This kit is designed for the quantitative detection of residual T7 RNA Polymerase content added in RNA pharmaceuticals processes by using a double-antibody sandwich method.
20x more sensitive than standard T7 ELISA kits (e.g., Merck’s 0.25 ng/mL LOD)
Spike recovery 92–108% in mRNA/LNP matrices (data available upon request)
21 CFR Part 11-ready electronic reporting templates included
Sample/standard preparation, assay reagent preparation, sample loading
Incubation and plate washing
Color development and reaction termination
Reading
| Specification | 96 Test |
Assay range | 20-640 ng/mL |
Limit of quantitation | 20 ng/mL |
Limit of detection | 5 ng/mL |
Precision | CV%≤10%, RE%≤±15% |
| Validity period | 12 months |
| Storage conditions | 4℃ |
| LOQ | 0.25ng/mL |
| LOD | 0.012ng/Ml |
| Concentration of standard (ng/mL) | OD value 1 | OD value 2 | Mean value |
| 640 | 2.213 | 2.110 | 2.162 |
| 320 | 1.661 | 1.641 | 1.651 |
| 160 | 1.181 | 1.143 | 1.162 |
| 80 | 0.743 | 0.755 | 0.749 |
| 40 | 0.486 | 0.478 | 0.482 |
| 20 | 0.298 | 0.292 | 0.295 |
| 0 | 0.151 | 0.15 | 0.151 |
Standard curve:
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