Comparative assessment of multiple COVID-19 serological technologies supports continued evaluation of point-of-care lateral flow assays in hospital and community healthcare settings

Pickering, Suzanne; Betancor, Gilberto; Galão, Rui Pedro; Merrick, Blair; Signell, Adrian W.; Wilson, Harry; Ik, Mark Tan Kia; Seow, Jeffrey; Graham, Carl; Acors, Sam; Kouphou, Neophytos; Steel, Kathryn J A; Hemmings, Oliver; Patel, Amita; Nebbia, Gaia; Douthwaite, Sam; O’Connell, Lorcan; Lupták, Jakub; McCoy, Laura E; Brouwer, Philip J.M.; Gils, Marit J. van; Sanders, Rogier W.; Nunez, Rocio Martinez; Bisnauthsing, Karen; O’Hara, Geraldine; MacMahon, Eithne; Batra, Rahul; Malim, Michael H.; Neil, Stuart J. D.; Doores, Katie J.; Edgeworth, Jonathan D

doi:10.1371/journal.ppat.1008817

Cited by 107 publications

(95 citation statements)

References 16 publications

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“…The sensitivity of the CoViDiag test kit after 14 days since symptom onset varies from 92.0 to 100.0%. However, it remains too low in the first 6 days after the onset of symptoms to correctly identify all positive patients, as confirmed by other studies [ 31 , 32 ]. Nevertheless, detection of early seroconversion may be useful to understand the heterogeneity of clinical presentations and the interactions between antibody isotypes and viral proteins [ 33 , 34 , 35 ].…”

Section: Discussionsupporting

confidence: 54%

An Original ELISA-Based Multiplex Method for the Simultaneous Detection of 5 SARS-CoV-2 IgG Antibodies Directed against Different Antigens

Gillot

Douxfils

Cadrobbi

et al. 2020

JCM

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Strategies to detect SARS-CoV-2 are increasingly being developed. Among them, serological methods have been developed. Nevertheless, although these may present an interesting clinical performance, they are often directed against only one antigen. This study aims at evaluating the clinical performance of an innovative multiplex immunoassay (i.e., CoViDiag assay) detecting simultaneously the presence of antibodies directed against N, S1, S2, RBD and NTD antigens. Sensitivity was evaluated in 135 samples obtained from 94 rRT-PCR confirmed coronavirus disease 2019 (COVID-19) patients. Non-SARS-CoV-2 sera (n = 132) collected before the COVID-19 pandemic with potential cross-reactions to the SARS-CoV-2 immunoassay were included in the specificity analysis. The antibody signature was also studied in hospitalized and non-hospitalized patients. The specificity of the CoViDiag assay was excellent for all antibodies (99.2 to 100%) using adapted cut-offs. None of the false positive samples were positive for more than one antibody. The sensitivity obtained from samples collected 14 days since symptom onset varied from 92.0 to 100.0% depending on the antibody considered. Among samples collected more than 14 days after symptom onset, 12.8, 66.3, 3.5, 9.3, 5.8 and 2.3% were positive for 5, 4, 3, 2, 1 or 0 antibodies, respectively. A trend toward higher antibody titers was observed in hospitalized patient in the early days since symptom onset. However, no significant difference was observed compared to non-hospitalized patients after 14 days since symptom onset. The clinical performance of the CoViDiag 5 IgG assay is sufficient to recommend its use for the detection and the characterization of the antibody signature following SARS-CoV-2 infection. The combination of several antigens in the same test improves the overall specificity and sensitivity of the test. Further research is needed to investigate whether this strategy may be of interest to identify severe disease outcome in patients with SARS-CoV-2 infection.

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Section: Discussionsupporting

confidence: 54%

An Original ELISA-Based Multiplex Method for the Simultaneous Detection of 5 SARS-CoV-2 IgG Antibodies Directed against Different Antigens

Gillot

Douxfils

Cadrobbi

et al. 2020

JCM

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“…Laboratory testing is an essential component of LFIA evaluation. 15 18 In this study, as in previous work, we have shown that most LFIAs evaluated had lower sensitivity or specificity than reported in preliminary results by the manufacturers. Only three LFIAs in round 2, and eight of 18 LFIAs evaluated in the React 2 programme to date showed sufficient sensitivity and specificity during analysis on sera to justify progression to clinic testing.…”

