Table 1.
Analytical sensitivity of Quidel SARS Antigen FIA test using dilution of a pooled positive.
| Sample Dilution | Initial Replicates Detected | Initial% Positive | Confirmatory Replicates Detected | Copies/mL (ddPCR) | Copies/swab (ddPCR) | Copies/mL (Cobas 6800) | Copies/swab (Cobas 6800) |
|---|---|---|---|---|---|---|---|
| Neat | 3/3 | 100% | 1.10E+07 | 5.50E+05 | 8.66E+06 | 1.73E+05 | |
| 1:9 | 3/3 | 100% | 20/20 | 1.22E+06 | 6.11E+04 | 9.62E+05 | 4.81E+04 |
| 1:10 | 3/3 | 100% | 12/20 | 1.10E+06 | 5.50E+04 | 8.66E+05 | 4.33E+04 |
| 1:20 | 0/3 | 0% | 5.50E+05 | 2.75E+04 | 4.33E+05 | 8.66E+03 | |
| 1:30 | 0/3 | 0% | 3.67E+05 | 1.83E+04 | 2.89E+05 | 5.77E+03 | |
| 1:40 | 0/3 | 0% | 2.75E+05 | 1.38E+04 | 2.16E+05 | 4.33E+03 | |
| 1:50 | 0/3 | 0% | 2.20E+05 | 1.10E+04 | 1.73E+05 | 3.46E+03 | |
| 1:100 | 0/3 | 0% | 1.10E+05 | 5.50E+03 | 8.66E+04 | 1.73E+03 | |
| 1:1000 | 0/3 | 0% | 1.10E+04 | 5.50E+02 | 8.66E+03 | 4.81E+01 | |
| 1:10,000 | 0/3 | 0% | 1.10E+03 | 5.50E+01 | 8.66E+02 | 4.33E+01 | |
| 1:100,000 | 0/3 | 0% | 1.10E+02 | 5.50E+00 | 8.66E+01 | 8.66E+00 | |
| Pos Control | 6/6 | 100% | |||||
| Neg Control | 0/6 | 0% |