Corpus overview


MeSH Disease

Human Phenotype


    displaying 1 - 10 records in total 45
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    Meta-analysis of the clinical performance SERO of commercial SARS-CoV-2 nucleic acid, antigen and antibody tests SERO up to 22 August 2020

    Authors: Ivo Van Walle; Katrin Leitmeyer; Eeva K Broberg; - The European COVID-19 microbiological laboratories group; Jaime Nieto-Zermeno; Juan Garduno-Espiosa; MARIA F CASTILLA-PEON; Javed Akram; Ravi K Amaravadi; Derek C Angus; Yaseen M Arabi; Shehnoor Azhar; Lindsey R Baden; Arthur W Baker; Leila Belkhir; Thomas Benfield; Marvin A H Berrevoets; Cheng-Pin Chen; Tsung-Chia Chen; Shu-Hsing Cheng; Chien-Yu Cheng; Wei-Sheng Chung; Yehuda Z Cohen; Lisa N Cowan; Olav Dalgard; Fernando F de Almeida e Val; Marcus V G de Lacerda; Gisely C de Melo; Lennie Derde; Vincent Dubee; Anissa Elfakir; Anthony C Gordon; Carmen M Hernandez-Cardenas; Thomas Hills; Andy I M Hoepelman; Yi-Wen Huang; Bruno Igau; Ronghua Jin; Felipe Jurado-Camacho; Khalid S Khan; Peter G Kremsner; Benno Kreuels; Cheng-Yu Kuo; Thuy Le; Yi-Chun Lin; Wu-Pu Lin; Tse-Hung Lin; Magnus Nakrem Lyngbakken; Colin McArthur; Bryan McVerry; Patricia Meza-Meneses; Wuelton M Monteiro; Susan C Morpeth; Ahmad Mourad; Mark J Mulligan; Srinivas Murthy; Susanna Naggie; Shanti Narayanasamy; Alistair Nichol; Lewis A Novack; Sean M O'Brien; Nwora Lance Okeke; Lena Perez; Rogelio Perez-Padilla; Laurent Perrin; Arantxa Remigio-Luna; Norma E Rivera-Martinez; Frank W Rockhold; Sebastian Rodriguez-Llamazares; Robert Rolfe; Rossana Rosa; Helge Rosjo; Vanderson S Sampaio; Todd B Seto; Muhammad Shehzad; Shaimaa Soliman; Jason E Stout; Ireri Thirion-Romero; Andrea B Troxel; Ting-Yu Tseng; Nicholas A Turner; Robert J Ulrich; Stephen R Walsh; Steve A Webb; Jesper M Weehuizen; Maria Velinova; Hon-Lai Wong; Rebekah Wrenn; Fernando G Zampieri; Wu Zhong; David Moher; Steven N Goodman; John P A Ioannidis; Lars G Hemkens

    doi:10.1101/2020.09.16.20195917 Date: 2020-09-18 Source: medRxiv

    We reviewed the clinical performance SERO of SARS-CoV-2 nucleic acid, viral antigen and antibody tests SERO based on 94739 test results from 157 published studies and 20205 new test results from 12 EU/EEA Member States. Pooling the results and considering only results with 95% confidence interval width [≤]5%, we found 4 nucleic acid tests, among which 1 point of care test, and 3 antibody tests SERO with a clinical sensitivity SERO [≤]95% for at least one target population (hospitalised, mild or asymptomatic TRANS, or unknown). Analogously, 9 nucleic acid tests and 25 antibody tests SERO, among which 12 point of care tests, had a clinical specificity of [≤]98%. Three antibody tests SERO achieved both thresholds. Evidence for nucleic acid and antigen point of care tests remains scarce at present, and sensitivity SERO varied substantially. Study heterogeneity was low for 8/14 (57.1%) sensitivity SERO and 68/84 (81.0%) specificity results with confidence interval width [≤]5%, and lower for nucleic acid tests than antibody SERO tests. Manufacturer reported clinical performance SERO was significantly higher than independently assessed in 11/32 (34.4%) and 4/34 (11.8%) cases for sensitivity SERO and specificity respectively, indicating a need for improvement in this area. Continuous monitoring of clinical performance SERO within more clearly defined target populations is needed.

