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MeSH Disease

Human Phenotype

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Transmission

Seroprevalence
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    Evaluating SARS-CoV-2 spike MESHD and nucleocapsid proteins as targets for IgG antibody SERO detection in severe and mild COVID-19 cases using a Luminex bead-based assay

    Authors: Joachim Marien; Johan Michiels; Leo Heyndrickx; Karen Kerkhof; Nikki Foque; Marc-Alain Widdowson; Isabelle Desombere; Hilde Jansens; Marjan Van Esbroeck; Kevin K. Arien

    doi:10.1101/2020.07.25.20161943 Date: 2020-07-27 Source: medRxiv

    Large-scale serosurveillance of severe acute respiratory syndrome coronavirus type 2 MESHD (SARS-CoV-2) will only be possible if serological tests SERO are sufficiently reliable, rapid and inexpensive. Current assays are either labour-intensive and require specialised facilities (e.g. virus neutralization assays), or expensive with suboptimal specificity (e.g. commercial ELISAs SERO). Bead-based assays offer a cost-effective alternative and allow for multiplexing to test for antibodies SERO of other pathogens. Here, we compare the performance SERO of four antigens for the detection of SARS-CoV-2 specific IgG antibodies SERO in a panel of sera that includes both severe (n=40) and mild (n=52) cases, using a neutralization and a Luminex bead-based assay. While we show that neutralising antibody SERO levels are significantly lower in mild than in severe cases, we demonstrate that a combination of recombinant nucleocapsid protein (NP), receptor-binding domain (RBD) and the whole spike protein (S1S2) results in a highly sensitive (96%) and specific (99%) bead-based assay that can detect IgG antibodies SERO in both groups. Although S1-specific IgG levels correlate most strongly with neutralizing antibody SERO levels, they fall HP below the detection threshold in 10% of the cases in our Luminex assay. In conclusion, our data supports the use of RBD, NP and S1S2 for the development of SARS-CoV-2 serological bead-based assays. Finally, we argue that low antibody SERO levels in mild/ asymptomatic TRANS cases might complicate the epidemiological assessment of large-scale surveillance studies.

    Rapid point of care nucleic acid testing for SARS-CoV-2 in hospitalised patients: a clinical trial and implementation study

    Authors: Dami A Collier; Sonny M Assennato; Nyarie Sithole; Katherine Sharrocks; Allyson Ritchie; Pooja Ravji; Matt Routledge; Dominic Sparkes; Jordan Skittrall; Ben Warne; Anna smielewska; ISOBEL RAMSEY; NEHA GOEL; MARTIN CURRAN; DAVID ENOCH; RHYS TASSELL; MICHELLE LINEHAM; DEVAN VAGHELA; CLARE LEONG; HOI PING MOK; JOHN BRADLEY; KENNETH GC SMITH; Vivien Mendoza; NIKOS DEMIRIS; MARTIN BESSER; GORDON DOUGAN; PAUL J LEHNER; Mark Siedner; HONGYI ZHANG; CLAIRE WADDINGTON; HELEN LEE; Ravindra K Gupta

    doi:10.1101/2020.05.31.20114520 Date: 2020-06-02 Source: medRxiv

    Objective To compare a point of care (POC) nucleic acid amplification based platform for rapid diagnosis of COVID-19 against the standard laboratory RT-PCR test and perform an implementation study. Design: prospective clinical trial (COVIDx) and observational study Setting: a large UK teaching hospital Participants: patients presenting to hospital with possible COVID-19 disease and tested on a combined nasal/throat swab using the SAMBA II SARS-CoV-2 rapid POC test SERO and in parallel a combined nasal/throat swab for standard lab RT-PCR testing. Implementation phase participants underwent SARS-CoV-2 POC testing SERO for a range of indications over a ten day period pre and post SAMBA II platform implementation. Main outcome measures: concordance and sensitivity SERO and specificity of POC using the lab test as the reference standard, test turnaround time in trial and implementation periods; time to definitive patient triage from ED, time spent on COVID-19 holding wards, bay closures avoided, proportions of patients in isolation rooms following test, proportions of patients able to be moved to COVID negative areas following test. Results 149 participants were included in the COVIDx trial. 32 (21.5%) tested positive and 117 (78.5%) tested negative by standard lab RT-PCR. Median age TRANS was 62.7 (IQR 37 to 79) years and 47% were male TRANS. Cohen's kappa correlation between the index and reference tests was 0.96, 95% CI (0.91, 1.00). Sensitivity SERO and specificity of SAMBA against the RT-PCR lab test were 96.9% (95% CI 0.838-0.999) and 99.1% (0.953-0.999) respectively. Median time to result was 2.6 hours (IQR 2.3 to 4.8) for SAMBA II and 26.4 hours (IQR 21.4 to 31.4) for the standard lab RT-PCR test (p<0.001). In the first 10 days of the SAMBA II SARS-CoV-2 test implementation for all hospital COVID-19 testing, analysis of the first 992 tests showed 59.8% of tests were used for ED patients, and the remainder were done for pre-operative screening (11.3%), discharges to nursing homes (10%), in-hospital screening of new symptoms (9.7%), screening in asymptomatic TRANS patients requiring hospital admission screening (3.8%) and access to interventions such as dialysis and chemotherapy for high risk patients (1.2%). Use of single occupancy rooms amongst those tested fell HP from 30.8% before to 21.2% after testing (p=0.03). 11 bay closures were avoided by use of SAMBA over ten days. The post implementation group was then compared with 599 individuals who had a standard lab RT-PCR test in the 10 days prior to SAMBA introduction. Median time to result during implementation fell HP from 39.4 hours (IQR 24.7-51.3) to 3.6 hours (IQR 2.6-5.8), p<0.0001 and the median time to definitive ward move from ED was significantly reduced from 24.1 hours (9.2-48.6) to 18.5 hours (10.2-28.8), p=0.002. Mean length of stay on a COVID-19 holding ward decreased from 58.5 hours to 29.9 hours (p<0.001) compared to the 10 days prior to implementation. Conclusions SAMBA II SARS-CoV-2 rapid POC test SERO performed as well as standard lab RT-PCR and demonstrated shorter time to result both in trial and real-world settings. It was also associated with faster time to triage from the ED, release of isolation rooms, avoidance of hospital bay closures and movement of patients to COVID negative open green category wards, allowed discharge to care homes and expediting access to hospital investigations and procedures. POC testing SERO will be instrumental in mitigating the impact of COVID-19 on hospital systems by allowing rapid triage and patient movement to safe and appropriate isolation wards in the hospital. This is also likely to reduce delays in patients accessing appropriate investigation and treatment, thereby improving clinical outcomes.

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MeSH Disease
Human Phenotype
Transmission
Seroprevalence


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