Analyse-it® Method Evaluation Edition
Validate, verify, or demonstrate method linearity and recovery over the reportable
range, to satisify CLSI EP6 and FDA method validation requirements.
Establish or verify linearity and recovery of the method over the reportable range,
and at important decision levels. The industry-recognised Emancipator-Kroll linearity
procedure, now adopted by the CLSI as EP6, is used.
- Establish linearity
Satisfies CLSI EP6-A. Determines linearity of the method over a range of concentrations.
Compares and visualises linear & best polynomial fits, as per Emancipator-Kroll,
to determine degree of linearity.
- Demonstrate linearity is within allowable goal or meets manufacturer's claim
Express goal linearity as absolute/percentage of concentration, or as Linearity
Error% of Total Allowable Error (TAe).
- Determine precision and recovery over reportable range.
Precision expressed as SD, CV(%), with recovery shown as percentage.
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