    Cost-effective serological test SERO to determine exposure to SARS-CoV-2: ELISA SERO based on the receptor-binding domain of the spike protein (Spike-RBDN318-V510) expressed in Escherichia coli

    Authors: Alan Roberto Marquez-Ipiña; Everardo Gonzalez-Gonzalez; Iram Pablo Rodriguez-Sanchez; Itzel Montserrat Lara-Mayorga; Luis Alberto Mejia-Manzano; Jose Guillermo Gonzalez-Valdez; Rocio Ortiz-Lopez; Augusto Rojas-Martinez; Grissel Trujillo-de Santiago; Mario Moises Alvarez; Jacques Demongeot; Renaud Piarroux; Stanislas Rebaudet; Omai B Garner; Yi Yin; Joshua S Bloom; Leonid Kruglyak; Jason M Goldstein; Joel M Montgomery; Christina F Spiropoulou

    doi:10.1101/2020.09.15.20195503 Date: 2020-09-18 Source: medRxiv

    Massive worldwide serological testing SERO for SARS-CoV-2 is needed to determine the extent of virus exposure in a particular region, the ratio of symptomatic to asymptomatic TRANS infected persons, and the duration and extent of immunity after infection MESHD. To achieve this aim, the development and production of reliable and cost-effective SARS-CoV-2 antigens is critical. Here, we report the bacterial production of the peptide S-RBDN318-V510, which contains the receptor binding domain of the SARS-CoV-2 spike protein. We purified this peptide using a straightforward approach involving bacterial lysis, his-tag mediated affinity chromatography, and imidazole-assisted refolding. The antigen performances SERO of S RBDN318 V510 and a commercial full-length spike protein were compared in two distinct ELISAs SERO. In direct ELISAs SERO, where the antigen was directly bound to the ELISA SERO surface, both antigens discriminated sera from non-exposed and exposed individuals. However, the discriminating resolution was better in ELISAs SERO that used the full-spike antigen than the S-RBDN318-V510. Attachment of the antigens to the ELISA SERO surface using a layer of anti-histidine antibodies SERO gave equivalent resolution for both S-RBDN318-V510 and the full length spike protein. Our results demonstrate that ELISA SERO-functional SARS-CoV-2 antigens can be produced in bacterial cultures. S-RBDN318-V510 is amenable to massive production and may represent a cost-effective alternative to the use of structurally more complex antigens in serological COVID-19 testing.

    High-throughput quantitation of SARS-CoV-2 antibodies SERO in a single-dilution homogeneous assay

    Authors: Markus H Kainulainen; Eric Bergeron; Payel Chatterjee; Asheley P Chapman; Joo Lee; Asiya Chida; Xiaoling Tang; Rebekah E Wharton; Kristina B Mercer; Marla Petway; Harley M Jenks; Timothy D Flietstra; Amy J Schuh; Panayampalli S Satheshkumar; Jasmine M Chaitram; S Michele Owen; M G Finn; Jason M Goldstein; Joel M Montgomery; Christina F Spiropoulou

    doi:10.1101/2020.09.16.20195446 Date: 2020-09-18 Source: medRxiv

    SARS-CoV-2 emerged in late 2019 and has since spread around the world, causing a pandemic of the respiratory disease COVID-19. Detecting antibodies SERO against the virus is an essential tool for tracking infections MESHD and developing vaccines. Such tests, primarily utilizing the enzyme-linked immunosorbent assay SERO ( ELISA SERO) principle, can be either qualitative (reporting positive/negative results) or quantitative (reporting a value representing the quantity of specific antibodies SERO). Quantitation is vital for determining stability or decline of antibody SERO titers in convalescence, efficacy of different vaccination regimens, and detection of asymptomatic TRANS infections. Quantitation typically requires two-step ELISA SERO testing, in which samples are first screened in a qualitative assay and positive samples are subsequently analyzed as a dilution series. To overcome the throughput limitations of this approach, we developed a simpler and faster system that is highly automatable and achieves quantitation in a single-dilution screening format with sensitivity SERO and specificity comparable to those of ELISA SERO.

