TABLE 2.
FDA‐approved gold nanoparticle‐based serology tests for SARS‐CoV‐2 under EUA designation (as of January 17, 2021)
| Diagnostic | Manufacturer | Antibody/assay format | Sample | Authorized setting(s) a |
|---|---|---|---|---|
| COVID‐19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | Healgen Scientific LLC | IgM and IgG, lateral flow | Serum, plasma, and venous whole blood | H, M |
| qSARS‐CoV‐2 IgG/IgM Rapid Test | Cellex Inc. | IgM and IgG, lateral flow | Serum, plasma, and venipuncture whole blood | H, M |
| WANTAI SARS‐CoV‐2 Ab Rapid Test | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | Total antibody, lateral flow | Serum, plasma, and venous whole blood | H, M |
| Rapid COVID‐19 IgM/IgG Combo Test Kit | Megna Health, Inc. | IgM and IgG, lateral flow | Serum and plasma | H, M |
| Tell Me Fast Novel Coronavirus (COVID‐19) IgG/IgM Antibody Test | Biocan Diagnostics | IgM and IgG, lateral flow | Serum, plasma, and venous whole blood | H, M |
| TBG SARS‐CoV‐2 IgG / IgM Rapid Test Kit | TBG Biotechnology | IgM and IgG, lateral flow | Serum and plasma | H, M |
| SGTi‐flex COVID‐19 IgG | Sugentech | IgG, lateral flow | Serum, venous whole blood, and plasma | H, M |
| Assure COVID‐19 IgG/IgM Rapid Test Device | Assure Tech. (Hangzhou) | IgM and IgG, lateral flow | Serum, plasma, venous whole blood, and fingerstick whole blood | H, M, W |
| MosaiQ COVID‐19 Antibody Magazine | Quotient Suisse SA | Total Antibody, photometric immunoassay | Serum and plasma | H |
| Nirmidas COVID‐19 (SARS‐CoV‐2) IgM/IgG Antibody Detection Kit | Nirmidas Biotech | IgM and IgG, lateral flow | Serum and plasma | H, M |
| Biohit SARS‐CoV‐2 IgM/IgG Antibody Test Kit | Biohit Healthcare (Hefei) | IgM and IgG, lateral flow | Serum, plasma, and venipuncture whole blood | H, M |
| CareStart COVID‐19 IgM/IgG | Access Bio | IgM and IgG, lateral flow | Serum, plasma, and venous whole blood | H, M |
| BIOTIME SARS‐CoV‐2 IgG/IgM Rapid Qualitative Test | Xiamen Biotime Biotechnology | IgM and IgG, lateral flow | Serum, plasma, and venous whole blood | H, M |
| Jiangsu Well Biotech | Orawell IgM/IgG Rapid Test | IgM and IgG, lateral flow | Serum and plasma | H, M |
| Innovita 2019‐nCoV Ab Test | Innovita (Tangshan) Biological Technology | IgM and IgG, lateral flow | Serum, plasma, and venous whole blood | H, M |
| RightSign COVID‐19 IgG/IgM Rapid Test Cassette | Hangzhou Biotest Biotech | IgM and IgG, lateral flow | Serum, plasma, venous whole blood, and fingerstick whole blood | H, M, W |
| ACON SARS‐CoV‐2 IgG/IgM Rapid Test | ACON Laboratories | IgM and IgG, lateral flow | Serum, plasma, and venous whole blood | H, M |
| LYHER Novel Coronavirus (2019‐nCoV) IgM/IgG Antibody Combo Test Kit | Hangzhou Laihe Biotech | IgM and IgG, lateral flow | Serum and plasma | H, M |
| MidaSpot COVID‐19 Antibody Combo Detection Kit | Nirmidas Biotech | IgM and IgG, lateral flow | Fingerstick whole blood, serum, and plasma | H, M, W |
| Sienna‐Clarity COVIBLOCK COVID‐19 IgG/IgM Rapid Test Cassette | Salofa Oy | IgM and IgG, Lateral Flow | Fingerstick whole blood | H, M, W |
| RapCov Rapid COVID‐19 Test | ADVAITE | IgG, Lateral Flow | Fingerstick whole blood | H, M, W |
Abbreviation: EUA, Emergency Use Authorization.
a
Authorized settings include the following: H—Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests. M—Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests. W—Patient care settings operating under a CLIA Certificate of Waiver.