Table 4

Precision and sample linearity of UAD assay

SerotypePositivity cutoff value (PnPS U/ml)Assay range based on:
PrecisionSample linearity
GMC (PnPS U/ml)% RSD rangeGMC (PnPS U/ml)% biasa range
Lower limitUpper limitLower limitUpper limit
117.89.1477.25.5–25.59.1477.282.6–117.5
3330.58.61,153.35.7–24.18.61,153.371.4–114.0
427.31.9192.56.5–13.21.9192.594.6–110.6
52.50.832.98.5–15.21.132.982.2–119.8
6A106.74.8644.72.9–12.34.8472.177.1–123.8
6B79.74.3504.25.7–21.34.3504.289.6–114.8
7F6.60.5211.35.1–14.50.6165.480.4–121.1
9V15.64.31,480.510.3–27.85.91,480.572.5–122.5
141.70.616.45.7–15.10.616.490.2–110.6
18C4.30.615.211.0–15.10.615.288.8–116.2
19A9.89.8174.310.6–26.72.0174.368.1*–115.3
19F150.05.3428.65.4–6.45.3428.685.3–111.5
23F8.02.9122.48.1–14.52.985.672.9–119.0
  • a Sample linearity is considered acceptable if the percent relative bias for any one dilution is outside of the acceptance criterion but the percent relative bias for the dilutions immediately above and below this dilution is within the acceptance criterion.