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You are at: Statistical services for clinical laboratories: method validation

ACOMED statistics - service provider for statistical analyses of method validation experiments

ACOMED statistics provides statistical analyses necessary for evaluation and validation of laboratory performance of in vitro diagnostica 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-A2)
  • method comparison and bias (accuracy) (CLSI guideliune EP9-A2). Dr. Keller is member (observer) of subcommittee of CLSI for development of new version of this guideline.
  • linearity (CLSI guideline EP6-A)
  • reference range (cut off) (CLSI guideline C28-A2)
  • detection limit (CLSI guideline EP17-A)
  • matrix effects, interferences (CLSI guidelines EP14-A2, EP7-A2)
  • test performance qualitative tests (CLSI guideline EP12-A2)
  • preliminary evaluation (CLSI guideline EP10-A2)
  • diagnostic accuracy, ROC-anaysis (CLSI guideline GP10-A)
  • robustness
  • matrix effects, interferences (CLSI guidelines EP14-A2, EP7-A2)
  • specificity
  • 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® 9.2, Analyse-It®, Medcalc®, SPSS® 15.0/18.0.

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

 
statistical analyses of method validation experiments
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