Table 6.
Comparision of Major Diagnostics approved for Patient-Care settings for COVID-19 with FDA-EUA Approval.
| Manufacturer | Test | Test Type | SARS-CoV-2 Gene Biomarkers | Sample Accepted | Time to Result | Sensitivity/Specificity | References |
|---|---|---|---|---|---|---|---|
| Mesa Biotech | Accula SARS-CoV-2 Test | RT-PCR | N | Throat swab, Nasal swab | ~30 min | 100% (30/30)/100% (30/30) | https://www.mesabiotech.com/coronavirus |
| Abbott | ID NOW COVID-19 test | Isothermal DNA amplifciation | RdRp | NP swab, OP swab | <13 min | 2X LOD (100%, 20/20)5X LOD (100%, 20/20)/100% (30/30) | https://www.alere.com/en/home/product-details/id-now-covid-19.html |
| Cepheid | Xpert Xpress SARS-CoV-2 test for use on GeneXpert Xpress System | RT-PCR | N2, E | NP swab, Nasal swab, mid-turbinate swabs, OP swab | ~40 min | 100% (30/30)/100% (35/35) | https://www.cepheid.com/coronavirus |
| Cue Health | Cue COVID-19 Test | Isothermal DNA amplification | N | Nasal swabs | ~20 min | 1-2X LoD (19/20, 95%) 5X LoD (4/4, 100%) 10X LoD (4/4100%) 50X LoD (2/2100%)/30/30,100% | https://www.cuehealth.com/covid-19 |