Luminex xPONENT 3.1 Rev 2 (IVD) - Manual (Page 103)

Term Definition
21 CFR Part 11 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
analyzer.
APD Avalanche Photo Diode; Measures the excitation
emission intensity of the color coding
classification dye mixtures inside the microsphere
and the amount of light scattered as particles
pass by the lasers.
assay A substance or analyte or a group of substances
or analytes undergoing evaluation or analysis.
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 Shorthand terminology for an xMAP microsphere.
Appendix A: Glossary
93