Table 3. Estimated assay lower limit of quantitation and percent recovery for type-specific anti-HPV concentrations of the reference serum.
| Series 1 | Series 2 | Estimated LLOQ | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Antigen | Expected Concentration (AU/mL) | Observed Concentration (AU/mL) | Percent Recovery | Intra-plate %CV | Inter-plate %CV | Expected Concentration (AU/mL) | Observed Concentration (AU/mL) | Percent Recovery | Intra-plate %CV | Inter-plate %CV | Signal | Concentration (AU/mL) |
| HPV16 E6 | 0.600 | 0.6953 | 116% | 7.1 | 16.8 | 0.120 | 0.0973 | 81% | 4.3 | 15.3 | 1000 | 0.0681 |
| 0.400 | 0.4141 | 104% | 4.8 | 16.8 | 0.080 | 0.0729 | 91% | 3.7 | 11.3 | |||
| 0.267 | 0.2765 | 104% | 3.2 | 12.9 | 0.053 | 0.0509 | 95% | 2.7 | 19.2 | |||
| 0.178 | 0.1623 | 91% | 4.9 | 25.9 | 0.036 | 0.0305 | 86% | 3.6 | 22.6 | |||
| 0.119 | 0.1112 | 94% | 7.3 | 19.6 | 0.024 | 0.0187 | 79% | 16.0 | 36.1 | |||
| 0.079 | 0.0762 | 96% | 5.0 | 30.5 | 0.016 | 0.0131 | 83% | 21.6 | 33.7 | |||
| 0.053 | 0.0474 | 90% | 11.5 | 36.8 | 0.011 | 0.0087 | 83% | 8.0 | 30.1 | |||
| 0.035 | 0.0297 | 85% | 3.3 | 32.6 | 0.007 | 0.0051 | 73% | 31.1 | 46.7 | |||
| HPV16 E7 | 0.100 | 0.1182 | 118% | 7.0 | 11.4 | 0.020 | 0.0177 | 89% | 22.9 | 24.0 | 600 | 0.0457 |
| 0.067 | 0.0672 | 101% | 4.2 | 18.5 | 0.013 | 0.0135 | 101% | 24.4 | 24.6 | |||
| 0.044 | 0.0443 | 100% | 7.6 | 18.3 | 0.009 | 0.0095 | 107% | 40.1 | 43.4 | |||
| 0.030 | 0.0266 | 90% | 9.8 | 35.1 | 0.006 | 0.0059 | 100% | 42.7 | 44.6 | |||
| 0.020 | 0.0201 | 102% | 11.0 | 19.7 | 0.004 | NE | NE | 56.8 | 56.8 | |||
| 0.013 | 0.0143 | 109% | 15.6 | 35.6 | 0.003 | NE | NE | 64.8 | 64.8 | |||
| 0.009 | 0.0074 | 84% | 22.5 | 36.8 | 0.002 | NE | NE | 39.9 | 42.8 | |||
| 0.006 | 0.0047 | 80% | NE | 38.6 | 0.001 | NE | NE | 69.3 | 67.2 | |||
| HPV18 E6 | 1.000 | 1.1673 | 117% | 7.6 | 16.6 | 0.200 | 0.1511 | 76% | 20.0 | 12.5 | 2500 | 0.1265 |
| 0.667 | 0.6814 | 102% | 5.5 | 18.8 | 0.133 | 0.1145 | 86% | 11.7 | 11.0 | |||
| 0.444 | 0.4515 | 102% | 2.8 | 15.0 | 0.089 | 0.0813 | 91% | 18.9 | 17.4 | |||
| 0.296 | 0.2649 | 89% | 4.7 | 29.5 | 0.059 | 0.0471 | 79% | 18.2 | 19.5 | |||
| 0.198 | 0.1912 | 97% | 5.9 | 25.0 | 0.040 | 0.0301 | 76% | 24.0 | 26.1 | |||
| 0.132 | 0.1281 | 97% | 7.1 | 35.5 | 0.026 | 0.0221 | 84% | 33.6 | 36.8 | |||
| 0.088 | 0.0794 | 90% | 9.0 | 36.0 | 0.018 | 0.0144 | 82% | 37.7 | 24.0 | |||
| 0.059 | 0.0507 | 87% | 5.7 | 32.6 | 0.012 | 0.0087 | 74% | 32.2 | 33.5 | |||
| HPV18 E7 | 0.400 | 0.4964 | 124% | 10.3 | 12.4 | 0.080 | 0.0642 | 80% | 21.6 | 15.9 | 1000 | 0.0561 |
| 0.267 | 0.2732 | 102% | 5.4 | 13.0 | 0.053 | 0.0478 | 90% | 17.2 | 18.6 | |||
| 0.178 | 0.1818 | 102% | 2.7 | 12.0 | 0.036 | 0.0327 | 92% | 19.5 | 20.0 | |||
| 0.119 | 0.1056 | 89% | 7.5 | 27.4 | 0.024 | 0.0174 | 73% | 35.2 | 37.9 | |||
| 0.079 | 0.0782 | 99% | 5.5 | 19.4 | 0.016 | 0.0125 | 79% | 40.4 | 42.1 | |||
| 0.053 | 0.0494 | 94% | 5.7 | 31.4 | 0.011 | 0.0082 | 78% | 41.0 | 42.6 | |||
| 0.035 | 0.031 | 88% | 8.9 | 32.0 | 0.007 | 0.0055 | 78% | 48.7 | 51.4 | |||
| 0.023 | 0.0197 | 84% | 7.1 | 25.5 | 0.005 | 0.0033 | 70% | 40.3 | 33.5 | |||