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  1. Article ; Online: SARS-CoV-2 enzyme-linked immunosorbent assays as proxies for plaque reduction neutralisation tests.

    Kay, Grant A / Owen, Sophie I / Giorgi, Emanuele / Clark, David J / Williams, Christopher T / Menzies, Stefanie / Cuevas, Luis E / Davies, Benedict M O / Eckersley, Nicholas M / Hughes, Grant L / Kirwan, Daniela E / Krishna, Sanjeev / Patterson, Edward I / Planche, Tim / Staines, Henry M / Adams, Emily R

    Scientific reports

    2022  Volume 12, Issue 1, Page(s) 3351

    Abstract: Severe acute respiratory coronavirus 2 (SARS-CoV-2) has spread globally since its emergence in 2019. Most SARS-CoV-2 infections generate immune responses leading to rising levels of immunoglobulins (Ig) M, A and G which can be detected using diagnostic ... ...

    Abstract Severe acute respiratory coronavirus 2 (SARS-CoV-2) has spread globally since its emergence in 2019. Most SARS-CoV-2 infections generate immune responses leading to rising levels of immunoglobulins (Ig) M, A and G which can be detected using diagnostic tests including enzyme-linked immunosorbent assays (ELISA). Whilst implying previous SARS-CoV-2 infection, the detection of Ig by ELISA does not guarantee the presence of neutralising antibodies (NAb) that can prevent the virus infecting cells. Plaque reduction neutralisation tests (PRNT) detect NAb, but are not amenable to mass testing as they take several days and require use of SARS-CoV-2 in high biocontainment laboratories. We evaluated the ability of IgG and IgM ELISAs targeting SARS-CoV-2 spike subunit 1 receptor binding domain (S1-RBD), and spike subunit 2 (S2) and nucleocapsid protein (NP), at predicting the presence and magnitude of NAb determined by PRNT. IgG S2 + NP ELISA was 96.8% [95% CI 83.8-99.9] sensitive and 88.9% [95% CI 51.8-99.7] specific at predicting the presence of NAbs (PRNT
    MeSH term(s) Aged ; Antibodies, Viral/immunology ; COVID-19/immunology ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Immunoglobulin G/immunology ; Immunoglobulin M/immunology ; Male ; Middle Aged ; Neutralization Tests ; SARS-CoV-2/immunology ; Spike Glycoprotein, Coronavirus/immunology
    Chemical Substances Antibodies, Viral ; Immunoglobulin G ; Immunoglobulin M ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
    Language English
    Publishing date 2022-03-01
    Publishing country England
    Document type Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-022-07263-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: The QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology.

    Caffry, Jessica / Selby, Matthew / Barr, Katie / Morgan, George / McGurk, David / Scully, Philip / Park, Catherine / Caridis, Anna-Maria / Southworth, Emily / Morrison, Jack / Clark, David J / Davies, Benedict M O / Eckersley, Nicholas M / Groppelli, Elisabetta / Kirwan, Daniela E / Monahan, Irene / Augustin, Yolanda / Toombs, Colin / Planche, Tim /
    Staines, Henry M / Krishna, Sanjeev

    Scientific reports

    2023  Volume 13, Issue 1, Page(s) 9827

    Abstract: Accurate and rapid point-of-care (PoC) diagnostics are critical to the control of the COVID-19 pandemic. The current standard for accurate diagnosis of SARS-CoV-2 is laboratory-based reverse transcription polymerase chain reaction (RT-PCR) assays. Here, ... ...

