Table 2.
Calculated lower limits of detection and quantitation of the regular and avidity hexaplex mouse DTP MIA in comparison to ELISA
| Assay | LLOD (LLOQa) (mU/ml) for: |
|||||
|---|---|---|---|---|---|---|
| FHA | Ptx | Fim2/3 | P.69 Prn | Dtx | TT | |
| IgG MIA | 4.7 (14.1) | 0.1 (0.3) | 0.2 (0.6) | 0.7 (2.1) | 0.2 (0.6) | 1.9 (5.7) |
| IgG ELISA | 1.2 (3.6) | 0.1 (0.3) | 0.3 (0.9) | 0.7 (2.1) | 0.1 (0.3) | 0.1 (0.3) |
| Avidity MIA | 5.4 (16.2) | 0.2 (0.6) | 0.3 (0.9) | 0.5 (1.5) | 0.2 (0.6) | 0.1 (0.3) |
| Avidity ELISA | 3.5 (10.5) | 0.1 (0.3) | 0.3 (0.9) | 0.7 (2.1) | 0.1 (0.3) | 0.1 (0.3) |
a
The LLOQ of the assays can be calculated by multiplying the LLOD by a factor of 3 [in accordance with the guideline ICH Topic 2 (R1) of the European Medicines Agency, Validation of analytical procedures: text and methodology (CPMP/ICH/381/95) (htttp://www.ema.europa.eu)].