Table 3.
Determining accuracy of the HEK-Blue hTLR2-TLR1 assay for quantitation of Immulina potency. Immulina (Method A) and NaOH-treated Immulina (Method B) samples were evaluated in triplicate at 4 concentrations, alone and spiked with Pam3CSK4 (5.00 ng/mL) or HKEB (1.10 × 106 cells/mL). Percent interference ± SD was calculated using the following formula: [(activity of spiked Immulina – activity of unspiked Immulina) / (activity exhibited by the concentration of added Pam3CSK4 spike or HKEB spike)] × 100. 100% is defined as no interference of sample matrix components.
| Immulina Concentration (μg/mL) | Method A - Immulina | Method B - NaOH-treated Immulina | ||
|---|---|---|---|---|
| Percent Interference | Percent Interference | |||
| Spiked with Pam3CSK4 | Spiked with HKEB | Spiked with Pam3CSK4 | Spiked with HKEB | |
| 3.3 | 86.1 ± 47.9 | 75.3 ± 14.3 | 57.7 ± 22.3 | 69.5 ± 34.8 |
| 1.1 | 70.2 ± 6.9 | 77.8 ± 10.8 | 51.7 ± 11.7 | 67.2 ± 15.6 |
| 0.37 | 70.8 ± 15.1 | 46.8 ± 5.7 | 52.2 ± 8.8 | 62.7 ± 22.9 |
| 0.12 | 50.8 ± 14.9 | 66.7 ± 29.4 | 58.6 ± 12.8 | 76.5 ± 28.1 |
| Mean = 69.5 | Mean = 66.7 | Mean = 55.1 | Mean = 68.9 | |