Table 2.

Calculated lower limits of detection and quantitation of the regular and avidity hexaplex mouse DTP MIA in comparison to ELISA

AssayLLOD (LLOQa) (mU/ml) for:
FHAPtxFim2/3P.69 PrnDtxTT
IgG MIA4.7 (14.1)0.1 (0.3)0.2 (0.6)0.7 (2.1)0.2 (0.6)1.9 (5.7)
IgG ELISA1.2 (3.6)0.1 (0.3)0.3 (0.9)0.7 (2.1)0.1 (0.3)0.1 (0.3)
Avidity MIA5.4 (16.2)0.2 (0.6)0.3 (0.9)0.5 (1.5)0.2 (0.6)0.1 (0.3)
Avidity ELISA3.5 (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)].