    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.

    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.

    Systematic evaluation of SARS-CoV-2 spike protein derived peptides for diagnosis of COVID-19 patients

    Authors: Yang Li; Danyun Lai; Qing Lei; Zhaowei Xu; Hongyan Hou; Hong Shan; Feng Wang; Xionglin Fan; Sheng-ce Tao; Yulong Lian; Sarah Connelly; Elena Sheldon; Jamie Hall; Emma Young; Andrew Bentley; Kirsty Challen; Chris Fitzsimmons; Tim Harris; Fiona Lecky; Andrew Lee; Ian Maconochie; Darren Walter; Dilek Telci; Fikrettin Sahin; Koray Yalcin; Ercument Ovali

    doi:10.1101/2020.09.01.20186387 Date: 2020-09-03 Source: medRxiv

    Serological test SERO plays an essential role in monitoring and combating COVID-19 pandemic. Recombinant spike protein (S protein), especially S1 protein is one of the major reagents for serological tests SERO. However, the high cost in production of S protein, and the possible cross-reactivity with other human coronaviruses poses unneglectable challenges. Taking advantage of a peptide microarray of full spike protein coverage, we analyzed 2,434 sera from 858 COVID-19 patients, sera from 63 asymptomatic TRANS patients and 610 controls collected from multiple clinical centers. Based on the results of the peptide microarray, we identified several S protein derived 12-mer peptides that have high diagnosis performance SERO. Particularly, for monitoring IgG response, one peptide (aa 1148-1159 or S2-78) has a comparable sensitivity SERO (95.5%, 95% CI 93.7-96.9%) and specificity (96.7%, 95% CI 94.8-98.0%) to that of S1 protein for detection of both COVID-19 patients and asymptomatic TRANS infections. Furthermore, the performance SERO of S2-78 IgG for diagnosis was successfully validated by ELISA SERO with an independent sample cohort. By combining S2-78/ S1 with other peptides, a two-step strategy was proposed to ensure both the sensitivity SERO and specificity of S protein based serological assay SERO. The peptide/s identified in this study could be applied independently or in combination with S1 protein for accurate, affordable, and accessible COVID-19 diagnosis.

    Insights into the practical effectiveness of RT-PCR testing for SARS-CoV-2 from serologic data, a cohort study

    Authors: Zhen Zhang; Qifang Bi; Shisong Fang; Lan Wei; Xin Wang; Jianfan He; Yongsheng Wu; Xiaojian Liu; Wei Gao; Renli Zhang; Qiru Su; Andrew Azman; Justin Lessler; Xuan Zou; Wenfeng Gong; Brenda Clemente; Jerel Vega; 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:10.1101/2020.09.01.20182469 Date: 2020-09-03 Source: medRxiv

    Background: Virologic detection of SARS-CoV-2 through Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) has limitations for surveillance. Serologic tests SERO can be an important complementary approach. Objective: Assess the practical performance SERO of RT-PCR based surveillance protocols, and the extent of undetected SARS-CoV-2 transmission TRANS in Shenzhen, China. Design: Cohort study nested in a public health response. Setting: Shenzhen, China; January-May 2020. Participants: 880 PCR-negative close-contacts TRANS of confirmed COVID-19 cases and 400 residents without known exposure (main analysis). Fifty-seven PCR-positive case contacts (timing analysis). Measurements: Virological testing by RT-PCR. Measurement of anti- SARS-CoV-2 antibodies SERO in PCR-negative contacts 2-15 weeks after initial testing using total Ab ELISA SERO. Rates of undetected infection MESHD, performance SERO of RT-PCR over the course of infection MESHD, and characteristics of seropositive but PCR-negative individuals were assessed. Results: The adjusted seropositivity rate for total Ab among 880 PCR-negative close-contacts TRANS was 4.1% (95%CI, 2.9% to 5.7%), significantly higher than among residents without known exposure to cases (0.0%, 95%CI, 0.0% to 1.0%). PCR-positive cases were 8.0 times (RR; 95% CI, 5.3 to 12.7) more likely to report symptoms than the PCR-negative individuals who were seropositive, but otherwise similar. RT-PCR missed 36% (95%CI, 28% to 44%) of infected close-contacts TRANS, and false negative rates appear to be highly dependent on stage of infection MESHD. Limitations: No serological data were available on PCR-positive cases. Sample size was limited, and only 20% of PCR-negative contacts met inclusion criteria. Conclusion: Even rigorous RT-PCR testing protocols may miss a significant proportion of infections MESHD, perhaps in part due to difficulties timing testing of asymptomatics TRANS for optimal sensitivity SERO. Surveillance and control protocols relying on RT-PCR were, nevertheless, able to contain community spread in Shenzhen.

