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Research article
Anwar M Hashem
Corresponding Author
ORCiD: https://orcid.org/0000-0002-8471-7011
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: The Coronavirus Disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several commercial SARS-CoV-2 rapid serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2 specific antibodies in COVID-19 patient samples.
Method: We have evaluated the performance of seven commercially available rapid lateral flow immunoassay (LFIA) serological assays obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2 specific IgG and IgM antibodies in COVID-19 patients.
Results: While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays in which it ranged from 0 to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54 to 88% for samples collected at later time points during infection (8-27 days post symptoms onset).
Conclusion: Commercially available LFIA assays for detection of SARS-CoV-2 specific antibodies may be specific and show high degree of variation in their sensitivity. Further evaluations and validation of rapid serological assays is needed before being routinely used in detecting IgM and IgG in COVID-19 patients.
Keywords
SARS-CoV-2, COVID-19, Rapid assay, Antibodies, Serology
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This is a preprint. It has not completed peer review.
Research article
Anwar M Hashem
Corresponding Author
ORCiD: https://orcid.org/0000-0002-8471-7011
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
Version 1
Posted 10 Jul, 2020
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Infectious Diseases
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: The Coronavirus Disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread globally. Although several commercial SARS-CoV-2 rapid serological assays have been developed, little is known about their performance and accuracy in detecting SARS-CoV-2 specific antibodies in COVID-19 patient samples.
Method: We have evaluated the performance of seven commercially available rapid lateral flow immunoassay (LFIA) serological assays obtained from different manufacturers, and compared them to in-house developed and validated ELISA assays for the detection of SARS-CoV-2 specific IgG and IgM antibodies in COVID-19 patients.
Results: While all evaluated LFIA assays showed high specificity, our data showed a significant variation in sensitivity of these assays in which it ranged from 0 to 54% for samples collected early during infection (3-7 days post symptoms onset) and from 54 to 88% for samples collected at later time points during infection (8-27 days post symptoms onset).
Conclusion: Commercially available LFIA assays for detection of SARS-CoV-2 specific antibodies may be specific and show high degree of variation in their sensitivity. Further evaluations and validation of rapid serological assays is needed before being routinely used in detecting IgM and IgG in COVID-19 patients.
Figure 1
Figure 2
Figure 3
Figure 4
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