method_validation, CLSI guidelines, method evaluation CLSI guidelines, method evaluationr


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You are at: Statistical services for clinical laboratories - method validation accoreding CLSI guidelines

statistical design and analyses of method validation experiments according CLSI guidelines

ACOMED statistics provides statistical analyses necessary for evaluation and validation of laboratory performance of in vitro diagnostics according to CLSI (Clinical and Laboratory Standards Institute®) guidelines.

Evaluation / Validation of your IVD method according to CLSI guidelines

  • intraserial and total precision using ANOVA methods with nested factors (CLSI guideline EP5)
  • method comparison and bias (accuracy) (CLSI guideline EP9). Dr. Keller was a member (observer) of subcommittee of CLSI for development of new version of this guideline.
  • linearity (CLSI guideline EP6)
  • reference range (cut off) (CLSI guideline C28)
  • Detection cability (detection limit, limit of quantition, CLSI guideline EP17)
  • Commutablity of processed samples (matrix effects, interferences, CLSI guidelines EP14, EP7)
  • test performance qualitative tests (CLSI guideline EP12)
  • preliminary evaluation (CLSI guideline EP10)
  • diagnostic accuracy, ROC-anaysis
  • robustness
  • matrix effects, interferences (CLSI guidelines EP14, EP7)
  • specificity
  • total analytical error, uncertainty (CLSI guidelines EP29,EP21)
  • stability (CLSI guideline EP25)
  • relationship to other methods (Bland-Altman Plot, Passing-Bablock regression)

All these analyses are conducted according to an internal GLP compliant SOP-system.

Statistical analyses are performed using following software: SAS® 9.4, Analyse-It®, Medcalc®.

Using SAS®, ACOMED statistics can provide analyses performed under regulated conditions (complete traceability, formal exclusion of any manipulation of data and output).

Thomas Keller has been a member of CLSI subcommittees for new versions of EP 09 (method comparison and bias estimation) and EP 25 (stability).

statistical analyses of method validation experiments
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statistical analyses of method validation experiments according CLSI guidelines
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