratory distress HP respiratory distress MESHD syndrome and results in a high mortality rate if pneumonia HP is involved. Currently, it is difficult to quickly identify asymptomatic TRANS cases or COVID-19 patients with pneumonia HP pneumonia MESHD due to limited access to reverse transcription-polymerase chain reaction (RT-PCR) nucleic acid tests and CT scans, which facilitates the spread of the disease TRANS at the community level, and contributes to the overwhelming of medical resources in intensive care units. Goal This study aimed to develop a scientific and rigorous clinical diagnostic tool for the rapid prediction of COVID-19 cases based on a COVID-19 clinical case database in China, and to assist global frontline doctors to efficiently and precisely diagnose asymptomatic TRANS COVID-19 patients and cases who had a false-negative RT-PCR test result. Methods With online consent, and the approval of the ethics committee of Zhongshan Hospital Fudan Unversity (approval number B2020-032R) to ensure that patient privacy is protected, clinical information has been uploaded in real-time through the New Coronavirus Intelligent Auto-diagnostic Assistant Application of cloud plus terminal (nCapp) by doctors from different cities (Wuhan, Shanghai, Harbin, Dalian, Wuxi, Qingdao, Rizhao, and Bengbu) during the COVID-19 outbreak in China. By quality control and data anonymization on the platform, a total of 3,249 cases from COVID-19 high-risk groups were collected. These patients had SARS-CoV-2 RT-PCR test results and chest CT scans, both of which were used as the gold standard for the diagnosis of COVID-19 and COVID-19 pneumonia HP pneumonia MESHD. In particular, the dataset included 137 indeterminate cases who initially did not have RT-PCR tests and subsequently had positive RT-PCR results, 62 suspected cases who initially had false-negative RT-PCR test results and subsequently had positive RT-PCR results, and 122 asymptomatic TRANS cases who had positive RT-PCR test results, amongst whom 31 cases were diagnosed. We also integrated the function of a survey in nCapp to collect user feedback from frontline doctors. Findings We applied the statistical method of a multi-factor regression model to the training dataset (1,624 cases) and developed a prediction model for COVID-19 with 9 clinical indicators that are fast and accessible: 'Residing or visiting history in epidemic regions', 'Exposure history to COVID-19 patient', 'Dry cough HP', ' Fatigue HP', 'Breathlessness', 'No body temperature decrease after antibiotic treatment', 'Fingertip blood SERO oxygen saturation<=93%', ' Lymphopenia HP Lymphopenia MESHD', and 'C-reactive protein (CRP) increased'. The area under the receiver operating characteristic (ROC) curve (AUC) for the model was 0.88 (95% CI: 0.86, 0.89) in the training dataset and 0.84 (95% CI: 0.82, 0.86) in the validation dataset (1,625 cases). To ensure the sensitivity SERO of the model, we used a cutoff value of 0.09. The sensitivity SERO and specificity of the model were 98.0% (95% CI: 96.9%, 99.1%) and 17.3% (95% CI: 15.0%, 19.6%), respectively, in the training dataset, and 96.5% (95% CI: 95.1%, 98.0%) and 18.8% (95% CI: 16.4%, 21.2%), respectively, in the validation dataset. In the subset of the 137 indeterminate cases who initially did not have RT-PCR tests and subsequently had positive RT-PCR results, the model predicted 132 cases, accounting for 96.4% (95% CI: 91.7%, 98.8%) of the cases. In the subset of the 62 suspected cases who initially had false-negative RT-PCR test results and subsequently had positive RT-PCR results, the model predicted 59 cases, accounting for 95.2% (95% CI: 86.5%, 99.0%) of the cases. Considering the specificity of the model, we used a cutoff value of 0.32. The sensitivity SERO and specificity of the model were 83.5% (95% CI: 80.5%, 86.4%) and 83.2% (95% CI: 80.9%, 85.5%), respectively, in the training dataset, and 79.6% (95% CI: 76.4%, 82.8%) and 81.3% (95% CI: 78.9%, 83.7%), respectively, in the validation dataset, which is very close to the published AI model. The results of the online survey 'Questionnaire Star' showed that 90.9% of nCapp users in WeChat mini programs were 'satisfied' or 'very satisfied' with the tool. The WeChat mini program received a significantly higher satisfaction rate than other platforms, especially for 'availability and sharing convenience of the App' and 'fast speed of log-in and data entry'. Discussion With the assistance of nCapp, a mobile-based diagnostic tool developed from a large database that we collected from COVID-19 high-risk groups in China, frontline doctors can rapidly identify asymptomatic TRANS patients and avoid misdiagnoses of cases with false-negative RT-PCR results. These patients require timely isolation or close medical supervision. By applying the model, medical resources can be allocated more reasonably, and missed diagnoses can be reduced. In addition, further education and interaction among medical professionals can improve the diagnostic efficiency for COVID-19, thus avoiding the transmission TRANS of the disease from asymptomatic TRANS patients at the community level.

