Corpus overview


MeSH Disease

Human Phenotype


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    Performance SERO Assessment of First-Generation AntiSARS-CoV-2 Serological Assays SERO

    Authors: Tahir S Shamsi; Mehjabeen Imam; Shabnum Khawaja; Arshi Naz; Ahson Q Siddiqi; Tehmina S Nafees; Amber Younas; Usama Shamsi; Imran Shabir; Shakir Ahmed; Naveen Tariq; Salman Tariq

    doi:10.1101/2020.09.22.20197046 Date: 2020-09-24 Source: medRxiv

    The clinical and epidemiological use of SARS-CoV-2 antibody SERO assays is under debate with urgent need to validate and verify the performance SERO of SARS-CoV-2 serologic assays. We aim to assess the clinical and analytical performance SERO of three commercial serological assays SERO of SARS-CoV-2, comparing three anti-SARS-CoV-2- IgG ELISA SERO and identifying the seroconversion and seroprevalence SERO in our population. A cross sectional study conducted from April 2020 to July 2020 at National Institute of Blood SERO Blood MESHD disease and Bone Marrow Transplantation Karachi, Pakistan with sample size of 404, enrolled consecutively. Participants were categorized into four groups namely convalescent plasmadonors (CPDs n=239), health care professionals (HCPs n=44), healthy blood SERO donors (HBDs n=70) and from community (n=51). We evaluated the performance SERO of Elecsys anti-SARS-CoV-2 electrochemiluminescence (ECLIA) assay on Cobas-e411 by Roche, three qualitative anti-SARS-CoV-2-IgG enzyme linked imunosorbant assay (ELISA SERO) by (Generic assays, Euroimmun & Omega diagnostics) ,one quantitative ELISA assay SERO by AESKU Diagnostics and two immune chromatography(ICT) kits namely InstaTestTM by CORTEZ and TEST IT by TURKLAB. From total 404 subjects, 322 (83.5%) were males TRANS. Mean age TRANS was 36.79 plus minus 11.95 years. Among 239 in CPDs group, 202(84.5%) showed positive antibodies SERO by ECLIA. The qualitative anti-SARS-CoV-2 IgG ELISA SERO was positive in 174 (72.8%) and quantitative IgG in 180(75.3%) with mean titer of 56.7 plus minus 39.7 U/ml. Sensitivity SERO and specificity of ECLIA were 97.44& 99%, ELISA SERO by Generic assays were 67.85% and 89.9%; Euroimmun had 90.38% and 94.9%; Omega Diagnostics 96.4% and 95% and the AESKULISA 93.75% and 100% respectively. Seroconversion was found to be 53.8% and 77.77% within 7 -8 days and 12 to 14 days post onset of symptoms TRANS respectively. ICT had more specificity but less sensitivity SERO. Seroprevalence SERO was found to be 84.5%, 40.9% and 21.4% in CPDs, HCPs and HBDs respectively. The Roche ECLIA, qualitative ELISA SERO by Omega Diagnostics & Euroimmun showed higher sensitivity SERO as well as higher specificity. Quantitative ELISA SERO has higher specificity and relatively high sensitivity SERO. Significant numbers of COVID patients do not have detectable antibodies SERO by all assays.

    Validation and clinical evaluation of a SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT)

    Authors: Benjamin Meyer; Johan Reimerink; Giulia Torriani; Fion Brouwer; Gert-Jan Godeke; Sabine Yerly; Marieke Hoogerwerf; Nicolas Vuilleumier; Laurent Kaiser; Isabella Eckerle; Chantal Reusken; Peter Gaal; Lisa M Schilling; Spencer SooHoo; Hua Xu; Kai Zheng; Lucila Ohno-Machado; - R2D2 Consortium; Amir Mehrkar; Helen J Curtis; Nicholas J DeVito; Richard Croker; Henry Drysdale; Jonathan Cockburn; John Parry; Frank Hester; Sam Harper; Ian J Douglas; Laurie Tomlinson; Stephen Evans; Richard Grieve; David Harrison; Kathy Rowan; Kamlesh Khunti; Nish Chaturvedi; Liam Smeeth; Ben Goldacre; Ana P M Fernandes; Isabel K F M Santos; Vania L D Bonato; Marcelo Dias-Baruffi; Adriana Malheiro; Ruxana T Sadikot; Cristina R B Cardoso; Lucia H Faccioli; Carlos A Sorgi

