Comparison of the diagnostic performance with whole blood and plasma of four rapid antibody tests for SARS-CoV-2

Decru, Bram; Elslande, Jan Van; Weemaes, Matthias; Houben, Els; Empsen, Ine; André, Emmanuel; Ranst, Marc Van; Lagrou, Katrien; Vermeersch, Pieter

doi:10.1515/cclm-2020-0817

Cited by 13 publications

(11 citation statements)

References 6 publications

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“…While the diagnostic performance of a number of rapid tests for detection of IgG anti-SARS-CoV-2 antibodies is good [ 19 , 25 ], the availability of automated assays for the detection of anti-SARS-CoV-2 antibodies opens the possibility for largescale testing. There are, however, still a number of important questions.…”

Section: Discussionmentioning

confidence: 99%

Antibody response against SARS-CoV-2 spike protein and nucleoprotein evaluated by four automated immunoassays and three ELISAs

Elslande

Decru

Jonckheere³

et al. 2020

Clinical Microbiology and Infection

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148

132

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Objectives The aim was to determine the antibody response against SARS-CoV-2 spike protein and nucleoprotein using four automated immunoassays and three ELISAs for the detection of total Ig antibodies (Roche) or IgG (Abbott, Diasorin, Snibe, Euroimmun, Mikrogen) in COVID-19 patients. Methods Sensitivity and dynamic trend to seropositivity were evaluated in 233 samples from 114 patients with moderate, severe or critical COVID-19 confirmed with PCR on nasopharyngeal swab. Specificity was evaluated in 113 samples collected before January 2020, including 24 samples from patients with non-SARS coronavirus infection. Results Sensitivity for all assays was 100% (95% confidence interval 83.7–100) 3 weeks after onset of symptoms. Specificity varied between 94.7% (88.7–97.8) and 100% (96.1–100). Calculated at the cut-offs that corresponded to a specificity of 95% and 97.5%, Roche had the highest sensitivity (85.0% (79.8–89.0) and 81.1% (76.6–85.7), p < 0.05 except vs. Abbott). Seroconversion occurred on average 2 days earlier for Roche total Ig anti-N and the three IgG anti-N assays (Abbott, Mikrogen, Euroimmun) than for the two IgG anti-S assays (Diasorin, Euroimmun) (≥50% seroconversion day 9–10 vs. day 11–12 and p < 0.05 for percent seropositive patients day 9–10 to 17–18). There was no significant difference in the IgG antibody time to seroconversion between critical and non-critical patients. Discussion Seroconversion occurred within 3 weeks after onset of symptoms with all assays and on average 2 days earlier for assays detecting IgG or total Ig anti-N than for IgG anti-S. The specificity of assays detecting anti-N was comparable to anti-S and excellent in a challenging control population.

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Section: Discussionmentioning

confidence: 99%

Antibody response against SARS-CoV-2 spike protein and nucleoprotein evaluated by four automated immunoassays and three ELISAs

Elslande

Decru

Jonckheere³

et al. 2020

Clinical Microbiology and Infection

Self Cite

148

132

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“…The selection of RDT products covered the different antigens used and had various regulatory approvals. Some of them were produced by reputable manufacturers and had been successfully validated in peer-reviewed studies [ 6 , 21 , 25 , 34 , 63 , 64 , 65 , 66 ] and approved by regulatory authorities (FDA EUA) and independent actors such as FIND [ 2 ]. In addition, the laboratory workflow was highly standardized and monitored.…”

Section: Discussionmentioning

confidence: 99%

“…This retrospective reference study was conducted by the WHO Collaborating Centre for HIV/AIDS Diagnostics and Laboratory Support and (re) emerging viral infections and malaria (BEL-27) at the Institute of Tropical Medicine (ITM), Belgium. COVID-19 Ab RDTs were selected based on design (LFA platform, visual reading), regulatory approval, independent product evaluations [ 33 , 34 ] and representation of different detecting antigens. A comparator enzyme immune assay detecting IgG and IgM antibodies was selected based on the low required sample volume (10 µL) and separate detection of IgG and IgM.…”

