Table 4.
Clinical performance and workflow comparison between modified CDC SARS-CoV-2 assay and the commercial assays.
| A | ||||||||
|---|---|---|---|---|---|---|---|---|
| Commercial assays | Modified CDC SARS-COV-2 assay |
Ct ranges | Kappa (%) | PPA/NPA(%) | 95 % CI | |||
| Positive | Negative | Total | ||||||
| NeuMoDx | Positive | 67 | 0 | 67 | 10.04−40.07 | 100 | 100/100 | 96.9−100 |
| Negative | 0 | 49 | 49 | |||||
| Total | 67 | 49 | 116 | |||||
| DiaSorin | Positive | 22 | 0 | 22 | 12.00−36.10 | 100 | 100/100 | 91.8−100 |
| Negative | 0 | 21 | 21 | |||||
| Total | 22 | 21 | 43 | |||||
| B | |||
|---|---|---|---|
| *Workflow | Assays |
||
| Modified CDC | NeuMoDx | DiaSorin | |
| Hands-on | ∼45 min | ∼5min | ∼15 min |
| Extraction | ∼35 min | ∼1h20min | N/A |
| PCR | ∼90 min | ∼1h25min | |
| Overall TAT | ∼2h50min | ∼1h 25min | ∼1h40min |
| Max samples/run | 10 | 24 | 8 |
| **Throughput/8-h shift | ∼40 | ∼96 | ∼40 |
PPA: Positive percent agreement; NPA negative percent agreement; CI: confidence interval.
*
Workflow and overall turnaround time (TAT) is based on 8 samples per run.
**
Number of samples that can be resulted in an 8-h shift.