Section: Discussionsupporting

confidence: 78%

“…Altogether, three LFIAs were selected for testing in the clinic in round 2: Panbio (Abbott 13 ), AbC-19 (TT3, Abingdon rapid test consortium 14 ), and Surescreen. 15 …”

Section: Methodsmentioning

confidence: 99%

SARS-CoV-2 lateral flow assays for possible use in national covid-19 seroprevalence surveys (React 2): diagnostic accuracy study

Moshe

Daunt

Flower

et al. 2021

BMJ

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Objective To evaluate the performance of new lateral flow immunoassays (LFIAs) suitable for use in a national coronavirus disease 2019 (covid-19) seroprevalence programme (real time assessment of community transmission 2—React 2). Design Diagnostic accuracy study. Setting Laboratory analyses were performed in the United Kingdom at Imperial College, London and university facilities in London. Research clinics for finger prick sampling were run in two affiliated NHS trusts. Participants Sensitivity analyses were performed on sera stored from 320 previous participants in the React 2 programme with confirmed previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Specificity analyses were performed on 1000 prepandemic serum samples. 100 new participants with confirmed previous SARS-CoV-2 infection attended study clinics for finger prick testing. Interventions Laboratory sensitivity and specificity analyses were performed for seven LFIAs on a minimum of 200 serum samples from participants with confirmed SARS-CoV-2 infection and 500 prepandemic serum samples, respectively. Three LFIAs were found to have a laboratory sensitivity superior to the finger prick sensitivity of the LFIA currently used in React 2 seroprevalence studies (84%). These LFIAs were then further evaluated through finger prick testing on participants with confirmed previous SARS-CoV-2 infection: two LFIAs (Surescreen, Panbio) were evaluated in clinics in June-July 2020 and the third LFIA (AbC-19) in September 2020. A spike protein enzyme linked immunoassay and hybrid double antigen binding assay were used as laboratory reference standards. Main outcome measures The accuracy of LFIAs in detecting immunoglobulin G (IgG) antibodies to SARS-CoV-2 compared with two reference standards. Results The sensitivity and specificity of seven new LFIAs that were analysed using sera varied from 69% to 100%, and from 98.6% to 100%, respectively (compared with the two reference standards). Sensitivity on finger prick testing was 77% (95% confidence interval 61.4% to 88.2%) for Panbio, 86% (72.7% to 94.8%) for Surescreen, and 69% (53.8% to 81.3%) for AbC-19 compared with the reference standards. Sensitivity for sera from matched clinical samples performed on AbC-19 was significantly higher with serum than finger prick at 92% (80.0% to 97.7%, P=0.01). Antibody titres varied considerably among cohorts. The numbers of positive samples identified by finger prick in the lowest antibody titre quarter varied among LFIAs. Conclusions One new LFIA was identified with clinical performance suitable for potential inclusion in seroprevalence studies. However, none of the LFIAs tested had clearly superior performance to the LFIA currently used in React 2 seroprevalence surveys, and none showed sufficient sensitivity and specificity to be considered for routine clinical use.

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“…Data were normalized using a min/max normalization to compare samples across batches. Values >0.15 were considered positive, which is 4 fold of background based on results from 300 patient samples pre-COVID-19 ( Pickering et al., 2020 ) ( Table S4 ).…”

Section: Methodsmentioning

confidence: 99%

Acute Immune Signatures and Their Legacies in Severe Acute Respiratory Syndrome Coronavirus-2 Infected Cancer Patients

et al. 2021

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Comparative assessment of multiple COVID-19 serological technologies supports continued evaluation of point-of-care lateral flow assays in hospital and community healthcare settings

Cited by 107 publications

References 16 publications

An Original ELISA-Based Multiplex Method for the Simultaneous Detection of 5 SARS-CoV-2 IgG Antibodies Directed against Different Antigens

An Original ELISA-Based Multiplex Method for the Simultaneous Detection of 5 SARS-CoV-2 IgG Antibodies Directed against Different Antigens

SARS-CoV-2 lateral flow assays for possible use in national covid-19 seroprevalence surveys (React 2): diagnostic accuracy study

Acute Immune Signatures and Their Legacies in Severe Acute Respiratory Syndrome Coronavirus-2 Infected Cancer Patients

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