TABLE 4.
Basic performance characteristics of three sample-to-answer EUA molecular SARS-CoV-2 assays evaluateda
| Characteristic | Xpert Xpress SARS-CoV-2 | ID NOW COVID-19 | ePlex SARS-CoV-2 |
|---|---|---|---|
| Manufacturer | Cepheid | Abbott | GenMark |
| Sample type(s) | NPS, NS, midturbinate swab, nasal wash, nasal aspirate | NPS, NS, TS | NPS |
| Sample vol required (μl) | 300 | 200 | 200 |
| Extraction required | Yes (automated) | No | Yes (automated) |
| Detection platform/system | GeneXpert, Xpress, Infinity | ID NOW | ePlex |
| Target region of SARS-CoV-2 | N2, E | RdRp | N |
| Analytical sensitivity per claim | 250 copies/ml | 125 genome equivalents/ml | 100,000 RNA transcript copies/ml |
| Maximum throughput | 4 per instrument (4-module configuration) | 1 per instrument | 6 per tower |
| Hands-on time (per specimen) | ∼1 min | ∼2 min | ∼2 min |
| Assay run time | ∼45 min | <15 min | ∼90 min |
| User results interpretation | No | No | No |
| Overall turnaround time (per specimen) | ∼46 min | ∼17 min | ∼1.5 h |
a
NPS, nasopharyngeal swab; NS, nasal swab; TS, throat swab.