    Abstract Accurate and rapid point-of-care (PoC) diagnostics are critical to the control of the COVID-19 pandemic. The current standard for accurate diagnosis of SARS-CoV-2 is laboratory-based reverse transcription polymerase chain reaction (RT-PCR) assays. Here, a preliminary prospective performance evaluation of the QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay is reported. Between November 2020 and March 2021, 49 longitudinal combined nose/throat (NT) swabs from 29 individuals hospitalised with RT-PCR confirmed COVID-19 were obtained at St George's Hospital, London. In addition, 101 mid-nasal (MN) swabs were obtained from healthy volunteers in June 2021. These samples were used to evaluate the Q-POC SARS-CoV-2 RT-PCR assay. The primary analysis was to compare the sensitivity and specificity of the Q-POC test against a reference laboratory-based RT-PCR assay. The overall sensitivity of the Q-POC test compared with the reference test was 96.88% (83.78- 99.92% CI) for a cycle threshold (Ct) cut-off value for the reference test of 35 and 80.00% (64.35-90.95% CI) without altering the reference test's Ct cut-off value of 40. The Q-POC test is a sensitive, specific and rapid PoC test for SARS-CoV-2 at a reference Ct cut-off value of 35. The Q-POC test provides an accurate option for RT-PCR at PoC without the need for sample pre-processing and laboratory handling, enabling rapid diagnosis and clinical triage in acute care and other settings.
    MeSH term(s) Humans ; COVID-19/diagnosis ; SARS-CoV-2/genetics ; Reverse Transcriptase Polymerase Chain Reaction ; Point-of-Care Systems ; Pandemics ; Prospective Studies ; COVID-19 Testing ; Clinical Laboratory Techniques ; Sensitivity and Specificity
    Language English
    Publishing date 2023-06-17
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-023-35479-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: IgG Seroconversion and Pathophysiology in Severe Acute Respiratory Syndrome Coronavirus 2 Infection.

    Staines, Henry M / Kirwan, Daniela E / Clark, David J / Adams, Emily R / Augustin, Yolanda / Byrne, Rachel L / Cocozza, Michael / Cubas-Atienzar, Ana I / Cuevas, Luis E / Cusinato, Martina / Davies, Benedict M O / Davis, Mark / Davis, Paul / Duvoix, Annelyse / Eckersley, Nicholas M / Forton, Daniel / Fraser, Alice J / Garrod, Gala / Hadcocks, Linda /
    Hu, Qinxue / Johnson, Michael / Kay, Grant A / Klekotko, Kesja / Lewis, Zawditu / Macallan, Derek C / Mensah-Kane, Josephine / Menzies, Stefanie / Monahan, Irene / Moore, Catherine M / Nebe-von-Caron, Gerhard / Owen, Sophie I / Sainter, Chris / Sall, Amadou A / Schouten, James / Williams, Christopher T / Wilkins, John / Woolston, Kevin / Fitchett, Joseph R A / Krishna, Sanjeev / Planche, Tim

    Emerging infectious diseases

    2020  Volume 27, Issue 1

    Abstract: We investigated the dynamics of seroconversion in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. During March 29-May 22, 2020, we collected serum samples and associated clinical data from 177 persons in London, UK, who had SARS- ... ...

    Abstract We investigated the dynamics of seroconversion in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. During March 29-May 22, 2020, we collected serum samples and associated clinical data from 177 persons in London, UK, who had SARS-CoV-2 infection. We measured IgG against SARS-CoV-2 and compared antibody levels with patient outcomes, demographic information, and laboratory characteristics. We found that 2.0%-8.5% of persons did not seroconvert 3-6 weeks after infection. Persons who seroconverted were older, were more likely to have concurrent conditions, and had higher levels of inflammatory markers. Non-White persons had higher antibody concentrations than those who identified as White; these concentrations did not decline during follow-up. Serologic assay results correlated with disease outcome, race, and other risk factors for severe SARS-CoV-2 infection. Serologic assays can be used in surveillance to clarify the duration and protective nature of humoral responses to SARS-CoV-2 infection.
    MeSH term(s) Adult ; Aged ; Antibodies, Viral/blood ; COVID-19/blood ; COVID-19/immunology ; COVID-19/physiopathology ; Enzyme-Linked Immunosorbent Assay ; Female ; Humans ; Immunoglobulin G/blood ; Male ; Middle Aged ; Reverse Transcriptase Polymerase Chain Reaction ; SARS-CoV-2 ; Seroconversion
    Chemical Substances Antibodies, Viral ; Immunoglobulin G
    Language English
    Publishing date 2020-11-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1380686-5
    ISSN 1080-6059 ; 1080-6040
    ISSN (online) 1080-6059
    ISSN 1080-6040
    DOI 10.3201/eid2701.203074
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Rapid development of COVID-19 rapid diagnostics for low resource settings: accelerating delivery through transparency, responsiveness, and open collaboration