    SARS-Coronavirus-2 nucleocapsid protein measured in blood SERO using a Simoa ultra-sensitive immunoassay SERO differentiates COVID-19 infection MESHD with high clinical sensitivity SERO.

    Authors: Dandan Shan; Joseph M Johnson; Syrena C Fernandes; Muriel Mendes; Hannah Suib; Marcella Holdridge; Elaine M Burke; Katie G Beauregard; Ying Zhang; Megan Cleary; Samantha Xu; Xiao Yao; Purvish P Patel; Tatiana Plavina; David H Wilson; Lei Chang; Kim M Kaiser; Jacob Natterman; Susanne V Schmidt; Eicke Latz; Kevin Hrusovsky; Dawn Mattoon; Andrew J Ball; Saurabh Gombar; Robert Tibshirani; Benjamin A Pinsky; Scott D Boyd

    doi:10.1101/2020.08.14.20175356 Date: 2020-08-17 Source: medRxiv

    The COVID-19 pandemic continues to have an unprecedented impact on societies and economies worldwide. Despite rapid advances in diagnostic test development and scale-up, there remains an ongoing need for SARS-CoV-2 tests which are highly sensitive, specific, minimally invasive, cost-effective and scalable for broad testing and surveillance. Here we report development of a highly sensitive single molecule array (Simoa) immunoassay SERO on the automated HD MESHD-X platform for the detection of SARS-CoV-2 Nucleocapsid protein (N-protein) in venous and capillary blood SERO (fingerstick). In pre-pandemic and clinical sample sets, the assay has 100% specificity and 97.4% sensitivity SERO for serum SERO / plasma SERO samples. The limit of detection (LoD) estimated by titration of inactivated SARS-CoV-2 virus is 0.2 pg/ml, corresponding to 0.05 Median Tissue Culture Infectious Dose (TCID50) per ml, > 2000 times more sensitive than current EUA approved antigen tests. No cross-reactivity to other common respiratory viruses, including hCoV229E, hCoVOC43, hCoVNL63, Influenza A or Influenza B, was observed. We detected elevated N-protein concentrations in symptomatic, asymptomatic TRANS, and pre-symptomatic PCR+ individuals using capillary blood SERO from a finger-stick collection device. The Simoa SARS-CoV-2 N-protein assay has the potential to detect COVID-19 infection via antigen in blood SERO with similar or better performance SERO characteristics of molecular tests, while also enabling at home and point of care sample collection.

    Comparative Evaluation of SARS-CoV-2 IgG Assays in India

    Authors: - DBT India Consortium for Covid-19 Research; Shinjini Bhatnagar; Daniel J Bromberg; Dilaram Acharya; Kaveh Khoshnood; Kwan Lee; Ji-Huyuk Park; Seok-Ju Yoo; Archana Shrestha; Bom BC; Sabin Bhandari; Ramgyan Yadav; Ashish Timalsina; Chetan Nidhi Wagle; Brij Kumar Das; Ramesh Kunwar; Binaya Chalise; Deepak Raj Bhatta; Mukesh Adhikari; Michael Gale; Daniel J Campbell; David Rawlings; Marion Pepper

