TABLE 2.
SARS-CoV-2 serology assay evaluations grouped by assay type and target antigen
| Evaluationsa | Lateral flow | ELISA | CIAb |
|---|---|---|---|
| Antibody Type | |||
| IgG | 75 | 4 | 2 |
| IgM | 72 | 2 | 0 |
| Pan-Ig | 1 | 3 | 1 |
| IgM/IgA | 1 | 0 | 0 |
| IgM/IgG | 2 | 0 | 0 |
| IgA | 0 | 1 | 0 |
| Target antigens | |||
| Spike | 11 | 5 | 1 |
| Nucleocapsid | 3 | 0 | 2 |
| Spike and nucleocapsid | 7 | 1 | 0 |
| Unknown | 57 | 4 | 0 |
91 total evaluations. Four assays (Zhuhai Livzon Diagnostics Inc. Livzon IgM/IgG Diagnostic kit for IgM/IgG Antibody to Coronavirus (SARS-Cov-2) Lateral Flow; BTNX Inc. COVID-19 IgG/IgM Test Cassettes; Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection kit; and Jiangsu Well Biotech Co., Ltd. COVID-19 IgM/IgG Rapid Test) were evaluated twice on two separate panels with either the same lot number of assays (n = 3) or a different lot number of the assay (n = 1). These assays were evaluated twice because they represented cases where PPA or NPA were below the recommended performance threshold.
Automated chemiluminescent immunoassays (CIA) is a general term used to describe a variety of automated clinical immunoassays, such as Abbott, Architect i1000 SARS-CoV-2 IgG; Roche Diagnostic Corporation, Elecsys Anti-SARS-CoV-2; and Ortho-Clinical Diagnostics, Inc., VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack.