Luminex xPONENT 3.1 Manual de usuario descargar pdf (Pagina 131)

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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 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.

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

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Luminex xPONENT 3.1 Manual de usuario Pagina 131