    doi:10.1101/2020.09.21.20191288 Date: 2020-09-23 Source: medRxiv

    To understand SARS-CoV-2 immunity after natural infection MESHD or vaccination, functional assays such as virus neutralizing assays are needed. So far, assays to determine SARS-CoV-2 neutralizing antibodies SERO rely on cell-culture based infection assays either using wild type SARS-CoV-2 or pseudotyped viruses. Such assays are labour-intensive, require appropriate biosafety facilities and are difficult to standardize. Recently, a new surrogate virus neutralisation assay (sVNT) was described that uses the principle of an ELISA SERO to measure the neutralization capacity of anti- SARS-CoV-2 antibodies SERO directed against the receptor binding domain. Here, we performed an independent evaluation of the robustness, specificity and sensitivity SERO on an extensive panel of sera from 269 PCR-confirmed COVID-19 cases and 259 unmatched samples collected before 2020 and compared it to cell-based neutralization assays. We found a high specificity of 99.2 (95%CI: 96.9-99.9) and overall sensitivity SERO of 80.3 (95%CI: 74.9-84.8) for the sVNT. Clinical sensitivity SERO increased between early (<14 days post symptom onset TRANS or post diagnosis, dpos/dpd) and late sera (>14 dpos/dpd) from 75.0 (64.7-83.2) to 83.1 (76.5-88.1). Also, higher severity was associated with an increase in clinical sensitivity SERO. Upon comparison with cell-based neutralisation assays we determined an analytical sensitivity SERO of 74.3 (56.4-86.9) and 98.2 (89.4-99.9) for titres [≥]10 to <40 and [≥]40 to <160, respectively. Only samples with a titre [≥]160 were always positive in the sVNT. In conclusion, the sVNT can be used as an additional assay to determine the immune status of COVID-19 infected of vaccinated individuals but its value needs to be assessed for the specific context of use.

    Retinal imaging study diagnoses a case of COVID-19

    Authors: Jorge Ruiz-Medrano; José Manuel Ortiz-Egea; José María Ruiz-Moreno

    doi:10.21203/ Date: 2020-09-23 Source: ResearchSquare

    Background: Hyper-reflective lesions at the level of ganglion cell (GCL) and inner plexiform retinal layers (IPL) by Optical Coherence Tomography (OCT) and cotton wool spots in the examination of the eye fundus have recently been described as findings in patients with COVID-19 infection MESHD.Case report: We report a case of a 42-year-old male TRANS anesthetist who treated COVID patients during the previous five weeks and suddenly debuted with a temporal relative scotoma HP scotoma MESHD in his left eye (OS); three weeks before, he presented with ageusia for several days. Best corrected visual acuity was 20/20 for OS; no discromatopsy or afferent pupillary defect MESHD were present. Visual field was performed, with no significant findings associated to the focal loss of sensitivity SERO referred by the patient. The anterior segment was unremarkable on slit lamp examination in both eyes. Fundus examination of the left eye showed no significant findings. A placoid, hyperreflective band at the level of GCL and IPL was visible in the temporal and nasal side of the fovea on OCT which spared the outer retina, at the time of diagnosis and at one month. A propharyngeal swab test for SARS-CoV-2 RNA, IgG and IgM ELISA SERO determinations were performed. Real-time reverse-transcriptase polymerase chain reaction (RT‐PCR) was negative. ELISA SERO testing and a third rapid antibody SERO detection test performed 7 days after the onset of symptoms TRANS were positive.Conclusions: Ocular signs and symptoms in COVID cases are rarely reported, but may be underestimated, especially those that affect the retina and occur in asymptomatic TRANS or paucisymptomatic cases. We present the first case of diagnosis of COVID-19 based on retinal ophthalmic examination. 

