Table 1.
Sensitivity, linearity, and precision results for the ART assay
| Specimen source | Nominal VL (log10 IU/ml)a | No. tested | No. detectable | Mean (SD) VL (log10 IU/ml) | CV (%) |
|---|---|---|---|---|---|
| Panelb | 0 | 3 | 0 | Target not detected | |
| 1.04 | 12 | 10 | <1.08c | ||
| 1.52 | 12 | 12 | 1.26 (0.17)d | 13.9 | |
| 2.20 | 12 | 12 | 1.63 (0.11) | 6.7 | |
| 2.79 | 9 | 9 | 2.21 (0.08) | 3.8 | |
| 3.67 | 9 | 9 | 3.23 (0.13) | 4.0 | |
| 4.71 | 9 | 9 | 4.29 (0.05) | 1.1 | |
| 5.28 | 9 | 9 | 4.81 (0.07) | 1.4 | |
| 5.72 | 9 | 9 | 5.29 (0.07) | 1.4 | |
| 6.73 | 9 | 9 | 6.38 (0.09) | 1.5 | |
| Patiente | 0.89 | 5 | 5 | <1.08c | |
| 1.89 | 5 | 5 | 1.66 (0.1) | 5.9 | |
| 2.89 | 5 | 5 | 2.65 (0.08) | 2.9 | |
| 3.89 | 5 | 5 | 3.68 (0.04) | 1.2 | |
| 4.89 | 5 | 5 | 4.68 (0.11) | 2.3 | |
| 5.89 | 5 | 5 | 5.72 (0.09) | 1.5 | |
| 6.89 | 3 | 3 | 6.61 (0.005) | 0.1 | |
| 7.89 | 5 | 5 | 7.89 (0.03) | 0.4 |
For the panel specimens, the assay-specific nominal VL (provided by the manufacturer) was used; for the patient dilution series, the reported nominal viral load is the mean of experimental values for undiluted replicates.
Specimens from the SeraCare panel (see Materials and Methods); nominal VL values are based on the manufacturer's results with the ART assay.
All results were above the limit of detection but below the limit of quantitation.
Mean of 7 results above the limit of quantitation.
Serial 10-fold dilutions of a patient specimen with a high viral load; the nominal VL was calculated by averaging all VL results (n = 5) from the undiluted specimen (7.89 log10 IU/ml) and adjusting for the dilution factor.