Table 3.
Limit of Detection Determination Using Serial Dilutions of a Positive Specimen in Replicates
| Concentration, copies/reaction |
Replicates, n | Passing genomes∗ | % Passing† | |
|---|---|---|---|---|
| RT-qPCR | RT-ddPCR | |||
| 698.0 | 1080.7 | 4 | 4 | 100 |
| 309.1 | 599.0 | 20 | 20 | 100 |
| 157.5 | 287.0 | 20 | 20 | 100 |
| 82.0 | ND | 20 | 20 | 100 |
| 51.1 | ND | 20 | 19 | 95 |
| 14.8 | ND | 5 | 4 | 80 |
| 7.9 | ND | 5 | 2 | 40 |
ND, not determined; RT-ddPCR, reverse transcription digital droplet PCR; RT-qPCR, quantitative RT-PCR.
∗
Number of genomes satisfying all acceptability criteria.
†
Percentage of genomes satisfying all acceptability criteria.