Clinical evaluation of commercial SARS-CoV-2 serological assays in a malaria endemic setting
Year: 2023
Type: article
Study design: Observational Study
Abstract: The levels of immune response to SARS-CoV-2 infection or vaccination are poorly understood in African populations and is complicated by cross-reactivity to endemic pathogens as well as differences in host responsiveness. To begin to determine the best approach to minimize false positive antibody levels to SARS-CoV-2 in an African population, we evaluated three commercial assays, namely Bio-Rad Platelia SARS-CoV-2 Total Antibody (Platelia), Quanterix Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test (anti-Spike), and the GenScript cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit (cPass) using samples collected in Mali in West Africa prior to the emergence of SARS-CoV-2. A total of one hundred samples were assayed. The samples were categorized in two groups based on the presence or absence of clinical malaria. Overall, thirteen out of one hundred (13/100) samples were false positives with the Bio-Rad Platelia assay and one of the same one hundred (1/100) was a false positive with the anti-Spike IgG Quanterix assay. None of the samples tested with the GenScript cPass assay were positive. False positives were more common in the clinical malaria group, 10/50 (20%) vs. the non-malaria group 3/50 (6%); p = 0.0374 using the Bio-Rad Platelia assay. Association between false positive results and parasitemia by Bio-Rad remained evident, after adjusting for age and sex in multivariate analyses. In summary, the impact of clinical malaria on assay performance appears to depend on the assay and/or antigen being used. A careful evaluation of any given assay in the local context is a prerequisite for reliable serological assessment of anti-SARS-CoV-2 humoral immunity.
Source: Journal of Immunological Methods
Authors: Djeneba Dabitao, Kathryn Shaw-Saliba, Drissa S. Konate, Helene C. Highbarger, Perrine Lallemand, Ibrahim Sanogo, Tauseef Rehman, Mamadou Wague, Nadie Coulibaly, Bourahima Kone, Bocar Baya, Seidina A.S. Diakite, Seydou Samake, Esther Akpa, Moctar Tounkara, Sylvain Laverdure, Seydou Doumbia, H. Clifford Lane, Mahamadou Diakite, Robin L. Dewar
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,520
Funders: U.S. Department of Health and Human Services, Frederick National Laboratory for Cancer Research, Leidos, National Institutes of Health, Office of the Director, NIH Office of the Director, National Cancer Institute, National Institute of Allergy and Infectious Diseases, Fogarty International Center, Office of Research on Women's Health
Awards: G1079592143, The Role of Sex Steroid Hormones in CD4+ T Cell-mediated Immune Responses to Tuberculosis, G2511952497, G2530353047, G3756319201, G3817188917, G5643061932, G6012682559, G6336093431, G8882569155, G9000250571, Mali-Guinea Research Leadership Training Program for Sustainable control and elimination of Malaria and Neglected tropical diseases
OpenAlex ID: W4376129752