Abstract
Severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has been identified as the causative agent of COVID-19. Accurate detection of SARS-CoV-2 infection is not only important for management of infected individuals but also to break the chain of transmission. Although the polymerase chain reaction (PCR) is the gold standard for diagnosis of acute SARS-CoV-2 infection, there are a number of limitations of these assays, which include the inability to detect past infection and decline in sensitivity 14 days post-symptom onset. There are several serology tests developed for the detection of SARS-CoV-2 antibodies including high-throughput serology platforms and lateral flow immunoassays. These tests should be evaluated for their performance to meet local regulations acceptance criteria. To optimize the diagnostic algorithm for SARS-CoV-2, this protocol describes the evaluation of serological antibody testing using various automated serology platforms and lateral flow immunoassays. This protocol was evaluated in both serum and plasma samples. The sample preparation, procedure, and data analysis are described. The protocol can be adapted for any serological testing.
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Acknowledgments
We would like to acknowledge staff members from the Department of Immunology, National Health Laboratory Service, Braamfontein.
Funding
Validation studies were funded as follows: sample collection was supported through a grant provided by the Bill and Melinda Gates Foundation iLEAD grant OPP1171455 awarded to Professors Wendy Stevens and Lesley Scott; and sample storage and processing was partially supported by an NIH grant number 5U24HG007438-09 awarded to Professor Elizabeth Mayne.
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Gededzha, M.P. et al. (2022). Evaluation Protocol for SARS-CoV-2 Serological Assays. In: Guest, P.C. (eds) Multiplex Biomarker Techniques. Methods in Molecular Biology, vol 2511. Humana, New York, NY. https://doi.org/10.1007/978-1-0716-2395-4_23
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DOI: https://doi.org/10.1007/978-1-0716-2395-4_23
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