TABLE 1.
Intra-assay and interassay precision (%CV) and accuracy (%DEV) results for rifapentine and desacetyl-rifapentine quality control samples prepared in plasma and in whole-blood dried blood spots
| QC levela | Intra-assay precision and accuracy |
Interassay precision and accuracy |
||||||
|---|---|---|---|---|---|---|---|---|
| Mean (ng/ml) | SD (ng/ml) | %CV | %DEV | Mean (ng/ml) | SD (ng/ml) | %CV | %DEV | |
| RPT | ||||||||
| DBS | ||||||||
| LLOQ | 53.5 | 3.46 | 6.47 | 6.96 | 51.3 | 3.48 | 6.78 | 2.63 |
| Low | 158 | 5.15 | 3.26 | 5.33 | 155 | 9.65 | 6.23 | 3.33 |
| Medium | 2,644 | 94.5 | 3.57 | 5.76 | 2,625 | 95.7 | 3.64 | 5.01 |
| High | 70,100 | 3,979 | 5.68 | 0.14 | 70,367 | 6,706 | 9.53 | 0.52 |
| Plasma | ||||||||
| LLOQ | 56.6 | 4.47 | 7.88 | 13.3 | 53.6 | 4.64 | 8.66 | 7.19 |
| Low | 136 | 3.73 | 2.75 | −9.67 | 133 | 5.92 | 4.45 | −11.3 |
| Medium | 2,475 | 187 | 7.57 | −1.00 | 2,516 | 136 | 5.41 | 0.64 |
| High | 73,533 | 2,183 | 2.97 | 5.05 | 74,306 | 3,141 | 4.23 | 6.15 |
| desRPT | ||||||||
| DBS | ||||||||
| LLOQ | 49.8 | 2.77 | 5.56 | −0.32 | 47.1 | 4.32 | 9.19 | −5.89 |
| Low | 149 | 6.78 | 4.55 | −0.67 | 146 | 8.66 | 5.94 | −2.80 |
| Medium | 2,424 | 65.8 | 2.71 | −3.04 | 2,424 | 97.8 | 4.04 | −3.04 |
| High | 70,220 | 6,491 | 9.24 | 0.31 | 69,420 | 7,175 | 10.3 | −0.83 |
| Plasma | ||||||||
| LLOQ | 51.4 | 3.55 | 6.91 | 2.70 | 52.9 | 4.47 | 8.46 | 5.70 |
| Low | 136 | 4.62 | 3.39 | −9.22 | 137 | 14.8 | 10.8 | −8.41 |
| Medium | 2,685 | 99.1 | 3.69 | 7.40 | 2,601 | 131 | 5.04 | 4.02 |
| High | 72,717 | 2,651 | 3.65 | 3.88 | 72,911 | 3,258 | 4.47 | 4.16 |
a
The quality control (QC) levels are defined as follows: LLOQ, 50 ng/ml; low, 150 ng/ml; medium, 2,500 ng/ml; and high, 70,000 ng/ml. RPT, rifapentine; DBS, dried blood spots; desRPT, desacetyl-rifapentine.