Luminex xPONENT for MAGPIX - Manual (Page 122)

Glossary
21CFRPart11 21 CFR Part 11 sets the criteria under which the Food and Drug
Administration (FDA) considers electronic records, electronic signatures,
and handwritten signatures executed to electronic records to be
trustworthy, reliable, and generally equivalent to paper records and
handwritten signatures executed on paper.
agglutination The coalescing of small particles that are suspended in solution; these
larger masses are then (usually) precipitated.
ambient temperature The temperature of the surrounding environment.
analyte A substance that is detected through assay analysis. Each test or bead
set will test for a specific analyte.
analyzer This term is used to refer to the Luminex MAGPIX.
background (noise) That portion of a bead set result that can be attributed to excess reporter
molecules in the solution, nonspecific binding, or fluorescent spillover
from another fluorochrome into the reporter channel.
batch A group of samples that are processed using a selected protocol.
bead See microsphere.
bead map A collection of bead sets with defined classification coordinates.
bead set A set of xMAP microspheres that have a uniquely identifiable ratio of two
classification dyes. The unique ratio is identified by a unique spectral
address. Also sometimes called “microsphere set”, “microsphere region”,
or “test” by the software during acquisition.
calibration A process used to normalize the settings for the reporter channel, both
classification channels, and the doublet discriminator channel for the
Luminex system. Calibration ensures optimal and consistent
microsphere classifications and reporter readings.
calibrators xMAP microspheres used to normalize the settings for the reporter
channel, both classification channels, and the doublet discriminator
channel for the Luminex system.
CL1 Refers to dyes embedded in the microsphere. Also see classification
channel.
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