Table 1.
Precision of the Freelite™ FLC Assay on the SPAPLUS™ Using Two Concentration Levels of Control Material (n = 20)
| Test result | Claim of manufacturer | Allowable imprecisiona | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | Within‐run imprecision | Total imprecision | Within‐run imprecision | Total imprecision | |||||||||
| Analyte (mg/l) | SD | 95% CI | %CV | SD | 95% CI | %CV | SD | %CV | SD | %CV | SD | %CV | |
| κFLC | 15.1 | 0.51 | 0.358–0.898 | 3.40 | 0.72 | 0.505–1.275 | 4.80 | 0.319 | 2.11 | 1.584 | 10.49 | 0.50 | 3.30 |
| 29.4 | 0.99 | 0.694–1.742 | 3.40 | 1.23 | 0.922–1.850 | 4.20 | 0.483 | 1.64 | 2.764 | 9.40 | 0.97 | ||
| λFLC | 30.0 | 0.40 | 0.279–0.701 | 1.30 | 1.33 | 0.866–2.823 | 4.40 | 0.754 | 2.51 | 1.495 | 4.98 | 1.58 | 5.25 |
| 60.1 | 1.13 | 0.791–1.988 | 1.90 | 2.96 | 1.872–6.945 | 4.90 | 1.356 | 2.26 | 2.941 | 4.89 | 3.16 | ||
a
Minimum specifications for imprecision derived from biologic variation of κFLC and λFLC.