Is It Necessary to Perform a Full Validation With All New Specimen Types? EP35 provides the answers.

Written By: Nils B. Person, PhD, FAACC

EP35—Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition provides recommendations for assessing clinically equivalent performance for additional specimen types. When a measurement procedure is developed, it is typically validated for the specimen type most commonly used. Measurement of other specimen types may also be clinically useful. However, measurement procedure performance needs to be verified with these additional specimen types. Does that mean another full validation with each specimen type? This is where EP35 provides guidance.

EP35 provides specific guidance on how to determine what studies may need to be performed. The intent is to adequately assess performance with each candidate specimen type without necessarily repeating a full validation. The recommendations provide guidance for both quantitative and qualitative measurement procedures. The principle factor determining which studies may need to be performed is how similar the matrix of the candidate specimen type is to the original specimen type used for initial validation. For new specimen types with similar matrix, the studies are similar to those used to verify performance of a new implementation of an established measurement procedure. For new specimen types with dissimilar matrix, the studies focus on verifying that performance is consistent with appropriate clinically based performance goals specific to the new specimen type.

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