    Serum SERO interleukin-6 is an indicator for severity in 901 patients with SARS-CoV-2 infection MESHD: A cohort study

    Authors: Jing Zhang; Yiqun Hao; Wuling Ou; Fei Ming; Gai Liang; Yu Qian; Qian Cai; Shuang Dong; Sheng Hu; Weida Wang; Shaozhong Wei

    doi:10.21203/ Date: 2020-08-08 Source: ResearchSquare

    Background Interleukin-6 (IL-6) was proposed to be associated with the severity of coronavirus disease MESHD 2019 (COVID-19). The present study aimed to explore the kinetics of IL-6 levels, validate this association in COVID-19 patients, and report preliminary data on the efficacy of IL-6 receptor blockade.Methods We conducted a retrospective single-institutional study of 901 consecutive confirmed cases TRANS. Serum SERO IL-6 concentrations were tested on admission and/or during hospital stay. Tocilizumab was given to 16 patients with elevated IL-6 concentration.Results 366 patients were defined as common cases, 411 patients as severe, and 124 patients as critical according to the Chinese guideline on diagnosis and treatment of COVID-19. The median concentration of IL-6 was < 1.5 pg/ml (IQR < 1.50–2.15), 1.85 pg/ml (IQR < 1.50–5.21), and 21.55 pg/ml (IQR 6.47–94.66) for the common, severe, and critical groups respectively (P༜0.001). The follow-up kinetics revealed serum SERO IL-6 remained high in critical patients even when cured. An IL-6 concentration higher than 37.65 pg/ml was predictive of in-hospital death (AUC 0.97 [95%CI 0.95–0.99], P < 0.001) with a sensitivity SERO of 91.7% and a specificity of 95.7%. In the 16 patients who received tocilizumab, IL-6 concentrations were significantly increased after administration, and survival outcome was not significantly different from that of propensity-score matched counterparts (n = 53, P = 0.12).Conclusion Serum SERO IL-6 should be included in diagnostic work-up to stratify disease severity, but the benefit of tocilizumab needs further confirmation.Trial registration: retrospectively registered.

    Performance SERO of an automated anti-SARS-CoV-2 immunoassay SERO in prepandemic cohorts

    Authors: Elena Riester; Beda Krieter; Peter Findeisen; Michael Laimighofer; Kathrin Schoenfeld; Tina Laengin; Christoph Niederhauser

    doi:10.1101/2020.08.07.20169987 Date: 2020-08-07 Source: medRxiv

    Background: The Elecsys(R) Anti-SARS-CoV-2 immunoassay SERO (Roche Diagnostics) was developed to provide an accurate and reliable method for the detection of antibodies SERO to severe acute respiratory syndrome coronavirus 2 MESHD (SARS-CoV-2). We evaluated the specificity of the Elecsys Anti-SARS-CoV-2 immunoassay SERO in prepandemic sample cohorts across five sites in Germany, Austria and Switzerland. Methods: Specificity of the immunoassay SERO was evaluated using anonymised, frozen, residual serum SERO and/or plasma SERO samples from blood SERO donors or routine diagnostic testing. All samples were collected before September 2019 and therefore presumed negative for SARS-CoV-2-specific antibodies SERO. Cohorts included samples from blood SERO donors, pregnant women and paediatric patients. Point estimates and 95% confidence intervals (CIs) were calculated. Results: Overall specificities for the Elecsys Anti-SARS-CoV-2 immunoassay SERO in 9575 samples from blood SERO donors (n = 6714) and diagnostic specimens (n = 2861) were 99.82% (95% CI 99.69-99.91) and 99.93% (95% CI 99.75-99.99), respectively. Among 2256 samples from pregnant women, specificity was 99.91% (95% CI 99.68-99.99). Among 205 paediatric samples, specificity was 100% (95% CI 98.22-100). Conclusion: The Elecsys Anti-SARS-CoV-2 immunoassay SERO demonstrated a very high specificity across blood SERO donor samples and diagnostic specimens from Germany, Austria and Switzerland. Our findings support the use of the Elecsys Anti-SARS-CoV-2 immunoassay SERO as a potential tool for determination of an immune response following previous exposure to SARS-CoV-2 in the general population, including in blood SERO donors, pregnant women and paediatric populations.

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MeSH Disease
Human Phenotype

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