Manual

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