Table 2.
Description of the SARS-CoV-2 serological assays and the test codes used in this study.
| Test Code | Manufacturer | Kit Name | Antigen/Target | Catalogue number | Company reported assay specificity |
|---|---|---|---|---|---|
| A | Mikrogen Diagnostik GmbH, Germany* | recomWell SARS-CoV-2 IgG ELISA kit | Nucleocapsid protein | 7304 | IgG: 98.7% |
| B | Epitope Diagnostics, Inc., San Diego, USA | EDI Novel Coronavirus COVID-19 IgG ELISA Kit | Nucleocapsid protein | KT-1032 | IgG: 100% |
| C | Jiangsu Medomics medical technology Co., Ltd, China | Rapid IgM-IgG combined Antibody Test Kit for SARS-CoV-2 (ICA) | Spike protein (RBD MK201027) |
201030 | Not specified |
| D | Salafa Oy, Salo, Finland | Salacor (Biohit) SARS-CoV-2 IgG/IgM rapid test kit | Nucleocapsid protein | COV-01-S | IgM: 99.2% IgG: 99.9% |
| E | Salafa Oy, Salo, Finland | Sienna SARS-CoV-2 IgG/IgM rapid test kit | Spike protein (RBD) | 102222 | IgM: 100% IgG: 98.8% |
| F | Liming Bio-Products Co., Ltd. Jiangsu, China | StrongStep_SARS-CoV-2 IgM/IgG_REF502090_ Antibody Rapid Test | Nucleocapsid and Spike protein | 502090 | IgM: 100% IgG: 98,7% |
| G | Zhejiang Orient Gene Biotech Co., Ltd. (China) | COVID-19 IgG/IgM Rapid Test Cassette alt. HEALGEN_ COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma_REF GCCOV-402a |
Nucleocapsid and Spike protein (25)^ | GCCOV-402a | IgM: 98.46% IgG: 98.46% |
| H | InTec Products inc., Haicang Xiamen, China | INTEC_ Colloidal Gold (whole blood/Serum/Plasma) Rapid SARS-CoV-2 Antibody (IgM/IgG) | Nucleocapsid protein (25) | ITP16001-TC25 | Combined IgM+IgG: 98% |
| I | Sugentech Inc., South Korea* | SGTi-flex COVID-19 IgM/IgG | Nucleocapsid and Spike protein^ | COVT025E | IgM: 98.3% (90% FDA August 2020) IgG:100% |
| J | Xiamen Biotime Biotechnology Co., Ltd. China | SARS-CoV2 IgG/IgM Rapid Qualitative Test | Spike protein^ | BT1301 | Not specified |
| K | Zhuhai Livzon Diagnostics Inc. (China) | COVID-19 IgG/IgM Lateral flow Rapid Test Cassette | Nucleocapsid protein | Not specified | IgM: 99.7% IgG: 99.4% |
| L | Abbott Point of Care Inc. USA* | Panbio COVID-19 lgG/lgM Rapid Test Device | Nucleocapsid protein (26) | ICO -T402 | IgM: 92.8% IgG: 92.8% |
| M | SureScreen Diagnostics Ltd, UK | SureScreen Diagnostics COVID-19 IgG/IgM Rapid Test Cassette (Whole blood/serum/Plasma) | Spike protein/RBD | COVID19C | IgM: 99.2% IgG: 99.2% |
| N | Wuhan Easy Diagnosis Biomedicine Co., Ltd (China)* | COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test kit | Not specified | SA-2-D | IgM: 100% IgG: 100% |
| O | Zhuhai Encode Medical Engineering Co., Ltd., China* | SARS-CoV-2 IgG/IgM Rapid test | S1-RBD and nucleocapsid protein | RCD-422 | IgM: 100% IgG: 100% |
| P | Jiangsu SuperbioBiomedical Co., Ltd, China | SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) | Spike and nucleocapsid protein^ | B00502 | IgG: 95.8% IgM: 95.8% |
| Q | Lumigenex (Suzhou) Co., Ltd. China | Lumigenex SARS-CoV-2 IgG/IgM Antibody Rapid Test Kit | Spike and nucleocapsid protein | Not specified | Not specified |
| R | Wondfo, Guangzhou, China | Wondfo Biotech SARS-CoV-2 Antibody Test | Not specified | W195 | Combined: IgM+IgG:99.57% |
| S | Innovita (Tangshan) Biological Technology Co Ltd China* | 2019-nCoV Ab Test (Colloidal Gold) | Spike and Nucleocapsid protein^ | Not specified | IgM: 100% IgG: 100% |
^Emergency Use Authorization (EUA) Serology Test Performance | Food and Drug Administration (FDA).
*Stated in the instructions to have tested interference with RA and/or RF or other autoantibodies.
As of January 2021 tests C, G, I, K, N, O, P are not FDA approved.
For updated status of assays visit https://www.finddx.org/covid-19/pipeline.