    Adams, Emily R / Augustin, Yolanda / Byrne, Rachel L / Clark, David J / Cocozza, Michael / Cubas-Atienzar, Ana I / Cuevas, Luis E / Cusinato, Martina / Davies, Benedict M. O. / Davies, Mark / Davies, Paul / Duvoix, Annelyse / Eckersley, Nicholas M / Edwards, Thomas / Fletcher, Thomas / Fraser, Alice j / Garrod, Gala / Hadcocks, Linda / Hu, QInxue /
    johnson, Michael / Kay, Grant A / Keymer, Katherin / Kirwan, Daniela / Klekotko, Kesja / Lewis, Zawditu / Mason, Jenifer / Mensah-Kane, Josie / Menzies, Stefanie / Monahan, Irene / Moore, Catherine M / Nebe-von-Caron, Gerhard / Owen, Sophie I / Planche, Tim / Sainter, Chris / Schouten, James / Staines, Henry M / Turtle, Lance / Williams, Chris / Wilkins, John / Woolston, Kevin / Sall, Amadou A / Fitchett, Joseph R.A. / Krishna, Sanjeev

    Abstract: In January, Mologic, embarked on a product development pathway for COVID-19 diagnostics focusing on ELISA and rapid diagnostic tests (RDTs), with anticipated funding from Wellcome Trust and DFID. 755 clinical samples from known COVID-19 patients and ... ...

    Abstract In January, Mologic, embarked on a product development pathway for COVID-19 diagnostics focusing on ELISA and rapid diagnostic tests (RDTs), with anticipated funding from Wellcome Trust and DFID. 755 clinical samples from known COVID-19 patients and hospital negative controls were tested on Mologics IgG ELISA. The reported sensitivity on 191 SGUL prospectively enrolled patients was 95% on day 7 or more post diagnosis, and 97% 10 days or more post-diagnosis. A specificity panel comprising 564 samples pre-December 2019 were tested to include most common respiratory pathogens, other types of coronavirus, and flaviviruses. Specificity in this panel was 97%. This is the first in a series of Mologic products for COVID-19, which will be deployed for COVID-19 diagnosis, contact tracing and sero-epidemiological studies to estimate disease burden and transmission with a focus on ensuring access, affordability, and availability to lowest resource settings.
    Keywords covid19
    Publisher MedRxiv; WHO
    Document type Article ; Online
    Note WHO #Covidence: #20082099
    DOI 10.1101/2020.04.29.20082099
    Database COVID19

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  5. Article ; Online: Rapid development of COVID-19 rapid diagnostics for low resource settings: accelerating delivery through transparency, responsiveness, and open collaboration

    Adams, Emily R / Augustin, Yolanda / Byrne, Rachel L / Clark, David J / Cocozza, Michael / Cubas-Atienzar, Ana I / Cuevas, Luis E / Cusinato, Martina / Davies, Benedict M. O. / Davies, Mark / Davies, Paul / Duvoix, Annelyse / Eckersley, Nicholas M / Edwards, Thomas / Fletcher, Thomas / Fraser, Alice j / Garrod, Gala / Hadcocks, Linda / Hu, QInxue /
    johnson, Michael / Kay, Grant A / Keymer, Katherin / Kirwan, Daniela / Klekotko, Kesja / Lewis, Zawditu / Mason, Jenifer / Mensah-Kane, Josie / Menzies, Stefanie / Monahan, Irene / Moore, Catherine M / Nebe-von-Caron, Gerhard / Owen, Sophie I / Planche, Tim / Sainter, Chris / Schouten, James / Staines, Henry M / Turtle, Lance / Williams, Chris / Wilkins, John / Woolston, Kevin / Sall, Amadou A / Fitchett, Joseph R.A. / Krishna, Sanjeev

    medRxiv

    Abstract: In January, Mologic, embarked on a product development pathway for COVID-19 diagnostics focusing on ELISA and rapid diagnostic tests (RDTs), with anticipated funding from Wellcome Trust and DFID. 755 clinical samples from known COVID-19 patients and ... ...

    Abstract In January, Mologic, embarked on a product development pathway for COVID-19 diagnostics focusing on ELISA and rapid diagnostic tests (RDTs), with anticipated funding from Wellcome Trust and DFID. 755 clinical samples from known COVID-19 patients and hospital negative controls were tested on Mologics IgG ELISA. The reported sensitivity on 191 SGUL prospectively enrolled patients was 95% on day 7 or more post diagnosis, and 97% 10 days or more post-diagnosis. A specificity panel comprising 564 samples pre-December 2019 were tested to include most common respiratory pathogens, other types of coronavirus, and flaviviruses. Specificity in this panel was 97%. This is the first in a series of Mologic products for COVID-19, which will be deployed for COVID-19 diagnosis, contact tracing and sero-epidemiological studies to estimate disease burden and transmission with a focus on ensuring access, affordability, and availability to lowest resource settings.
    Keywords covid19
    Language English
    Publishing date 2020-05-05
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.04.29.20082099
    Database COVID19

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  6. Article ; Online: Dynamics of IgG seroconversion and pathophysiology of COVID-19 infections

    Staines, Henry M / Kirwan, Daniela E / Clark, David J / Adams, Emily R / Augustin, Yolanda / Byrne, Rachel L / Cocozza, Michael / Cubas-Atienza, Ana I / Cuevas, Luis E / Cusinato, Martina / Davies, Benedict M O / Davis, Mark / Davis, Paul / Duvoix, Annelyse / Eckersley, Nicholas M / Forton, Daniel / Fraser, Alice / Garrod, Gala / Hadcocks, Linda /
    Hu, Qinxue / Johnson, Michael / Kay, Grant A / Klekotko, Kesja / Lewis, Zawditu / Mensah-Kane, Josephine / Menzies, Stefanie / Monahan, Irene / Moore, Catherine / Nebe-von-Caron, Gerhard / Owen, Sophie I / Sainter, Chris / Sall, Amadou A / Schouten, James / Williams, Chris / Wilkins, John / Woolston, Kevin / Fitchett, Joseph R A / Krishna, Sanjeev / Planche, Tim

    medRxiv

    Abstract: We report dynamics of seroconversion to SARS-CoV-2 infections detected by IgG ELISA in 177 individuals diagnosed by RT-PCR. Longitudinal analysis identifies 2-8.5% of individuals who do not seroconvert even weeks after infection. They are younger than ... ...

    Abstract We report dynamics of seroconversion to SARS-CoV-2 infections detected by IgG ELISA in 177 individuals diagnosed by RT-PCR. Longitudinal analysis identifies 2-8.5% of individuals who do not seroconvert even weeks after infection. They are younger than seroconverters who have increased co-morbidity and higher inflammatory markers such as C-Reactive Protein. Higher antibody responses are associated with non-white ethnicity. Antibody responses do not decline during follow up almost to 2 months. Serological assays increase understanding of disease severity. Their application in regular surveillance will clarify the duration and protective nature of humoral responses to SARS-CoV-2.
    Keywords covid19
    Language English
    Publishing date 2020-06-09
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2020.06.07.20124636
    Database COVID19

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