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Standardising clinical measurements of bacteria and viruses using nucleic acid tests

Pavšič J, Devonshire AS, Parkes H, Schimmel H, Foy CA, Karczmarczyk M, Gutiérrez-Aguirre I, Honeyborne I, Huggett JF, McHugh TD, Milavec M, Zeichhardt H, Zel J.
J Clin Microbiol. 2014 Nov 12. pii: JCM.02136-14. [Epub ahead of print]
Published November 2014
DOI: 10.1128/JCM.02136-14
Link to publication: http://www.ncbi.nlm.nih.gov/pubmed/25392365

Abstract

Nucleic acid based tests for infectious diseases currently used in the clinical laboratory and in point of care devices are diverse. Measurement challenges associated with standardisation of quantitative viral load testing are discussed in relation to human cytomegalovirus, BK and Epstein Barr virus, whilst the importance of defining the performance of qualitative methods is illustrated with Mycobacterium tuberculosis and Influenza virus. The development of certified reference materials of which values are traceable to higher order standards and reference measurement procedures, using for instance digital PCR, will further contribute to the understanding of analytical performance characteristics and promote clinical data comparability.

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