INTENDED USE
/ INTENDED USE
13
MosaiQ 125 - User Manual - November 2020 - Reference n°: MMSURM.0010.02
2.1 INTENDED
USE
The
MosaiQ 125
is an automated instrument intended for the qualitative infectious
disease screening of human blood using MosaiQ magazines and MosaiQ system
reagents. It is intended for professional use within a blood donor environment.
NOTICE
Immunohematology testing (IH) is defined by antigen typing and
antibody detection. Currently the
MosaiQ 125
cannot perform
antigen typing (AT) and antibody detection (ABD/ABID). For this
reason, please ignore any reference to IH (AT and ABID) in the GUI.
2.2
MOSAIQ SYSTEM COMPOSITION
The MosaiQ System is made up of the following key components:
The
MosaiQ 125
consisting of:
භ
Various hardware modules, some of them controlled by firmware running on
various micro-controllers.
භ
MosaiQ Software driving the Graphical User Interface (GUI).
The MosaiQ Standard Magazines or MosaiQ Quantum Magazines for Serological
Disease Screening (SDS).
The associated MosaiQ system reagents (sample diluents, wash buffers, detection
reagents and enhancement reagents) needed to run the assay.
System liquid (purified water).
2.3
PRINCIPLES OF OPERATION
This section describes the principles of operation governing the
MosaiQ 125
test orders
process.
2.3.1
MOSAIQ 125 PROCESS WORKFLOWS
Centrifuged and decapped blood sample tubes are loaded into the
MosaiQ 125
.
The
MosaiQ 125
is designed for the fully-automated testing of blood donor samples. It
consists of an analyzer which performs serological disease screening assays based on a
qualitative
in vitro
detection method.
The analytical process is entirely automated. It is composed of several steps and is assay
dependent. The different steps (sample dilution, shaking, incubation, washing, reagent
dispensing) are performed by hardware or fluidic modules controlled by software.
