TABLE 1.

Assay ruggedness for the 54 separate conditions evaluated in the validation test

FactorLevelLS meana (μg/ml) (95% CI)Comparison% Difference (95% CI)
Secondary MAb1162 (158, 166)1 vs 23.0 (−0.7, 6.7)
2157 (153, 162)
Microsphere1156 (152, 161)1 vs 2−4.2 (−8.3, 0.0)
2163 (158, 168)1 vs 3−2.8 (−6.3, 0.8)
3161 (156, 165)2 vs 31.4 (−2.7, 5.8)
IsdB1157 (152, 162)1 vs 2−1.5 (−5.8, 2.9)
2159 (154, 165)1 vs 3−3.7 (−7.8, 0.6)
3163 (158, 165)2 vs 3−2.2 (−6.5, 2.2)
Operator1153 (149, 158)1 vs 2−5.4 (−9.4, −1.2)
2162 (157, 167)1 vs 3−6.8 (−10.8, −2.6)
3164 (159, 170)2 vs 3−1.5 (−5.8, 3.0)
  • a LS mean, least square mean.