TABLE 2.
Summary of limit of detection results
| Molecular assay | Target region |
No. (%) of detected replicates at indicated dilution (copies/ml)a |
No. of copies/ml (95% CI)b |
||||||
|---|---|---|---|---|---|---|---|---|---|
| 2,000 | 1,000 | 500 | 100 | 50 | 5 | Probit | Final LoDc | ||
| Modified CDC | N1 | 4/4 (100) | 8/8 (100) | 7/10 (70) | 1/10 (10) | 0/8 (0) | 1/4 (25) | 779 ± 27 | 779 ± 27 |
| N2 | 4/4 (100) | 8/8 (100) | 10/10 (100) | 6/10 (60) | 3/8 (38) | 0/4 (0) | 356 ± 20 | ||
| DiaSorin Molecular | S | 1/1 (100) | 10/10 (100) | 10/10 (100) | 10/10 (100) | 8/8 (100) | 0/4 (0) | 39 ± 23 | 39 ± 23 |
| ORF1ab | 1/1 (100) | 10/10 (100) | 8/10 (80) | 4/10 (40) | 1/8 (13) | 0/4 (0) | 602 ± 28 | ||
| GenMark | N | 10/10 (100) | 9/9 (100) | 7/10 (70) | 1/10 (10) | 1/4 (25) | 0/4 (0) | NAd | 1,000 |
| Hologic | ORF1ab | 3/3 (100) | 9/9 (100) | 12/12 (100) | 12/12 (100) | 5/9 (56) | 0/6 (0) | 83 ± 36 | 83 ± 36 |
a
The limit of detection by positive rate for each assay is highlighted in bold.
b
95% CI, upper/lower (±) 95% confidence interval.
c
The final LoD data were determined on the basis of each manufacturer’s results interpretation algorithm.
d
NA, not applicable.