TABLE 4.
Assay | n | Substance SP level (pg/ml) (mean ± SD)
|
95% CI of LOA and biasa | ||
---|---|---|---|---|---|
Recommended | User-modified | Mean difference | |||
Cayman EIA | 5 | 58.6 ± 3.1 | 67.0 ± 5.7 | −8.4 ± 6.2 | Biasb (−16.1, −0.7) |
LOAc (−20.5, 3.7) | |||||
Lower LOAd (−33.8, −7.2) | |||||
Upper LOAd (−9.6, 17.0) | |||||
Assay Designs EIA | 5 | 183.2 ± 51.2 | 28.4 ± 5.8 | −154.9 ± 51.5 | Bias (−218.8, −91.0) |
LOA (−255.8, −54.0) | |||||
Lower LOA (−366.6, −145.1) | |||||
Upper LOA (−164.7, 56.8) |
95% CI bias = mean difference ± t critical value on n − 1 degrees of freedom × standard error of mean difference (SE).
95% CI LOA = mean difference ± 1.96 × SD.
95% CI lower LOA = (mean difference − 1.96 × SD) ± t critical value on n − 1 degrees of freedom × 1.732 × SE; 95% CI upper LOA = (mean difference + 1.96 × SD) ± t critical value on n − 1 degrees of freedom × 1.732 × SE.