CLSI EP09-A3

Per CLSI on January 9, 2018

CLSI was recently informed of errors and inconsistencies in CLSI document EP09-A3, MeasurementProcedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—ThirdEdition. 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 theregression slope was poor
• Incomplete formula for computing the confidence intervals of bias estimates at medical decisionpoints
• Inadequate coverage of Deming regression principles, especially with regard to the use ofprecision profiles
• Insufficient detail on performing bootstrapping for Passing-Bablok parameter confidence intervalestimates

Because of these errors and inconsistencies, EP09-A3 has been withdrawn from the CLSIdocument library until appropriate corrections are made.

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

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

Published:

08/30/2013

ISBN(s):

1562388886