Table 5.
Comparision of major serological assays for COVID-19 with FDA-EUA approval.
| Manufacturer | Test | Test Type | SARS-CoV-2 Biomarkers | Time to Result | Sensitivity/Specificity | References |
|---|---|---|---|---|---|---|
| Autobio Diagnostics | Anti-SARS-CoV-2 Rapid Test | Lateral flow immunoassay | IgG and IgM only against S protein | ~15 min | 99.0% (299/302)/99.04% (309/312) | https://www.cardinalhealth.com/en/cmp/ext/med/med-lab/hardy-diagnostics-autobio-anti-sars-cov-2-rapid-test.html |
| Cellex | qSARS-CoV-2 IgG/IgM Rapid Test | Lateral flow immunoassay | IgG and IgM only against S and N proteins | ~15–20 min | 93.8% (120/128)/96% (240/250) | https://cellexcovid.com/ |
| Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack | Chemi-luminescent immunoassay | Total antibody against S1 protein | ~50 min | 100% (49/49)/100% (400/400) | https://www.orthoclinicaldiagnostics.com/en-us/home/ortho-covid-19-answer |
| DiaSorin | LIAISON SARS-CoV-2 S1/S2 IgG | Chemi-luminescent immunoassay | IgG against S1/S2 protein | ~35 min | 97.56% (40/41) ≥ 15 days post-symptom onset/99.3% (1082/1090) | https://www.diasorin.com/en/node/11756/ |
| Abbott Laboratories | SARS-CoV-2 IgG Assay | Chemi-luminescent microparticle immunoassay | IgG only against N protein | ~30 min | 100% (88/88) ≥ 14 days post-symptom onset/99.63% (1066/1070) | https://www.corelaboratory.abbott/us/en/offerings/segments/infectious-disease/sars-cov-2 |
| Bio-Rad Laboratories | Platelia SARS-CoV-2 Total Ab assay | ELISA | Total antibody against N protein | ~100 min | 92.2% (47/51)/99.6% (684/687) | https://www.bio-rad.com/en-us/sku/72710-platelia-sars-cov-2-total-ab-assay?ID=72710 |
| Roche | Elecsys Anti-SARS-CoV-2 | Electrochemi-luminescence immunoassay | Total antibody against N protein | ~18 min | 100% (29/29) ≥14 days post-symptom onset/99.81% (5262/5272) | https://diagnostics.roche.com/us/en/products/params/elecsys-anti-sars-cov-2.html |
| Siemens Healthcare | Atellica IM SARS-CoV-2 Total (COV2T) | Chemi-luminescent microparticle immunoassay | Total antibody against RBD of S1 protein | ~10 min | 100% (42/42) 14 days post-symptom onset/99.8% (1089/1091) | https://www.siemens-healthineers.com/en-us/laboratory-diagnostics/assays-by-diseases-conditions/infectious-disease-assays/cov2t-assay |