Section: Methodsmentioning

confidence: 99%

COVID-19 Antibody Detecting Rapid Diagnostic Tests Show High Cross-Reactivity When Challenged with Pre-Pandemic Malaria, Schistosomiasis and Dengue Samples

et al. 2021

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COVID-19 Antibody Detecting Rapid Diagnostic Tests (COVID-19 Ab RDTs) are the preferred tool for SARS-CoV-2 seroprevalence studies, particularly in low- and middle-income countries. The present study challenged COVID-19 Ab RDTs with pre-pandemic samples of patients exposed to tropical pathogens. A retrospective study was performed on archived serum (n = 94) and EDTA whole blood (n = 126) samples obtained during 2010–2018 from 196 travelers with malaria (n = 170), schistosomiasis (n = 25) and dengue (n = 25). COVID-19 Ab RDTs were selected based on regulatory approval status, independent evaluation results and detecting antigens. Among 13 COVID-19 Ab RDT products, overall cross-reactivity was 18.5%; cross-reactivity for malaria, schistosomiasis and dengue was 20.3%, 18.1% and 7.5%, respectively. Cross-reactivity for current and recent malaria, malaria antibodies, Plasmodium species and parasite densities was similar. Cross-reactivity among the different RDT products ranged from 2.7% to 48.9% (median value 14.5%). IgM represented 67.9% of cross-reactive test lines. Cross-reactivity was not associated with detecting antigens, patient categories or disease (sub)groups, except for schistosomiasis (two products with ≥60% cross-reactivity). The high cross-reactivity for malaria, schistosomiasis and—to a lesser extent—dengue calls for risk mitigation when using COVID-19 Ab RDTs in co-endemic regions.

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“…All human coronaviruses are associated with respiratory illnesses, ranging from mild common colds to more severe lower respiratory tract symptoms (23). Within 214 d after SARS-CoV-2 exposure, newly infected individuals may develop fever, fatigue, myalgia, and respiratory symptoms, including cough and shortness of breath (24).…”

mentioning

confidence: 99%

Genome-Wide B Cell, CD4+, and CD8+ T Cell Epitopes That Are Highly Conserved between Human and Animal Coronaviruses, Identified from SARS-CoV-2 as Targets for Preemptive Pan-Coronavirus Vaccines

Prakash

Srivastava

Coulon

et al. 2021

The Journal of Immunology

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Over the last two decades, there have been three deadly human outbreaks of coronaviruses (CoVs) caused by SARS-CoV, MERS-CoV, and SARS-CoV-2, which has caused the current COVID-19 global pandemic. All three deadly CoVs originated from bats and transmitted to humans via various intermediate animal reservoirs. It remains highly possible that other global COVID pandemics will emerge in the coming years caused by yet another spillover of a bat-derived SARS-like coronavirus (SL-CoV) into humans. Determining the Ag and the human B cells, CD4 1 and CD8 1 T cell epitope landscapes that are conserved among human and animal coronaviruses should inform in the development of future pan-coronavirus vaccines. In the current study, using several immunoinformatics and sequence alignment approaches, we identified several human B cell and CD4 1 and CD8 1 T cell epitopes that are highly conserved in 1) greater than 81,000 SARS-CoV-2 genome sequences identified in 190 countries on six continents; 2) six circulating CoVs that caused previous human outbreaks of the common cold; 3) nine SL-CoVs isolated from bats; 4) nine SL-CoV isolated from pangolins; 5) three SL-CoVs isolated from civet cats; and 6) four MERS strains isolated from camels. Furthermore, the identified epitopes: 1) recalled B cells and CD4 1 and CD8 1 T cells from both COVID-19 patients and healthy individuals who were never exposed to SARS-CoV-2, and 2) induced strong B cell and T cell responses in humanized HLA-DR1/HLA-A*02:01 double-transgenic mice. The findings pave the way to develop a preemptive multiepitope pancoronavirus vaccine to protect against past, current, and future outbreaks.

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Comparison of the diagnostic performance with whole blood and plasma of four rapid antibody tests for SARS-CoV-2

Cited by 13 publications

References 6 publications

Antibody response against SARS-CoV-2 spike protein and nucleoprotein evaluated by four automated immunoassays and three ELISAs

Antibody response against SARS-CoV-2 spike protein and nucleoprotein evaluated by four automated immunoassays and three ELISAs

COVID-19 Antibody Detecting Rapid Diagnostic Tests Show High Cross-Reactivity When Challenged with Pre-Pandemic Malaria, Schistosomiasis and Dengue Samples

Genome-Wide B Cell, CD4+, and CD8+ T Cell Epitopes That Are Highly Conserved between Human and Animal Coronaviruses, Identified from SARS-CoV-2 as Targets for Preemptive Pan-Coronavirus Vaccines

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