1. A novel multiplex electrochemiluminescent immunoassay for detection and quantification of anti-SARS-CoV-2 IgG and anti-seasonal endemic human coronavirus IgG.
- Author
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Li, Fang Fang, Liu, Aaron, Gibbs, Ebrima, Tanunliong, Guadalein, Marquez, Ana Citlali, Gantt, Soren, Frykman, Hans, Krajden, Mel, Morshed, Muhammad, Prystajecky, Natalie A., Cashman, Neil, Sekirov, Inna, and Jassem, Agatha N.
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IMMUNOASSAY , *COVID-19 , *SURFACE plasmon resonance , *HUMORAL immunity , *POLYMERASE chain reaction , *IMMUNOGLOBULIN G - Abstract
• Meso Scale Diagnostics' V-PLEX Coronavirus Panel 2 IgG immunoassay allows for sensitive and specific detection of SARS-CoV-2 serostatus by a newly designed interpretative algorithm that can help distinguish recent infection vs. vaccine-induced/remote infection humoral responses. • Measurements of antibodies against HCoV-OC43 and HCoV-HKU1 are concordant with surface plasmon resonance imaging, another pan-coronavirus antibody detection technique. • Comparable performance in diagnosis of SARS-CoV-2 infection with chemiluminescent immunoassays currently approved for clinical use in Canada. Multiplex immunoassays capture a comprehensive profile of the humoral response against SARS-CoV-2 and human endemic coronaviruses. We validated a multiplex panel (V-PLEX Panel 2) from Meso Scale Diagnostics targeting antibodies against nine coronavirus antigens. Performance was compared against alternative single- and multi-antigen immunoassays. Sera collected for clinical or public health testing from 2018 to 2020 (n = 135) were used to compare all tested platforms, and inter-test agreement was assessed by Cohen's kappa coefficient. Sample category (positive/negative) was assigned based on collection date relative to the index case in Canada, and SARS-CoV-2 PCR and serology results. 117 out of the 135 samples (31 positive, 86 negative) were assigned a category and were used to calculate sensitivity and specificity, with MSD's test results based upon manufacturer-set cut-offs. We observed SARS-CoV-2 target sensitivities of 100% and specificities >94% for all antigens (RBD, Nucleocapsid, Spike) in V-PLEX Panel 2. When targets were combined, we found a SARS-CoV-2 sensitivity of 100% and specificity of 98.8% with no difference in performance compared to clinical assays, and Cohen's kappa ranging from 0.798 to 0.945 compared to surface plasmon resonance imaging (SPRi). Quantitative measurements of antibodies against the Spike protein of endemic human coronaviruses were concordant with SPRi. Meso Scale Diagnostics' V-PLEX Coronavirus Panel 2 allows for highly sensitive and specific detection of anti-coronavirus IgG, and is concordant with other serological assays for detection of antibodies against SARS-CoV-2 and the endemic human coronaviruses, making it a good tool for humoral response characterization after both infection and vaccination. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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