helios new offen schraeg cropped

FDA clears Automated Vasculitis Test from AESKU

AESKU Receives FDA 510(k) Clearance for Anti-Neutrophil Cytoplasmic Antibody (ANCA) test to aid in the Diagnosis of ANCA Associated Vasculitides with the HELIOS Automated immunofluorescence assay (IFA) System

(Wendelsheim, Germany / Oakland, California) AESKU.GROUP – a science-focused manufacturer of autoimmune, allergy, and infectious disease diagnostics – received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES ANCA Ethanol, and ANCA Formalin with the new HELIOS AUTOMATED IFA SYSTEM. Next to be submitted are esophageal and tissue section slides.

nDNA (Crithidia luciliae) now FDA cleared with HELIOS

AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM

(Wendelsheim, Germany / Oakland, California,) AESKU.GROUP received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES nDNA (Crithidia luciliae) with the new HELIOS AUTOMATED IFA SYSTEM. The kit is the second FDA cleared immunofluorescence assay on the HELIOS, after ANA HEp-2 (cleared in 2016), and will be followed by ANCA and tissue section slides.

HELIOS automated IFA System - now FDA cleared

helios fda closed image AESKU receives FDA 510(k) Clearance for HELIOS automated IFA System with AESKUSLIDES ANA HEp-2-Gamma

NEW | Pattern Recognition

The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most propable IFA pattern by analysing captured IFA images.

Read more...

NEW | Estimated Endpoint Titer

The Estimated Endpoint Titer option saves time and reagents. This option makes it easier to find the target solution and less dilution steps are needed.

The endpoint titer is defined as the highest dilution in which staining intensity is still detectable.

Overview

HELIOS is a revolutionary system that automates the complete pipetting and image capturing of IFA (immunofluorescence) tests.

It is the first and only system to automate this process completely from beginning to end - offering unparalleled process control, traceability, standardization, ease of use, and maximum efficiency by requiring technical intervention only for expert review.

HELIOS HARDWARE HIGHLIGHTS

HELIOS SOFTWARE HIGHLIGHTS

HELIOS Software big

IFA Processing and Image Capturing

The HELIOS processor is capable of performing all IFA processing and reading automatically.

IFA Processing

The HELIOS uses the robust and widely adopted HELMED IFA Software, which is compatible with most IFA test kits, regardless of their manufacturer. However, non-AESKU slides will be processed without reading.

Image Capturing

This module starts automatically after slide processing is complete or can be used independently from other modules. The well imaging positions and image number is user configurable for all AESKUSLIDES tests, prior to reading. A Pre-Classification suggestion ( + or - ) is performed for each image for AESKUSLIDES ANA HEp2, ANCA, and nDNA.

Result Confirmation

All IFA analysis data can be loaded and evaluated patient by patient. The evaluation process is complemented by the AESKU pattern library. The “show all negatives” option displays all pre-classified negative results, helping to save reporting time by automatically releasing the negative results with the push of a button. The “sample overview” option allows all results related to one sample to be compared side by side. Activating the pattern recognition tool give the Helios the ability to autonomously suggest the most probable IFA patterns for Hep-2, ANCA, and nDNA.

Estimated Endpoint Titer
In addition, an End Point Titer determination from one serum dilution can be performed atomatically.

More information...

Configuration

This module is used to manage pre-classification settings and user rights.

LIS

The LIS Module sends all classified results to the LIS. ASTM standard connection configuration is done via a user-friendly interface.

helios new offen schraeg cropped

FDA clears Automated Vasculitis Test from AESKU

AESKU Receives FDA 510(k) Clearance for Anti-Neutrophil Cytoplasmic Antibody (ANCA) test to aid in the Diagnosis of ANCA Associated Vasculitides with the HELIOS Automated immunofluorescence assay (IFA) System

(Wendelsheim, Germany / Oakland, California) AESKU.GROUP – a science-focused manufacturer of autoimmune, allergy, and infectious disease diagnostics – received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES ANCA Ethanol, and ANCA Formalin with the new HELIOS AUTOMATED IFA SYSTEM. Next to be submitted are esophageal and tissue section slides.

nDNA (Crithidia luciliae) now FDA cleared with HELIOS

AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM

(Wendelsheim, Germany / Oakland, California,) AESKU.GROUP received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES nDNA (Crithidia luciliae) with the new HELIOS AUTOMATED IFA SYSTEM. The kit is the second FDA cleared immunofluorescence assay on the HELIOS, after ANA HEp-2 (cleared in 2016), and will be followed by ANCA and tissue section slides.

HELIOS automated IFA System - now FDA cleared

helios fda closed image AESKU receives FDA 510(k) Clearance for HELIOS automated IFA System with AESKUSLIDES ANA HEp-2-Gamma

NEW | Pattern Recognition

The pattern recognition Add-ons give the HELIOS the ability to autonomously provide a suggestion of the most propable IFA pattern by analysing captured IFA images.

Read more...

NEW | Estimated Endpoint Titer

The Estimated Endpoint Titer option saves time and reagents. This option makes it easier to find the target solution and less dilution steps are needed.

The endpoint titer is defined as the highest dilution in which staining intensity is still detectable.

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Did you know?

You can hover the Mouse-pointer over the red dots ( ico 5 ) in the interactive HELIOS picture to activate detailed information regarding the serveral HELIOS features.

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Did you know?

You can hover the Mouse-pointer over the red dots ( ico 5 ) in the interactive HELMED picture to activate detailed information regarding the serveral HELMED features.