HELIOS automated IFA System - now FDA cleared
AESKU receives FDA 510(k) Clearance for HELIOS automated IFA System with AESKUSLIDES ANA HEp-2-Gamma
(Wendelsheim / Oakland, California, 29.07.2016) AESKU.GROUP, a research-focused supplier of innovative products and services for the early detection, diagnosis and prognosis of autoimmune diseases, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new HELIOS AUTOMATED IFA SYSTEM with AESKUSLIDES ANA HEp-2-Gamma Assay.
The HELIOS is a new revolutionary platform that employs automated immunofluorescence (IFA) technology to process and analyze patient samples. It is the first clinical diagnostics platform to offer automation of the IFA process to this extent.
The HELIOS is an automated system for immuno-fluorescence processing with image capturing with an integrated fluorescence microscope and software. Results must be confirmed by a trained user. It is the first and only system that performs this process continuously from start to finish.
The HELIOS fully addresses and overcomes the known limitations of IFA, enabling the user to adopt it as the Autoimmunity reference screening method. The HELIOS is currently in use in 29 countries worldwide.
High flexibility, accepts most tubes
- Tube diameters ranging from 11-13 mm and lengths from 55-100 mm
- Multi-rack sample tube capacity: 106
- The design of the rack and the clamping of the sample tubes increases the overall stability
- Position numbers are clearly printed and easy to read
- The tubes are clamped in the holders to avoid rotation during the reading process of the sample barcodes
- In addition, the use of small control tubes with flat bottoms is also possible
The new HELIOS Multi-Rack is an optional accessory, not included in the HELIOS, sold separately.
Estimated Endpoint Titer Option
Saves Time and Reagents
Easier to find the target dilution - less dilution steps needed.
The endpoint titer is defined as the highest dilution in which staining intensity is still detectable. It is an important indicator for the classification of immunofluorescence images. After the first screening run, a titration of positive samples is strongly recommended.
The HELIOS EPT Plus offers the possibility to estimate an endpoint titer for wells that were pre-classified as positive in a previous screening mode run. Supported by this endpoint titer estimation, the next dilution steps can easily be selected during the user classification process.
The HELIOS Endpoint Titer is a preinstalled option. Activation only on customer request, activation key sold separately.
Pattern Recognition Add-ons
The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most probable IFA pattern by analyzing captured IFA images.
Rheumatology Pattern Plus Add-on:
This Add-on is able to recognize the following ANA HEp2 IFA patterns:
- Nuclear membrane
- Nuclear Dots
- Speckled (granular)
Vasculitis Pattern Plus Add-on:
This Add-on is able to recognize the following ANCA IFA patterns:
- A-ANCA (X-ANCA)
- Undefined positive
DNA Pattern Plus Add-on:
This Add-on is able to descriminate postive/negative nDNA samples.
The HELIOS Pattern Recognition Add-ons are preinstalled options. Activation only on customer request, activation key sold separately
Improved Tissue Processing