Table 3.
Inter-test comparison of RdRP gene mean Ct values with standard deviations (SD) and coefficient of variation (CV) generated by all diagnostic approaches tested and difference between platform with highest (hi) and lowest (lo) individual test mean Ct value (Δ hi-lo) for respective concentration of 10 clinically relevant SARS-CoV-2 genomic variants altogether and separately.
| 1 × 104 [PFU/mL] |
1 × 103 [PFU/mL] |
1 × 102 [PFU/mL] |
1 × 101 [PFU/mL] |
1 × 100 [PFU/mL] |
1 × 10−1 [PFU/mL] |
||
|---|---|---|---|---|---|---|---|
| all variants | inter-assay mean Ct ± SD | 13.5 ± 1.5 | 16.9 ± 1.5 | 20.6 ± 1.6 | 24.2 ± 1.6 | 27.6 ± 1.7 | 30.9 ± 1.8 |
| Δ hi-lo | 5.7 | 6.5 | 6.6 | 6.8 | 7.2 | 7.6 | |
| inter-assay CV [%] | 11.1 | 8.9 | 7.8 | 6.6 | 6.2 | 5.8 | |
| B.1 | inter-assay mean Ct ± SD | 13.3 ± 1.8 | 16.1 ± 1.8 | 19.9 ± 1.8 | 23.7 ± 1.8 | 27.2 ± 2.1 | 30.4 ± 2.0 |
| Δ hi-lo | 5.0 | 5.5 | 5.3 | 4.9 | 6.0 | 5.1 | |
| inter-assay CV [%] | 13.5 | 11.2 | 9.0 | 7.6 | 7.7 | 6.6 | |
| B.1.258.17 | inter-assay mean Ct ± SD | 14.0 ± 1.7 | 17.4 ± 1.7 | 21.2 ± 2.0 | 24.9 ± 1.7 | 28.1 ± 2.1 | 31.7 ± 2.4 |
| Δ hi-lo | 4.8 | 5.0 | 5.9 | 4.9 | 5.4 | 6.7 | |
| inter-assay CV [%] | 12.1 | 9.8 | 9.4 | 6.8 | 7.5 | 7.6 | |
| A.27 | inter-assay mean Ct ± SD | 13.5 ± 1.5 | 16.5 ± 1.7 | 20.4 ± 1.8 | 23.5 ± 1.7 | 27.3 ± 1.7 | 30.5 ± 1.9 |
| Δ hi-lo | 4.6 | 4.7 | 5.0 | 4.7 | 5.1 | 5.2 | |
| inter-assay CV [%] | 11.1 | 10.3 | 8.8 | 7.2 | 6.2 | 6.2 | |
| Alpha | inter-assay mean Ct ± SD | 13.9 ± 1.3 | 17.3 ± 1.4 | 21.0 ± 1.6 | 24.5 ± 1.7 | 27.9 ± 1.6 | 31.2 ± 1.8 |
| Δ hi-lo | 3.8 | 4.3 | 5.1 | 5.3 | 4.9 | 5.7 | |
| inter-assay CV [%] | 9.4 | 8.1 | 7.6 | 6.9 | 5.7 | 5.8 | |
| Beta | inter-assay mean Ct ± SD | 13.4 ± 1.2 | 17.2 ± 1.4 | 20.4 ± 1.3 | 23.9 ± 1.3 | 27.3 ± 1.3 | 30.7 ± 1.3 |
| Δ hi-lo | 3.1 | 3.9 | 3.5 | 4.2 | 3.8 | 3.9 | |
| inter-assay CV [%] | 9.0 | 8.1 | 6.4 | 5.4 | 4.8 | 4.2 | |
| Gamma | inter-assay mean Ct ± SD | 13.2 ± 1.5 | 17.0 ± 1.0 | 20.5 ± 1.3 | 24.0 ± 1.1 | 27.7 ± 1.6 | 31.5 ± 1.7 |
| Δ hi-lo | 4.2 | 2.6 | 3.5 | 3.3 | 4.8 | 5.0 | |
| inter-assay CV [%] | 11.4 | 5.9 | 6.3 | 4.6 | 5.8 | 5.4 | |
| Delta | inter-assay mean Ct ± SD | 12.2 ± 0.9 | 15.5 ± 1.1 | 19.4 ± 1.3 | 22.9 ± 1.4 | 26.5 ± 1.4 | 29.6 ± 1.5 |
| Δ hi-lo | 2.4 | 2.8 | 3.6 | 3.8 | 4.0 | 4.0 | |
| inter-assay CV [%] | 7.4 | 7.1 | 6.7 | 6.1 | 5.3 | 5.1 | |
| Eta | inter-assay mean Ct ± SD | 13.2 ± 1.6 | 16.6 ± 1.5 | 20.7 ± 1.6 | 24.5 ± 1.7 | 28.1 ± 1.9 | 30.8 ± 1.1 |
| Δ hi-lo | 4.4 | 4.5 | 4.9 | 4.6 | 5.2 | 3.3 | |
| inter-assay CV [%] | 12.1 | 9.0 | 7.7 | 6.9 | 6.8 | 3.6 | |
| Iota | inter-assay mean Ct ± SD | 14.7 ± 1.3 | 17.9 ± 1.4 | 22.1 ± 1.3 | 25.8 ± 1.3 | 29.0 ± 1.2 | 32.7 ± 1.1 |
| Δ hi-lo | 3.5 | 3.6 | 3.7 | 4.0 | 3.2 | 3.0 | |
| inter-assay CV [%] | 8.8 | 7.8 | 5.9 | 5.0 | 4.1 | 3.4 | |
| Omicron | inter-assay mean Ct ± SD | 13.5 ± 1.4 | 17.2 ± 1.7 | 20.8 ± 1.7 | 24.0 ± 1.5 | 27.0 ± 1.8 | 29.8 ± 1.7 |
| Δ hi-lo | 4.0 | 4.9 | 5.4 | 4.8 | 5.6 | 5.1 | |
| inter-assay CV [%] | 10.4 | 9.9 | 8.2 | 6.3 | 6.7 | 5.7 |