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. 2020 Jul;66:21–29. doi: 10.1016/j.biologicals.2020.05.002

Table 5.

Causes of assay invalidity in Vi-PLL ELISA.

Invalidity reason Number of invalid cases
Non-parallel (slope ratio < 0.80) 26a
Non-parallel (slope ratio > 1.25) 7
10/126 low (<72.7 IU mL−1) 2
10/126 high (>163.5 IU mL−1) 4
10/126 non-parallel (slope ratio < 0.80) 0
10/126 non-parallel (slope ratio > 1.25) 0
Sample H low (<66.7 IU mL−1) 0
Sample H high (>150 IU mL−1) 4
H non-parallel (slope ratio < 0.80) 1
H non-parallel (slope ratio > 1.25) 2
No convergence (cannot fit model) 4
Poor plate precision (wide CI) 3
Total of invalid cases 53 (out of 474b)
a

21 out of 26 cases are for sample K in the Vi-PLL-ELISA by labs 2, 3, 5 and 7.

b

Maximum number of potency estimates possible in this study.