TY - JOUR
T1 - Highly sensitive and specific SARS-CoV-2 serological assay using a magnetic modulation biosensing system
AU - Avivi-Mintz, Shira
AU - Lustig, Yaniv
AU - Indenbaum, Victoria
AU - Schwartz, Eli
AU - Danielli, Amos
N1 - Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2022/1
Y1 - 2022/1
N2 - Sensitive serological assays are needed to provide valuable information about acute and past viral infections. For example, detection of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibodies could serve as the basis for an “immunity passport” that would enable individuals to travel internationally. Here, utilizing a novel Magnetic Modulation Biosensing (MMB) system and the receptor-binding domain of the SARS-CoV-2 spike protein, we demonstrate a highly sensitive and specific anti-SARS-CoV-2 IgG serological assay. Using anti-SARS-CoV-2 IgG antibodies, RT-qPCR SARS-CoV-2-positive and healthy patients’ samples, and vaccinees’ samples, we compare the MMB-based SARS-CoV-2 IgG assay’s analytical and clinical sensitivities to those of the enzymelinked immunosorbent assay (ELISA). Compared with ELISA, the MMB-based assay has an ~6-fold lower limit of detection (129 ng/L vs. 817 ng/L), and it detects an increase in the IgG concentration much earlier after vaccination. Using 85 RT-qPCR SARS-CoV-2-positive samples and 79-negative samples, the MMB-based assay demonstrated similar clinical specificity (98% vs. 99%) and sensitivity (93% vs. 92%) to the ELISA test, but with a much faster turnaround time (45 min vs. 245 min). The high analytical and clinical sensitivity, short turnaround time, and simplicity of the MMB-based assay makes it a preferred method for antibody detection.
AB - Sensitive serological assays are needed to provide valuable information about acute and past viral infections. For example, detection of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) IgG antibodies could serve as the basis for an “immunity passport” that would enable individuals to travel internationally. Here, utilizing a novel Magnetic Modulation Biosensing (MMB) system and the receptor-binding domain of the SARS-CoV-2 spike protein, we demonstrate a highly sensitive and specific anti-SARS-CoV-2 IgG serological assay. Using anti-SARS-CoV-2 IgG antibodies, RT-qPCR SARS-CoV-2-positive and healthy patients’ samples, and vaccinees’ samples, we compare the MMB-based SARS-CoV-2 IgG assay’s analytical and clinical sensitivities to those of the enzymelinked immunosorbent assay (ELISA). Compared with ELISA, the MMB-based assay has an ~6-fold lower limit of detection (129 ng/L vs. 817 ng/L), and it detects an increase in the IgG concentration much earlier after vaccination. Using 85 RT-qPCR SARS-CoV-2-positive samples and 79-negative samples, the MMB-based assay demonstrated similar clinical specificity (98% vs. 99%) and sensitivity (93% vs. 92%) to the ELISA test, but with a much faster turnaround time (45 min vs. 245 min). The high analytical and clinical sensitivity, short turnaround time, and simplicity of the MMB-based assay makes it a preferred method for antibody detection.
KW - COVID-19
KW - Fluorescence-based assay
KW - Magnetic modulation
KW - Optical biosensing
KW - SARS-CoV-2
KW - Serology
UR - http://www.scopus.com/inward/record.url?scp=85121592789&partnerID=8YFLogxK
U2 - 10.3390/bios12010007
DO - 10.3390/bios12010007
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C2 - 35049635
AN - SCOPUS:85121592789
SN - 2079-6374
VL - 12
JO - Biosensors
JF - Biosensors
IS - 1
M1 - 7
ER -
