Validation of Clinical Laboratory Results: Discussion of Essential Validation Elements
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Drug Infomalion Journal. Vol. 31. pp. 243-250. 1997
Printed in the USA. All rights reserved.
VALIDATION OF CLINICAL LABORATORY RESULTS: DISCUSSION OF ESSENTIAL VALIDATION ELEMENTS JEAN-CLAUDE LIBEER,PHD, PHD EQA Coordinator. Department of Clinical Biology, Institute of Hygiene and Epidemiology, Brussels, Belgium
In this article, a review is given of all elements involved in the validation of clinical laboratory results. Validation will include: 1. Method validation, 2. Instrument validation, 3. Preanalytical validation procedures, 4. Analytical validation procedures, and 5. Postanalytical validation procedures. Within the scope of this publication, all of these different elements are discussed in detail. The management of all these steps is the only way to guarantee a correct result, if this is used either for patient treatment or in clinical evaluation studies. Key Words: Laboratory results; Validation; Quality control
INTRODUCTION
of techniques, it is impossible to discuss within the scope of this paper detailed performance characteristics for validation. Instead, some relevant publications will be referred to. The management of all validation elements is essential to guarantee a correct result, if this is used either for patient treatment or in clinical evaluation studies.
THE VALIDATION OF clinical laboratory results is complex and includes the followup of check and acceptance procedures of all steps involved in the production of these results. Consequently, validation will include:
1. Method validation, 2. Instrument validation, 3. Preanalytical validation procedures, 4. Analytical validation procedures, and 5 . Postanalytical validation procedures.
REVIEW OF ESSENTIAL VALIDATION ELEMENTS Method Validation
Each of these elements will be reviewed and split up into relevant components. As laboratory medicine covers several disciplines (clinical chemistry, immunology, microbiology, histopathology, etc.) and a broad range
Presented at the DIA Workshop “Quality Issues in Laboratory Data,” October 1 6 1 7 , 1995, Copenhagen. Reprint address: Jean-Claude Libeer, PhD, PhD, EQA Coordinator, Department of Clinical Biology, Institute of Hygiene and Epidemiology, Juliette Wytsman-Straat, 14, B-1050, Brussels, Belgium.
With the exception of microbiology, most laboratory tests in other fields of laboratory medicine are performed with industrially prepared kits and reagents. A method is defined as a reagent kit in combination with one or more calibrators and measurement equipment. Methods quality has been improved substantially during the last 20 years. Libeer (1) could demonstrate that interlaboratory coefficients of variation during the 1980s for most routine clinical chemistry analytes were halved between 1980 and 1990. This improvement is explained by better re-
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Jean-Claude Libeer
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agent kits and by automation in this field. The work procedures, recommended by the manufacturer of the kit, normally guarantee an optimized use of
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