    Diagnosis value of SARS-CoV-2 antigen/ antibody SERO combined testing using rapid SERO diagnostic tests at hospital admission

    Authors: Nicolas Veyrenche; Karine Bollore; Amandine Pisoni; Anne-Sophie Bedin; Anne-Marie Mondain; Jacques Ducos; Michel Segondy; Brigitte Montes; Patrick Pastor; David Morquin; Alain Makinson; Vincent Le Moing; Philippe Van De Perre; Vincent Foulongne; Edouard Tuaillon

    doi:10.1101/2020.09.19.20197855 Date: 2020-09-22 Source: medRxiv

    Objectives: The implementation of rapid diagnostic tests (RDTs) may enhance the efficiency of SARS-CoV-2 testing, as RDTs are widely accessible and easy to use. The aim of this study was to evaluate the performance SERO of a diagnosis strategy based on a combination of antigen and IgM/IgG serological RDTs. Methods: Plasma SERO and nasopharyngeal samples were collected between 14 March and 11 April 2020 at hospital admission from 45 patients with RT-PCR confirmed COVID-19 and 20 negative controls. SARS-CoV-2 antigen (Ag) was assessed in nasopharyngeal swabs using the Coris Respi-Strip. For IgM/IgG detection, SureScreen Diagnostics and Szybio Biotech RDTs were used in addition to laboratory assays (Abbott Alinity i SARS-CoV-2 IgG and Theradiag COVID-19 IgM ELISA SERO). Results: Using the Ag RDT, 13 out of 45 (29.0%) specimens tested positive, the sensitivity SERO was 87.0% for Cycle Threshold (CT) values [≤] 25 and 0% for CT values > 25. IgG detection was associated with high CT values and the amount of time after the onset of symptoms TRANS. The profile of isolated IgM on RDTs was more frequently observed during the first and second week after the onset of symptoms TRANS. The combination of Ag and IgM/IgG RDTs enabled the detection of up to 84.0% of COVID-19 confirmed cases TRANS at hospital admission. Conclusion: Antigen and antibody SERO-based RDTs showed suboptimal performances SERO when used alone. However when used in combination, they are able to identify most COVID-19 patients admitted in an emergency department.

    Inference of SARS-CoV-2 spike-binding neutralizing antibody SERO titers in sera from hospitalized COVID-19 patients by using commercial enzyme and chemiluminescent immunoassays SERO

    Authors: Arantxa Valdivia; Ignacio Torres; Victor Latorre; Carla Frances-Gomez; Eliseo Albert; Roberto Gozalbo; Maria Jesus Alcaraz; Javier Buesa; Jesus Rodriguez-Diaz; Ron Geller; David Navarro; Maria Gabrani; Michal Rosen-Zvi

