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APPENDIX 2
PRECISION AND ACCURACY STUDY
ANALYTE :
ANALYZER :
A) VERIFICATION FOR IMPRECISION
a) WITHIN RUN IMPRECISION
b) BETWEEN RUN IMPRECISION
c) TOTAL IMPRECISION
a) Estimation of within run imprecision
1. Use at least 2 levels QC (inclusive of medical decision limit)
2. Run in triplicates within 2 hours for 5 days
3. Calculate mean for each day
2
4. Calculatewithin run variance(σ WR) for each day.
2
Formula: σ = Σ(Xi –MEAN)
2
(n-1) Where n: no of replicates =3
5. Calculate overall mean (OM)
2
6. Calculate average within run variance, σ WR
7. Calculate within run SD (SD WR) by SQRT σ WR
2
8. Calculate within run CV [SD WR/Overall mean*100]
9. Compare with manufacturer’s within run CV
