Clinical evaluation of commercial SARS-CoV-2 serological assays in a malaria endemic setting

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

doi:10.1016/j.jim.2023.113488

Clinical evaluation of commercial SARS-CoV-2 serological assays in a malaria endemic setting

J Immunol Methods. 2023 Jun:517:113488. doi: 10.1016/j.jim.2023.113488. Epub 2023 May 11.

Authors

Djeneba Dabitao¹, Kathryn Shaw-Saliba², Drissa S Konate³, Helene C Highbarger⁴, Perrine Lallemand⁴, Ibrahim Sanogo³, Tauseef Rehman⁴, Mamadou Wague³, Nadie Coulibaly³, Bourahima Kone³, Bocar Baya³, Seidina A S Diakite³, Seydou Samake³, Esther Akpa², Moctar Tounkara³, Sylvain Laverdure⁵, Seydou Doumbia³, H Clifford Lane², Mahamadou Diakite³, Robin L Dewar⁴

Affiliations

¹ University Clinical Research Center (UCRC), Faculty of Pharmacy and Faculty of Medicine and Odonto-Stomatology, University of Sciences, Techniques, and Technologies of Bamako (USTTB), West Africa, Mali. Electronic address: ddabitao@icermali.org.
² Collaborative Clinical Research Branch (CCRB), Division of Clinical Research (DCR), National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, USA.
³ University Clinical Research Center (UCRC), Faculty of Pharmacy and Faculty of Medicine and Odonto-Stomatology, University of Sciences, Techniques, and Technologies of Bamako (USTTB), West Africa, Mali.
⁴ Virus Isolation and Serology Laboratory, Frederick National Laboratory (FNL), Frederick, Maryland, USA.
⁵ Laboratory of Human Retrovirology and Immunoinformatics, Frederick National Laboratory (FNL), Frederick, Maryland, USA.

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.

Keywords: Antibodies; COVID-19; Mali; Plasmodium falciparum; Validation.

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Antibodies, Viral
Biological Assay
Black People
COVID-19* / diagnosis
Humans
SARS-CoV-2*
Sensitivity and Specificity

Substances

Antibodies, Viral

Abstract

Publication types

MeSH terms

Substances

Grants and funding