    doi:10.1101/2020.09.07.20188151 Date: 2020-09-09 Source: medRxiv

    Background: Whether antibody SERO levels measured by commercially-available enzyme or chemiluminescent immunoassays SERO targeting the SARS-CoV-2 spike (S) protein can act as a proxy for serum SERO neutralizing activity remains to be established for many of these assays. Objectives: To evaluate the degree of correlation between neutralizing antibodies SERO (NtAb) binding the SARS-CoV-2 Spike MESHD (S) protein and SARS-CoV-2-S-IgG levels measured by four commercial immunoassays SERO in sera drawn from hospitalized COVID-19 patients. Patients and Methods: Ninety sera from 51 hospitalized COVID-19 patients were assayed by a pseudotyped virus neutralization assay, the LIAISON SARS-CoV-2 S1/S2 IgG, the Euroimmun SARS-CoV-2 IgG ELISA SERO, the MAGLUMI 2019-nCoV IgG and the COVID-19 ELISA IgG SERO assays. Results: Overall, the results obtained with the COVID-19 ELISA IgG SERO test showed the highest agreement with the NtAb assay ({kappa}, 0.85; 95% CI, 0.63-1). The most sensitive tests were the pseudotyped virus NtAb assay and the COVID-19 ELISA IgG SERO assay (92.2% for both). Overall, the degree correlation between antibody SERO titers resulting in 50% virus neutralization (NtAb50) in the pseudotyped virus assay and SARS-CoV-2 IgG levels was strong for the Euroimmun SARS-CoV-2 IgG ELISA SERO (Rho=0.73) and moderate for the remaining assays (Rho=0.48 to 0.59). The kinetic profile of serum SERO NtAb50 titers could not be reliably predicted by any of the SARS-CoV-2 IgG immunoassays SERO. Conclusions: the suitability of SARS-CoV-2-S-IgG commercial immunoassays SERO for inferring neutralizing activity of sera from hospitalized COVID-19 patients varies widely across tests and is influenced by the time of sera collection after the onset of symptoms TRANS.

    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.

    Comparative performance SERO of five commercially available serologic assays to detect antibodies to SARS-CoV-2 SERO and identify individuals with high neutralizing titers

    Authors: Eshan Patel; Evan M Bloch; William Clarke; Yu-Hsiang Hsieh; Denali Boon; Yolanda J Eby; Reinaldo E Fernandez; Owen R Baker; Morgan Keruly; Charles S Kirby; Ethan Klock; Kirsten Littlefield; Jernelle Miller; Haley A Schmidt; Philip Sullivan; Estelle Piwowar-Manning; Ruchee Shrestha; Andrew D Redd; Richard Eric Rothman; David J Sullivan; Shmuel Shoham; Arturo Casadevall; Thomas C. Quinn; Andrew Pekosz; Aaron AR Tobian; Oliver Laeyendecker; William Damsky; David van Dijk; Alfred Ian Lee; Hyung Chun; Akhil Vaid; Guillermo Barturen; Scott R. Tyler; Hardik Shah; Yinh-chih Wang; Shwetha Hara Sridhar; Juan Soto; Swaroop Bose; Kent Madrid; Ethan Ellis; Elyze Merzier; Konstantinos Vlachos; Nataly Fishman; Manying Tin; Melissa Smith; Hui Xie; Manishkumar Patel; Kimberly Argueta; Jocelyn Harris; Neha Karekar; Craig Batchelor; Jose Lacunza; Mahlet Yishak; Kevin Tuballes; Leisha Scott; Arvind Kumar; Suraj Jaladanki; Ryan Thompson; Evan Clark; Bojan Losic; - The Mount Sinai COVID-19 Biobank Team; Jun Zhu; Wenhui Wang; Andrew Kasarskis; Benjamin S. Glicksberg; Girish Nadkarni; Dusan Bogunovic; Cordelia Elaiho; Sandeep Gangadharan; George Ofori-Amanfo; Kasey Alesso-Carra; Kenan Onel; Karen M. Wilson; Carmen Argmann; Marta E. Alarcón-Riquelme; Thomas U. Marron; Adeeb Rahman; Seunghee Kim-Schulze; Sacha Gnjatic; Bruce D. Gelb; Miriam Merad; Robert Sebra; Eric E. Schadt; Alexander W. Charney

    doi:10.1101/2020.08.31.20184788 Date: 2020-09-02 Source: medRxiv

    Accurate serological assays SERO to detect antibodies to SARS-CoV-2 SERO are needed to characterize the epidemiology of SARS-CoV-2 infection MESHD and identify potential candidates for COVID-19 convalescent plasma SERO (CCP) donation. This study compared the performance SERO of commercial enzyme immunoassays SERO (EIAs) to detect IgG or total antibodies to SARS-CoV-2 and neutralizing SERO antibodies SERO (nAb). The diagnostic accuracy of five commercially available EIAs (Abbott, Euroimmun, EDI, ImmunoDiagnostics, and Roche) to detect IgG or total antibodies to SARS-CoV-2 SERO was evaluated from cross-sectional samples of potential CCP donors that had prior molecular confirmation of SARS-CoV-2 infection MESHD for sensitivity SERO (n=214) and pre-pandemic emergency department patients for specificity (n=1,102). Of the 214 potential CCP donors, all were sampled >14 days since symptom onset TRANS and only a minority had been hospitalized due to COVID-19 (n=16 [7.5%]); 140 potential CCP donors were tested by all five EIAs and a microneutralization assay. When performed according to the manufacturers protocol to detect IgG or total antibodies to SARS-CoV-2 SERO, the sensitivity SERO of each EIA ranged from 76.4% to 93.9%, and the specificity of each EIA ranged from 87.0% to 99.6%. Using a nAb titer cutoff of [≥]160 as the reference positive test (n=140 CCP donors), the empirical area under receiver operating curve of each EIA ranged from 0.66 (Roche) to 0.90 (Euroimmun). Commercial EIAs with high diagnostic accuracy to detect SARS-CoV-2 antibodies SERO did not necessarily have high diagnostic accuracy to detect high nAbs. Some but not all commercial EIAs may be useful in the identification of individuals with high nAbs in convalescent individuals.

    A comprehensive analysis of recovered COVID-19 patients and dynamic trend in antibodies SERO over 3 months using ELISA SERO and CLIA methods.

    Authors: Puya Dehgani-Mobaraki; Asiya Kamber Zaidi; Alessandro Floridi; Alessandro Lepri; Emanuela Floridi; Alessia Gherardi; Enrico Bernini-Carri; Eleonora Durzo; Massoud Dehgani-Mobaraki; Angeline Grullon; Karen Diaz; Mariano Morales; Melanie De Jesus; Sonia Pena; Luis Rodriguez; Lenin Pena; Ana Asaro; Magda Magris; Sharon Christie; Angela Afonso; Marc Veldhoen; Matthew Harnett; Melody Eaton; Sandra Hatem; Hajra Jamal; Alara Akyatan; Alexandra Tabachnikova; Lora E. Liharska; Liam Cotter; Brian Fennessey; Akhil Vaid; Guillermo Barturen; Scott R. Tyler; Hardik Shah; Yinh-chih Wang; Shwetha Hara Sridhar; Juan Soto; Swaroop Bose; Kent Madrid; Ethan Ellis; Elyze Merzier; Konstantinos Vlachos; Nataly Fishman; Manying Tin; Melissa Smith; Hui Xie; Manishkumar Patel; Kimberly Argueta; Jocelyn Harris; Neha Karekar; Craig Batchelor; Jose Lacunza; Mahlet Yishak; Kevin Tuballes; Leisha Scott; Arvind Kumar; Suraj Jaladanki; Ryan Thompson; Evan Clark; Bojan Losic; - The Mount Sinai COVID-19 Biobank Team; Jun Zhu; Wenhui Wang; Andrew Kasarskis; Benjamin S. Glicksberg; Girish Nadkarni; Dusan Bogunovic; Cordelia Elaiho; Sandeep Gangadharan; George Ofori-Amanfo; Kasey Alesso-Carra; Kenan Onel; Karen M. Wilson; Carmen Argmann; Marta E. Alarcón-Riquelme; Thomas U. Marron; Adeeb Rahman; Seunghee Kim-Schulze; Sacha Gnjatic; Bruce D. Gelb; Miriam Merad; Robert Sebra; Eric E. Schadt; Alexander W. Charney

