Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis
This article defines requirements for Laboratory Accreditation Standards and Guidelines for Nucleic Acid Detection and Analysis
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This document has been developed by a sub-committee of NPAAC, drawing from guidelines published by the National Committee for Clinical Laboratory Standards and a number of draft guideline documents under development by the South Australian Genetics Service, the Australian Cancer Network and the National Health and Medical Research Council.
The document was initiated following the outcomes of a review completed in 1997 by the Australian Health Technology Advisory Committee (AHTAC). This review considered the scientific evidence on the clinical value, impact on disease management and cost-effectiveness of nucleic acid amplification in six key areas of clinical practice. It highlighted the need for a coordinated program of accreditation and quality assurance for laboratories using nucleic acid detection techniques for diagnostic testing and included recommendations relating to quality assurance.
The document seeks to address the findings of the AHTAC report by providing consensus guidelines and requirements for nucleic acid detection techniques and are directed at:
- laboratories using nucleic acid detection techniques in medical diagnosis or intending to establish a testing program using these techniques; and
- accreditation authorities, in order that laboratories using nucleic acid detection techniques may be assessed for compliance.