Table 3.
Commercially available COVID-19 antibody diagnostic tests by continent*
| Antibody test and company | Country | Sensitivity | Specificity | Days measured |
|---|---|---|---|---|
| North America | ||||
| RDT – Cellex | US | 93.8% | 95.6% | – |
| RDT – ChemBio | US | – | – | – |
| ELISA – Mount Sinai Laboratory | US | – | – | – |
| CI – Ortho-Clinical Diagnostics | US | – | – | – |
| RDT – Autobio Diagnostics | US | IgM, 95.7%; IgG, 99% | IgM, 99%; IgG, 99% | – |
| ELISA – DiaSorin | US | 90%–97% | 90% | 5–15 |
| CI – Abbott Laboratories | US | – | – | – |
| ELISA – Bio-Rad | US | 98% | 99% | – |
| Microsphere immunoassay – Wadsworth Center | US | – | 93–100% | – |
| Electro-CI – Roche | US | 0–6 days, 65.5%; 7–13 days, 88.1%; >14 days, 100% | 99.8% | 0–14 |
| ELISA – Euroimmun AG | US | 0–10 days, 13.9%; 11–20 days, 61.1%; <21 days, 100% | 100% | 0–21 |
| RDT – Healgen Scientific | US | IgM, 86.7%; IgG, 96.7%; IgM and IgG, 96.7% | IgM, 99%; IgG, 98%; IgM/IgG, 97% | – |
| CI – Siemens Health care Diagnostics | US | 0–6 days, 60.7%; 7–13 days, 97.5%; >14 days, 100% | 99.8% | 0–14 |
| CI – Siemens Health care Diagnostics | US | 0–6 days, 65.1%; 7–13 days, 97.5%; >14 days, 100% | 99.8% | 0–14 |
| Electro-CI – Roche Diagnostics | US | 84% | 63% | – |
| CI – Vibrant America Clinical Labs | US | 98.1% | 98.6% | – |
| CI – Babson Diagnostics | US | 8–14 days, 66.7%; >15 days, 100% | 100% | – |
| CI – Beckman Coulter | US | 0–7 days, 75%; 8–14 days, 95.3%; >15 days, 96.8% | 100% | – |
| ELISA – InBios International | US | 92.5% | 98.5% | 0–12 |
| CI – Diazyme Laboratories | US | 91.7% | 97.4% | – |
| ELISA – Mayo Clinic/Univ Minnesota | US | – | – | – |
| RDT – Advaite | US | 89% | 100% | – |
| RDT – Kabla Clinical Diagnostics | Mexico | IgM, 85%; IgG, 99.9% | IgM, 96%; IgG, 98% | – |
| Europe | ||||
| Multiplexed Immuno Refractive Assay – Quotient | Switzerland | 100% | 99.8% | – |
| RDT – Edinburgh Genetics | UK | 100% | 98.7% | – |
| ELISA – Euroimmun AG | Germany | 0–10 days, 13.9%; 11–20 days, 61.1%; >21 days, 100% | 100% | 0–21 |
| Asia | ||||
| NA – Singapore/ Wang Lab | Singapore | 90% | – | – |
| RDT – Aytu Biosciences/Orient Gene Biotech | China | IgM, 87.9%; IgG, 97.2% | IgM, 100%; IgG, 100% | – |
| Proprietary – ScanWell Health/INNOVITA | China | 87.3% | 100% | – |
| RDT – Ringbio | China | IgM, 89.4%; IgG, 97.9% | IgM, 97.7%; IgG, 97.7% | – |
| RDT – Cellex | China | 93.8% | 95.6% | – |
| RDT – Healgen Scientific | China | IgM, 86.7%; IgG, 96.7%; IgM/IgG, 96.7% | IgM, 99%; IgG, 98%; IgM/IgG, 97% | – |
| RDT – Hangzhou Biotest Biotech | China | IgM, 92.5%; IgG, 91.56% | IgM, 98.1%; IgG, 99.52% | 0–14 |
| RDT – Biohit Health care (Heifei) | China | 1–7 days: IgM, 33%; 8–14 days: IgM, 83%; IgG, 56.6%; >15 days, IgM, 97.7%; IgM, 96.2% | IgM, 99.46%; IgG,100% | 0–15 |
| RDT – Hangzhou Laihe Biotech | China | 0–6 days: IgM, 100%; IgG, 0%; 7–14 days: IgM, 85.7%; IgG, 76%; >14 days: IgM, 99.3%; IgG, 98.5% | 99.4% | 0–14 |
| RDT – Assure Biotech (Hangzhou) | China | 95.1% | 100% | – |
| RDT – Beijing Wantai Biological Pharmacy Enterprise | China | 94.7% | 98.9% | – |
*
Source: The Johns Hopkins Center for Health.12 Positive controls were COVID-19 patients with varying clinical severity in symptoms.
CI indicates chemiluminescent immunoassay; ELISA, enzyme-linked immunosorbent assay; NA, neutralization assay; RDT, rapid diagnostic test.