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 in point-of-care devices are diverse. Measurement challenges associated with standardization of quantitative viral load testing are discussed in relation to human cytomegalovirus, BK virus, and Epstein-Barr virus, while the importance of defining the performance of qualitative methods is illustrated with Mycobacterium tuberculosis and influenza virus. The development of certified reference materials whose 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.
National Institute of Biology, Department of Biotechnology and Systems Biology, Ljubljana, Slovenia Jožef Stefan International Postgraduate School, Ljubljana, Slovenia.
Jernej
J
Pavšič
LGC, Queens Road, Teddington, Middlesex, United Kingdom alison.devonshire@lgcgroup.com.
Alison S
AS
Devonshire
LGC, Queens Road, Teddington, Middlesex, United Kingdom.
Helen
H
Parkes
European Commission Directorate-General Joint Research Centre (JRC), Institute for Reference Materials and Measurements, Geel, Belgium.
Heinz
H
Schimmel
LGC, Queens Road, Teddington, Middlesex, United Kingdom.
Carole A
CA
Foy
European Commission Directorate-General Joint Research Centre (JRC), Institute for Reference Materials and Measurements, Geel, Belgium.
Maria
M
Karczmarczyk
National Institute of Biology, Department of Biotechnology and Systems Biology, Ljubljana, Slovenia.
Ion
I
Gutiérrez-Aguirre
Centre for Clinical Microbiology, Department of Infection, Royal Free Campus, University College London, London, United Kingdom.
Isobella
I
Honeyborne
LGC, Queens Road, Teddington, Middlesex, United Kingdom.
Jim F
JF
Huggett
Centre for Clinical Microbiology, Department of Infection, Royal Free Campus, University College London, London, United Kingdom.
Timothy D
TD
McHugh
National Institute of Biology, Department of Biotechnology and Systems Biology, Ljubljana, Slovenia.
Mojca
M
Milavec
Charité-University Medicine Berlin, Campus Benjamin Franklin, Institute of Virology, Berlin, Germany.
Heinz
H
Zeichhardt
National Institute of Biology, Department of Biotechnology and Systems Biology, Ljubljana, Slovenia.
Jana
J
Žel
D001419:Bacteria / Q000302:isolation & purification*; D001424:Bacterial Infections / Q000382:microbiology; D058491:Bacterial Load / Q000379:methods / Q000592:standards*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods / Q000592:standards*; D012015:Reference Standards; D019562:Viral Load / Q000379:methods / Q000592:standards*; D014777:Virus Diseases / Q000821:virology; D014780:Viruses / Q000302:isolation & purification*