Validation Methods

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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

Abstract and PDF
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