Table 2.
Selected FDA EUA authorized Lab-based ELISA tests for COVID-19 detection [44].
| Manufacture | Test | Target Antigen | Antibody | Technique | Sensitivity | Specificity |
|---|---|---|---|---|---|---|
| Mount Sinai Laboratory | Mt. Sinai Laboratory COVID-19 ELISA Antibody Test | Full length S antigen | IgG | High Throughput 2-Step direct ELISA | 92.5% | 100% |
| InBios International, Inc. | SCoV-2 Detect IgG ELISA | SARS-CoV-2 S antigen | IgG | High Throughput ELISA | 100% | 100% |
| InBios International, Inc. | SCoV-2 Detect IgM ELISA | S antigen | IgM | High Throughput ELISA | 96.7% | 98.8% |
| Siemens Healthcare Diagnostics | Dimension Vista SARS-CoV-2 Total antibody assay (COV2T) | S antigen | Total Antibody | Fully automated, fvfRapid High Throughput ELISA (10 min for one result, 440 assays per hour) | 100% | 99.8% |
| Quanterix Corporation | Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test | S antigen | IgG | High Throughput, Automated Paramagnetic Microbead-based Sandwich ELISA. 96 tests in 2 h and 45 min | 100% (LoD: 0.77 µg/mL) | 99.2% |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | WANTAI SARS-CoV-2 Ab ELISA | S antigen (RBD domain) | IgG | High Throughput ELISA | 96.7% | 97.5% |
| Emory Medical Laboratories | SARS-CoV-2 RBD IgG test | S antigen (RBD domain) | IgG | High Throughput ELISA | 100% | 96.4% |
| Siemens Healthcare Diagnostics | Dimension EXL SARS-CoV-2 Total antibody assay (CV2T) | S antigen (RBD domain) | Total Antibody | High Throughput ELISA | 100% | 99.9% |
| GenScript USA Inc. | cPass SARS-CoV-2 Neutralization Antibody Detection Kit | S antigen (RBD domain) | Total Neutralizing Antibodies | High Throughput Blocking ELISA (92 samples in 1 h) | 100% | 100% |
| EUROIMMUN US Inc. | Anti-SARS-CoV-2 ELISA | S antigen (S1 subunit) | IgG | High Throughput ELISA | 90.0% | 100% |
| Luminex Corporation | xMAP SARS-CoV-2 Multi-Antigen IgG Assay | S antigen (S1 subunit and RBD domain) and N antigen | IgG | Multiplex, microsphere-based and high-throughput FMIA (96 samples per run in each 3 h) | 100% | 99.2% |
| Bio-Rad Laboratories, Inc. | Platelia SARS-CoV-2 Total Ab assay | Recombinant N antigen | Total Antibody | High Throughput Semi-quantitative ELISA | 92.2% | 99.6% |
| Wadsworth Center, New York State Department of Health | New York SARS-CoV Microsphere Immunoassay for Antibody Detection | N antigen | Total Antibody | High Throughput MIA (FMIA) | 88.0% | 98.8% |