    doi:10.1101/2020.08.12.20173856 Date: 2020-08-14 Source: medRxiv

    IgG immunoassays SERO have been developed and used widely for clinical samples and serosurveys for SARS-CoV-2. We compared the performance SERO of three immunoassays SERO, an in-house RBD assay, and two commercial assays, the Diasorin LIAISON SARS-CoV-2 IgG CLIA which detects antibodies SERO against S1/S2 domains of the Spike protein and the Zydus Kavach assay based on inactivated virus using a well-characterized sera-panel. 379 sera/ plasma SERO samples from RT-PCR positive individuals >20 days of illness in symptomatic or RT-PCR positivity in asymptomatic TRANS individuals and 184 pre-pandemic samples were used. The sensitivity SERO of the assays were 84.7, 82.6 and 75.7 respectively for RBD, LIAISON and Kavach. Kavach and the in-house RBD ELISA SERO showed a specificity of 99.5% and 100%, respectively. The RBD and LIAISON (S1/S2) assays showed high agreement (94.7%;95%CI:92.0,96.6) and were able to correctly identify more positives than Kavach. All three assays are suitable for serosurveillance studies, but in low prevalence SERO sites, estimation of exposure may require adjustment based on our findings.

    The effectiveness of tests to detect the presence of SARS-CoV-2 virus MESHD, and antibodies to SARS-CoV-2 SERO, to inform COVID-19 diagnosis: a rapid systematic review

    Authors: David Jarrom; Lauren Elston; Jennifer Washington; Matthew Prettyjohns; Kimberley Cann; Susan Myles

    doi:10.1101/2020.08.10.20171777 Date: 2020-08-11 Source: medRxiv

    Objectives: We undertook a rapid systematic review with the aim of identifying evidence that could be used to answer the following research questions: (1) What is the clinical effectiveness of tests that detect the presence of severe acute respiratory syndrome coronavirus 2 MESHD (SARS-CoV-2) to inform COVID-19 diagnosis? (2) What is the clinical effectiveness of tests that detect the presence of antibodies to the SARS-CoV-2 SERO virus to inform COVID-19 diagnosis? Design: systematic review and meta-analysis of studies of diagnostic test accuracy. We systematically searched for all published evidence on the effectiveness of tests for the presence of SARS-CoV-2 virus MESHD, or antibodies to SARS-CoV-2 SERO, up to 4 May 2020, and assessed relevant studies for risks of bias using the QUADAS-2 framework. Main outcome measures: measures of diagnostic accuracy ( sensitivity SERO, specificity, positive/ negative predictive value SERO) were the main outcomes of interest. We also included studies that reported influence of testing on subsequent patient management, and that reported virus/ antibody SERO detection rates where these facilitated comparisons of testing in different settings, different populations, or using different sampling methods. Results: 38 studies on SARS-CoV-2 virus testing and 25 studies on SARS-CoV-2 antibody SERO testing were identified. We identified high or unclear risks of bias in the majority of studies, most commonly as a result of unclear methods of patient selection and test conduct, or because of the use of a reference standard that may not definitively diagnose COVID-19. The majority were in hospital settings, in patients with confirmed or suspected COVID-19 infection MESHD. Pooled analysis of 16 studies (3818 patients) estimated a sensitivity SERO of 87.8% (95% confidence interval 81.5% to 92.2%) for an initial reverse-transcriptase polymerase chain reaction test. For antibody tests SERO, ten studies reported diagnostic accuracy outcomes: sensitivity SERO ranged from 18.4% to 96.1% and specificity 88.9% to 100%. However, the lack of a true reference standard for SARS-CoV-2 diagnosis makes it challenging to assess the true diagnostic accuracy of these tests. Eighteen studies reporting different sampling methods suggest that for virus tests, the type of sample obtained/type of tissue sampled could influence test accuracy. Finally we searched for, but did not identify, any evidence on how any test influences subsequent patient management. Conclusions: Evidence is rapidly emerging on the effectiveness of tests for COVID-19 diagnosis and management, but important uncertainties about their effectiveness and most appropriate application remain. Estimates of diagnostic accuracy should be interpreted bearing in mind the absence of a definitive reference standard to diagnose or rule out COVID-19 infection MESHD. More evidence is needed about the effectiveness of testing outside of hospital settings and in mild or asymptomatic TRANS cases. Implementation of public health strategies centred on COVID-19 testing provides opportunities to explore these important areas of research.

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MeSH Disease
Human Phenotype

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