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Table 1 Immunogenicity assay characteristics

From: Immunogenicity of panitumumab in combination chemotherapy clinical trials

   

Drug Tolerance

Assay

Assay Sensitivity*

LLRD

Anti-panitumumab

Panitumumab

ELISA

10 ng/mL

60 ng/mL

60 ng/mL

500 ng/mL

9 μg/mL

81 μg/mL

Biacore

1.8 μg/mL

1.8 μg/mL

4 μg/mL

20 μg/mL

1.9 μg/mL

7.8 μg/mL

Bioassay

~62.5 ng/mL

~125 ng/mL

~1 μg/mL

~2.5 μg/mL

  1. *Intersection of the assay threshold with the rabbit polyclonal anti-panitumumab antibody dose-response curve.
  2. Level of anti-panitumumab antibodies that can be detected in the presence of the amount of panitumumab in the adjacent column.
  3. LLRD, lower limit of reliable detection, the lowest concentration of the rabbit polyclonal anti-panitumumab antibody that could be reliably detected as positive when spiked into neat serum from multiple donors.