Linearity

Method validation software for IVDs, Clinical Laboratories and Researchers to validate, verify, and demonstrate analytical and diagnostic method performance.

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.
  See an example Analyse-it Linearity report
  See example Linearity plot with level & recovery% statistics
  See example Linearity difference plot with linearity statistics
• 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.