Principles Of Operation; Performance Characteristics And Specifications - Meridian Bioscience illumipro-10 Manual Del Operador

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Operator's Manual

Principles of Operation

The illumipro-10 is an automated isothermal amplification and detection system for target nucleic acid
sequences found in human specimens. The instrument is used in conjunction with Meridian Bioscience,
Inc's illumigene LOOP-Mediated Amplification in vitro diagnostic products.
The illumipro-10 is a menu driven laboratory instrument with two independent sample processing blocks,
identified as Block A and Block B. Sample heating and optical detection is carried out for up to five two-
chambered illumigene devices per Block. Each two-chambered illumigene device contains a Sample
Chamber and a Control Chamber. Amplification of target DNA occurs during the heat cycle and results in
the formation of precipitate detected by the illumipro-10 optics system. The precipitate generated by the
presence of amplified target DNA leads to a turbid Sample/Control reaction solution which is then
measured by absorbance. The illumipro-10 uses the change in turbidity of each Sample/Control reaction
solution to report assay results as INVALID, POSITIVE, or NEGATIVE.
The illumipro-10 operates in four basic modes: ASSAY, RESULTS, SERVICE, and SYSTEM. Assay
Selection and Sample Amplification occurs in the ASSAY mode; Test Results are managed in the
RESULTS mode; basic instrument set-up is performed in the SYSTEM mode; and optical performance
verification is completed in the SERVICE mode.

Performance Characteristics and Specifications

Performance Characteristics
The illumipro-10 is an automated isothermal amplification and detection system for use with Meridian
Bioscience, Inc. illumigene Loop-Mediated Amplification products. The illumipro-10 was designed with a
simple User Interface which includes a keypad, liquid crystal display (LCD), barcode scanner, printer and
optional external keyboard. Menu-driven operating instructions are shown on the display and the user
inputs commands to the instrument by making selections through the keypad.
Isothermal amplification is carried out by two independently controlled heat blocks capable of operating
between 55 C and 65 C, and within 1 C of the temperature set point. The isothermal amplification
temperature set point is dictated by the illumigene Assay selected. Isothermal amplification time is
monitored by the illumipro-10's internal timer. When in operation, the illumipro-10 will display 'Test in
Progress' as well as block temperature and incubation time remaining.
DNA amplification detection is completed by the illumipro-10 optics system. Each illumipro-10 block
contains laser diodes illuminating at 650 ± 20 nm and corresponding detectors monitoring light
transmission across each illumipro-10 well. The illumipro-10 performs an initial check of the optics
system prior to run start. Observed failures in the optics system disable the instrument block until the
failure can be resolved. After successful optics verification, the illumipro-10 checks for the presence of
an illumigene test device in each well. The illumipro-10 automatically enters a Sample ID of 'EMPTY
WELL' for all wells that a test device cannot be detected in. The illumipro-10 measures the absorbance
of each illumigene test device at the beginning and end of the isothermal amplification incubation.
Sample results are reported as INVALID, POSITIVE, or NEGATIVE based on the observed change in
absorbance.
illumipro-10 Operator's Manual: ENGLISH Page 5
Copyright© Meridian Bioscience, Inc.
SN11007, REV. 07/2010