Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline
|Publication Date:||1 February 2014|
Microarrays can be distinguished from each other based upon characteristics such as the nature of the probe, the solid surface support used, and the specific method used for probe addressing and/or target detection. MM22 focuses on the use of nucleic acid microarrays in microbiology and immunology laboratories and specifies the requirements and recommendations for the use of microarrays for diagnosis and monitoring of infectious diseases. It also covers infectious disease pathogen detection, identification, and genotyping (strain characterization) as well as virulence and resistance genetic markers.
The intended users of this guideline are clinical laboratories performing qualitative, multiplexed nucleic acid-based testing, which includes, but is not limited to, bacteriology, mycobacteriology, mycology, parasitology, and virology. This guideline is not intended for use by research laboratories, but the research community may use this guideline in order to translate their findings more easily. MM22 is not intended for in vitro diagnostic (IVD) device manufacturers or to provide manufacturing guidelines, and does not cover protein microarrays nor address microarray applications for unknown pathogen discovery, host or microbial gene expression profiling, or host genomic polymorphism determination related to microbial infections.