Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses

Nucleic acid based tests for infectious diseases currently used in the clinical laboratory and as part of point of care devices are diverse, and results between laboratories can lack comparability. Here, two pathogens, human cytomegalovirus and Mycobacterium tuberculosis, were chosen to highlight the challenges associated with standardising molecular detection and quantification methods, by illustrating potential sources of measurement variation and bias. The development of reference materials of which values are traceable to higher order standards and reference measurement procedures, such as digital PCR, will support improved understanding of analytical performance characteristics and improvements in the quality and comparability of the diagnostic testing.

PAVSIC Jernej;  DEVONSHIRE A.;  PARKES H.;  SCHIMMEL Heinz;  FOY C.A.;  KARCZMARCZYK Maria;  GUTIÉRREZ-AGUIRRE Ion;  HONEYBORNE Isobella;  HUGGETT Jim;  MCHUGH Timothy;  MILAVEC Mojca;  ZEICHHARDT Heinz;  ZEL Jana; 

2016-01-08

AMER SOC MICROBIOLOGY

JRC91656

0095-1137,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC91656,   

10.1128/JCM.02136-14,