Table 2a.
Number of tested samples and performance of the Novodiag® Covid-19 assay and the Xpress® SARS-CoV-2 assay in the initial evaluation.
| Reference | Novodiag® Covid-19 |
Xpert Xpress® SARS-CoV-2 |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pos | Neg | Inv | Total | Agr | Sens (95% CI) |
Spec (95% CI) |
Pos | Neg | Inv | Total | Agr | Sens (95% CI) |
Spec (95% CI) |
||
| LDT | Pos | 29 | 0 | 0 | 29 | 100% | 28 | 0 | 0 | 28 | 100% | ||||
| Neg | 0 | 26 | 0 | 26 | 100% | 0 | 11 | 0 | 11 | 100% | |||||
| cobas® SARS-CoV2 | Pos | 19 | 4 | 0 | 23 | 82% | 23 | 0 | 0 | 23 | 100% | ||||
| Neg | 0 | 7 | 1 | 8 | 89% | 0 | 7 | 0 | 7 | 100% | |||||
| Amplidiag® COVID-19 | Pos | 9 | 0 | 0 | 9 | 100% | 9 | 0 | 0 | 9 | 100% | ||||
| Neg | 0 | 12 | 0 | 12 | 100% | 0 | 12 | 0 | 12 | 100% | |||||
| Total | Pos | 57 | 4 | 0 | 61 | 92% | 60 | 0 | 0 | 60 | 100% | ||||
| Neg | 0 | 45 | 1 | 46 | 98% | 0 | 30 | 0 | 30 | 100% | |||||
| Total | 57 | 49 | 1 | 107 | 93.4 (84.3-97.4) |
100.0 (92.1-100) |
60 | 30 | 0 | 90 | 100.0 (94.0-100) |
100.0 (88.6-100) |
|||
LDT; laboratory developed test; Pos, positive; Neg, negative, Inv, invalid; Agr, agreement; Sens, sensitivity; Spec, specificity; CI, confidence interval.