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

Operator's Manual

Principles of Operation

Alethia 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 Alethia
LOOP-Mediated Amplification in vitro diagnostic assays.
Alethia 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
Alethia test devices per block. Each two-chambered Alethia test device contains a Test Chamber and a
Control Chamber. Amplification of target DNA occurs during the heat cycle and results in the formation of
precipitate detected by the Alethia optics system. The precipitate generated by the presence of amplified
target DNA leads to a turbid Test/Control reaction solution which is then measured by absorbance. Alethia
uses the change in turbidity of each Test/Control reaction solution to report assay results as INVALID,
POSITIVE, or NEGATIVE.
Alethia 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 verification can be completed in the
SERVICE mode.

Performance Characteristics and Specifications

Performance Characteristics
Alethia is an automated isothermal amplification and detection system for use with Meridian Bioscience,
Inc.'s Alethia Loop-Mediated Amplification products. Alethia was designed with a simple User Interface
which includes a keypad, liquid crystal display (LCD), onboard 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 Alethia assay selected. Isothermal amplification time is monitored
by the Alethia's internal timer. When in operation, Alethia will display block temperature and incubation
time remaining on the main menu screen.
DNA amplification detection is completed by the Alethia optics system. Each Alethia block contains laser
diodes illuminating at 650 ± 20 nm and corresponding detectors monitoring light transmission across each
Alethia well. Alethia performs an Optics Path Verification prior to run start known as the Empty Well Test.
Observed failures in the optics system disable the instrument block until the failure can be resolved. After
successful Empty Well Test, Alethia checks for the presence of an Alethia test device in each well. Alethia
automatically enters a Sample ID of 'EMPTY WELL' for all wells that a test device cannot be detected in.
Alethia measures the absorbance of each Alethia 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.
Alethia Operator's Manual: ENGLISH Page 5
Copyright© Meridian Bioscience, Inc.
SN11042, REV. 07/2018