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Validation Methods

Validation of Laboratory-Developed Molecular Assays for Infectious Diseases
Molecular tests to detect infectious agents are now widely used in many clinical laboratories. In spite of their widespread use, there is confusion surrounding the requirements that need to be met when bringing a molecular test, whether FDA approved/cleared or laboratory developed, into a clinical laboratory. This review presents information that laboratories may consider in their efforts to meet regulatory requirements.
E. M. Burd 
Clin. Microbiol. Review July 2010 23: 550-576
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 Cumitech 31A: Verification and Validation of Procedures in the Clinical Microbiology Laboratory
Focusing on the common qualitative and semi–quantitative test procedures performed in clinical microbiology labs, this Cumitech helps readers understand and comply with the criteria and decision-making process for verifying tests considered for clinical use.  Moreover, it enables readers to confidently validate tests already in use in order to assess their continued clinical relevance.  

Clark, R. B., M. A. Lewinski, M. J. Loeffelholz, and R. J. Tibbetts. 2009. Cumitech 31A, Verification and Validation of Procedures in the Clinical Microbiology Laboratory. Coordinating ed., S. E. Sharp. ASM Press, Washington, DC.

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