Table 1 Repeatability (intra-assay precision) and reproducibility (inter-assay precision).

From: Preclinical immunogenicity testing using anti-drug antibody analysis of GX-G3, Fc-fused recombinant human granulocyte colony-stimulating factor, in rat and monkey models

 

High PC

Middle PC

Low PC

Negative cut-off

Intra-assay

Rat

Mean (%CV)

3.337 (2.6%)

1.512 (3.4%)

0.150 (4.3%)

0.067 (6.3%)

Monkey

Mean (%CV)

3.204 (1.8%)

1.367 (2.0%)

0.178 (8.3%)

0.083 (9.7%)

Inter-assay

Rat

Mean (%CV)

3.414 (1.6%)

1.618 (5.4%)

0.169 (6.7%)

0.068 (4.6%)

Ratio (%CV)a

49.9 (5.1%)

23.7 (5.8%)

2.5 (6.2%)

 − 

Monkey

Mean (%CV)

3.255 (2.3%)

1.469 (8.6%)

0.183 (10.6%)

0.086 (4.0%)

Ratio (%CV)

37.9 (3.9%)

17.1 (9.4%)

2.1 (11.7%)

 − 

Stability (freeze/thaw)

Rat

Mean

3.306

NAc

0.179

0.072

Ratio (%difference)b

45.9 (8.0%)

NA

2.5 (0%)

 − 

Monkey

Mean

3.287

NA

0.185

0.088

Ratio (%difference)

37.4 (1.3%)

NA

2.1 (0%)

 − 

Stability (12-week)

Rat

Mean

3.431

NA

0.208

0.069

Ratio (%difference)

49.7 (0.4%)

NA

3.0 (20%)

 − 

Monkey

Mean

3.360

NA

0.206

0.084

Ratio (%difference)

40 (5.5%)

NA

2.5 (19%)

 − 

  1. aRatio of absorbance of the PC to absorbance of the negative cut-off.
  2. bAbsolute value of %difference from precision.
  3. cNot applied.