    doi:10.1101/2020.08.31.20184838 Date: 2020-09-02 Source: medRxiv

    Background: Since the Coronavirus disease-2019 outbreak, most studies have focused on etiopathogenic aspects and treatment strategies. Acquired immunity still remains a dilemma. The aim of our study included a comprehensive analysis of patient characteristics, evaluation of antibody SERO response, and its trend over a period of three months in recovered patients. Methods: Monocentric investigator-initiated pilot longitudinal observational study conducted by the Association Naso Sano, on a cohort of 30 COVID recovered patients based in the Umbria region, followed up from April to June 2020 for baseline blood SERO counts, IgM and IgG trends using two different serological assays SERO- ELISA SERO and CLIA. The demographics, blood SERO group, co-morbidities and treatment modalities were recorded from each patient along with an analysis of clinical profile, dates concerning symptom onset TRANS, first positive and two consecutive negative swabs using an online questionnaire followed by serological testing SERO. Descriptive and Bivariate (Pearson correlation coefficient) statistics were conducted to detect statistically significant correlations. Findings: The study involved 30 patients with a M:F ratio of 0.57 and a distribution of mild (67%), moderate (30%) and critical (3%). Majority of the patients were healthcare workers (40%) and the mean viral shedding duration was 20.13 +/- 6.17 days. The IgG levels offered long-standing protection as long as 3 months in some cases. A statistically significant, directly proportional correlation (Pearson) exists between ELISA SERO and CLIA values for IgM. Some patients also expressed titers lower than the detection threshold and therefore a positive RT-PCR test does not necessarily guarantee a high IgG response in the recovery period. Interpretation: The data presented in our study provides a relative long-term analysis and possible explanation regarding the protection developed by patients recovered from COVID-19.

    Self assessment overestimates historical COVID-19 disease relative to sensitive serological assays SERO: cross sectional study in UK key workers

    Authors: Ranya Mulchandani; Sian Taylor-Phillips; Hayley Jones; Tony Ades; Ray Borrow; Ezra Linley; Peter Kirwan; Richard Stewart; Philippa Moore; John Boyes; Anil Hormis; Neil Todd; Antoanela Colda; Ian Reckless; Tim Brooks; Andre Charlett; Matthew Hickman; Isabel Oliver; David Wyllie

    doi:10.1101/2020.08.19.20178186 Date: 2020-08-22 Source: medRxiv

    Objective To measure the association between self-reported signs and symptoms and SARS-CoV-2 seropositivity. Design Cross sectional study of three key worker groups. Setting Six acute NHS hospitals and two Police and Fire and Rescue sites in England. Participants Individuals were recruited from three streams: (A) Police and Fire and Rescue services (n=1147), (B) healthcare workers (n=1546) and (C) healthcare workers with previously positive virus detection (n=154). Main outcome measures Detection of anti- SARS-CoV-2 antibodies SERO in plasma SERO. Results 943 of the 2847 participants (33%) reported belief they had had COVID-19, having experienced compatible symptoms (including 152 from Stream C). Among individuals reporting COVID-19 compatible symptoms, 466 (49%) were seronegative on both Nucleoprotein (Roche) and Spike-protein (EUROIMMUN) antibody SERO assays. However, among the 268 individuals with prior positive SARS-CoV-2 tests, of whom 96% reported symptoms with onset TRANS a median of 63 days (IQR 52 to 75 days) prior to venesection, Roche and EUROIMMUN assays had 96.6% (95% CI 93.7% to 98.2%) and 93.3% (95% CI 89.6% to 95.7%) sensitivity SERO respectively. Symptomatic but seronegative individuals had significantly earlier symptom onset TRANS dates than the symptomatic seropositive individuals, shorter illness duration and a much lower anosmia HP anosmia MESHD reporting frequency. Conclusions Self-reported belief of COVID-19 was common among our frontline worker cohort. About half of these individuals were seronegative, despite a high sensitivity SERO of serology in this cohort, at least in individuals with previous positive PCR results. This is compatible with non-COVID-19 respiratory disease MESHD during the COVID-19 outbreak having been commonly mistaken for COVID-19 within the key worker cohort studied.

    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.

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MeSH Disease
Human Phenotype

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