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Per CLSI on January 9, 2018

CLSI was recently informed of errors and inconsistencies in CLSI document EP09-A3, Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition. The issues cited include:
  • Inability to replicate some examples provided in the guideline
  • Inaccuracy of the bias definition generated when averaging bias over the assay range when the regression slope was poor
  • Incomplete formula for computing the confidence intervals of bias estimates at medical decision points
  • Inadequate coverage of Deming regression principles, especially with regard to the use of precision profiles
  • Insufficient detail on performing bootstrapping for Passing-Bablok parameter confidence interval estimates
Because of these errors and inconsistencies, EP09-A3 has been withdrawn from the CLSI document library until appropriate corrections are made.

Please note the errors in EP09-A3 present negligible risk of harm to patients, because laboratories often use a software package or obtain assistance from a test system manufacturer when computing measurement procedure comparison statistics.

A detailed description of the corrections will accompany the forthcoming corrected guideline. If you require any additional clarification regarding these corrections, please contact CLSI Customer Service ([email protected]).
 

Document History

  1. CLSI EP09


    Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition, EP09c

    • Most Recent
  2. CLSI EP09-A3

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    viewing


    Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline--Third Edition, EP09A3E

    • Historical Version
  3. CLSI EP09-A2-IR


    Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline--Second Edition (Interim Revision), EP09A2IR

    • Historical Version
  4. CLSI EP09-A2


    Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, EP09-A2

    • Historical Version