UniCel DxI Reference Manual 1.

1: System Technology Overview

1.1 System Technology Overview

The UniCel DxI Access Immunoassay System is an in vitro diagnostic device used
for the quantitative, semi-quantitative, or qualitative determination of various analyte
concentrations found in human body fluids.

Access Immunoassay System assays are heterogeneous, enzyme-mediated assays.

During sample processing, coated paramagnetic particles react with patient sample
and assay-specific reagents to form immune complexes. A magnetic field
immobilizes the bound immune complexes while the unbound components are
washed away. Chemiluminescent substrate reacts with an enzyme label present in the
bound complexes and releases light. A luminometer measures the light emitted, and
the system converts this reading, measured in relative light units (RLUs), into a test
result. For more information, see Section 1.2: Assay Technology.

To optimize laboratory efficiency, the system provides continuous random access

processing. The system uses a real-time, multi-tasking environment to allocate
instrument resources and schedule assay steps to process various assay methodologies
at the same time. Pipetting, washing, and reading of multiple assays, in various stages,
can take place concurrently. While the instrument is processing samples, additional
samples can be loaded, reagents and system supplies can be replenished, and waste
containers can be emptied.

To maximize throughput, the UniCel DxI 800 instrument uses four reagent pipettors
to enable the instrument to perform dilutions and add reagents for four samples at
once. The UniCel DxI 600 instrument uses two reagent pipettors, and processes two
samples at once.

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